Management of sickle cell diseaselast revised December 20 ...



Management of sickle cell disease last revised December 20, 2000

Management of Patients with Sickle Cell Disease

An Overview

Contents

Background

Nature of the Problem

Modulators of SCD Severity

Origin of the Sickle Mutation

Management of Acute Problems

Pain

Acute chest syndrome

Infection

Bone marrow necrosis

Stroke

Splenic sequestration crisis

Aplastic crisis

Hepatic sequestration crisis

Priapism

Management of Chronic Problems

Pain

Anemia

infection prophylaxis

Avascular bone necrosis

Osteomyelitis

skin ulcers

Renal dysfunction

Retinopathy

Heart

Pregnancy

Newer Therapies

Hydroxyurea

Erythropoietin

Butyrate

Clotrimazole

Nitric Oxide

FluocorTM

Bone marrow transplantation

Gene replacement therapy

References

Background

Nature of the Problem

Sickle cell disease (SCD) results from the substitution of a valine residue for

glutamic acid at position 6 in the beta-subunit of hemoglobin (Ingram, 1956).

With a few minor exceptions, people with only one gene for hemoglobin S (Hb S)

are phenotypically normal (sickle trait). People who inherit two Hb S genes from

their parents have sickle cell disease. Deoxygenated Hb S tends to polymerize

non-covalently into long strands that deform the erythrocyte, giving the

characteristic "sickle cell" morphology (Eaton and Hofrichter, 1990). Hb S with

bound oxygen (e.g., in the arterial circulation) does not polymerize.

The mechanism by which these changes in the physical properties of the

hemoglobin molecule produce the clinical manifestations of the disease is not

unequivocally proven. The most widely accepted hypothesis is that erythrocytes

deform as they release their oxygen in the capillaries and are trapped in the

microcirculation (Eaton et al., 1976) (Kaul et al., 1989). The blockade of blood

flow produces areas of tissue ischemia, leading to the myriad of clinical

problems seen with sickle cell disease. Although a good deal of indirect

evidence supports this theory, definitive proof that this is the

pathophysiologic mechanism in sickle cell disease is lacking.

Recently, investigators have focused on other factors outside the red cell that

could contribute to the manifestations of sickle cell disease. Hebbel and

colleagues first showed that sickle erythrocytes adhere abnormally to vascular

endothelial cells. Their observations were confirmed and extended by other

workers. The endothelial cells may abnormally express adhesion receptors,

perhaps in response to activators released from sickle red cells (e.g., reactive

oxygen species). Other investigators have focused on leucocytes and platelets

which might also contribute to disturbed blood flow in sickle cell disease. The

involvement of multiple components of the blood in the manifestations of sickle

cell disease makes understanding the pathophysiology more difficult. On the

other hand, these additional modulators could be targeted by new therapies, with

diminution in the severity of sickle cell symptoms.

Sickle cell disease is extremely varied in its manifestations (Ballas, 1991)

(Wethers, 1982). This includes both the organ systems that are affected as well

as the severity of the affliction. A study of the natural history of sickle cell

disease indicated that about 5% of patients account for nearly one-third of

hospital admissions (Platt et al., 1991). A significant number of patients with

the disease have few admissions and live productive and relatively healthy

lives. The average life-span of people with sickle cell disease is shorter than

normal, however, reflecting increased mortality due to the complications of the

disease.

Modulators of SCD Severity

Fetal Hemoglobin

Variations in the severity of sickle cell disease between individuals usually

defy explanation. Some factors have been identified that ameliorate the severity

of the condition, however. The most important of these is a high level of

hemoglobin F (Hb F) in the erythrocytes (Platt et al., 1991). The first insight

into the role of fetal hemoglobin in the clinical manifestations of SCD was made

by a pediatrician, Janet Watson (Watson, et al., 1948). She and her colleagues

at a New York hospital noted that babies with SCD rarely had manifestations of

the condition in the first year of life. They proposed that the high level of

fetal Hb in the red cells, which persists during the first year of life, somehow

protects the infant. Fetal Hb levels decline to their routinely low steady-state

level between the ages of one to two years. The childhood manifestations of SCD

are seen thereafter.

Patients with sickle cell disease who also have hereditary persistence of fetal

hemoglobin (HPFH) often have few if any symptoms (Stamatoyannopoulos et al.,

1975). In these individuals, Hb F usually comprises greater than 20% of the

hemoglobin in the erythrocytes. Patients may be partially protected from the

ravages of sickle cell disease with even lower levels of Hb F. Unfortunately,

few patients with SCD have Hb F levels of greater than 10 or 11% in the absence

of HPFH.

Fetal Hb disrupts the polymerization of deoxy-Hb-S (Goldberg et al., 1977).

Since polymerization of deoxy-Hb-S is the signal event in the pathogenesis of

SCD, fetal Hb effectively prevents disease manifestation. The distribution of Hb

F among RBCs is also important. In hereditary persistence of fetal hemoglobin

(HPFH), Hb F exists at high levels in all red cells. All red cells are equally

protected from sickling. In the absence of HPFH, patients with high levels of Hb

F have a heterogeneous distribution of fetal hemoglobin between cells. An over

simplified example is a patient in whom half the cells have 30% Hb F and half

have 0%. The patient would have 15% Hb F overall. However, half the cells would

sickle and occlude flow through the microcirculation. These deformed cells would

block the flow of the normally shaped high Hb F cells. The patient would

experience all the manifestations of sickle cell disease.

Alpha-thalassemia

Relative to patients with straightforward sickle cell disease, the rate of

hemolysis is lower in people who also have two-gene deletion alpha-thalassemia

(Embury et al., 1982). The mechanism by which alpha-thalassemia ameliorates red

cell destruction is unknown. Polymerization of sickle hemoglobin is

exponentially related to its concentration in the cell. The red cell hemoglobin

concentration in patients with two gene deletion alpha-thalassemia and sickle

cell disease is no different from that of patients with ordinary sickle cell

disease, however (Steinberg and Embury, 1986). The Hb F concentrations often is

higher in the red cells of these patients and may contribute partially to the

reduction in the rate of hemolysis.

Harbingers of Ill

The advent of therapies that can significantly ameliorate the clinical course of

sickle cell disease opens the possibility of early intervention. If physicians

could predict which children will fall victim to recurrent severe pain crises or

bouts of acute chest syndrome, they could intervene before the clinical episodes

thereby preventing the associated morbidity and possible mortality. This is

particularly relevant for treatments such as bone marrow transplantation that

can cure sickle cell disease but also carry the risk of significant morbidity

and even mortality.

Table 1. Factors that Correlate with a Severe Clinical Course in Sickle Cell

DiseaseAn episode of dactylitis prior to one year of age.

A hemoglobin level of less than 7 g/dl before age 2 years.

Persistent leucocytosis in the absence of infection

Miller and colleagues (2000) examined the records of nearly 400 children

followed at comprehensive sickle cell centers. Their multivariate analysis of

the clinical courses of these children between infancy and 10 years of age

uncovered several factors that augured severe complications, including recurrent

severe pain episodes, stroke and acute chest syndrome. As seen in Table 1, the

variables can be easily identified. Children who manifest these characteristics

can be considered for aggressive early treatment of their sickle cell disease. A

smaller study that tracked the course of adult and pediatric patients over a

7-year period found that adults with an elevated white count experienced more

frequent hospital admissions for painful vaso-occlusive crises than did those

with lower white counts (Olatunji, et al., 2000). Interestingly, none of the

assessed variables correlated with severity in the children. The smaller size of

the study and the the greater age range of the children evaluated likely account

for the difference from the report by Miller and colleagues (2000). Together,

these reports point to high white count as a significant risk factor of adverse

events in patients with sickle cell disease.

The relationship of stroke risk to high blood velocity in the intracranial

arteries is discussed below.

Origin of the Sickle Mutation

Beta-globin haplotypes

The beta-globin gene exists in a region of chromosome 11 called the "beta globin

locus." Random mutations occur in the non-coding regions of the beta-globin

locus which are neither selected for or against. When a gene mutation occurs in

the coding region of the beta-globin gene (for instance, the conversion of

glutamic acid to valine at postion 6 in sickle hemoglobin), the surrounding

non-coding region is not affected. The genetic background of the surrounding

region is called the "haplotype" of that particular mutation. The chance is

extreme small that another radom mutation will occur in the non-coding region.

Therefore, the haplotype of a particular gene mutation event is fixed. Analysis

of the genomic structure of the beta-globin gene shows consistent patterns of

base substitutions in the non-coding regions of the Hb S gene (Bouhassira et

al., 1989). The structural regions of the Hb S genes are identical. The

substitutions in the flanking regions of the gene (the haplotypes) show that Hb

S arose separately at least four times in Africa, and once in Asia, probably in

India (Nagel and Fleming, 1992). The four African haplotypes show broad trends

in disease severity. The Central African Republic haplotype tends to have the

least favorable clinical course, followed by the Benin and Senegal haplotypes

(Powars and Hiti, 1993). The ranking of the more recently described fourth

haplotype, Cameroon, is uncertain.

No clear explanation exists for the differences in average severity between the

haplotypes. The mutations in the flanking region could secondarily affect

severity by altering Hb F expression in the cells. This is only a hypothesis,

however. The patterns of severity apply only to populations. Broad overlap in

the clinical patterns prevents the use of haplotypes to predict the clinical

course in a particular person. Usually, people with sickle cell disease outside

Africa (e.g., blacks in the United States) or India have mixed haplotypes for

their sickle cell genes. Analysis of haplotype in this setting is even less

likely to provide clinically useful information.

Hb S is common in some areas of the Mediterranean basin, including regions of

Italy, Greece, Albania and Turkey (Boletini et al., 1994) (Schiliro et al.,

1990). Haplotype analysis shows that the Hb S in these areas originated in

Africa. The genes probably moved along ancient trading routes between wealthy

kingdoms in western Africa and the trade centers in the Mediterranean basin. The

high levels of Hb S attained in some areas reflects partial protection against

protection against malaria provided by sickle cell trait (see below).

The Hb S mutation arose independently a fifth time in southwest Asia (Miller et

al., 1987). The area of the Middle East near the head of the Persian Gulf is

very marshy. In the past the area was swampy and harbored malaria. Malaria

remains endemic to much of the Indian subcontinent. The fact that the Hb S

mutation apparently arose in response to malaria in southwest Asia supports the

"malaria explanation" of the prevalence of the gene. The identity of the

hemoglobin S haplotype in India and the Persian Gulf region suggests that it

arose in one area and moved to the other with trade or migration (Ramasamy et

al., 1994) (Kar et al., 1986). Although we cannot be certain of the origin of

the Asian haplotype of the sickle cell gene, the very high prevalence of the

gene in tribal peoples of India suggest that the subcontinent was the place of

origin. This Asian variety of Hb S may on average produce fewer complications

than its African counterparts (Perrine et al., 1978).

The Sickle Gene and Malaria

The high representation of the hemoglobin S gene in some populations reflects

the protection it provides against malaria (Gendrel et al., 1991) (Carlson et

al., 1994). The malaria parasite does not survive as well in the erythrocytes of

people with sickle trait as it does in the cells of normals (Orjih et al.,

1985). The basis of the toxicity of sickle hemoglobin for the parasite is

unknown. One possibility is that the malarial parasite produces extreme hypoxia

in the red cells of people with sickle trait. These cells then sickle and are

cleared (along with the parasites they harbor) by the reticuloendotheila system

(Roth, et al, 1978). Another possible mechanism is that low levels of

hemichromes are formed in sickle trait erythrocytes. Hemichromes are complexes

that contain heme moieties that have dissociated from the hemoglobin.

Hemichromes catalize the formation of reactive oxygen species, such as the

hydroxyl radical, which can injury or even kill the malarial parasites

(Anastasi, 1984).

The malaria hypothesis maintains that during prehistory, on average, people

without the sickle gene died of malaria at a high frequency. On the other hand,

people with two genes for sickle hemoglobin died of sickle cell disease. In

contrast, the heterozygotes (sickle trait) were more resistant to malaria than

normals and yet suffered none of the ill-effects of sickle cell disease. This

selection for heterozygotes is termed "balanced polymorphism". Support for this

concept comes from epidemiological studies in malaria-endemic regions of Africa.

The frequency of sickle cell trait is lower in people coming for treatment to

malaria clinics than is seen in the general population (Wilcox, et al., 1983).

The reasonable assumption is that relative protection form malaria is at work in

this situation.

Although malaria remains a major health problem in many tropical regions of the

world, the disease is not a significant threat to people in the temperate zones.

Consequently, the protection afforded by sickle trait no longer has a survival

advantage for many groups of people in whom the sickle cell gene is common. This

has left sickle cell disease as the major health issue in these populations.

Management of Acute Problems

Pain

Vaso-occlusive pain episodes experienced by patients with sickle cell disease

vary tremendously in frequency and severity. Some patients rarely have painful

crises, while others spend the greater part of a given year in the hospital

receiving analgesics. The cooperative study of the natural history of sickle

cell disease showed that about 5% of patients accounted for one-third of

hospital days devoted to pain control (Platt et al., 1991). To complicate

matters further, the pattern of pain varies over time, so that a patient who has

a particularly severe year may later have a prolonged period characterized by

only minor pain. The frequency and severity of vaso-occlusive pain episodes

often change as a person moves from childhood to being an adult. The

"breakpoint" often occurs during the late teens or early 20's. Changes in

hormonal status that occur during these years could contribute to the changes in

severity of sickle cell disease. However, no causal relationship has been

established, so the association remains only temporal.

The mode of onset of sickle cell pain crises likewise varies. Patients can

develop agonizingly severe pain in as little as 15 minutes. In other instances,

the pain gradually escalates over hours or even days. Patients manage most

episodes of pain at home. Oral analgesics, combined with rest and fluids often

allows a person to "ride out" the pain episode. Some patients report that warm

baths or warm compresses applied to aching joints ameliorates the severity of

the pain.

The sites affected in acute painful crises vary for each patient. Pain occurs

commonly in the extremities, thorax, abdomen, and back (Ballas and Delengowski,

1993). Pain tends to recur at the same site for a particular person. For each

person, the quality of the crisis pain is usually similar from one crisis to

another. During the evaluation, the provider should question the patient as to

whether the pain feels like "typical" sickle cell pain. Most patients can

distinguish back pain due to pyelonephritis or abdominal pain due to

cholecystitis, for instance, from their typical sickle cell pain. If the quality

of the pain is not typical of their sickle cell disease, other causes should be

investigated before ascribing it to vaso-occlusion.

No reliable objective index of pain exists. The provider depends solely on the

patient's report. One of the most difficult problems that patients with sickle

cell disease face is seeking treatment for pain in a setting in which they are

unknown. The typical scenario is one in which a patient is brought to a busy

emergeny room complaining of pain. Some patients writh with severe pain while

others are stoic. The person who bears the pain with as much poise as possible

runs the risk of not being believed by the staff. Some providers mistakenly

believe that the number of deformed sickle cells on the peripheral blood smear

reflects the degree of pain that a patient is experiencing. Other providers look

to parameters such as blood pressure and heart rate. Although these measures

provide more information than the peripheral smear, they do not reliably reflect

pain severity. Trust in the patient report is key to the management of sickle

cell pain crises.

Opiods

The pain experienced with an acute painful crisis typically is quite severe.

