Once-weekly epoetin alfa dosing is as effective as three times-weekly dosing in increasing hemoglobin levels and is associated with improved quality of life in anemic HIV-infected patients
Once-weekly epoetin alfa dosing is as effective as three times-weekly dosing in increasing hemoglobin levels and is associated with improved quality of life in anemic HIV-infected patients
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DOI：
10.1097/00126334-200312010-00003
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发表时间：
2003-12-01
影响因子：
3.6
通讯作者：
Leitz, G
中科院分区：
文献类型：
--
作者：
Grossman, HA;Goon, B;Leitz, G
背景：尽管在高活性抗逆转录病毒治疗中使用了较低剂量的齐多夫定，但贫血在hiv阳性患者中仍很普遍。在此之前，epoetin是每周给药3次（TIW）。在贫血hiv阳性患者中，我们比较了更方便的每周一次（QW）方案与TIW epoetin α的血液学和生活质量（QOL）效果和耐受性。方法：285名接受稳定抗逆转录病毒治疗的贫血（血红蛋白[Hb] < 12 g/dL） hiv阳性成人纳入了这项为期16周的随机多中心研究。入组患者随机接受4万至6万U/kg TIW或100至300 U/kg TIW的促生成素剂量。结果：272例患者可评估疗效。两种给药方案在第2周时Hb水平均显著升高（平均Hb升高1.3 g/dL [QW]和1.0 g/dL [TIW]; P < 0.0001），并持续升高至第8周并维持至研究结束，在最终Hb测量时两组之间无显著差异（平均Hb升高2.9 g/dL [QW]和2.5 g/dL [TIW]）。第8周时，两组患者的生活质量指标均较基线有显著改善（P < 0.05），第16周时两组间差异无统计学意义。两种给药方案均耐受良好。结论：QW剂量的促生成素与TIW剂量的促生成素在增加Hb水平方面同样有效，这与改善贫血hiv阳性患者的生活质量有关。QW给药也应该为患者和护理人员提供更多的便利。
Background: Anemia is prevalent in HIV-positive patients despite lower doses of zidovudine used in highly active antiretroviral therapy. Previously, epoetin alfa has been administered 3 times weekly (TIW). We compared the hematologic and quality of life (QOL) effects and tolerability of the more convenient once-weekly (QW) regimen with TIW epoetin alfa in anemic HIV-positive patients.Methods: Two hundred eighty-five anemic (hemoglobin [Hb] < 12 g/dL) HIV-positive adults receiving stable antiretroviral therapy were enrolled in this 16-week, randomized, multicenter study. Enrolled patients were randomized to receive epoetin alfa doses of 40,000 to 60,000 U QW or 100 to 300 U/kg TIW.Results: Two hundred seventy-two patients were evaluable for efficacy. Both epoetin alfa dosing schedules produced significant Hb level increases by week 2 (mean Hb increase of 1.3 g/dL [QW] and 1.0 g/dL [TIW]; P < 0.0001) that continued to increase until week 8 and were maintained until study completion, with no significant difference between treatment groups at final Hb measurement (mean Hb increase of 2.9 g/dL [QW] and 2.5 g/dL [TIW]). All QOL parameters improved significantly (P < 0.05) from baseline by week 8 in both groups, with no significant differences between groups at week 16. Both dosing schedules were well tolerated.Conclusions: QW dosing of epoetin alfa is as effective as TIW dosing in increasing Hb levels, which was associated with improved QOL in anemic HIV-positive patients. QW dosing should also off er added convenience for patients and caregivers.