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双氢青蒿素/哌喹(科泰新)治疗卢旺达儿童非复杂性恶性疟原虫疟疾的安全性和有效性

Safety and efficacy of dihydroartemisinin/piperaquine (Artekin) for the treatment of uncomplicated Plasmodium falciparum malaria in Rwandan children.

作者信息

Karema Corine, Fanello Caterina I, van Overmeir Chantal, van Geertruyden Jean-Pierre, van Doren Walli, Ngamije Daniel, D'Alessandro Umberto

机构信息

National Malaria Control Program, Kigali, Rwanda.

出版信息

Trans R Soc Trop Med Hyg. 2006 Dec;100(12):1105-11. doi: 10.1016/j.trstmh.2006.01.001. Epub 2006 Jun 12.

DOI:10.1016/j.trstmh.2006.01.001
PMID:16766006
Abstract

In Rwanda, amodiaquine+sulfadoxine/pyrimethamine (AQ+SP) is the current first-line treatment for malaria, introduced in 2001 as an interim strategy before the future deployment of an artemisinin-based combination treatment (ACT). Dihydroartemisinin/piperaquine (DHA-PQP) is a new co-formulated and well tolerated ACT increasingly used in Southeast Asia where it has proved to be highly effective against Plasmodium falciparum malaria. We tested the efficacy, safety and tolerability of DHA-PQP in children with uncomplicated P. falciparum malaria. A randomised, open trial was carried out in 2003-2004. Seven hundred and sixty-two children aged 12-59 months with uncomplicated P. falciparum malaria were randomly allocated to one of the following treatments: amodiaquine+artesunate; AQ+SP; or DHA-PQP. Patients were followed-up until Day 28 after treatment. Adverse events and clinical and parasitological outcomes were recorded. Children treated with DHA-PQP or AQ+AS had a significantly higher cure rate compared with those treated with amodiaquine+sulfadoxine/pyrimethamine (95.2% and 92.0% vs. 84.7%, respectively). Parasite clearance was significantly faster in children treated with DHA-PQP and AQ+AS compared with those treated with amodiaquine+sulfadoxine/pyrimethamine. The frequency of adverse events was significantly lower in patients treated with DHA-PQP than in those treated with combinations containing amodiaquine. A 3-day treatment with DHA-PQP proved to be efficacious with a good safety and tolerability profile and could be a good candidate for the next first-line treatment.

摘要

在卢旺达,阿莫地喹+磺胺多辛/乙胺嘧啶(AQ+SP)是目前疟疾的一线治疗药物,于2001年作为青蒿素联合疗法(ACT)未来推广之前的临时策略引入。双氢青蒿素/哌喹(DHA-PQP)是一种新的复方制剂,耐受性良好,在东南亚越来越多地使用,已证明对恶性疟原虫疟疾高度有效。我们测试了DHA-PQP在非复杂性恶性疟原虫疟疾儿童中的疗效、安全性和耐受性。2003年至2004年进行了一项随机、开放试验。762名年龄在12至59个月的非复杂性恶性疟原虫疟疾儿童被随机分配到以下治疗组之一:阿莫地喹+青蒿琥酯;AQ+SP;或DHA-PQP。对患者进行随访至治疗后第28天。记录不良事件以及临床和寄生虫学结果。与接受阿莫地喹+磺胺多辛/乙胺嘧啶治疗的儿童相比,接受DHA-PQP或AQ+AS治疗的儿童治愈率显著更高(分别为95.2%和92.0%对84.7%)。与接受阿莫地喹+磺胺多辛/乙胺嘧啶治疗的儿童相比,接受DHA-PQP和AQ+AS治疗的儿童寄生虫清除速度明显更快。接受DHA-PQP治疗的患者不良事件发生率明显低于接受含阿莫地喹联合治疗的患者。为期3天的DHA-PQP治疗被证明是有效的,具有良好的安全性和耐受性,可能是下一线治疗的良好候选药物。

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