Most patients describe a full blown crisis as the most intense pain that they

have ever experienced. The pain sometimes increases in severity slowly over a

couple of days. At other times, a crescendo is reached in less than 15 minutes.

Pain control often requires large quantities of opiod analgesics. The exact

amount varies, and depends in part on the frequency with which the person

requires opiods. For many patients, 4 to 8 mg of hydromorphone can be given as

an intravenous bolus over 15 to 20 minutes followed by another 4 mg in 30

minutes if pain control is inadequate.

Patients often feel that one analgesic, such as hydromorphone for example,

controls pain more effectively than others. Therefore, they should be questioned

about the kind of medication that has worked best in the past. Also, some

patients may experience reactions with one analgesic (e.g., itching with

meperidine) but not with others (Pegelow, 1992).

Pain relief occurs more slowly with intramuscular injections, and the injections

themselves can produce substantial discomfort. Consequently, intravenous

administration of analgesics is usually preferable. As pain control improves,

the analgesia should be maintained to prevent the patient from slipping back

into a painful cycle. The "prn" administration of analgesics should be avoided,

if possible (Robieux et al., 1992). Following stabilization in the emergency

situation with intravenous boluses of opiods, the patient should be transferred

to the floor and placed a maintenance regimen. "Patient-controlled analgesia"

(PCA) often works well for pain relief (Holbrook, 1990) (McPherson et al.,

1990). With these infusion devices, patients can administer small doses of

additional medication over their continuous infusion (to a fixed maximum) to

control flares of pain.

Patients can become drowsy as their pain is controlled. Often, this reflects the

fatigue that comes with one or more sleepless nights with pain at home. The

analgesics should not be discontinued automatically for somnolence as long as

the patient is easily aroused. A common misconception is that if a person is

sleeping, the analgesics are controlling the pain. Patients often sleep despite

severe pain. The quantity of analgesia can be slowly reduced as the patient's

symptoms improve. While the tapering of intravenous analgesics can require only

two or three days, control of a full blown crisis often requires 10 to 14 days.

Less commonly, bouts of sickle vaso-occlusive pain require several weeks to

control.

Meperidine can present problems for pain control in patients with sickle cell

disease. The half-life of the drug in the circulation is about 4 hours. The

liver converts meperidine to normeperidine, a derivative that has analgesic

activity but which also is toxic. Grand mal seizure is a particularly serious

complication that occurs with the administration of large amounts of meperidine.

Normeperidine likely is the primary culprit in this situation. Other opiod

analgesics, therefore, are preferable to meperidine. The American Pain Society

recommends that meperidine no longer be used for control of pain in people who

require long-term analgesic treatment.

Eventually the patient should be switched to oral opiod analgesics, which may

be necessary for a week or more after discharge (Friedman et al., 1986). The

parenteral analgesics should be tapered after the oral medication is started.

Abrupt termination of parenteral analgesics when oral medications are begun can

cause a rebound in sickle cell crisis pain. Most patients with sickle cell

disease manage their analgesics responsibly. If possible, they should have a

supply of analgesics at home to control less severe episodes of pain. In

addition to analgesia, patients with painful crises should also receive

supplemental oxygen and intravenous fluids. Once the pain is under control, oral

hydration can replace the intravenous fluids.

Epidural analgesia has been used for pain control in some patients with sickle

cell disease (Tobias, 1993) (Yaster et al., 1994). This approach is most

effective when the major discomfort is below the level of the chest. Although

some patients receive good relief with epidural analgesia alone, others continue

to require systemic analgesics, albeit at lower doses. Some patients have a

psychological aversion to having needles introduced into their backs and balk at

epidural analgesia, despite its superior pain relief relative to systemic

analgesics.

Non-steroidal anti-inflammatory drugs (NSAIDs)

Recently, NSAIDs have been added to the management algorithm of acute sickle

cell pain (Sanders et al., 1992). The drug that has been used most often in this

context is ketorolac tromethamine. The reports of the use of this agent to

control acute painful episodes in patients with sickle cell disease have been

largely anecdotal (Perlin et al., 1994). While some reports are positive, others

show no effect of ketorolac in the treatment of acute vaso-occlusive pain crises

(Wright et al., 1992). Ketorolac comes in a preparation that is designated for

intramuscular injection. However, the medication can be diluted into normal

saline and infused as an intravenous bolus. Ketorolac alone usually will not

control an episode of acute sickle cell pain. However, the medication appears to

operate synergistically with opiod analgesics. Patients often recover more

rapidly and require less opiods when ketorolac is added to the treatment

regimen. A single 30 mg intravenous bolus is usually administered for

supplemental pain control. Ketorolac can produce gastritis and bleeding. The

drug should be used cautiously in patients with peptic ulcer disease or a

history of gastrointestinal bleeding. NSAIDs can impair kidney function and

accelerate the renal injury produced by sickle cell disease itself. For these

reasons, many specialists avoid NSAIDs in patients with sickle cell disease.

Transfusion

Transfusion therapy appears intuitively reasonable for a disorder that results

from polymerization of deoxygenated hemoglobin in the red cells. The complex

pathophysiology of sickle cell disease confounds the picture, however.

Vaso-occlusive sickle cell crises are probably fueled, at least in part, by

sluggish blood flow through the microcirculation (Clark et al., 1980). Slow

blood flow promotes deoxygenation of hemoglobin and polymerization of the

molecules. Although the oxygen carrying capacity of blood increases with

hematocrit, so does viscosity. As the hematocrit rises beyond the range of the

low-30's, increased viscosity may outweigh enhanced oxygen delivery and swing

the dynamics of the situation toward sickling.

In areas where tissues are poorly perfused due to vaso-occlusion, the ability of

additional red cells to reverse local hemoglobin S polymerization is

questionable. Transfused erythrocytes will not improve blood flow through

regions of the microcirculation that are occluded by deformed red cells.

Although the transfused red cells do not sickle in the microcirculation even

with slow flow, the overwhelming predominant sickle erythrocytes in the

circulation is decisive in the development of local vaso-occlusion.

Simple transfusion is not an effective intervention for the management of acute

painful episodes in patients with sickle cell disease. Exchange transfusion has

been used in attempts to alleviate bouts of severe, intractable pain with better

effect, overall (Davies and Brozovic, 1989). In addition, chronic transfusion

therapy has been used to decrease the frequency of pain in patients with

recurrent debilitating painful crises (Keidan et al., 1987). While sometimes

effective, this approach as a number of problems, as detailed below.

Corticosteroids

A recent report described the use of corticosteroids in a cohort of children

with severe sickle cell pain crises (Griffin et al., 1994). The patients

received large doses of intravenous steroids on each of the first two days of

their painful sickle crises. The treatment group required narcotic analgesics

for approximately half as long as the control patients. The rate of pain relapse

was significantly higher in patients who received the steroid treatment. This

intriguing observation awaits confirmation, particularly in adults with sickle

cell disease.

Acute Chest Syndrome

Acute chest syndrome (ACS) is difficult to diagnose because its etiology varies

and its manifestations are variegate. Common characteristics include fever,

dyspnea, cough, and pulmonary infiltrates (Haynes Jr and Kirkpatrick, 1993)

(Poncz et al., 1985). The infiltrates can have a lobar distribution, but often

are bilateral. Sometimes, the pulmonary picture is one of diffuse, hazy

opacities that resemble adult respiratory distress syndrome. In other instances,

ACS looks like a simple pneumonia. This problem in diagnosis is aggravated by

the fact that infectious agents such as viruses, bacteria, and mycoplasma can

trigger the syndrome (Charache et al., 1979) (Kirkpatrick et al., 1991) (Miller

et al., 1991). Bone marrow infarction with secondary pulmonary fat emboli also

can trigger the acute chest syndrome (Vichinsky et al., 1994) (Gelfand et al.,

1993). In most instances, the etiology of ACS is a mystery.

The arterial blood oxygen saturation commonly falls with ACS to a greater degree

than occurs with a simple pneumonia of the same magnitude. Patients with the

acute chest syndrome often have progressive pulmonary infiltrates despite

treatment with antibiotics (Koren et al., 1990). Infection may set off a wave of

local ischemia that produces focal sickling, deoxygenation and additional

sickling.

The microcirculatory vessels in the lung tend to constrict with hypoxia rather

than dilate, as occurs with vessels in other parts of the body. Regions of

vascular constriction could worsen the occlusion of the microcirculation.

Unchecked, ACS can produce cardiovascular collapse and death. ACS occurs more

commonly in children than adults (Sprinkle et al., 1986) (Gill et al., 1995).

People who survive an episode of ACS are more likely than the general sickle

cell population to have future attacks. Patients who suffer recurrent episodes

of ACS are prone to develop chronic lung insufficiency.

Given the baseline anemia in SCD, pulmonary compromise is a serious

complication. The most important step in the treatment of ACS is to recognize

the disorder. Potential bacterial infections should be treated with appropriate

antibiotics. When symptoms progress, particularly with a worsening of the chest

roentgenogram, ACS must be considered. Sometimes, the pulmonary pattern mimics

congestive heart failure. However, congestive heart failure is uncommon in

patients with SCD who are in the 15 to 30 year age range, making the presumptive

diagnosis of ACS more likely. A relentless decline in arterial oxygenation is

often a harbinger of ACS, and demands prompt action.

Exchange transfusion is the treatment of choice for ACS (Lanzkowsky et al.,

1978) (Emre et al., 1995). The procedure involves exchange of the total blood

volume and is done most efficiently using an apheresis machine. When an

apheresis machine is not available, sequential transfusion/phlebotomy can be

performed. A hemoglobin electrophoresis should be sent prior to the exchange

transfusion. A second should be sent after the procedure. The object is to

ensure that the exchange has reduced the percentage of Hb S cells to under 30%.

Patients often improve substantially within hours of an exchange. Rising

arterial oxygenation and decreasing dyspnea usually augur recovery. The chest

roentgenogram typically lags behind the clinical status. Since a bacterial

pneumonia rarely can be excluded in these patients, most receive concomitant

broad-spectrum antibiotics.

A serious potential problem with exchange transfusion is delayed transfusion

reaction (Diamond et al., 1980). Most patients with SCD are of African ancestry.

Most of the blood available for transfusion comes from people of European

descent. A number of minor red cell antigens are expressed at different

frequencies in these two groups. Repeated transfusion of any African-American

can, therefore, induce antibodies directed against these minor antigens.

Should years pass between transfusions, the titers of antibody can fall to

levels that are undetectable by routine cross matching. Transfusion with blood

containing the offending antigen often rekindles antibody production to high

levels in only a few days. In a person who has received exchange transfusion, a

large fraction of the circulating red cells can be destroyed in a deadly delayed

transfusion reaction.

The transfusion records of any exchange transfusion candidate should be

searched thoroughly for any history of antibodies to minor red cell antigens.

Antibody screening should be repeated three to four weeks after the exchange

transfusion to look for new alloantibodies to minor antigens.

Infection

Patients with sickle cell disease are susceptible to overwhelming infection

(Olopoenia et al., 1990) (Overturf et al., 1977) (Landesman et al., 1982). The

most significant factor is splenic autoinfarction during childhood (Fernbach and

Burdine Jr, 1970). Functional asplenia leaves patients vulnerable to infections

with encapsulated organisms such as Streptococcus pneumoniae and Hemophilus

influenzae. Further, some studies suggest that neutrophils do not function

properly in patients with sickle cell disease (Humbert et al., 1990). How the

mutation in sickle cell disease might lead to a defect in neutrophil function is

unclear.

Patients with SCD and unexplained fever should be cultured thoroughly. If the

clinical condition suggests septicemia, the best action is to start broad

spectrum antibiotics after complete culturing. Signs of systemic infection

include fever, shaking chills, lethargy, malaise, and hypotension. Patients with

septicemia can expire in only a few hours. Therefore, observation is not a good

option when sepsis is suspected.

Acute Bone Marrow Necrosis

Acute bone marrow necrosis is now recognized more often as a complication of

sickle cell disease, in part due to improved methods of detection (Johnson et

al., 1994) (Shapiro and Hayes, 1984). In the past, the diagnosis could only be

made by bone marrow biopsy or inferred from the complications that resulted. If

the necrosis occurred in regions of the marrow that were not easily biopsied,

the diagnosis was almost impossible to confirm. This has changed with the

introduction of magnetic resonance imaging (MRI) techniques (Mankad et al.,

1990) (Rao et al., 1989). Bone marrow should have the density of other body

tissues on MRI scans. With bone marrow necrosis, marrow liquefaction is easily

detected on scan.

Patients with bone marrow necrosis often suffer excruciatingly severe pain. Some

patients require drastic measures, such as epidural anesthesia for control of

wrenchingly intense pain. Patients often describe acute bone marrow necrosis as

producing "the worst pain I've ever experienced." The necrosis frequently occurs

in the marrow of the ribs, femur or tibia.

Pulmonary fat emboli can complicate bone marrow necrosis (Johnson et al., 1994).

Fat emboli can trigger respiratory insufficiency or even acute chest syndrome.

Making the diagnosis of fat emboli to the lungs is difficult. In some cases,

sputum samples stained with Oil Red O will show fat-laden macrophages. Exchange

transfusion has been used with success in some patients with acute bone marrow

necrosis. The experience is anecdotal, since the ability to document bone marrow

necrosis in patients is a relatively recent development.

Stroke

Strokes are much more common in children than in adults. The average age of

stroke victims is about 4 years (Ohene-Frempong, 1991). Frequently, large

arteries such as the internal carotid or the middle cerebral are occluded

(Balkaran et al., 1992) (Earley, et al., 1998). The mechanism of occlusion of

these vessels is not clear, despite necropsy examination of a number of children

who succumbed to the condition. Imaging procedures such as angiography and the

non-invasive magnetic resonance angiography (MRA) have provided information on

the sequence of events that proceed a stroke (Adams et al., 1992) (DeBaun et

al., 1995) (Wang et al., 1992). Narrowing of arteries near sharp turns often are

seen. A common finding is narrowing at the separation of the middle cerebral and

the internal corotid arteries. Paradoxically, the higher rate of blood flow

produced by arterial narrowing is believed to contribute to the risk of complete

arterial occlusion. A complete occlusion at this critical location produces

massive strokes.

A key question is whether medical intervention can prevent a stroke in a child

with an arterial lesion. The Stroke Prevention Trial in Sickle Cell Anemia

(STOP), sponsored by the NHLBI, was conducted at several institutions (Adams, et

al., 1998) to address this question.

Between February, 1995 and October, 1996, the trial, coordinated through the

Medical College of Georgia (Dr. Robert Adams) and the New England Research

Institutes (Dr. Donald Brambilla), enrolled 130 subjects, ages 2 to 16, who were

at high risk for stroke on the basis of elevated cerebral blood flow measured by

transcranial doppler (TCD) screening tests (greater than or equal to 200 cm/sec

time averaged mean velocities). The patients, drawn from 13 US clinical centers

and one in Canada, were randomized to receive either standard supportive care or

periodic blood transfusions. The primary endpoint was the rate of stroke rates

in the treated and control groups.

The primary data analysis in the STOP Trial compared stroke rates in 63

children randomized to receive repeated exchange or simple transfusions and 67

children who received standard supportive care. A stroke was defined as

clinically significant neurologic impairment and physical findings, supported by

an abnormal magnetic resonance imaging (MRI) study. The clinical records and

MRI's were analyzed by a panel that was blinded to the treatment assignment of

the study subjects.

