Médecins Sans Frontières-Switzerland, North Sudan mission, Gedaref, Sudan.
Trop Med Int Health. 2014 Feb;19(2):146-52. doi: 10.1111/tmi.12238. Epub 2014 Jan 17.
The aim of this study was to report the patient profile and treatment outcomes, including relapses, of patients with visceral leishmaniasis (VL) treated with liposomal amphotericin B (AmBisome) in Gedaref, Sudan.
AmBisome was offered to two groups of patients: primary VL patients with specific criteria (age ≤2 or ≥45 years, advanced clinical disease, pregnancy, HIV co-infection and contraindications for antimonials) and VL relapses. AmBisome was given at a total dose of 30 mg/kg, over 10 days. Slow responders received up to 50 mg/kg. Treatment failure was confirmed parasitologically. Standardised treatment outcomes were assessed.
Between March 2010 and June 2012, a total of 281 (74%) patients with primary VL and 98 (26%) patients with VL relapses received AmBisome (54% male, median age = 11 years, interquartile range 2-30). End-of-treatment outcomes for primary VL were 260 (92%) initial cure including three (1%) slow responders, three (1%) treatment failures, 14 (5%) deaths and four (1%) unknown outcomes. Outcomes for VL relapses were 92 (94%) initial cure with five (5%) slow responders, four (4%) treatment failures, one (1%) death and one (1%) unknown outcome. At 6 months, there were 19 (7%) relapses amongst primary VL and 10 (10%) VL relapses had a new relapse. Loss to follow-up in both groups was 38%. None of the deaths that occurred during the study period was attributed to AmBisome.
AmBisome appears to be effective for initial cure of VL and the drug seems safe, but is expensive (400 USD/treatment). Sustained mechanisms to allow improved access of this expensive drug particularly in East Africa are urgently needed. Relapses and losses to follow-up require specific investigation.
本研究旨在报告在苏丹加达里夫接受脂质体两性霉素 B（AmBisome）治疗的内脏利什曼病（VL）患者的患者特征和治疗结果，包括复发情况。
AmBisome 提供给两组患者：符合特定标准的原发性 VL 患者（年龄≤2 或≥45 岁、晚期临床疾病、妊娠、HIV 合并感染和锑剂禁忌证）和 VL 复发患者。AmBisome 的总剂量为 30mg/kg，分 10 天给予。反应迟缓者给予高达 50mg/kg。通过寄生虫学确认治疗失败。评估了标准化的治疗结果。
2010 年 3 月至 2012 年 6 月期间，共有 281 例（74%）原发性 VL 患者和 98 例（26%）VL 复发患者接受了 AmBisome 治疗（54%为男性，中位年龄为 11 岁，四分位间距为 2-30）。原发性 VL 的治疗结束时的结果为 260 例（92%）初始治愈，包括 3 例（1%）反应迟缓者、3 例（1%）治疗失败、14 例（5%）死亡和 4 例（1%）未知结局。VL 复发的结果为 92 例（94%）初始治愈，包括 5 例（5%）反应迟缓者、4 例（4%）治疗失败、1 例（1%）死亡和 1 例（1%）未知结局。在 6 个月时，原发性 VL 中有 19 例（7%）复发，VL 中有 10 例（10%）复发出现新的复发。两组均有 38%的患者失访。在研究期间发生的死亡均与 AmBisome 无关。
AmBisome 似乎对 VL 的初始治愈有效，且该药似乎安全，但很昂贵（每次治疗 400 美元）。迫切需要建立持续的机制，以改善这种昂贵药物的可及性，特别是在东非。复发和失访需要进行专门调查。
