Penali Louis Koné, Jansen Frans Herwig
Unité de Paludologie, Institut Pasteur, Abidjan, Ivory Coast.
Int J Infect Dis. 2008 Jul;12(4):430-7. doi: 10.1016/j.ijid.2007.12.006. Epub 2008 Mar 17.
Malaria kills approximately 1.5 to 2.7 million people each year. Despite the introduction of artemisinin-based combination therapies (ACTs), the treatment of malaria is hampered by problems such as inadequate efficacy, recrudescence, early re-infection, low patient compliance, and high cost price of drugs. This study tested the hypothesis that the co-formulated fixed dose combination (FDC) artesunate/sulfamethoxypyrazine/pyrimethamine (As/SMP) administered as a 24-hour therapy with a dose interval of 12 hours is as efficacious and safe as the administration of the same drug over 3 days given with a dose interval of 24 hours, for the treatment of uncomplicated Plasmodium falciparum malaria in Ivory Coast.
Two hundred and twenty-one patients presenting with uncomplicated P. falciparum malaria were randomly assigned to either one of the two dosing schemes. Treatment efficacy was assessed using the current 28-day World Health Organization protocol, success being determined by absence of recrudescence and parasitemia on day 28.
Both treatment regimens were highly efficacious, with a success rate of 100% (111/111) for the 3-day therapy and 99% (109/110) for the 24-hour therapy. Only one patient in the 24-hour therapy group showed late treatment failure. No serious adverse events or significant laboratory abnormalities were seen.
The 24-hour therapy is as well tolerated and efficacious as the same medicament administered over 3 days. This low cost and simplified three-pill treatment is certain to improve compliance.
疟疾每年导致约150万至270万人死亡。尽管引入了以青蒿素为基础的联合疗法(ACTs),但疟疾治疗仍受到疗效不佳、复发、早期再感染、患者依从性低以及药物成本高等问题的阻碍。本研究检验了以下假设:对于科特迪瓦单纯性恶性疟原虫疟疾的治疗,以12小时的给药间隔进行24小时治疗的复方固定剂量组合(FDC)青蒿琥酯/磺胺多辛/乙胺嘧啶(As/SMP)与以24小时的给药间隔给药3天的相同药物疗效和安全性相当。
221例单纯性恶性疟原虫疟疾患者被随机分配到两种给药方案中的一种。使用当前的28天世界卫生组织方案评估治疗效果,成功的判定标准为第28天无复发和寄生虫血症。
两种治疗方案均具有高效性,3天疗法的成功率为100%(111/111),24小时疗法的成功率为99%(109/110)。24小时疗法组中只有1例患者出现晚期治疗失败。未观察到严重不良事件或显著的实验室异常。
24小时疗法与给药3天的相同药物耐受性和疗效相当。这种低成本且简化为三片的治疗方法肯定会提高依从性。