F reticulocyte response in sickle cell anemia treated with recombinant human erythropoietin: a double-blind study

Studies on baboons and preliminary observations in three patients with sickle cell anemia (SS) suggested that high doses of pulse administered recombinant human erythropoietin (rHuEPO) stimulate F-reticulocyte production. We now report on the administration of rHuEPO in a double- blind format to ascertain frequency of response and potential precipitation of side effects. Ten patients were enrolled, but one was discontinued due to the indication of a blood transfusion. Of the other nine, five received rHuEPO in escalating doses (from 400 to 1,500 U per kg twice daily [BID] per week), alternating with a placebo, in blinded fashion. The second group, consisting of four patients, followed an identical protocol (except starting dose was 1,000 U/Kg, BID per week) and were iron supplemented during treatment. The criterion of response was a transient doubling (as a minimum) of the steady-state F- reticulocyte level. We found that none of the five patients in the first group responded to rHuEPO, and two of them became iron deficient, as judged by a significant decrease in ferritin. Of the second group, four patients responded with F-reticulocyte increases. In three patients, open label administration of rHuEPO confirmed the effect. We observed seven painful episodes during this study, two during the EPO administration and five during the placebo arm. Three patients were phlebotomized because the hemoglobin level increased 1.5 g/dL more than steady-state levels. Of the six patients followed-up by percent dense cell determinations, one exhibited increased levels during periods of the treatment, whereas the other five showed no change. No anti-rHuEPO antibodies were detected. We conclude that rHuEPO can stimulate F- reticulocyte response in some patients with sickle cell anemia, without apparent negative clinical side effects. The state of iron stores may be critical. Whether higher doses of rHuEPO and/or a different regimen might induce sustained F cells and fetal hemoglobin increases remains to be determined.

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F reticulocyte response in sickle cell anemia treated with recombinant human erythropoietin: a double-blind study

Blood ◽

10.1182/blood.v81.1.9.9 ◽

1993 ◽

Vol 81 (1) ◽

pp. 9-14 ◽

Cited By ~ 61

Author(s):

RL Nagel ◽

E Vichinsky ◽

M Shah ◽

R Johnson ◽

E Spadacino ◽

...

Keyword(s):

Steady State ◽

Side Effects ◽

Sickle Cell ◽

Sickle Cell Anemia ◽

Recombinant Human Erythropoietin ◽

The Other ◽

Double Blind Study ◽

Double Blind ◽

Human Erythropoietin ◽

Iron Deficient

Abstract Studies on baboons and preliminary observations in three patients with sickle cell anemia (SS) suggested that high doses of pulse administered recombinant human erythropoietin (rHuEPO) stimulate F-reticulocyte production. We now report on the administration of rHuEPO in a double- blind format to ascertain frequency of response and potential precipitation of side effects. Ten patients were enrolled, but one was discontinued due to the indication of a blood transfusion. Of the other nine, five received rHuEPO in escalating doses (from 400 to 1,500 U per kg twice daily [BID] per week), alternating with a placebo, in blinded fashion. The second group, consisting of four patients, followed an identical protocol (except starting dose was 1,000 U/Kg, BID per week) and were iron supplemented during treatment. The criterion of response was a transient doubling (as a minimum) of the steady-state F- reticulocyte level. We found that none of the five patients in the first group responded to rHuEPO, and two of them became iron deficient, as judged by a significant decrease in ferritin. Of the second group, four patients responded with F-reticulocyte increases. In three patients, open label administration of rHuEPO confirmed the effect. We observed seven painful episodes during this study, two during the EPO administration and five during the placebo arm. Three patients were phlebotomized because the hemoglobin level increased 1.5 g/dL more than steady-state levels. Of the six patients followed-up by percent dense cell determinations, one exhibited increased levels during periods of the treatment, whereas the other five showed no change. No anti-rHuEPO antibodies were detected. We conclude that rHuEPO can stimulate F- reticulocyte response in some patients with sickle cell anemia, without apparent negative clinical side effects. The state of iron stores may be critical. Whether higher doses of rHuEPO and/or a different regimen might induce sustained F cells and fetal hemoglobin increases remains to be determined.

