López-Vélez Rogelio, Videla Sebastián, Márquez Manuel, Boix Vicente, Jiménez-Mejías Manuel E, Górgolas Miguel, Arribas José R, Salas Ana, Laguna Fernando, Sust Mariano, Cañavate Carmen, Alvar Jorge
Enfermedades Infecciosas, Hospital Ramón y Cajal, Carretera de Colmenar, km 9.100, 28034-Madrid, Spain.
J Antimicrob Chemother. 2004 Mar;53(3):540-3. doi: 10.1093/jac/dkh084. Epub 2004 Jan 22.
Visceral leishmaniasis (VL) in HIV-positive patients is characterized by a chronic course with frequent relapse. The aim of this study was to evaluate the efficacy and safety of amphotericin B lipid complex (ABLC) in preventing VL relapses in HIV-infected patients.
This was a multicentre, open-label (with blinded centralized randomization), parallel, no-treatment, controlled clinical trial. HIV-infected patients, with at least one previous treated episode of VL and with negative bone marrow aspirate for Leishmania parasites prior to the study, were randomized to receive either ABLC 3 mg/kg/day every 21 days (ABLC) or no treatment (NT). Patients were followed-up every 9 weeks for up to 12 months, and the efficacy was measured as the proportion of patients remaining free (non-relapse) of VL at 1 year of follow-up. The primary analysis was performed on an intention-to-treat basis.
One hundred and fifteen patients were screened, but only 17 were randomized: eight in the ABLC group and nine in the NT group. The intention-to-treat analysis of data showed 50% of patients remaining free of VL at 12 months of follow-up (95% CI = 15.7%, 84.3%) in the ABLC group, and 22.2% (95% CI = 2.8%, 60.0%) in the NT group. The non-relapse odds ratio was 3.5 (95% CI = 0.30%, 52.0%) favouring ABLC. ABLC was well tolerated: patients only presented infusion-related mild adverse events. No patients from either group discontinued treatment or died during follow-up.
ABLC, administered every 21 days for 12 months, is useful as secondary prophylaxis in preventing VL relapse in HIV-infected patients, and is well tolerated.
HIV阳性患者的内脏利什曼病（VL）具有病程慢性且频繁复发的特点。本研究的目的是评估两性霉素B脂质体复合物（ABLC）预防HIV感染患者VL复发的疗效和安全性。
这是一项多中心、开放标签（采用盲法集中随机分组）、平行、无治疗对照的临床试验。HIV感染患者，既往至少有一次VL治疗史且在研究前骨髓穿刺利什曼原虫检测为阴性，被随机分为每21天接受3mg/kg/天的ABLC治疗（ABLC组）或不接受治疗（NT组）。患者每9周随访一次，最长随访12个月，疗效以随访1年时无VL复发（未复发）患者的比例来衡量。主要分析基于意向性治疗原则进行。
共筛选了115例患者，但只有17例被随机分组：ABLC组8例，NT组9例。意向性治疗数据分析显示，ABLC组在随访12个月时50%的患者无VL复发（95%CI = 15.7%，84.3%），NT组为22.2%（95%CI = 2.8%，60.0%）。未复发的优势比为3.5（95%CI = 0.30%，52.0%），支持ABLC组。ABLC耐受性良好：患者仅出现与输注相关的轻度不良事件。两组均无患者在随访期间停止治疗或死亡。
每21天给予ABLC治疗12个月，作为二级预防措施，对预防HIV感染患者VL复发有效，且耐受性良好。