The patients in the transfusion arm received simple or exchange transfusions

every 3-to- 4 weeks in an effort to maintain the Hb S level below 30%. After one

year, 10 of the children in the standard care group had suffered a cerebral

infarction, compared with one child in the transfusion group. This difference

represents a 90% relative decrease in the stroke rate in the transfused

patients. These results were so compelling that the study's Data and Safety

Monitoring Board, composed of independent, outside experts in the fields of

pediatric hematology, neurology, radiology, statistics, and ethics recommended

that the trial be terminated early so that the children who had been receiving

standard supportive care could be offered an effective treatment to prevent

first-time stroke. On September 2, 1997, the study was halted, and the

investigators in the 14 participating centers were notified of the results and

the efficacy of transfusion therapy.

The STOP Trial confirmed that TCD can identify children with sickle cell anemia

at high risk for first-time stroke. Since the greatest risk of stroke occurs in

early childhood, the NHLBI recommends that children ages 2-16 receive TCD

screening. Screening should be conducted at a site where clinicians have been

trained to provide TCDs of comparable quality and information content to those

used in the STOP Trial. The clinicians should also be able to read them in a

manner consistent with what was done in STOP. To apply the predictive and

therapeutic information developed in the STOP Trial, two abnormal

STOP-comparable TCDs are needed to identify patients at high risk of stroke

(velocity greater than 200 cm/sec on two separate occasions).

During follow-up, some children in the large screening population, who

initially had normal or ambiguous TCD readings developed frankly abnormal TCD

readings. These data suggest that children with normal TCDs should be

re-screened at an interval which depends on their age and the prior result of

TCD. Although the optimal timing is not known, re-screening approximately every

6 months is a reasonable objective.

Stroke in SCD is a medical emergency. The deficits are often profound, although

many children recover substantial function. Exchange transfusion followed by

maintenance hypertransfusion is mandatory (Cohen et al., 1992) (Pegelow et al.,

1995). This action improves recovery and reduces the risk of recurrent stroke.

In the absence of this intervention, as many as two-thirds of children will

suffer subsequent events (Wang et al., 1991). The optimal duration of therapy is

unclear. Several studies have shown that as many of 50% of children on

maintenance therapy for as long as 5 years suffer new strokes within months of

stopping treatment.

A newly recognized area of concern in patients with sickle cell disease is

"silent stroke" (White and DeBaun, 1998). Recent technological advances,

including MRI, MRA, and PET scanning have been combined with neuropsychiatric

testing to gain a new window into the effect of silent strokes in children with

sickle cell disease. Analysis of 42 children followed as part of the Cooperative

Study of Sickle Cell Disease showed that nearly 20% had suffered silent cerebral

infarction, as detected by MRI (Kinney, et al., 1999). Multivariate analysis

showed a number of associations, including a greater risk of silent infarctions

with lower hematocrits. This association was found in another study of 50

patients (Steen, et al., 1999). One-third of the latter children showed evidence

of mild intellectual impairment on cognitive testing. Positron emission scans

and magnetic resonance angiography could be useful adjuncts in the effort to

diagnose children with silent cerebral infarction (Powars, et al., 1999),

(Gilliams, et al., 1998). Clearly this is an area of major concern that deserves

much more investigation.

In adults, hemorrhagic stokes occur more frequently than arterial occlusive

strokes (Van Hoff et al., 1985). Subarachnoid hemorrhages are most common.

Bleeds that involve deep structures in the brain, such as the thalamus, also

occur, however. In some instances, this reflects the development of "moya-moya"

syndrome years after an earlier thrombotic stroke. A network of delicate

capillaries can form, often in the area of the old infarction. Angiography

reveals the complex filamentous structure of the moya-moya lesion (Peerless,

1997). Should these capillaries rupture, disastrous intracranial hemorrhage

occurs. Easily accessible lesions are sometimes surgically excised. Thrombotic

strokes in adults are as mysterious as those in children. Nonetheless, exchange

transfusion followed by maintenance hypertransfusion is a prudent course of

action.

Splenic Sequestration Crisis

Splenic sequestration crisis results from the acute entrapment of large amounts

of blood in the spleen (Sears and Udden, 1985). The manifestations are left

upper quadrant pain, exacerbated anemia and, often, hypotension. In children, a

large fraction of the circulating blood volume is frequently sequestered.

Splenic sequestion crisis is a medical emergency that demands prompt and

appropriate treatment. Parents should be familiar with the signs and symptoms of

splenic sequestion crisis. Children should be seen as speedily as possible in

the emergency room.

Circulatory collapse and death can occur in less than thirty minutes. Splenic

autoinfarction makes splenic sequestration crisis uncommon in adults with

homozygous Hb S sickle cell disease. The condition can occur in adults with

sickle beta-thalassemia or sickle-hemoglobin C (SC) disease since autoinfarction

does not occur in these syndromes (Roshkow and Sanders, 1990) (Solanki et al.,

1986). The most prominent symptom is left upper quadrant pain. The larger blood

volumes of adults make hypotension and circulatory collapse much less common

than in children.

The treatment of splenic sequestration crisis includes intravenous fluids and

transfusion as necessary to maintain the intravascular volume. A child who

suffers one episode of splenic sequestration crisis is at greater risk of a

second attack (Kinney et al., 1990). Specialists debate whether children who

survive an episode of splenic sequestration crisis should undergo prophylactic

splenectomy after their recovery (Szwed et al., 1980). Less is known about the

condition in adults. Given the lower morbidity and mortality in adults,

splenectomy is rarely a consideration.

Aplastic Crisis

Aplastic crisis is a potentially deadly complication of sickle cell disease that

develops when erythrocyte production temporarily drops. Infection with

parvovirus B-19 frequently causes aplastic crises (Saarinen et al., 1986). This

adeno-associated virus causes "Fifth Disease", a normally benign childhood

disorder associated with fever, malaise, and a mild rash. The virus has a

trophism for erythroid progenitor cells, and impairs cell division for a few

days during the infection. Normal people experience, at most, a slight drop in

hematocrit since the half-life of erythrocytes in the circulation is 40 to 60

days. The picture is different in patients with hemolytic anemias, who maintain

reasonable hematocrits only through prodigious production of new red cells. A

shut-down in erythroid production for a few days in these patients can lead to

potentially deadly declines in hematocrit (Mallouh and Qudah, 1993). Often, but

not always, aplastic crises coincide with a painful crises. The reticulocyte

count should be checked on admission to the emergency room or to the hospital in

patients with SCD. The treatment of aplastic crisis is purely supportive, with

transfusions to maintain an acceptable hematocrit until marrow activity is

restored.

Hepatic Sequestration Crisis

Sickled cells can become lodged in the liver obstructing blood flow through the

organ (Davies and Brozovic, 1989). The result is painful hepatic enlargement

accompanied by an increase in the plasma levels of hepatic synthetic enzymes

(e.g., ALT, AST). The serum bilirubin levels often skyrocket to levels in the

range of 30 to 40 mg/dl. Acute hepatic failure can ensue. Fluids, oxygen and

analgesia are the usual management interventions taken. The benefit of more

aggressive measures such as exchange transfusion is unknown.

Priapism

Priapism is a potentially serious problem for young men with sickle cell

disease. The condition is believed to result from impaired blood egress from the

corpus spongiosum of the penis, leading to prolonged erections (Fowler Jr et

al., 1991). The affliction often occurs in association with spontaneous

nocturnal erections. Episodes of priapism can last from several hours to several

days. One group of investigators reported a ninety percent actuarial probability

of at least one episode of priapism by age twenty-one years (Mantadakis, et al.,

1999).

Stuttering priapism is common. Here, the (typically) young man develops

erections lasting one to two hours, initially, that resolve spontaneously. The

condition then progresses to a point where the erections are quite prolonged and

painful. Priapism lasting more than three or four hours is a medical emergency

since it can produce impotence (Mykulak and Glassberg, 1990) (Emond et al.,

1980).

The most commonly used intervention in the past was irrigation of the ventral

vein of the penis by a urologist in an attempt to remove the blockage to blood

flow. Since the problem is one of microvascular occlusion, the results of this

approach were generally poor. Not only does the surgery often fail to resolve

the priapism, but the procedure itself risks inducing impotence (Yang et al.,

1990). More recently, exchange transfusion has been used in some of these

patients with mixed results (Seeler, 1973). Non-acute cases of priapism are

sometimes treated with conjugated estrogens (Serjeant et al., 1985) or

vasodilators (Baruchel et al., 1993). While there is some clinical data to

support the short-term use of estrogens, the opinions of specialists in sickle

cell disease remain divided.

Management of Chronic Problems

Pain

Chronic pain is a major problem for many patients with sickle cell disease. The

etiology of chronic pain in sickle cell disease is uncertain. Organ injury and

necrosis produced by years of intermittent ischemia from vaso-occlusion likely

plays a large role. Radiographs of bones show characteristic deformities of the

ribs, for instance. The damage that produced the deformities likely produces

chronic pain. The severity of the pain varies greatly and can change over time.

Some patients control their pain by intermittently using mild analgesics, such

as non-steroidal anti-inflammatory agents. Others require frequent doses of

opiod analgesics. Consequently, no universally applicable formula exists for

management of chronic pain. The patients who frequently present the greatest

management challenges for physicians, are those with persistent severe pain

controlled by chronically administered opiod analgesics.

Non-steroidal anti-inflammatory drugs

Non-steroidal anti-inflammatory drugs (NSAIDs) can control chronic pain in many

patients with sickle cell disease (Sanders et al., 1992). The agents can be used

alone or in conjunction with opiod analgesics. Most commonly, NSAIDs are used

intermittently to control flairs of pain. One potential problem with these

agents is renal damage. Patients with sickle cell disease are more susceptible

than normal people to renal injury. Since renal damage can be compounded by

NSAIDs, physicians must closely monitor renal function in patients on these

drugs. Cox-2 inhibitors allegedly produce less nephrotoxicity than do standard

NSAID's. Limited experience exists with the use of these agents to control

chronic pain in people with sickle cell disease. They are nonetheless worth

serious consideration in these patients.

Opiod analgesics

Most patients who require large or frequent doses of opiods to control pain are

not seeking drugs for recreational purposes. Often, these patients become

tolerant to opiods. Consequently, the quantity of medication needed to control

severe pain exceeds that of an individual with a severe but self-limited painful

episode, such as torn knee ligaments. Most patients report accurately the

quantity of analgesics needed to control their pain (Gil et al., 1994). In some

instances, long-acting opiod analgesics can blunt the severity of the pain,

allowing patients to use less of the shorter acting agents. Unfortunately, no

objective measure of pain exists. Appropriate treatment of pain irrespective of

the cause requires an on-going dialogue between the doctor and patient

(Armstrong et al., 1992).

Whenever possible, patients should start taking their analgesics before the pain

becomes extremely severe. Maintaining pain at a tolerable level is easier than

reducing it from a high level of intensity. A typical episode of severe sickle

pain can require a patient to consume 4 to 8 mg of oral hydromorphone every

three hours to achieve relief. Many "severe" sickle crises can be managed at

home with analgesics, fluids, and rest. If the pain progresses despite the use

of reasonable quantities of medication, the patient should seek emergency

medical care.

Pain due to sickle cell disease is typically viewed as episodic bouts secondary

to occlusion of the microcirculation. Many health care providers do not realize

that severe chronic pain is also a consequence of sickle cell disease. Chronic

sickle cell pain occurs more commonly in adults than in children. Permanent

damage to the microcirculation secondary to years of recurrent sickle injury

likely is the basis of this syndrome. Bony abnormalities on x-ray, such as

vertebral body compression, attest to the injury that occurs over the years.

Other tissues, by inference, suffer similar problems.

One of the obstacles to control of chronic pain is the short duration of action

common to many analgesics, such as hydromorphone and meperidine. A number of

longer acting formulations are available. One of the most effective drugs for

the control of chronic sickle cell pain is methadone. Although best know for its

use in narcotic detoxification programs, methadone is a highly effective

analgesic when given three times per day. Methadone for control of narcotic

addiction can be dispensed only at certified detoxification centers. Methadone

for pain control can be given at other facilities in accordance with the

guidelines for use of any opiod.

Meperidine can present problems for pain control in patients with sickle cell

disease. The half-life of the drug in the circulation is about 4 hours. The

liver converts meperidine to normeperidine, a derivative that has analgesic

activity but which also is toxic. Grand mal seizure is a particularly serious

complication that occurs with the administration of large amounts of meperidine.

Normeperidine likely is the primary culprit in this situation. Other opiod

analgesics, therefore, are preferable to meperidine. The American Pain Society

recommends that meperidine no longer be used for control of pain in people who

require long-term analgesic treatment.

Drug-seeking behavior

Addiction is a concern for for medical providers and patients alike when chronic

pain require long-term use of opiods for control. The magnitude of the problem

is less than is often imagined, however. Those who develop an addiction or

drug-seeking behavior are seen frequently in emergency rooms and as hospital

inpatients. This overrepresentation of a small number of patients in the health

care system leads many providers to conclude that drug-seeking behavior is a

problem for most patients with sickle cell disease. Opiods used for pain

control, even when given in relatively high doses, usually do not lead to

addiction. As with any other group of people, some patients with sickle cell

disease have a propensity to develop addictive disorders. The "easier access"

that these patients have to narcotics brings out a problem that might have

developed in any event.

An important first step in managing this problem is to define drug-seeking

behavior. The use of large quantities of oral opiods or frequent visits to the

emergency room do not de facto signify drug-seeking behavior. Drug-seeking

behavior is the use of opiods in the absence of pain sufficiently severe to

justify these medications. Since no objective measure of pain exists, reaching

this conclusion is difficult. Drug-seeking behavior can be established only by

getting to know the patient and by observing the pattern of drug usage. This

means that over a period of months, frequent and heavy use of opiods by the

patient may need to be tolerated in order to establish the pattern of drug

consumption. Only then can the medical care provider reasonably say on the basis

of subtle signs such as facial expression, vocal inflexion, pulse rate, etc.,

that drug-seeking behavior is likely. At this point, the patient can be

approached to discuss what appears to be unwarranted use of drugs.

These patients can respond positively. Drug-seeking behavior can be a very

psychologically painful experience. Many patients are relieved when they are

confronted and given an option of help. Counseling or sessions with a

psychologist or social worker can be useful. In establishing drug-seeking

behavior, allowing a few patients to succeed in taking extra medication for a

while outweighs punishing patients who have a legitimate need by placing

arbitrary limits on everyone.

A few patients demonstrate incorrigible and sometimes frankly sociopathic

behavior. In these instances, the best approach is to limit opiod availability.

The patient should be informed that a limit is being imposed and the reason for

its implementation. Excuses for requesting additional medication fit a pattern

that can be a clue to drug-seeking behavior. Common pretexts include, (a)

forgetting to fill the prescription before expiration, (b) losing the drug after

the prescription is filled, (c) being robbed of the prescription or the

medication, (d) having a friend or relative abscond with the medication after

having the prescription filled. The limit should be followed strictly. Tracking

patterns of medication use is aided by keeping a log of all opiod prescriptions

issued. Photocopys of prescriptions provide excellent documentation. If

possible, a single provider at the institution should write the prescriptions

and maintain the record. Covering staff and ER physicians should be alerted to

the arrangement and should not supply additional prescriptions. The arrangement

is not punitive. Rather it allows the staff to better assess and treat

legitimate sickle cell pain. Health providers should document their efforts to

monitor and control excess use of opiods by their patients. Scrupulous

record-keeping also helps avoid entanglements with medical practice oversight

agencies.