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Is there a role for selective vasodilation in the management of sickle cell disease?

Blood ◽

10.1182/blood.v71.3.597.597 ◽

1988 ◽

Vol 71 (3) ◽

pp. 597-602 ◽

Cited By ~ 18

Author(s):

GP Rodgers ◽

MS Roy ◽

CT Noguchi ◽

AN Schechter

Keyword(s):

Blood Flow ◽

Steady State ◽

Sickle Cell Disease ◽

Sickle Cell ◽

Sickle Cell Anemia ◽

Microvascular Obstruction ◽

Controlled Study ◽

Control Group ◽

Cell Disease ◽

Retinal Arteriolar

Abstract To test the hypothesis that microvascular obstruction to blood flow at the level of the arteriole may be significant in individuals with sickle cell anemia, the ophthalmologic effects of orally administered nifedipine were monitored in 11 steady-state patients. Three patients with evidence of acute peripheral retinal arteriolar occlusion displayed a prompt reperfusion of the involved segment. Two other patients showed fading of retroequatorial red retinal lesions. Color vision performance was improved in six of the nine patients tested. The majority of patients also demonstrated a significant decrease in the amount of blanching of the conjunctiva which reflects improved blood flow to this frequently involved area. Such improvements were not observable in a control group of untreated stable sickle cell subjects. These findings support the hypothesis that inappropriate vasoconstriction or frank vasospasm may be a significant factor in the pathogenesis of the microvascular lesions of sickle cell disease and, further, that selective microvascular entrapment inhibition may offer an additional strategy to the management of this disorder. We believe a larger, placebo-controlled study with nifedipine and similar agents is warranted.

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Preliminary results with administration of recombinant human erythropoietin in sickle cell/β-thalassemia patients during pregnancy

European Journal Of Haematology ◽

10.1111/j.1600-0609.1996.tb00725.x ◽

2009 ◽

Vol 56 (5) ◽

pp. 326-328 ◽

Cited By ~ 2

Author(s):

K. Bourantas ◽

G. Makrydimas ◽

J. Georgiou ◽

St. Tsiara ◽

D. Lolis

Keyword(s):

Sickle Cell ◽

Recombinant Human Erythropoietin ◽

Preliminary Results ◽

Human Erythropoietin

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Study of Platelet Function in Patients with Sickle Cell Anemia during Steady State and Vaso-Occlusive Crisis

Acta Haematologica ◽

10.1159/000204519 ◽

1993 ◽

Vol 89 (4) ◽

pp. 180-183 ◽

Cited By ~ 18

Author(s):

Christos A. Papadimitriou ◽

Anthi Travlou ◽

Alexander Kalos ◽

Dimitrios Douratsos ◽

Polyxene Lalï

Keyword(s):

Steady State ◽

Sickle Cell ◽

Platelet Function ◽

Sickle Cell Anemia

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A Double-Blind Comparative Clinical Trial of Floctafenine and Four Other Analgesics Conducted in General Practice

Journal of International Medical Research ◽

10.1177/030006057600400306 ◽

1976 ◽

Vol 4 (3) ◽

pp. 179-182 ◽

Cited By ~ 2

Author(s):

D M Lomas ◽

J Gay ◽

R N Midha ◽

D L Postlethwaite

Keyword(s):

Clinical Trial ◽

General Practice ◽

Side Effects ◽

Analgesic Effect ◽

Rank Order ◽

Controlled Trial ◽

The Other ◽

Double Blind ◽

Comparative Clinical Trial

Three hundred and twelve patients suffering from painful conditions were admitted to a multicentre, double-blind controlled trial, conducted in general practice in which five analgesics—floctafenine (Idarac), paracetamol, aspirin, dihydrocodeine and pentazocine—were compared. Overall ratings of analgesic effect placed floctafenine first in rank order. Floctafenine was statistically significantly superior in effect to pentazocine but not to the other three agents as far as doctor ratings were concerned; and superior to both pentazocine and dihydrocodeine in the opinion of patients. Fewer patients experienced side-effects on floctafenine than on the other four analgesics and this difference between floctafenine and pentazocine, and floctafenine and dihydrocodeine was statistically significant.

