Fischl M, Galpin J E, Levine J D, Groopman J E, Henry D H, Kennedy P, Miles S, Robbins W, Starrett B, Zalusky R
University of Miami, Fla.
N Engl J Med. 1990 May 24;322(21):1488-93. doi: 10.1056/NEJM199005243222103.
Bone marrow suppression and anemia are frequent side effects of treatment of the acquired immunodeficiency syndrome (AIDS) with zidovudine (formerly azidothymidine [AZT]). We conducted a randomized, double-blind, placebo-controlled clinical trial of recombinant human erythropoietin (100 U per kilogram of body weight thrice weekly by intravenous bolus) in 63 patients with AIDS treated with zidovudine (29 in the erythropoietin group and 34 in the placebo group). Reductions in the number of units of red cells transfused and the number of patients given transfusions per month became apparent in the second and third months of the trial. The reductions were observed in patients with endogenous erythropoietin levels less than or equal to 500 IU per liter at base line, but not in patients whose levels were greater than 500 IU per liter at the beginning of the study. Although the hematocrit and hemoglobin level were not used as the primary criteria of efficacy because the patients received transfusions when their physicians decided that they needed them, a significantly higher rate of increase in the hematocrit was observed in the patients treated with recombinant human erythropoietin whose levels of endogenous erythropoietin were less than or equal to 500 IU per liter (0.00353 points per week) than in the patients given placebo (0.00116 points per week). This effect was not seen in patients with higher levels of endogenous erythropoietin. Serious side effects did not occur more often in the group treated with erythropoietin than in the placebo group. We conclude that recombinant human erythropoietin may be useful in patients with AIDS treated with zidovudine, although the indicators for its use remain to be clarified.
骨髓抑制和贫血是齐多夫定（原称叠氮胸苷[AZT]）治疗获得性免疫缺陷综合征（AIDS）时常见的副作用。我们对63例接受齐多夫定治疗的AIDS患者进行了一项随机、双盲、安慰剂对照临床试验，给予重组人促红细胞生成素（每千克体重100 U，每周静脉推注3次）（促红细胞生成素组29例，安慰剂组34例）。在试验的第二个月和第三个月，每月输注红细胞的单位数及接受输血的患者人数明显减少。在内源性促红细胞生成素水平基线时小于或等于500 IU/L的患者中观察到了这种减少，但在研究开始时水平大于500 IU/L的患者中未观察到。尽管血细胞比容和血红蛋白水平未被用作疗效的主要标准，因为患者在医生认为需要时接受输血，但内源性促红细胞生成素水平小于或等于500 IU/L的接受重组人促红细胞生成素治疗的患者血细胞比容的升高率（每周0.00353个百分点）明显高于接受安慰剂治疗的患者（每周0.00116个百分点）。在内源性促红细胞生成素水平较高的患者中未见到这种效应。促红细胞生成素治疗组严重副作用的发生频率并不高于安慰剂组。我们得出结论，重组人促红细胞生成素可能对齐多夫定治疗的AIDS患者有用，尽管其使用指标仍有待明确。
