Safety and effectiveness of meglumine antimoniate in the treatment of Ethiopian visceral leishmaniasis patients with and without HIV co-infection

Safety and effectiveness of meglumine antimoniate in the treatment of Ethiopian visceral leishmaniasis patients with and without HIV co-infection
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DOI:
10.1016/j.trstmh.2010.07.007
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发表时间:
2010-11-01
影响因子:
2.2
通讯作者:
Hailu, Asrat
Hailu, Asrat
中科院分区:
医学4区
文献类型:
--
作者:
Hailu, Workagegnehu;Weldegebreal, Teklu;Hailu, Asrat

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在撒哈拉以南非洲,内脏利什曼病(VL)用Pentoclavin(TM)(葡萄糖酸锑钠)或通用葡萄糖酸锑钠(SSG)治疗,但乌干达除外,那里的Glucantime(R)(葡甲胺锑酸盐)已使用至少十年。2008年1月至2009年2月期间,54名埃塞俄比亚VL患者接受了葡聚糖时间治疗。对这些患者的病历进行了审查,以评估Glucantime在常规医疗保健环境中的有效性和安全性特征。来自埃塞俄比亚南部的患者(n = 24)和来自埃塞俄比亚北部的患者(n = 30)中无HIV合并感染者。治疗完成时(第31天),埃塞俄比亚北部的治愈率为78.6%(95% CI 59.0-91.7%),埃塞俄比亚南部为100%(95% CI 85.8-100%)。在26例患者中观察到33例非严重不良事件和6例严重不良事件(2例胰腺炎,1例肾衰竭和3例死亡)。三分之一的非严重不良事件是由于生化胰腺炎。在治疗期间,埃塞俄比亚北部的病死率为10.0%,埃塞俄比亚南部为0.0%。这些数据表明,在HIV阴性患者中,Glucantime与Pentoclavin或SSG一样有效。数据还指出临床胰腺炎是一个安全性问题,特别是在合并HIV感染的患者中。(C)2010年皇家热带医学和卫生学会。由爱思唯尔有限公司出版。保留所有权利。
In sub-Saharan Africa, visceral leishmaniasis (VL) is treated with either Pentostam (TM) (sodium antimony gluconate) or generic sodium stibogluconate (SSG), except in Uganda where Glucantime (R) (meglumine antimoniate) has been in use for at least a decade. Between January 2008 and February 2009, 54 Ethiopian VL patients were treated with Glucantime. The medical charts of these patients were reviewed to assess the effectiveness and safety profile of Glucantime in a routine healthcare setting. None of the patients from south Ethiopia (n = 24) and 46.4% of the patients from north Ethiopia (n = 30) were HIV co-infected. At completion of treatment (Day 31), cure rates were 78.6% (95% CI 59.0-91.7%) in north Ethiopia and 100% (95% CI 85.8-100%) in south Ethiopia. Thirty-three non-serious and six serious adverse events (two pancreatitis, one renal failure and three deaths) were observed in 26 patients. One-third of the non-serious adverse events were due to biochemical pancreatitis. During treatment, a case-fatality rate of 10.0% in north Ethiopia and 0.0% in south Ethiopia was noted. These data show that Glucantime can be as effective as Pentostam or SSG in HIV-negative patients. The data also point to clinical pancreatitis as a safety concern, especially in patients with HIV co-infection. (C) 2010 Royal Society of Tropical Medicine and Hygiene. Published by Elsevier Ltd. All rights reserved.