Patients with extreme drug seeking behavior or sociopathic personality disorders

often acquire medication from other hospitals or medical facilities. Sometimes

this is done under the cover of an alias. Health-care providers have limited

ability to control such activity. The provider must be sure that the pattern of

drug use at his or her institution is reasonable, but cannot police the entire

region.

Support Groups/Psychiatric Support

The psychosocial dynamics of sickle cell disease are complex. As with any other

chronic, and often debilitating, illness, patients face a plethora of social

problems that greatly influence their clinical condition (Whitten and Fischhoff,

1974). Loneliness, isolation, self-resentment, loss of self-esteem, and simple

anger are common in patients with sickle cell disease. These factors can

profoundly influence the patient's ability to cope with pain. Patient support

groups and psychological counseling often are very useful. The positive results

in studies in which children were taught psychological coping skills for pain,

reinforce the importance of this component of patient care (Gil et al., 1991).

Anemia

Vitamin Supplementation

Patients with sickle cell disease, like other people with hemolytic anemias,

require daily folic acid replacement. Folate is rapidly consumed by the

proliferating erythroid precursors. The normal daily intake of this vitamin

sometimes is insufficient to maintain a balance. One mg of supplemental folate

per day is more than enough to satisfy the needs of the erythron. A patient with

sickle cell disease whose hematocrit begins to fall unexpectedly should be

checked for folate deficiency as a part of the general work-up.

Sporadic Transfusion

Patients with sickle cell disease are anemic, by definition. The degree of the

anemia varies. The hematocrit frequently is in the mid- 20's. Some patients have

hematocrits in the low 30's while others have values in the high teens. The

baseline hematocrit remains relatively stable in a given patient, however.

Patients with Hemoglobin SC disease tend to run hematocrits in the low to mid

30's. Most patients are conditioned to tolerate their degree of anemia, and

routine transfusion is not necessary. Raising the hematocrit provides no

clinical benefit, unless the baseline value has fallen into the mid-teens, at

which point oxygen carrying capacity can be compromised. Hematocrits in such a

low range leave little leeway for further decline. On the other hand,

transfusing patients with sickle cell disease to hematocrits in the mid- to

upper-30's can be dangerous, since blood viscosity increases substantially at

higher hematocrits (Kaul et al., 1983). The increase in viscosity can worsen the

sickling propensity by increasing the time during which the cells remain in the

low oxygen tension regions of the circulation.

Chronic Transfusion Therapy

The best established use of chronic transfusion therapy is in patients who have

suffered strokes and have had initial exchange transfusions. Chronic transfusion

therapy is less well established for the treatment of other complications of

sickle cell disease. This modality has been advocated as a means of treating

recurrent severe episodes of sickle pain, priapism, and as a prophylactic

measure inpregnant patients. Variable improvement in these condition occurs. The

utility of transfusion therapy is limited by complications, most notably

alloimmunization and iron overload (Rosse et al., 1990) (Wang et al., 1986) .

Clinically significant iron overload can occur after as few as 30 red cell

transfusions. The only treatment for transfusional iron overload is chelation

therapy with desferrioxamine (Cohen and Schwartz, 1979). Marginal iron

mobilization with this drug is a frequent problem.

A major hurdle to the use of desferrioxamine is non-compliance. This is a

particular problem for young people, and occurs in other disorders that require

chelation therapy for transfusional iron overload, including beta-thalassemia

and congenital sideroblastic anemia. Investigation of other chelators, including

some orally active drugs, is ongoing. Approval is imminent for no agent,

however.

Alloimmunization

Alloimmunization against minor red cell antigens is a major problem for patients

with sickle cell disease who receive frequent transfusions (Rosse et al., 1990).

The representation of minor antigens, such as Kell, Duffy, and Kidd, differs

between African-Americans and European- Americans (Issitt, 1994). For patients

who receive only a few transfusions, the problem is not serious. With repeated

transfusion, however, antibodies develop against these minor determinants

complicating typing and jeopardizing further transfusion.

Blacks are substantially underrepresented as blood donors, compounding the

problem of alloimmunization for patients with sickle cell disease. In addition,

patients with sickle cell disease appear to develop alloantibodies more rapidly

than other black patients who are transfused (Vichinsky et al., 1990). Some

institutions perform extended panel matching which includes the most clinically

significant minor antigens in an effort to delay the development of

alloantibodies. Some patients develop such severe problems with alloantibodies

that transfusion becomes nearly impossible. A number of institutions have active

programs to recruit blood donors from the black community to lessen the impact

of alloimmunization.

Routine use of blood from black donors for black patients with sickle cell

disease is not warranted. The likelihood of finding matched units for patients

with sickle cell disease is greater when black people are in the donor pool.

Matching is necessary nonetheless since antigen variation among black people,

like all other humans, is great. An expanded donor pool substantially improves

the chance of a match with antigen testing.

Age and severity of anemia

Sometimes, the severity of the anemia in patients with sickle cell disease

gradually increases as they age. The reason for this marrow "burn-out"

phenomenon is unknown. The clinical situation is complicated by the fact that

many of the patients have end-organ damage, such as a dilated cardiomyopathy,

that may limit their ability to tolerate such severe anemia. Data from the

national cooperative study of sickle cell disease indicates that on average

patients with sickle cell disease survive until the mid 5th decade of life. Bone

marrow "burn-out" will be a greater issue as better general medical care and new

therapies prolong the lives of patients with sickle cell disease.

Infection Prophylaxis

Infection is a leading cause of death in patients with sickle cell disease.

Hyposplenism, due to splenic autoinfarction, is a major contributor.

Hyposplenism is not the sole cause of the defective host defense as evidenced by

the fact that overwhelming sepsis is the leading cause of death of children

under three years of age (Gill et al., 1995). Splenic autoinfarction is less

common in these very young children.

Antibiotics

A double-blind study of the use of penicillin prophylaxis for children between

the ages of six months and three years was terminated before the expected time

of completion (Gaston et al., 1986). The trend indicated clearly that penicillin

protected patients from infection or death due to overwhelming infection by

Streptococcus pneumoniae. The recommendation now is that all children be placed

on prophylactic penicillin at a dose of 250 mg twice a day. Patients with

allergies to penicillin should be treated with erythromycin. No recommended

duration of treatment with prophylactic penicillin exists.

A second study looking at the role of prophylactic penicillin in older children

was recently completed. No difference in the incidence of severe infection was

found in this cohort of children between the ages of 5 and 12 years (Falletta,

et al., 1995). The implication is that penicillin plays an important

prophylactic role only in young children. One caveat to the interpretation of

this study is that the incidence of pneumoccocal infection was strikingly low in

both groups. This could have been a clinical fluke. As such, a true difference

in infection rate between the two groups could possibly have been missed.

The role of prophylactic penicillin in adults with sickle cell disease is

unclear. Adults develop overwhelming sepsis, but at a much lower frequency than

do children. No controlled study to determine whether prophylactic antibiotics

are useful in adults has been done. The recently completed trial in older

children suggest that prophylactic antibiotics may not benefit adults.

Nonetheless, many physicians still prescribe prophylactic antibiotics for

adults.

Immunization

Immunization with the pneumococcal vaccine is standard practice both in adults

and children with sickle cell disease. Several studies suggest that immunization

provides some protection, although incomplete, against pneumoccocal infection

(Ammann et al., 1977) (Ammann, 1982) (Schwartz, 1982). The vaccine appears to be

effective even in adults where splenic function has been lost (Wong et al.,

1992). The more recently available 23-valent vaccine provides broader coverage

than earlier versions. Although the duration of protection is unknown, most

specialists re-innoculate patients once every 5 to 7 years. A noteworthy

contrary voice comes from a broadbased review of pneumococcal vaccine efficacy

that cast doubt on the role of the vaccine in patients with sickle cell disease

(Butler, et al., 1993).

More recently, a vaccine against Hemophilus influenzae has entered the clinical

arena (Rubin et al., 1989). The efficacy of this vaccine in sickle cell disease

is unknown. Given the serious nature of H. influenzae infections in these

patients, many specialists, particularly pediatricians, now routinely immunize

their patients against this organism.

Immunization against viral influenza is common practice. Viral influenza per se

is not a special threat for patients with sickle cell disease. Since influenza

is often complicated by bacterial infection and other problems, prevention of

the disease by immunization is a very practical intervention.

Recently, an effective vaccine against hepatitis B was developed. Since

patients with sickle cell disease are likely to require one or more transfusions

in their lifetime, immunization against hepatitis B is a reasonable precaution

(Mok et al., 1989).

Avascular Necrosis of Bone

Avascular necrosis of bone is a common problem in patients with sickle cell

disease. This process is distinctly different from the acute bone marrow

necrosis discussed earlier. The areas most frequently affected are cortical bone

of the acetabulum, the head of the femur, and the head of the humerus (Hernigou

et al., 1993). The etiology of avascular necrosis of bone is unknown. One

hypothesis posits marrow hyperplasia in the femoral head with tissue crowding

and secondary reduced blood flow to the bone as the inciting factor. Avascular

necrosis also occurs in patients with compound heterozygous conditions such as

Hb SC disease, as well as in patients with homozygous SS disease.

Patients usually report that the quality of the pain associated with avascular

bone necrosis differs substantially from their sickle cell pain. The articular

cartilage thins and often disappears as the process progresses. The joints can

deteriorate to a condition of bone-on-bone interface. Movement of the joint

becomes wrenchingly painful. Early on, non-steroidal anti-inflammatory agents

can be useful. With more severe situations, particularly those that involve the

shoulder, injections of corticosteroids may help. Finally, decompression of the

tissue in the head of the humerus or the head of the femur is used by some

orthopedic surgeons with success. This invasive procedure should be reserved for

patients with more advanced cases of avascular necrosis. The possible efficacy

of femoral head core decompression is currently being investigated in a

multicenter study coordinated by Dr. Elliot Vichinsky at the Children's Hospital

of Oakland, California.

Even with these interventions, the process cannot be completely halted, leading

to joint replacement in some instances. Since most of the patients are in their

20's or 30's when this becomes an issue, the decision to proceed with joint

replacement is difficult. Artificial joints are not well-tolerated by some

patients with sickle syndromes (Moran, 1995). As many as one-third of patients

require a second surgery within four years of joint replacement. Also, these

patients, for unclear reasons, are very vulnerable to infections of their

orthopedic hardware. The unfortunate result sometimes is a destroyed articular

interface and a flail joint which, in the case of the femur, can leave the

patient confined to a wheelchair.

More research is needed to identify patients at risk early in the course of the

degenerative process so that preventive measures can be instituted. One

promising addition to the diagnostic armamentarium is MRI imaging. This

technique can detect very early evidence of damage to the bone, and holds the

hope of improved management of this very debilitating complication of sickle

cell disease.

Osteomyelitis

Osteomyelitis often occurs at the site of necrotic segments of bone. Nearly

three-quarters of cases of osteomyelitis in patients with sickle cell disease

are due to Salmonella species (Anand and Glatt, 1994). Local pain and fever are

the most common indicators of chronic osteomyelitis (Epps Jr et al., 1991). In

the early stages of the disorder, bone roentenograms and even bone scans

frequently are unrevealing. Gallium scans can provide early evidence of the

disorder. Recently, MRI has been added to the diagnostic arsenal, and appears to

be a promising technique (Bonnerot et al., 1994). Definitive diagnosis often

requires bone biopsy. This procedure sometimes is not an option, due to the

location of the infection, however. Once the diagnosis is made, four to six

weeks of intravenous antibiotic therapy are needed.

If a causative organism is not identified, broad- spectrum antibiotics that have

good tissue penetration should be used. Evidence of effectiveness, in these

instances, is an improvement in the pattern of fever and pain. The advent of

home infusion services obviates the need for prolonged hospitalizations in many

cases.

Skin Ulcers

Skin ulcers are relatively infrequent in the United States in comparison to

reports from Jamaica. In that country, about 30% of patients with sickle cell

disease develop skin ulcers. This exceeds by far the incidence in the US, which

is closer to 1% (Koshy et al., 1989). Nonetheless, when skin ulcers occur, the

problems are very serious.

The most common site of skin ulcers is over the lateral malleoli. The

ulcerations often have no clear-cut antecedent trauma and progress over a period

of weeks to the point that the lesions extend into the dermis, and often into

the underlying subcutaneous tissue. With the breakdown in the protection

provided by the integument, patients are susceptible to infections and other

complications.

Treatment of ankle ulcers should be conservative. Rest, elevation, and dry

dressings with antimicrobial ointments are the best approaches to this problem.

Attempts at skin grafting are frequently thwarted by the poor blood flow to the

affected region. Healing usually takes weeks to months. The area should be

protected against trauma when the patient is up and about (Wethers et al.,

1994). Anecdotal reports exist of enhanced healing of ulcers in patients placed

on chronic transfusion therapy. In some instances, patients were begun on

chronic transfusion prior to skin grafting and maintained with monthly

transfusions for two or three months thereafter. Socks or other clothing that

cover the area should be avoided, to reduce friction injury. A simple dry

dressing provides additional protection. At one time, a group of investigators

advocated oral zinc supplementation as a means of speeding the healing of ankle

ulcers (Prasad et al., 1977). The rationale was that patients with sickle cell

disease are often deficient in zinc (which is the second most common metal ion

in red cells and is lost during hemolysis). Zinc is important for wound healing.

The evidence that zinc supplementation aids the healing of ankle ulcers is

controversial. However, the benign nature of zinc supplementation makes it a

reasonable option in patients with this terribly debilitating and often

recalcitrant condition.

Renal Dysfunction

The most common defect in patients with sickle cell disease is impaired urine

concentrating ability, or hyposthenuria (Kontessis, et al., 1992). Hyposthenuria

often occurs by the age of 3 or 4 years. The condition should be considered in

children with sickle cell disease who display bedwetting. Hyposthenuria is seen

in patients with homozygous sickle cell disease as well as in compound

heterozygotes (e.g., sickle-beta thalassemia). The extremely high osmolality in

the distal tubule produces some sickling even of the cells in patients with

sickle trait. As a consequence, hyposthenuria is the most common abnormality

seen that results from sickle cell trait (Gupta, et al., 1991).

The risk of renal dysfunction or failure is substantial in patients with sickle

cell disease (Flanagan et al., 1993). The high osmolality in the renal medulla

increases cell propensity to sickling. As a result, medullary ischemia and

papillary necrosis are common problems (Powars et al., 1991).

Sometimes, the necrotic papillae slough into the collecting system, obstructing

the outflow tract. No specific intervention has been devised that is

particularly effective in these patients. When the BUN and creatinine begin to

rise, limiting protein consumption is reasonable, as is recommended for other

patients with renal dysfunction. One report suggested that angiotensin

converting enzyme inhibitors may also retard the progression of nephropathy in

sickle cell disease (Falk et al., 1992). Further investigation of this promising

lead is needed.

Patients with sickle cell disease usually have low serum creatinine and BUN

levels. This is probably due to the high glomerular filtration rate along with a

high rate of creatinine secretion in the distal tubule. BUN values of 7 and

creatinine values of 0.5 are typical of those seen in patients with sickle cell

disease. A formal evaluation of glomerular filtration rate should be considered

in patients in whom the serum creatinine rises above the level of about 1.0..