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The Efficacy and Tolerability of Combined Antidepressant Treatment in Different Depressive Subgroups

The British Journal of Psychiatry ◽

10.1192/bjp.162.3.363 ◽

1993 ◽

Vol 162 (3) ◽

pp. 363-368 ◽

Cited By ~ 23

Author(s):

Sinead O'brien ◽

Patrick McKeon ◽

Myra O'regan

Keyword(s):

Treatment Group ◽

Side Effects ◽

Major Depression ◽

Orthostatic Hypotension ◽

Antidepressant Treatment ◽

Combined Treatment ◽

Endogenous Depression ◽

Double Blind Study ◽

Double Blind ◽

Global Improvement

Eighty patients admitted to hospital with major depression were randomly allocated to six weeks of treatment with tranylcypromine, amitriptyline, or tranylcypromine and amitriptyline in combination, in a double-blind study. Scores on the HRSD improved significantly in all three groups, but there were no differences between the three groups. Patients on tranylcypromine and amitriptyline combined improved more according to their self-ratings after six weeks, and response was earlier as measured by a clinical global improvement scale. Those with endogenous depression improved more than those with neurotic depression, irrespective of treatment group. Combined treatment was less well tolerated than single treatments and gave rise to more side-effects, although there was no serious toxicity. Orthostatic hypotension was observed more frequently in patients on combined treatment. This group also experienced a significant increase in weight and prolongation of the P-R interval on ECG.

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Low serum glutathione-S-transferase activity and vitamin e levels do not correlate with disease severity in steady state adults with sickle cell anemia

Journal of Applied Hematology ◽

10.4103/joah.joah_22_17 ◽

2017 ◽

Vol 8 (3) ◽

pp. 110 ◽

Cited By ~ 1

Author(s):

JohnC Aneke ◽

PatrickO Manafa ◽

ChideE Okocha ◽

Ujunwa Obiano ◽

NancyC Ibeh ◽

...

Keyword(s):

Steady State ◽

Vitamin E ◽

Disease Severity ◽

Sickle Cell ◽

Sickle Cell Anemia ◽

Transferase Activity ◽

Glutathione S Transferase ◽

Low Serum

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A prospective randomised double blind study of the comparison of two opioids- fentanyl and buprenorphine – as adjuvant to spinal bupivacaine in caesarean sections

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20170308 ◽

2017 ◽

Vol 4 (1) ◽

pp. 45

Author(s):

Kamal Sonya ◽

Davies C. V.

Keyword(s):

Side Effects ◽

Intrathecal Morphine ◽

Maximum Level ◽

Sensory Block ◽

Local Anaesthetics ◽

Blind Study ◽

Maximum Height ◽

Double Blind Study ◽

Double Blind ◽

Fentanyl Group

Background: Opioids are first introduced as additives to spinal anaesthesia in 1979, with intrathecal morphine as forerunner. Neuraxial opioids when added to local anaesthetics prolong the duration of sensory block, improve quality of block and no unwanted sympathetic blockade leading to hypotension. This prospective randomized double blind study was undertaken to evaluate the duration of analgesia, sensory and motor blocking properties and side effects of two opioids – Fentanyl and Buprenorphine, when used as adjuvant to spinal Bupivacaine in caesarean section.Methods: Sixty patients between the age group 18-35 years belonging to ASA I and II posted for elective LSCS were randomly divided into two groups. Each group consisting of 30 patients , received either 1.8 ml 0.5% Bupivacaine with 25 mcg Fentanyl (group F) or 1.8 ml 0.5% Bupivacaine with 75 mcg buprenorphine (Group B). The onset, maximum level and duration of sensory and motor blockade and hemodynamic parameters were monitored.Results: Maximum height of sensory block was achieved faster in fentanyl group (i.e. 4.09±1.12 minutes compared to 4.56±1.21 minutes in buprenorphine group). Duration of analgesia was significantly prolonged in buprenorphine group. It was 317±54 minutes and 214±35 minutes respectively for buprenorphine and fentanyl groups.Conclusions: The study thus concluded that although fentanyl produce faster sensory block, duration of analgesia is longer with buprenorphine, and both the drugs do not cause significant side effects.

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