Recombinant Human Erythropoietin in the Treatment of Anemia Associated with Human Immunodeficiency Virus (HIV) Infection and Zidovudine Therapy
| Autor: | William J. Robbins, Spotswood L. Spruance, Stephen J. Gabin, John J. Rinehart, Jean A. Smith, Ralph Zalusky, Allan R. Sampson, Jerome E. Groopman, Kay M. Larholt, Milan Fiala, Constance A. Benson, David H. Henry, John F. Toney, John C. Ruckdeschel, Thomas M. Hooton, Steven A. Miles, Michael S. Gottlieb, Lawrence A. Cone, Joseph G. Jemsek, Gildon N. Beall, Margaret A. Fischl, Randy L. Levine, Adan Rios, Robert I. Abels, Lawrence J. Eron, John T. Carey, Edward C. Bryant, Jeffrey E. Galpin, Seth A. Rudnick, Barbara Starrett |
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| Rok vydání: | 1992 |
| Předmět: |
Adult
Male medicine.medical_specialty Anemia medicine.medical_treatment Statistics as Topic Hematocrit Placebo Zidovudine Double-Blind Method Internal medicine Internal Medicine medicine Humans Blood Transfusion Adverse effect Erythropoietin Acquired Immunodeficiency Syndrome Chemotherapy Dose-Response Relationship Drug medicine.diagnostic_test business.industry General Medicine Middle Aged medicine.disease Recombinant Proteins Surgery Clinical trial Quality of Life Female business medicine.drug |
| Zdroj: | Annals of Internal Medicine. 117:739 |
| ISSN: | 0003-4819 |
| Popis: | OBJECTIVE To assess the effect of recombinant human erythropoietin (r-HuEPO) on anemia in patients with the acquired immunodeficiency syndrome (AIDS) who are receiving zidovudine therapy. DESIGN Combined analysis of four 12-week, randomized, double-blind, controlled clinical trials. SETTING Multiple centers in the United States. PATIENTS Two hundred and ninety-seven anemic (hematocrit < 30%) patients with AIDS who were receiving zidovudine therapy. Of the 297 patients, 255 were evaluable for efficacy, but all patients were included in analysis of safety. INTERVENTION Patients were randomly assigned to receive either r-HuEPO (100 to 200 U/kg body weight) or placebo, intravenously or subcutaneously, three times per week for up to 12 weeks. MEASUREMENTS Changes in mean hematocrit, transfusion requirement, and quality of life. RESULTS Sixty-nine percent of patients had endogenous serum erythropoietin levels less than or equal to 500 IU/L, and 31% had erythropoietin levels greater than 500 IU/L. In patients with low erythropoietin levels (< or equal to 500 IU/l), r-HuEPO therapy decreased the mean number of units of blood transfused per patient when compared with placebo (3.2 units and 5.3 units, respectively; P = 0.003) and increased the mean hematocrit from the baseline level (4.6 percentage points and 0.5 percentage points, respectively; P |
| Databáze: | OpenAIRE |
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