Potentially nephrotoxic drugs should be used with extreme caution in patients

with sickle cell disease. Antibiotics such as gentamicin should be avoided when

other agents are available that are less toxic to the kidney. As noted

previously, nonsteroidal anti-inflammatory drugs (NSAIDs) should be used

cautiously in patients with sickle cell disease. Heavy loads of radiographic

contrast agents formerly were a significant problem for patients with sickle

cell disease. The newer agents produce a much lower osmotic load, with less

dehydration of the kidneys, as a result.

Limited experience exists on the efficacy of dialysis in patients with sickle

cell disease (Falk et al., 1983). Reports that hemodialysis is problematic in

patients with sickle cell disease are anecdotal. Every effort to prevent renal

deterioration should be undertaken. Microscopic hematuria is a common problem in

patients with sickle cell disease (as well as some patients with sickle cell

trait). Hematuria per se requires no intervention unless blood loss is massive.

Some patients with sickle cell disease and renal failure have received

allografts (Gonzalez-Carrillo et al., 1982).

People with sickle cell trait sometimes develop massive hematuria (Sears,

1978). Interestingly, the bleeding often comes from the left kidney. Hydration

and alkalization of the urine are commonly used interventions. Anecdotal reports

of the use of DDAVP in this situation are encouraging (Baldree, et al., 1990).

Episilon amino caproic acid (Amicar) has been used in some patients with

refractory bleeding from the kidney (Black, et al., 1976). Bleeding can continue

for weeks. Iron replacement may be necessary in some cases as treatment

interventions continue.

Retinopathy

Retinopathy is a significant problem for 10% to 20% of patients with sickle cell

disease (Moriarty et al., 1988). The peak age of onset is in the 20's. For

unknown reasons, the condition develops more frequently in patients with

hemoglobin SC disease than in those with homozygous sickle cell disease

(Clarkson, 1992). The retinopathy resembles that seen in people with diabetes.

The condition is believed to result from ischemia to the retina. The areas

affected, at least initially, are in the periphery of the retina, so that direct

ophthalmoscopy is rarely revealing (Kimmel et al., 1986). An ophthalmologist

should evaluate the patient using pupillary dilation and indirect

ophthalmoscopy. Patients should be seen at least once a year, and more

frequently if abnormalities are noted. Ischemia can lead to retinal thinning as

well as neovascularization. The fragile vessels formed by neovascularization are

subject to rupture, often leading to disastrous intraorbital hemorrhages. This

complication can produce sudden loss of vision (Pulido et al., 1988). Laser

photocoagulation has been used in an effort to prevent retinal hemorrhage

(Condon and Serjeant, 1980). Another common problem is retinal detachment,

particularly as a sequel to retinal hemorrhage.

Heart

Cardiomegaly is common in patients with sickle cell disease. Usually this

condition reflects sustained state of high cardiac output. While high output

failure occurs in some patients with sickle cell disease, the heart is

hyperdynamic in most (Gerry et al., 1978).

Pulmonary congestion due to fluid overload during hydration for painful crisis

is not a common problem in young patients. The picture changes as patients age.

A distinct minority of patients will develop problems with fluid balance with

the fluid challenge that occurs with hydration (Haynes, Jr and Allison, 1986).

For some patients, the problem is more one of left atrial dysfunction than

impaired ventricular activity. Nonetheless, patients who develop a chest

roentgenographic picture suggestive of "congestive heart failure" during

treatment for painful crisis must be examined carefully to rule out other

complications such as acute chest syndrome.

Pregnancy

Women with sickle cell disease can carry pregnancies to term, but the process

sometimes is complicated (Koshy et al., 1987) (Seoud et al., 1994). The

frequency of painful crises sometimes increases. Physical activity should be

limited, particularly after the mid-second trimester when the intravascular

volume increases substantially. Fetal development is usually normal if the

patient can be coaxed through the pregnancy (Powars et al., 1986). Some

specialists in sickle cell disease advocate simple blood transfusion in these

patients. Others have found no benefit to this intervention (Tuck et al., 1987).

The object is to maintain a hematocrit that allows normal fetal development.

Exchange transfusion has been used in some instances in which patients had

particularly difficult problems during the pregnancy. These reports are

anecdotal.

Women who have painful crises during pregnancy should be treated with analgesics

as necessary, including narcotics. The newborns who have been exposed to opiods

must be withdrawn by administering decreasing doses of these drugs in the

neonatal period. Warned of this issue, neonatologists can easily manage the

problem.

Newer Therapies

Therapies of Proven Benefit

Hydroxyurea

Hydroxyureainhibits ribonucleotide reductase, blocking DNA synthesis and cell

division. The drug also enhances fetal hemoglobin by developing erythroid cells

(Platt et al., 1984) (Stamatoyannopoulos and Nienhuis, 1992). Since fetal

hemoglobin blocks sickling, hydroxyurea has been administered to patients with

sickle cell disease in an effort to enhance fetal hemoglobin production

(Charache, 1991) (Rodgers et al., 1990). Hydroxyurea induces fetal hemoglobin

production, increases the red cell mean corpuscular volume, and reduces the

number of dense cells and irreversibly sickled cells in the circulation

(Goldberg et al., 1992).

On January 31, 1995, the Multicenter Study of Hydroxyurea in Sickle Cell Anemia

(MSH) was suspended by the NIH because patients on the hydroxyurea arm of the

study had significantly fewer painful crises than did the controls (Charache et

al., 1995). This made hydroxyurea the first (and only) drug proven to prevent

sickle cell crises. A second major observation was that 50% fewer episodes of

acute chest syndrome occurred in the patients treated with hydroxyurea.

Hydroxyurea does not cure sickle cell disease, nor is it effective in all

patients. A detailed study showed that hydroxyurea modifies the characteristics

of red cells in patients with homozygous HbS disease to resemble those of

patients with HbSC disease (Bridges, et al, 1996). The heterogeneous response

seen in the MSH study is consistent with people with sickle cell disease being

"converted" to a HbSC disease physiognomy. Patients should be carefully screened

and meet certain criteria:

Age - 18 years or older.

Frequent painful vaso-occlusive crises. "Frequent" can reasonably be defined

as three or more crises per year that require hospitalization.

Use of accepted modes of contraception to prevent conception while on the

drug.

Hydroxyurea is not reasonable therapy for many patients with sickle cell

disease. Patients who have relatively few vaso-occlusive pain crises should not

receive hydroxyurea therapy. Other contraindications for hydroxyurea include:

Pregnancy

Allergy to the drug

Thrombocytopenia or neutropenia

Although thrombocytopenia and/or neutropenia are relative contraindications,

some patients can tolerate the medication despite these pre-existing factors

with close monitoring. Bimonthly blood counts are required when patients are

started on hydroxyurea. In some patients on hydroxyurea, the hematocrit rises to

the high 30's or even low 40's. No evidence exists to support hydroxyurea as

prophylaxis against stroke, chronic leg ulcers, priapism, or other complications

of sickle cell disease.

The dose of hydroxyurea needed to prevent painful crises is unknown. In the MSH

study, patients received the maximum tolerated dose (MTD). The dose administered

was increased stepwise until signs of toxicity, such as mild neutropenia,

developed. The dose of hydroxyurea was then reduced slightly. Whether such

intense treatment is required is unknown. Lower doses of hydroxyurea (e.g.,

25mg/Kg/day) are used by some specialists. Most patients treated with

hydroxyurea develop macrocytosis (e.g., MCV=110). Macrocytosis is not a good

treatment gauge, however.

The data on hydroxyurea applies only to patients with homozygous sickle cell

disease (two hemoglobin S genes). Patients with compound heterozygous conditions

(e.g., sickle-beta thalassemia, Hb SC disease) were excluded from the MSH study

to eliminate if possible any response variability in the data. Future trials may

address these issues.

Hydroxyurea is not approved for use in children. The MSH study was restricted to

people 18 years of age or older. An NIH-sponsored trial of the drug in children

is on-going. A number of issues have been raised regarding hydroxyurea in

children, including neurocognitive development and bone maturation. The

pediatric hydroxyurea study will address some of these issues.

Hydroxyurea is teratogenic in mice, but its toxicity to the human fetus is

unknown. The drug has not been associated with carcinogenesis. The carcinogenic

potential with very long-term use is unknown, however. The NIH-sponsored

Follow-up Study of Hydroxyurea in Sickle Cell Disease is designed to monitor the

300 people in the original MSH study for long-term side effects.

Bone Marrow Transplantation

Bone marrow transplantation can cure SCD. This intervention was first used in a

patient with sickle cell disease who also had relapsed acute lymphocytic

leukemia. The transplant was done to treat the leukemia, but cured the sickle

cell disease as well. The largest experience with transplantation for sickle

cell disease comes from Belgium and France, where about 80 patients have

undergone bone marrow transplantation (Apperley, 1993). The results have been

quite promising with cure of the sickle cell disease in every case in which

engraftment occurred.

Concerns about problems such as graft versus host disease and interstitial

pneumonia, two potentially fatal complications of bone marrow transplantation,

have limited the use of this modality in the United States (Kalinyak et al.,

1995) (Davies, 1993). A recently reported trial of bone marrow transplantation

in children from centers in the US reaffirmed that the procedure can cure sickle

cell (Walters et al., 1996). Ten percent of the children died from the

procedure, and some suffered severe complications, such as graph rejection. A

later report by this group includes thirty-four children under the age of 16

years who have received bone marrow transplants (Walters MC, et al., 1997). The

incidence of complications as lower in the children who underwent transplant

subsequent to the initial report.

The questions of when to perform a transplant and which patients should receive

the therapy are difficult. The optimal time for transplantation is during

childhood, since children fare better with transplantation than do adults. The

variable clinical manifestation of sickle cell disease makes it impossible to

predict in childhood which patients will have a more severe course. This issue

is particularly pertinent considering that transplantation is best carried out

prior to the development of end organ damage from the sickle cell disease.

Analysis of data from the Study of the Natural History of Sickle Cell Disease

reported by Platt, et al, suggested that patients with fetal hemoglobin levels

of less than 8.6% tend to have more severe disease over the long run (Platt et

al., 1994). This would seem to provide a guide that could be used in the

decision of which patients to transplant. However, the data are only statistical

values. With rare exceptions, statistical data cannot be applied to a particular

patient to predict the clinical course.

An unresolved ethical question surrounds bone marrow transplantation for

children with sickle cell disease. Sickle cell disease is often a debilitating

condition that makes life miserable for its victims. Although the Natural

History Study indicates that patients with sickle cell disease die earlier than

actuarial projections for other African-Americans, data collected in the 1980's

showed a life span that extends into the 40's. With the nearly universal use of

prophylactic penicillin in children to prevent overwhelming pneumococcal

infections along with other advances in supportive treatment, this figure is

likely to improve.

The question of who should decide to subject a child to this potentially fatal

procedure likewise is complex. Should the decision be left to parents and

physicians? In a study at the University of Chicago, parents were presented with

hypothetical data on cure/mortality rates for their children with sickle cell

disease, and asked to indicate when the risks of the procedure were acceptable

relative to the gravity of the disease (Kodish et al., 1991). About one-third of

the parents indicated that a transplant mortality rate of 15% along with a 15%

incidence of graft-versus-host disease were acceptable odds. However, young

adults older than 18 years were not allowed to participate in the decision

process. Should the patients, the ones with the most to gain and the most to

lose, be excluded from the decision-making loop? Should the courts appoint

advocates for the children, to ensure that the parents and physicians indeed are

acting in the "best interest" of the youngsters?

A program of bone marrow transplantation for beta-thalassemia major has been

successfully initiated in Italy (Lucarelli et al., 1993). Although sickle cell

disease and beta-thalassemia major are both hemoglobinopathies, clear

differences between the diseases exist. The most important is the monotonous

progression to disability and death that occurs with beta-thalassemia major.

Bone marrow transplantation for sickle cell disease offers promise. The jury has

not returned a final verdict, however.

Experimental Therapies

Erythropoietin

Erythropoietin is a hormone produced by the kidneys that stimulates red cell

production (Adamson and Eschbach, 1990). Usually, the hormone is made in

response to hypoxemia (Kario et al., 1992). Erythropoietin also increases fetal

hemoglobin levels in the red cells of many patients (Nagel et al., 1993). A

number of investigators have examined the extent to which erythropoietin will

raise fetal hemoglobin levels in sickle cell disease. The consensus is that the

drug can significantly raise fetal hemoglobin levels, particularly when given in

high doses.

In one report, the drug was used in a dose of over 1,000 U/kg three times per

week (Rodgers et al., 1993). The treatment significantly elevated fetal

hemoglobin levels. The quantity of erythropoietin required for this effect was

enormous, particularly when compared to patients on hemodialysis where the

typical dose is now about 150 U/kg three times per week. The cost of

erythropoietin at the higher dose is prohibitive. Further, while erythropoietin

can increase the fetal hemoglobin content of red cells, no controlled trial has

shown that it alters the clinical course of sickle cell disease.

Butyrate

Arginine butyrate and similar compounds have been tested in patients with sickle

cell disease (Perrine et al., 1989). The use of this agent stemmed from the

observation that babies born to diabetic mothers with poor glucose control had

sustained production of fetal hemoglobin after birth relative to infants born to

normal women. Butyrate produced as a byproduct of the hyperglycemia produced the

phenomenon. A group of investigators subsequently examined the use of butyrate

as a means of inducing fetal hemoglobin synthesis in patients with sickle cells

disease (Perrine et al., 1993).

Arginine butyrate can increase fetal hemoglobin levels, but the effect is

variable (Sher et al., 1995). Unfortunately, the drug must be given

intravenously and has a half-life of only about 5 minutes. Intermittent rather

than continuous infusion of arginine butyrate may induce fetal hemoglobin

synthesis more effectively. Side effects that have been seen in patients who

have received arginine butyrate include anorexia, nausea, vomiting, and abnormal

liver function tests (One patient had a seizure on the medication after

inadvertently receiving 4 times the recommended dose.) For most patients,

arginine butyrate is well-tolerated, however. The requirement for intravenous

administration limits the use of the agent. However, many drugs now are

administered intravenously to patients at home (e.g., desferrioxamine for iron

overload). Creative strategies are being explored to make arginine butyrate a

useful therapeutic option.

An effort is underway to identify orally active agents with longer half-lives.

Several compounds have been identified, and a couple have been placed into early

clinical trials. One of these is sodium phenylbutyrate, a drug that has been

used for patients with urea cycle disorders (Dover et al., 1994). Unfortunately,

patients tolerated the medication poorly, in part due to the fact up to 40

tablets per day are needed to obtain acceptable blood levels. The increase in Hb

F levels produced by the oral agents studied thus far have been significantly

less than that seen with arginine butyrate (Perrine et al., 1994). The butyrates

have a number of hurtles to leap before they are accepted for more general use,

including a demonstration that they consistently alter the red cell profile and,

ultimately, improve the clinical picture in sickle cell disease.

Clotrimazole

Red cell dehydration contributes substantially to polymerization of sickle

hemoglobin in patients with sickle cell disease. The cell membrane is damaged in

part through repeated physical distortion by hemoglobin

polymerization/depolymerization, and in part through oxidant damage from

reactive oxygen species generated by hemichromes and other hemoglobin

byproducts. K-CL co-transport increases, with K+ loss and associated water loss.

