Johnson Philip C, Wheat L Joseph, Cloud Gretchen A, Goldman Mitchell, Lancaster Dan, Bamberger David M, Powderly William G, Hafner Richard, Kauffman Carol A, Dismukes William E
Division of General Medicine, University of Texas-Houston Medical School, 6431 Fannin, MSB 1.122, Houston, TX 77030, USA.
Ann Intern Med. 2002 Jul 16;137(2):105-9. doi: 10.7326/0003-4819-137-2-200207160-00008.
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.
To compare amphotericin B with liposomal amphotericin B for induction therapy of moderate to severe disseminated histoplasmosis in patients with AIDS.
Randomized, double-blind, multicenter clinical trial.
21 sites of the U.S. National Institute of Allergy and Infectious Diseases Mycoses Study Group.
81 patients with AIDS and moderate to severe disseminated histoplasmosis.
Clinical success, conversion of baseline blood cultures to negative, and acute toxicities that necessitated discontinuation of treatment.
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% CI, 1 to 52 percentage points]). Culture conversion rates were similar. Three patients treated with amphotericin B and one treated with liposomal amphotericin B 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).
Liposomal amphotericin B seems to be a less toxic alternative to amphotericin B and is associated with improved survival.
在患有与艾滋病相关的中度至重度组织胞浆菌病的患者中，首选治疗方法一直是使用脱氧胆酸盐制剂的两性霉素B。然而，使用两性霉素B会产生严重的副作用。
比较两性霉素B与脂质体两性霉素B对艾滋病患者中度至重度播散性组织胞浆菌病的诱导治疗效果。
随机、双盲、多中心临床试验。
美国国立过敏和传染病研究所真菌病研究组的21个地点。
81例患有艾滋病且患有中度至重度播散性组织胞浆菌病的患者。
临床疗效、基线血培养转阴情况以及因急性毒性而需要停止治疗的情况。
接受两性霉素B治疗的22例患者中有14例（64%）取得临床成功，而接受脂质体两性霉素B治疗的51例患者中有45例（88%）取得临床成功（差异为24个百分点[95%置信区间，1至52个百分点]）。培养转阴率相似。3例接受两性霉素B治疗的患者和1例接受脂质体两性霉素B治疗的患者在诱导治疗期间死亡（P = 0.04）。两性霉素B的输液相关副作用（63%）高于脂质体两性霉素B（25%）（P = 0.002）。接受两性霉素B治疗的患者中有37%发生肾毒性，接受脂质体两性霉素B治疗的患者中有9%发生肾毒性（P = 0.003）。
脂质体两性霉素B似乎是一种毒性较小的两性霉素B替代药物，且与生存率提高相关。
