The Efficacy of Azidothymidine (AZT) in the Treatment of Patients with AIDS and AIDS-Related Complex

作者: Margaret A. Fischl , Douglas D. Richman , Michael H. Grieco , Michael S. Gottlieb , Paul A. Volberding

DOI: 10.1056/NEJM198707233170401

关键词: MacrocytosisAnemiaZidovudinePlacebo-controlled studyImmunologyBone marrow suppressionMedicinePlaceboAIDS-related complexInternal medicineNeutropeniaGastroenterology

摘要: We conducted a double-blind, placebo-controlled trial of oral azidothymidine (AZT) in 282 patients with the acquired immunodeficiency syndrome (AIDS) or AIDS-related complex. Although significant clinical benefit was documented (N Engl J Med 1987; 317:185-91), serious adverse reactions, particularly bone marrow suppression, were observed. Nausea, myalgia, insomnia, and severe headaches reported more frequently by recipients AZT; macrocytosis developed within weeks most AZT group. Anemia hemoglobin levels below 7.5 g per deciliter 24 percent 4 placebo (P less than 0.001). Twenty-one required multiple red-cell transfusions Neutropenia (less 500 cells cubic millimeter) occurred 16 recipients, as compared 2 Subjects who entered study low CD4 lymphocyte counts, serum vitamin B12 levels, anemia, neutrophil counts likely to have hematologic toxic effects. Concurrent use acetaminophen also associated higher frequency toxicity. subset tolerated for an extended period few effects, drug should be administered caution because its toxicity limited experience it date.

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