Also, sickle cells accumulate Ca2+. As a consequence, the Gardos channel

(Ca2+-activated K+ export) is activated, with further dehydration.

Clotrimazole and other imidazole antimycotics specifically inhibit the

Ca2+-activated K+ channel pathway of normal and sickle erythrocytes. The

original report of Alvarez and colleagues described the inhibition of the normal

human red cell Gardos channel by clotrimazole (CLT) and other imidazole

antimycotics. Dr. Carlo Brugnara showed in sickle erythrocytes that CLT blocks

K+ transport via the Gardos channel, prevents the change in membrane potential

observed when the Gardos channel is activated by internal Ca2+, and inhibits

dehydration induced by either the Ca2+ ionophore A 23187 or cyclic

oxygenation-deoxygenation.

Initial work by Dr. Brugnara and colleagues at Children's Hospital, Boston

showed that clotrimazole reduces the number of dense cells and the number of

irreversibly sickled cells in patients with sickle cell disease (Brugnara, et

al, 1996). A study of the agent at Children's Hospital and Brigham and Women's

Hospital evaluated the combined effects of clotrimazole and hydroxyuea in

patients with sickle cell disease. The hope was that the agents, which have

different mechanisms of action on sickle cells, would work at least

cooperatively, and perhaps synergistically, to reduce sickling. Clotrimazole

proved to have a number of side-effects that limited its success, including

severe dysuria in many men. A newer imidazole with fewer side-effects has

recently come available. Enrollment in the clotrimazole study has be suspended

in anticipation of this newer agent.

Nitric Oxide

Nitric oxide is one of the newest agents to enter testing for possible treatment

of patients with sickle cell disease. It is an inhaled gas that has been used in

a variety of investigational conditions, including neonatal pulmonary

hypertension and adult respiratory distress syndrome.

Nitric oxide is know primarily for its ability to relax smooth muscle

relaxation. However, the compound also forms a covalent link with hemoglobin,

particularly attaching as an S-nitroso group to the ß-93 cysteine (Gow and

Stamler, 1998). This amino acid residue is near the "acceptor pocket" on the

ß-subunit of hemoglobin where the ß-6 valine of Hb S forms a non-covalent

interaction. The hydrophilic S-nitroso cysteine at the ß-93 residue could

destabilize the interaction between deoxy-Hb S molecules in polymerized sickle

hemoglobin.

Dr. C. Alvin Head, of Massachusetts General Hospital, and Dr. Carlo Brugnara,

of Children's Hospital, studied the interaction of nitric oxide both in vitro

and in vivo in normal volunteers and patients with sickle cell disease (Head, et

al., 1997). Their data suggested that nitric oxide breathed at a concentration

of 80 ppm reduces the polymerization tendency of sickle hemoglobin. Reduced

polymerization was inferred by a fall in the P50 of sickle hemoglobin (no effect

occurred with Hb A). Nitric oxide for acute painful vaso-occlusive crisis is

being studied in an ongoing multicenter trial. Other investigators were unable

to reproduce the P50 effect (Gladwin, et al., 1999). Further work is needed to

determine whether nitric oxide has a role in the treatment of patients with

sickle cell disease.

FluocorTM

FluocorTM is a drug manufactured by the CytRx Corporation of Norcross, Georgia.

A phase III clinical trial of the drug for patients with acute sickle cell pain

crisis was recently completed. FluocorTM is a more highly purified version of

the drug, RheothRxTM which went through phase II clinical studies several years

ago. Fifty patients were followed in a placebo-control pilot study designed to

evaluate safety and efficacy of the compound (Adams-Graves, et al., 1997). The

investigators infused the drug continuously for 48 hours at the beginning of a

sickle cell crisis. The treated patients required less narcotic analgesic and

showed a net reduction in hospital length-of-stay relative to placebo control

patients. The multicenter study of FluocorTM failed to confirm these preliminary

results. The future of the drug in the treatment of sickle cell disease is

unclear.

Gene Replacement Therapy

The beta-globin gene was cloned a number of years ago, fueling interest in the

possibility of gene replacement therapy for sickle cell disease. While the idea

of simply replacing the defective gene with a normal one is appealing, a number

of major difficulties must be surmounted. The first is to engineer a construct

in which the beta-globin gene is expressed at high levels. Our understanding of

the factors that control globin gene expression has advanced significantly over

the past few years, but many of the nuances are yet to be worked out. A large

segment of DNA upstream of the beta-globin gene cluster, called the locus

control region, is necessary for efficient transcription of beta-globin mRNA.

Any attempt at gene therapy must include the large locus control region.

Another problem is that the inserted gene must be regulated in its expression so

that it produces beta-globin chains at a level roughly equal to the production

of endogenous alpha- globin chains. Failure to achieve such a balance would

produce a thalassemia. Further, the endogenous sickle beta-globin gene likely

would have to be silenced, so that it does not continue to produce sickle globin

chains.

Finally, the cloned gene would have to be introduced into pluripotent stem cells

so that the patient would continue to make normal beta-globin in perpetuity. The

retroviral vectors that have been used to this point infect dividing cells,

while pluripotent stem cells divide very slowly. To overcome this difficulty, a

number of researchers have turned to adeno-associated viruses (AAV) as vehicles

for gene therapy since these viruses can infect resting cells. Here a new

barrier, namely immune response to the viral vector, has appeared. In any event,

gene therapy for sickle cell disease, the ultimate cure for the disorder, is not

imminent.

Concluding Thoughts

Without major breakthroughs in gene therapy or bone marrow transplantation that

make these treatments applicable to a large number of patients, drug

intervention will remain the major therapeutic option for sickle cell disease.

The likelihood is low of finding a "magic bullet" medication that substantially

improves sickle cell disease for all or even most patients. Treatment likely

will involve the use of different agents alone or in combination to produce

optimal results. Most chronic illnesses, in fact, require combination drug

therapy. Hypertension, for instance, cannot be managed solely with diuretics.

Physicians test combinations of diuretics, beta blockers, calcium channel

blockers, and angiotensin converting enzyme (ACE) inhibitors to acheive opitmal

control of hypertension while producing the fewest side-effects.

Table 2. Future therapies for sickle cell diseaseTreatment

GoalCureMaintenanceAcute Pain Management

Bone Marrow Transplanthydroxyureanitric oxide

Gene TherapyclotrimazoleFluocorTM

magnesium pitolateInibitiors of endothelial cell adhesion

arginine butyrateAntiinflammatory agents

Combination therapy currently is not an option for sickle cell disease, since

only hydroxyurea has been proven to alter the course of the condition. Many, if

not most of the agents currently under investigation likely will fall short of

investigators' hopes. If a few survive the rigors of testing and joint the

clinical armamentarium, however, we could mix and match drugs for patients with

sickle cell disease. Ideally, the treatment regimens would include drugs with

differing modes of action. Hydroxyurea, for instance, combined with clotrimazole

would team a drug that enhances fetal hemoglobin production (hydroxyurea) with

one that reduces erythrocyte dehydration (clotrimazole). For a particular

patient, sickle cell symptoms might be improved substantially by neither drug

alone. The combination, however, might significantly ameliorate the condition.

Table 2 shows how therapies might be combined, using as examples some of the

agents currently under investigation. We cannot say whether the therapeutic

algorithm that eventually evolves will include these approaches or modalities

not yet conceived. The only statement that can be made with confidence is that

new vistas in the treatment of sickle cell disease will usher in better and more

fulfilling lives for these patients.

A major goal of investigation should be development of interventions that can be

used in very young patients. Many of the problems experienced by adults and

adolescents with sickle cell disease reflect incremental organ damage by bouts

of hypoxia. The affected areas may initially be microscopic. With time, these

foci of injury colasce to form regions of macroscopic injury, such as avascular

necrosis of the femur. Prevention must be the watchword as we seek to improve

the management of patients with sickle cell disease.

References

Adams, R., Mckie, V., Nichols, F., Carl, E., Zhang, D., Mckie, K., Figueroa,

R., Litaker, M., Thompson, W., and Hess, D. (1992). The use of transcranial

ultrasonography to predict stroke in sickle-cell disease. The New England

Journal of Medicine 326, 605-610.

Adams RJ, McKie VC, Brambilla D, Carl E, et. al. (1998). Stroke prevention in

sickle cell anemia. Control Clin Trials 19:110-129.

Adams-Graves P, Kedar A, Koshy M, Steinberg M, Veith R, et al. (1997) ReothRx

(poloxamer 188) injection for the acute painful episode of sickle cell

disease: a pilot study. Blood 90:2041-2046.

Adamson, J., and Eschbach, J. (1990). Treatment of anemia of chronic renal

failure with recombinant human erythropoietin. Annual Review of Medicine 41,

349-360.

Alvarez J , Montero M, Garcia-Sancho J: High affinity inhibition of

Ca2+-dependent K+ channels by cytochrome P-450 inhibitors. J Biol Chem

1992,267:11789-11793.

Ammann, A. (1982). Current status of pneumococcal polysaccharide immunization

in patients with sickle cell disease or impaired splenic function. American

Journal of Pediatric Hematology Oncology 4, 301-6.

Ammann, A., Addiego, J., Wara, D., Lubin, B., Smith, W., and Mentzer, W.

(1977). Polyvalent pneumococcal-polysaccharide immunization of patients with

sickle-cell anemia and patients with splenectomy. New England Journal of

Medicine 297, 897-900.

Anand, A., and Glatt, A. (1994). Salmonella osteomyelitis and arthritis in

sickle cell disease. Semin Arthritis Rheum 24, 211-21.

Anastasi J. 1984. Hemoglobin S-mediated membrane oxidant injury: protection

from malaria and pathology in sickle cell disease. Med Hypotheses 14: 311-320.

Apperley, J. (1993). Bone marrow transplant for the haemoglobinopathies: past,

present and future. Baillieres Clin Haematol 6, 299-325.

Armstrong, F., Pegelow, C., Gonzalez, J., and Martinez, A. (1992). Impact of

children's sickle cell history on nurse and physician ratings of pain and

medication decisions. J Pediatr Psychol 17, 651-64.

Baldree LA, Ault BH, Chesney CM, Stapleton FB. (1990) Pediatr 86:238-243.

Balkaran, B., Char, G., Morris, J., Thomas, P., Serjeant, B., and Serjeant, G.

(1992). Stroke in a cohort of patients with homozygous sickle cell disease.

Journal of Pediatrics 120, 360-6.

Ballas, S. (1991). Sickle cell anemia with few painful crises is characterized

by decreased red cell deformability and increased number of dense cells. Am J

Hematol 36, 122-30.

Ballas, S., and Delengowski, A. (1993). Pain measurement in hospitalized

adults with sickle cell painful episodes. Ann Clin Lab Sci 23, 358-61.

Baruchel, S., Rees, J., Bernstein, M., and Goodyer, P. (1993). Relief of

sickle cell priapism by hydralazine. Report of a case. American Journal of

Pediatric Hematology-Oncology 15, 115-6.

Black WD, Hatch FE, Acchiardo S. Aminocaproic acid in prolonged hematuria of

patients with sicklemia. Arch Intern Med 1976; 136: 678-81.

Boletini, E., Svobodova, M., Divoky, V., Baysal, E., Curuk, M., Dimovski, A.,

Liang, R., Adekile, A., and Huisman, T. (1994). Sickle cell anemia, sickle

cell beta-thalassemia, and thalassemia major in Albania: characterization of

mutations. Hum Genet 93, 182-7.

Bonnerot, V., Sebag, G., de Montalembert, M., Wioland, M., Glorion, C., Girot,

R., and Lallemand, D. (1994). Gadolinium-DOTA enhanced MRI of painful osseous

crises in children with sickle cell anemia. Pediatr Radiol 24, 92-5.

Bouhassira, E., Lachman, H., Krishnamoorthy, R., Labie, D., and Nagel, R.

(1989). A gene conversion located 5' to the A gamma gene in linkage

disequilibrium with the Bantu haplotype in sickle cell anemia. Journal of

Clinical Investigation 83, 2070-2073.

Bridges KR, Garabino GD, Brugnara C, Cho MR, et al. (1996) A multiparameter

analysis of sickle erythrocytes in patients undergoing hydroxyurea therapy.

Blood 88:4701-4710.

Brugnara C, B Gee, C Armsby, S Kurth, M Sakamoto, N Rifai, SL Alper, O. Platt:

Therapy with oral clotrimazole induces inhibition of the Gardos channel and

reduction of erythrocyte dehydration in patients with sickle cell disease. J.

Clin. Invest. 1996; 97: 1227-1234.

Butler JC, Breiman RF, Campbell JF, Lipman HB, Broome CV, Facklam RR. (1993>

Pneumococcal polysaccharide vaccine efficacy. An evaluation of current

recommendations. JAMA 270 1826-1831.

Carlson, J., Nash, G., Gabutti, V., al-Yaman, F., and Wahlgren, M. (1994).

Natural protection against severe Plasmodium falciparum malaria due to

impaired rosette formation. Blood 84, 3909-3814. Charache, S. (1991).

Hydroxyurea as treatment for sickle cell anemia. Hematol Oncol Clin North Am

5, 571-83.

Charache, S., Scott, J., and Charache, P. (1979). "Acute chest syndrome" in

adults with sickle cell anemia. Microbiology, treatment, and prevention.

Archives of Internal Medicine 139, 67-9.

Charache, S., Terrin, M., Moore, R., Dover, G., Barton, F., Eckert, S.,

McMahon, R., and Bonds, D. (1995). Effect of hydroxyurea on the frequency of

painful crises in sickle cell anemia. Investigators of the Multicenter Study

of Hydroxyurea in Sickle Cell Anemia. N Engl J Med 332, 1317-22.

Clark, M., Mohandas, N., and Shohet, S. (1980). Deformability of oxygenated

irreversibly sickled cells. J Clin Invest 65, 189-196.

Clarkson, J. (1992). The ocular manifestations of sickle-cell disease: a

prevalence and natural history study. Transactions of the American

Opthalmologic Society 90, 481-504.

Cohen, A., Martin, M., Silber, J., Kim, H., Ohene-Frempong, K., and Schwartz,

E. (1992). A modified transfusion program for prevention of stroke in sickle

cell disease. Blood 79, 1657-61.

Cohen, A., and Schwartz, E. (1979). Iron chelation therapy in sickle cell

anemia. American Journal of Hematology 7, 69-76.

Condon, P., and Serjeant, G. (1980). Photocoagulation in proliferative sickle

retinopathy: results of a 5-year study. British Journal of Opthalmology 64,

832-40.

Davies, S. (1993). Bone marrow transplant for sickle cell disease--the

dilemma. Blood Reviews 7, 4-9.

Davies, S., and Brozovic, M. (1989). The presentation, management and

prophylaxis of sickle cell disease. Blood Reviews 3, 29-44.

DeBaun, M., Glauser, T., Siegel, M., Borders, J., and Lee, B. (1995).

Noninvasive central nervous system imaging in sickle cell anemia. A

preliminary study comparing transcranial Doppler with magnetic resonance

angiography. J Pediatr Hematol Oncol 17, 29-33.

Diamond, W., Brown Jr, F., Bitterman, P., Klein, H., Davey, R., and Winslow,

R. (1980). Delayed hemolytic transfusion reaction presenting as sickle-cell

crisis. Ann Intern Med 93, 231-4.

