Fanello C I, Karema C, Ngamije D, Uwimana A, Ndahindwa V, Van Overmeir C, Van Doren W, Curtis J, D'Alessandro U
London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
Trans R Soc Trop Med Hyg. 2008 May;102(5):412-20. doi: 10.1016/j.trstmh.2008.01.013. Epub 2008 Mar 6.
We tested the efficacy and safety of chlorproguanil/dapsone co-administered with artesunate (CD+A) for the treatment of uncomplicated Plasmodium falciparum malaria in children compared with amodiaquine+sulfadoxine/pyrimethamine (AQ+SP) at two different sites in Rwanda. The trial was open label and 800 patients were randomly assigned to AQ+SP (n=400) or CD+A (n=400). Patients were hospitalised for 3 days and then followed-up weekly until Day 28 after treatment. Clinical and parasitological outcomes were recorded. Results showed that neither treatment was adequately efficacious. At one site, the adequate clinical and parasitological response (ACPR), PCR-adjusted, was 73.3% in the CD+A arm and 87.8% in the AQ+SP arm (P<0.001), and at the second site the ACPR, PCR-adjusted, was 70.5% in the CD+A arm and 38.1% in the AQ+SP arm (P<0.001). The combination CD+A is considered an alternative to, or replacement for, SP in Africa because CD has been shown to be effective in patients for whom SP treatment has failed and, with its short half-life, it is expected to exert less selection pressure for resistant parasites than SP. However, the results of this trial indicate that in an area of high SP resistance, CD+A may not be the best choice.
我们在卢旺达的两个不同地点，测试了氯胍/氨苯砜与青蒿琥酯联合用药（CD+A）治疗儿童单纯性恶性疟原虫疟疾的疗效和安全性，并与阿莫地喹+磺胺多辛/乙胺嘧啶（AQ+SP）进行了比较。该试验为开放标签试验，800名患者被随机分配至AQ+SP组（n=400）或CD+A组（n=400）。患者住院3天，然后每周随访直至治疗后第28天。记录临床和寄生虫学结果。结果显示，两种治疗方法均未达到充分的疗效。在一个地点，经PCR调整后的充分临床和寄生虫学反应（ACPR）在CD+A组为73.3%，在AQ+SP组为87.8%（P<0.001）；在第二个地点，经PCR调整后的ACPR在CD+A组为70.5%，在AQ+SP组为38.1%（P<0.001）。在非洲，CD+A组合被认为是SP的替代药物，因为已证明CD对SP治疗失败的患者有效，而且由于其半衰期短，预计与SP相比，它对耐药寄生虫产生的选择压力较小。然而，该试验结果表明，在SP耐药性高的地区，CD+A可能不是最佳选择。
