Safety and efficacy of liposomal amphotericin B compared with conventional amphotericin B for induction therapy of histoplasmosis in patients with AIDS
Safety and efficacy of liposomal amphotericin B compared with conventional amphotericin B for induction therapy of histoplasmosis in patients with AIDS
复制标题
脂质体两性霉素 B 诱导治疗艾滋病患者组织胞浆菌病的安全性和有效性与传统两性霉素 B 的比较
DOI：
10.7326/0003-4819-137-2-200207160-00008
复制
发表时间：
2002-07-16
影响因子：
39.2
通讯作者：
Dismukes, WE
中科院分区：
文献类型：
--
作者：
Johnson, PC;Wheat, LJ;Dismukes, WE
背景资料：在与AIDS相关的中度至重度组织胞浆菌病患者中，首选的治疗是阿替霉素B的脱氧胆酸盐制剂。然而，严重的副作用与使用阿替霉素B有关。目的：比较阿替霉素B与脂质体阿替霉素B用于诱导治疗AIDS患者中重度播散性组织胞浆菌病。设计：随机、双盲、多中心临床试验。设置：美国国家过敏和传染病研究所真菌病研究组的21个地点。患者：81例艾滋病和中度至重度播散性组织胞浆菌病患者，测量指标：临床成功率、基线血培养转阴率和需要停止治疗的急性毒性。结果如下：22例患者中有14例（64%）接受阿替霉素B治疗，51例患者中有45例（88%）接受脂质体阿替霉素B治疗（差异，24个百分点[95% CI，1至52个百分点]）。培养转化率相似。三名接受阿替霉素B治疗的患者和一名接受脂质体阿替霉素8治疗的患者在诱导期间死亡（P = 0.04）。与脂质体阿霉素B（25%）相比，阿霉素B（63%）的输注相关副作用更大（P = 0.002）。37%的患者发生肾毒性，而脂质体阿霉素B组仅为9%（P = 0.003）。结论：脂质体阿霉素B似乎是一种毒性较低的替代阿霉素B，并与改善生存相关。
Background: In patients with moderate to severe histoplasmosis associated with AIDS, the preferred treatment has been the deoxycholate formulation of amphotericin B. However, serious side effects are associated with use of amphotericin B.Objective: To compare amphotericin B with liposomal amphotericin B for induction therapy of moderate to severe disseminated histoplasmosis in patients with AIDS.Design: Randomized, double-blind, multicenter clinical trial.Setting: 21 sites of the U.S. National Institute of Allergy and Infectious Diseases Mycoses Study Group.Patients: 81 patients with AIDS and moderate to severe disseminated histoplasmosis.Measurements: Clinical success, conversion of baseline blood cultures to negative, and acute toxicities that necessitated discontinuation of treatment. Results: Clinical success was achieved in 14 of 22 patients (64%) treated with amphotericin B compared with 45 of 51 patients (88%) receiving liposomal amphotericin B (difference, 24 percentage points [95% Cl, 1 to 52 percentage points]). Culture conversion rates were similar. Three patients treated with amphotericin B and one treated with liposomal amphotericin 8 died during induction (P = 0.04). Infusion-related side effects were greater with amphotericin B (63%) than with liposomal amphotericin B (25%) (P = 0.002). Nephrotoxicity occurred in 37% of patients treated with amphotericin B and 9% of patients treated with liposomal amphotericin B (P = 0.003).Conclusion: Liposomal amphotericin B seems to be a less toxic alternative to amphotericin B and is associated with improved survival.