Dover, G., Brusilow, S., and Charache, S. (1994). Induction of fetal

hemoglobin production in subjects with sickle cell anemia by oral sodium

phenylbutyrate. Blood 84, 339-43.

Earley CJ, Kittner SJ, Feeser BR, Gardner J, Epstein A, Wozniak MA, Wityk R,

Stern BJ, Price TR, Macko RF, Johnson C, Sloan MA, Buchholz D. (1998) Stroke

in children and sickle-cell disease: Baltimore-Washington Cooperative Young

Stroke Study. Neurology 51:169-176.

Eaton, W., Hofrichter, J., and Ross, P. (1976). Delay Time of Gelation: A

Possible Determinant of Clinical Severity in Sickle Cell Disease. Blood 47,

621-627.

Eaton, W. A., and Hofrichter, J. (1990). Sickle cell hemoglobin

polymerization. [Review]. Advances in Protein Chemistry 40, 63-279.

Embury, S., Dozy, A., Miller, J., Davis, J. J., Kleman, K., Preisler, H.,

Vichinsky, E., Lande, W., Lubin, B., Kan, Y., and Mentzer, W. (1982).

Concurrent sickle-cell anemia and alpha-thalassemia: effect on severity of

anemia. N Engl J Med 306, 270-274.

Emond, A., Holman, R., Hayes, R., and Serjeant, G. (1980). Priapism and

impotence in homozygous sickle cell disease. Arch Intern Med 140, 1434-7.

Emre, U., Miller, S., Gutierez, M., Steiner, P., Rao, S., and Rao, M. (1995).

Effect of transfusion in acute chest syndrome of sickle cell disease. J

Pediatr 127, 901-4.

Epps Jr, C., Bryant 3d, D., Coles, M., and Castro, O. (1991). Osteomyelitis in

patients who have sickle-cell disease. Diagnosis and management. J Bone Joint

Surg 73, 1281-94.

Falk, R., Mattern, W., Lamanna, R., Gitelman, H., Parker, N., Cross, R., and

Rastall, J. (1983). Iron removal during continuous ambulatory peritoneal

dialysis using deferoxamine. Kidney Int 24, 110-2.

Falk, R., Scheinman, J., Phillips, G., Orringer, E., Johnson, A., and

Jennette, J. (1992). Prevalence and pathologic features of sickle cell

nephropathy and response to inhibition of angiotensin-converting enzyme. The

New England Journal of Medicine 326, 910-5.

Fernbach, D., and Burdine Jr, J. (1970). Sepsis and functional asplenia. New

England Journal of Medicine 282, 691.

Flanagan, G., Packham, D., and Kincaid-Smith, P. (1993). Sickle cell disease

and the kidney. American Journal of Kidney Diseases 21, 325-7.

Fowler Jr, J., Koshy, M., Strub, M., and Chinn, S. (1991). Priapism associated

with the sickle cell hemoglobinopathies: prevalence, natural history and

sequelae. J Urol 145, 65-8.

Friedman, E., Webber, A., Osborn, H., and Schwartz, S. (1986). Oral analgesia

for treatment of painful crisis in sickle cell anemia. Ann Emerg Med 15,

787-91.

Gaston, M., Verter, J., Woods, G., Pegelow, C., Kelleher, J., Presbury, G.,

Zarkowsky, H., Vinchinsky, E., Iyer, R., Lobel, J., Diamond, S., Holbrook, C.,

Gill, F., Ritchey, K., Falletta, J., and Group, t. P. P. S. (1986).

Prophylaxis with oral penicillin in children with sickle cell anemia. A

randomized trial. New England Journal of Medicine 314, 1593-9.

Gelfand, M., Daya, S., Rucknagel, D., Kalinyak, K., and Paltiel, H. (1993).

Simultaneous occurrence of rib infarction and pulmonary infiltrates in sickle

cell disease patients with acute chest syndrome. Journal of Nuclear Medicine

34, 614-8.

Gendrel, D., Kombila, M., Nardou, M., Gendrel, C., Djouba, F., and

Richard-Lenoble, D. (1991). Protection against Plasmodium falciparum infection

in children with hemoglobin S. Pediatr Infect Dis J 10, 620-1.

Gerry, J., Bulkley, B., and Hutchins, G. (1978). Clinicopathologic analysis of

cardiac dysfunction in 52 patients with sickle cell anemia. Am J Cardiol 42,

211-6.

Gil, K., Phillips Jr, G., Edens, J., Martin, N., and Abrams, M. (1994).

Observation of pain behaviors during episodes of sickle cell disease pain.

Clin J Pain 10, 128-32.

Gil, K., Williams, D., Thompson, R., and Kinney, T. (1991). Sickle cell

disease in children and adolescents: the relation of child and parent pain

coping strategies to adjustment. J. Ped. Psych. 16, 643-663.

Gill, F., Sleeper, L., Weiner, S., Brown, A., Bellevue, R., Grover, R.,

Pegelow, C., and Vichinsky, E. (1995). Clinical events in the first decade in

a cohort of infants with sickle cell disease. Cooperative Study of Sickle Cell

Disease. Blood 86, 776-83.

Gillams AR, McMahon L, Weinberg G, Carter AP (1998) MRA of the intracranial

circulation in asymptomatic patients with sickle cell disease. Pediatr Radiol

28:283-287.

Gladwin MT, Schechter AN, Shelhamer JH, Pannell LK, Conway DA, Hrinczenko BW,

Nichols JS, Pease-Fye ME, Noguchi CT, Rodgers GP, Ognibene FP. (1999) Inhaled

nitric oxide augments nitric oxide transport on sickle cell hemoglobin without

affecting oxygen affinity. J Clin Invest 104:937-945

Goldberg, M., Brugnara, C., Dover, G., Schapira, L., Charache ,S., and Bunn,

H. (1990. Treatment of sickle cell anemia with hydroxyurea and erythropoietin.

N Eng J Med 323, 366-372.

Goldberg, M., Brugnara, C., Dover, G., Schapira, L., Lacroix, L., and Bunn, H.

(1992). Hydroxyurea and erythropoietin therapy in sickle cell anemia.

Seminarys in Oncology 19, 74-81.

Gonzalez-Carrillo, M., Rudge, C., Parsons, V., Bewick, M., and White, J.

(1982). Renal transplantation in sickle cell disease. Clin Nephrol 18, 209-10.

Gow AJ, Stamler JS. (1998) Reactions between nitric oxide and haemoglobin

under physiological conditions. Nature 391:169-73.

Griffin, T., McIntire, D., and Buchanan, G. (1994). High-dose intravenous

methylprednisolone therapy for pain in children and adolescents with sickle

cell disease. N Engl J Med 330, 733-737.

Gupta AK, Kirchner KA, Nicholson R, Adams JG 3d, Schechter AN, Noguchi CT,

Steinberg MH. (1991) Effects of alpha-thalassemia and sickle polymerization

tendency on the urine-concentrating defect of individuals with sickle cell

trait J Clin Invest 88: 1963-1968.

Haynes Jr, J., and Allison, R. (1986). Pulmonary edema. Complication in the

management of sickle cell pain crisis. Am J Med 80, 833-40.

Haynes Jr, J., and Kirkpatrick, M. (1993). The acute chest syndrome of sickle

cell disease. American Journal of Medical Science 305, 326-30.

Head CA, Brugnara C, Martinez-Ruiz R, Kacmarek, et al. (1997) Low

concentrations of nitric oxide increase oxygen affinity of sickle erythrocytes

in vitro and in vivo. J Clin Invest 100:1193-1198.

Hernigou, P., Bachir, D., and Galacteros, F. (1993). Avascular necrosis of the

femoral head in sickle-cell disease. Treatment of collapse by the injection of

acrylic cement. J Bone Joint Surg Br 75, 875-80.

Holbrook, C. (1990). Patient-controlled analgesia pain management for children

with sickle cell disease. J Assoc Acad Minor Phys 1, 93-6.

Humbert, J., Winsor, E., Githens, J., and Schmitz, J. (1990). Neutrophil

dysfunctions in sickle cell disease. Biomed Pharmacother 44, 153-8.

Ingram, V.M. (1956) A specific chemical difference between globins of normal

and sickle-cell anúmia húmoglobins. Nature 178, 792-794.

Issitt, P. (1994). Race-related red cell alloantibody problems. Br J Biomed

Sci 51, 158-67.

Johnson, K., Stastny, J., and Rucknagel, D. (1994). Fat embolism syndrome

associated with asthma and sickle cell-beta(+)-thalassemia. Am J Hematol 46,

354-7.

Kalinyak, K., Morris, C., Ball, W., Ris, M., Harris, R., and Rucknagel, D.

(1995). Bone marrow transplantation in a young child with sickle cell anemia.

Am J Hematol 48, 256-61.

Kar, B., Satapathy, R., Kulozik, A., Kulozik, M., Sirr, S., Serjeant, B., and

Serjeant, G. (1986). Sickle cell disease in Orissa State, India. Lancet 2,

1198-201.

Kario, K., Matsuo, T., Kodama, K., Nakao, K., and Asada, R. (1992). Reduced

erythropoietin secretion in senile anemia. Am J Hematol 41, 252-7.

Kaul, D., Fabry, M., and Nagel, R. (1989). Microvascular sites and

characteristics of sickle cell adhesion to vascular endothelium in shear flow

conditions: pathophysiological implications. Proc Natl Acad Sci U S A 86,

3356-60.

Kaul, D. K., Fabry, M. E., Windisch, P., Baez, S., and Nagel, R. L. (1983).

Erythrocytes in sickle cell anemia are heterogeneous in their rheological and

hemodynamic characteristics. Journal of Clinical Investigation 72, 22-31.

Keidan, A., Marwah, S., Vaughan, G., Franklin, I., and Stuart, J. (1987).

Painful sickle cell crises precipitated by stopping prophylactic exchange

transfusions. J Clin Pathol 40, 505-7.

Kimmel, A., Magargal, L., and Tasman, W. (1986). Proliferative sickle

retinopathy and neovascularization of the disc: regression following treatment

with peripheral retinal scatter laser photocoagulation. Ophthalmic Surgery 17,

20-2.

Kinney, T., Ware, R., Schultz, W., and Filston, H. (1990). Long-term

management

Kinney TR, Sleeper LA, Wang WC, Zimmerman RA, Pegelow CH, Ohene-Frempong K,

Wethers DL, Bello JA, Vichinsky EP, Moser FG, Gallagher DM, DeBaun MR, Platt

OS, Miller ST. (1999) Silent cerebral infarcts in sickle cell anemia: a risk

factor analysis. The Cooperative Study of Sickle Cell Disease. Pediatrics

103:640-645.

of splenic sequestration in children with sickle cell disease. J Pediatr 117,

194-9.

Kirkpatrick, M., Haynes Jr, J., and Bass Jr, J. (1991). Results of

bronchoscopically obtained lower airway cultures from adult sickle cell

disease patients with the acute chest syndrome. American Journal of Medicine

90, 206-10.

Kodish, E., Lantos, J., Stocking, C., Singer, P., Siegler, M., and Johnson, F.

(1991). Bone marrow transplantation for sickle cell disease. A study of

parent's decisions. N Engl J Med 325, 1349-1353.

Kontessis P, Mayopoulou-Symvoulidis D, Symvoulidis A, Kontopoulou-Griva I.

(1992) Renal involvement in sickle cell-beta thalassemia. Nephron 61: 10-15.

Koren, A., Wald, I., Halevi, R., and Ben Ami, M. (1990). Acute chest syndrome

in children with sickle cell anemia. Pediatric Hematology Oncology 7, 99-107.

Koshy, M., Burd, L., Dorn, L., and Huff, G. (1987). Frequency of pain crisis

during pregnancy. Prog Clin Biol Res 240, 305-11.

Koshy, M., Entsuah, R., A, K., Kraus, A., Johnson, R., Bellvue, R.,

Flournoy-Gill, Z., and Levy, P. (1989). Leg ulcers in patients with sickle

cell disease. Blood 74, 1403-8.

Landesman, S., Rao, S., and Ahonkhai, V. (1982). Infections in children with

sickle cell anemia. Special reference to pneumococcal and salmonella

infections. American Journal of Pediatric Hematology and Oncology 4, 407-18.

Lanzkowsky, P., Shende, A., Karayalcin, G., Kim, Y., and Aballi, A. (1978).

Partial exchange transfusion in sickle cell anemia. Use in children with

serious complications. Am J Dis Child 132, 1206-8.

Lucarelli, G., Galimberti, M., Polchi, P., Angelucci, E., Baronciani, D.,

Giardini, C., Andreani, M., Agostinelli, F., Albertini, F., and Clift, R.

(1993). Marrow transplantation in patients with thalassemia responsive to iron

chelation therapy. N Engl J Med 329, 840-844.

Mallouh, A., and Qudah, A. (1993). Acute splenic sequestration together with

aplastic crisis caused by human parvovirus B19 in patients with sickle cell

disease. Journal of Pediatrics 122, 593-5.

Mankad, V., Williams, J., Harpen, M., Manci, E., Longenecker, G., RB, M.,

Shah, A., Yang, Y., and Brogdon, B. (1990). Magnetic resonance imaging of bone

marrow in sickle cell disease: clinical, hematologic, and pathologic

correlations. Blood 75, 274-83.

Mantadakis E, Cavender JD, Rogers ZR, Ewalt DH, Buchanan GR. 1999. Prevalence

of priapism in children and adolescents with sickle cell anemia. J Pediatr

Hematol Oncol 21: 518-522.

McPherson, E., Perlin, E., Finke, H., Castro, O., and Pittman, J. (1990).

Patient-controlled analgesia in patients with sickle cell vaso-occlusive

crisis. Am J Med Sci 299, 10-2.

Miller, B., Olivieri, N., Salameh, M., Ahmed, M., Antognetti, G., Huisman, T.,

Nathan, D., and Orkin, S. (1987). Molecular analysis of the high-hemoglobin-F

phenotype in Saudi Arabian sickle cell anemia. N Engl J Med 316, 244-50.

Miller, S., Hammerschlag, M., Chirgwin, K., Rao, S., Roblin, P., Gelling, M.,

Stilerman, T., Schachter, J., and Cassell, G. (1991). Role of Chlamydia

pneumoniae in acute chest syndrome of sickle cell disease. Journal of

Pediatrics 118, 30-3.

Miller ST, Sleeper, LA, Pegelow CH, Enos LE, Wang WC, Weiner SJ, Wethers DL,

Smith J, Kinney TR. (2000) Prediction of adverse outcomes in children with

sickle cell disease. N Engl J Med 342: 83-99.

Mok, Q., Underhill, G., Wonke, B., Aldouri, M., Kelsey, M., and Jefferies, D.

(1989). Intradermal hepatitis B vaccine in thalassaemia and sickle cell

disease. Arch Dis Child 64, 535-40.

Moran, M. (1995). Osteonecrosis of the hip in sickle cell hemoglobinopathy. Am

J Orthop 24, 18-24.

Moriarty, B., Acheson, R., Condon, P., and Serjeant, G. (1988). Patterns of

visual loss in untreated sickle cell retinopathy. Eye 2, 330-5.

Mykulak, D., and Glassberg, K. (1990). Impotence following childhood priapism.

J Urol 144, 134-5.

Nagel, R., and Fleming, A. (1992). Genetic epidemiology of the ßS gene.

Baillieres Clin Haematol 5, 331-365.

Nagel, R., Vichinsky, E., Shah, M., Johnson, R., Spadacino, E., Fabry, M.,

Mangahas, L., Abel, R., and Stamatoyannopoulos, G. (1993). F reticulocyte

response in sickle cell anemia treated with recombinant human erythropoietin:

a double-blind study. Blood 81, 9-14.

Ohene-Frempong, K. (1991). Stroke in sickle cell disease: demographic,

clinical and therapeutic considerations. Seminars in Hematology 28, 213-219.

Olatunji PO, Davies SC. (2000) The predictive value of white cell count in

assessing clinical severity of sickle cell anaemia in Afro-Caribbeans

patients. Afr J Med Med Sci 29: 27-30.

Olopoenia, L., Frederick, W., Greaves, W., Adams, R., Addo, F., and Castro, O.

(1990). Pneumococcal sepsis and meningitis in adults with sickle cell disease.

Southern Medical Journal 83, 1002-4.

Orjih, A., Chevli, R., and Fitch, C. (1985). Toxic heme in sickle cells: an

explanation for death of malaria parasites. Am J Trop Med Hyg 34, 223-7.

Overturf, G., Powars, D., and Baraff, L. (1977). Bacterial meningitis and

septicemia in sickle cell disease. American Journal of Diseases of Childhood

131, 784-7.

Pegelow, C. (1992). Survey of pain management therapy provided for children

with sickle cell disease. Clin Pediatr (Phila) 31, 211-4.

Pegelow, C., Adams, R., McKie, V., Abboud, M., Berman, B., Miller, S.,

Olivieri, N., Vichinsky, E., Wang, W., and Brambilla, D. (1995). Risk of

recurrent stroke in patients with sickle cell disease treated with erythrocyte

transfusions. J Pediatr 126, 896-9.

Perlin, E., Finke, H., Castro, O., Rana, S., Pittman, J., Burt, R., Ruff, C.,

and McHugh, D. (1994). Enhancement of pain control with ketorolac tromethamine

in patients with sickle cell vaso-occlusive crisis. Am J Hematol 46, 43-7.

Perrine, R., Pembrey, M., John, P., Perrine, S., and Shoup, F. (1978). Natural

history of sickle cell anemia in Saudi Arabs. A study of 270 subjects. Ann

Intern Med 88, 1-6.

Perrine, S., Dover, G., Daftari, P., Walsh, C., Jin, Y., Mays, A., and Faller,

D. (1994). Isobutyramide, an orally bioavailable butyrate analogue, stimulates

fetal globin gene expression in vitro and in vivo. Br J Haematol 88, 555-61.

Perrine, S., Ginder, G., Faller, D., Dover, G., Ikuta, T., Witkowska, E., Cai,

S.-P., Vichinsky, E., and Olivieri, N. (1993). A short-term trial of butyrate

to stimulate fetal-globin-gene expression in the beta-globin disorders. New

England Journal of Medicine 328, 81-86.

Perrine, S., Miller, B., Faller, D., Cohen, R., Vichinsky, E., Hurst, D.,

Lubin, B., and Papayannopoulou, T. (1989). Sodium butyrate enhances fetal

globin gene expression in erythroid progenitors of patients with Hb SS and

beta thalassemia. Blood 74, 454-9.

Platt, O., Brambilla, D., Rosse, W., Milner, P., Castro, O., Steinberg, M.,

and Klug, P. (1994). Mortality in sickle cell disease. Life expectancy and

risk factors for early death. N Engl J Med 330, 1639-44.

Platt, O., Orkin, S., Dover, G., Beardsley, G., Miller, B., and Nathan, D.

(1984). Hydroxyurea enhances fetal hemoglobin production in sickle cell

anemia. J Clin Invest 74, 652-656.

Platt, O., Thorington, B., Brambilla, D., Milner, P., Rosse, W., Vichinsky,

E., and Kinney, T. (1991). Pain in sickle cell disease. Rates and risk

factors. N Engl J Med 325, 11-16.

Poncz, M., Kane, E., and Gill, F. (1985). Acute chest syndrome in sickle cell

disease: etiology and clinical correlates. Journal of Pediatrics 107, 861-6.

Powars, D., Elliott-Mills, D., Chan, L., Niland, J., Hiti, A., Opas, L., and

Johnson, C. (1991). Chronic renal failure in sickle cell disease: risk

factors, clinical course, and mortality. Ann Intern Med 115, 614-20.

Powars, D., and Hiti, A. (1993). Sickle cell anemia. Beta s gene cluster

haplotypes as genetic markers for severe disease expression. Am J Dis Child

147, 1197-1202.

Powars, D., Sandhu, M., Niland-Weiss, J., Johnson, C., Bruce, S., and Manning,

P. (1986). Pregnancy in sickle cell disease. Obstet Gynecol 67, 217-28.

Powars DR, Conti PS, Wong WY, Groncy P, Hyman C, Smith E, Ewing N, Keenan RN,

Zee CS, Harold Y, Hiti AL, Teng EL, Chan LS. (1999) Cerebral vasculopathy in

sickle cell anemia: diagnostic contribution of positron emission tomography.

Blood 93:71-79.

Prasad, A., Abbasi, A., and Ortega, J. (1977). Zinc deficiency in man: studies

in sickle cell disease. Prog Clin Biol Res 14, 211-239.

Pulido, J., Flynn Jr, H., Clarkson, J., and Blankenship, G. (1988). Pars plana

vitrectomy in the management of complications of proliferative sickle

retinopathy. Arch Ophthalmol 106, 1553-7.

Ramasamy, S., Balakrishnan, K., and Pitchappan, R. (1994). Prevalence of

sickle cells in Irula, Kurumba, Paniya & Mullukurumba tribes of Nilgiris

(Tamil Nadu, India). Indian J Med Res 100, 242-5.

Rao, V., Mitchell, D., Rifkin, M., Steiner, R., Burk Jr, D., Levy, D., and

Ballas, S. (1989). Marrow infarction in sickle cell anemia: correlation with

marrow type and distribution by MRI. Magnetic Resonance Imaging 7, 39-44. <

Robieux, I., Kellner, J., Coppes, M., Shaw, D., Brown, E., Good, C.,

O'Brodovich, H., Manson, D., Olivieri, N., Zipursky, A., and al, e. (1992).

Analgesia in children with sickle cell crisis: comparison of intermittent

opioids vs. continuous intravenous infusion of morphine and placebo-controlled

study of oxygen inhalation. Pediatric Hematology Oncology 9, 317-26.

Rodgers, G., Dover, D., Uyesaka, N., Noguchi, C., Schechter, A., and Neinhuis,

A. (1993). Augmentation by erythropoietin of the fetal-hemoglobin response to

hydroxyurea in sickle cell disease. New England Journal of Medicine 328,

73-80.

Rodgers, G., Dover, G., Noguchi, C., Schechter, A., and Nienhuis, A. (1990).

Hematologic responses of patients with sickle cell disease to reatment with

hydroxyurea. N Engl J Med 322, 1037-45.

Roshkow, J., and Sanders, L. (1990). Acute splenic sequestration crisis in two

adults with sickle cell disease: US, CT, and MR imaging findings. Radiology

177, 723-5.

Rosse, W., Gallagher, D., Kinney, T., Castro, O., Dosik, H., Moohr, J., Wang,

W., and PS, L. (1990). Transfusion and alloimmunization in sickle cell

disease. The Cooperative Study of Sickle Cell Disease. Blood 76, 1431-7.

Roth Jr, EF, Friedman M, Ueda Y, Tellez I, Trager W Nagel RL. 1978. Sickling

rates of human AS red cells infected in vitro with Plasmodium falciparum

malaria. Science 202: 650-652.

Rubin, L., Voulalas, D., and Carmody, L. (1989). Immunization of children with

sickle cell disease with Haemophilus influenzae type b polysaccharide vaccine.

Pediatrics 84, 509-13.

Saarinen, U., Chorba, T., Tattersall, P., Young, N., Anderson, L., Palmer, E.,

and Coccia, P. (1986). Human parvovirus B19-induced epidemic acute red cell

aplasia in patients with hereditary hemolytic anemia. Blood 67, 1411-7.

Sanders, D., Severance, H., and Pollack, C. J. (1992). Sickle cell

vaso-occlusive pain crisis in adults: alternative strategies for management in

the emergency department. Southern Medical Journal 85, 808-11.

Schiliro, G., Spena, M., Giambelluca, E., and Maggio, A. (1990). Sickle

hemoglobinopathies in Sicily. American Journal of Hematology 33, 81-5.

Schwartz, J. (1982). Pneumococcal vaccine: clinical efficacy and

effectiveness. Annals of Internal Medicine 96, 208-20.

Sears D. (1978) The morbidity of sickle cell trait: a review of the

literature. Am J Med 64:1021-1036.

Sears, D., and Udden, M. (1985). Splenic infarction, splenic sequestration,

and functional hyposplenism in hemoglobin S-C disease. American Journal of

Hematology 18, 261-8.

Seeler, R. (1973). Intensive transfusion therapy for priapism in boys with

sickle cell anemia. J Urol 110, 360-3.

Seoud, M., Cantwell, C., Nobles, G., and Levy, D. (1994). Outcome of

pregnancies complicated by sickle cell and sickle-C hemoglobinopathies. Am J

Perinatol 11, 187-91.

Serjeant, G., de Ceulaer, K., and Maude, G. (1985). Stilboestrol and

stuttering priapism in homozygous sickle-cell disease. Lancet 2, 1274-6.

Shapiro, M., and Hayes, J. (1984). Fat embolism in sickle cell disease. Report

of a case with brief review of the literature. Archives of Internal Medicine

144, 181-2.

Sher, G., Ginder, G., Little, J., Yang, S., Dover, G., and Olivieri, N.

(1995). Extended therapy with intravenous arginine butyrate in patients with

beta-hemoglobinopathies. N Engl J Med 332, 1606-10.

Solanki, D., Kletter, G., and Castro, O. (1986). Acute splenic sequestration

crises in adults with sickle cell disease. American Journal of Medicine 80,

985-90.

Sprinkle, R., Cole, T., Smith, S., and Buchanan, G. (1986). Acute chest

syndrome in children with sickle cell disease. A retrospective analysis of 100

hospitalized cases. American Journal of Pediatric Hematology Oncology 8,

105-10.

Stamatoyannopoulos, G., Wood, W., Papayannopoulou, T., and Nute, P. (1975). A

new form of hereditary persistence of fetal hemoglobin in blacks and its

association with sickle cell trait. Blood 46, 683-92.

Stamatoyannopoulos, J., and Nienhuis, A. (1992). Therapeutic approaches to

hemoglobin switching in treatment of hemoglobinopathies. Annu Rev Med 43,

497-521.

Steinberg, M., and Embury, S. (1986). Alpha-thalassemia in blacks: genetic and

clinical aspects and interactions with the sickle hemoglobin gene. Blood 68,

985-90.

Szwed, J., Yum, M., and Hogan, R. (1980). A beneficial effect of splenectomy

in sickle cell anemia and chronic renal failure. Am J Med Sci 279, 169-72.

Tobias, J. (1993). Indications and application of epidural anesthesia in a

pediatric population outside the perioperative period. Clin Pediatr (Phila)

32, 81-5.

Tuck, S., James, C., Brewster, E., Pearson, T., and Studd, J. (1987).

Prophylactic blood transfusion in maternal sickle cell syndromes. Br J Obstet

Gynaecol 94, 121-5.

Van Hoff, J., Ritchey, A., and Shaywitz, B. (1985). Intracranial hemorrhage in

children with sickle cell disease. Am J Dis Child 139, 1120-3.

Vichinsky, E., Earles, A., Johnson, R., Hoag, M., Williams, A., and Lubin, B.

(1990). Alloimmunization in sickle cell anemia and transfusion of racially

unmatched blood. N Engl J Med 322, 1617-21.

Vichinsky, E., and Lubin, B. (1980). Sickle cell anemia and related

hemoglobinopathies. Pediatr Clin North Am 27, 429-447.

Vichinsky, E., Williams, R., Das, M., Earles, A., Lewis, N., Adler, A., and

McQuitty, J. (1994). Pulmonary fat embolism: a distinct cause of severe acute

chest syndrome in sickle cell anemia. Blood.

Walters, M., Patience, M., Leisenring, W., Eckman, J., Scott, J., Mentzer, W.,

Davies, S., Ohene-Frempong, K., Bernaudin, F., Matthews, D., Storb, R., and

Sullivan, K. (1996). Bone marrow transplantation for sickle cell disease. N

Engl J Med 335, 369-376.

Walters MC, Patience M, Leisering W, Rogers ZR, et. al. (1997) Collaborative

multicenter investigation of marrow transplantation for sickle cell disease:

current results and future directions. Biol Blood Marrow Transplant 3:310-315.

Wang, W., Ahmed, N., and Hanna, M. (1986). Non-transferrin-bound iron in

long-term transfusion in children with congenital anemias. J Pediatr 108,

552-557.

Wang, W., Kovnar, E., Tonkin, I., Mulhern, R., Langston, J., Day, S., Schell,

M., and Wilimas, J. (1991). High risk of recurrent stroke after discontinuance

of five to twelve years of transfusion therapy in patients with sickle cell

disease. J Pediatr 118, 377-82.

Wang, Z., Bogdan, A., Zimmerman, R., Gusnard, D., Leigh, J., and

Ohene-Frempong, K. (1992). Investigation of stroke in sickle cell disease by

1H nuclear magnetic resonance spectroscopy. Neuroradiology 35, 57-65.

Wethers, D. (1982). Problems and complications in the adolescent with sickle

cell disease. Am J Pediatr Hematol Oncol 4, 47-53.

Wethers, D., Ramirez, G., Koshy, M., Steinberg, M., Phillips Jr., G., Siegel,

R., Eckman, J., and Prchal, J. (1994). Accelerated healing of chronic

sickle-cell leg ulcers treated with RGD peptide matrix. RGD Study Group. Blood

84, 1775-9.

White DA, DeBaun M. (1998) Cognitive and behavioral function in children with

sickle cell disease: a review and discussion of methodological issues. J

Pediatr Hematol Oncol 20:458-462.

Willcox M, Bjorkman A, Brohult J, Pehrson PO, Rombo L, Bengtsson E. 1983. A

case-control study in northern Liberia of Plasmodium falciparum malaria in

haemoglobin S and beta-thalassaemia traits. Ann Trop Med Parasitol 77:239-246.

Wong, W., Powars, D., Chan, L., Hiti, A., Johnson, C., and Overturf, G.

(1992). Polysaccharide encapsulated bacterial infection in sickle cell anemia:

a thirty year epidemiologic experience. American Journal of Hematology 39,

176-82.

Wright, S., Norris, R., and Mitchell, T. (1992). Ketorolac for sickle cell

vaso-occlusive crisis pain in the emergency department: lack of a

narcotic-sparing effect. Ann Emerg Med 21, 925-8.

Yang, Y., Donnell, C., Farrer, J., and Mankad, V. (1990). Corporectomy for

intractable sickle-associated priapism. Am J Med Sci 300, 231-3.

Yaster, M., Tobin, J., Billett, C., Casella, J., and Dover, G. (1994).

Epidural analgesia in the management of severe vaso-occlusive sickle cell

crisis. Pediatrics 93, 310-5.

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