Department of Parasitology and Mycology, Faculty of Pharmaceutical and Biological Sciences, Abidjan, Côte d'Ivoire.
Malar J. 2011 Jul 20;10:198. doi: 10.1186/1475-2875-10-198.
The choice of appropriate artemisinin-based combination therapy depends on several factors (cost, efficacy, safety, reinfection rate and simplicity of administration). To assess whether the combination dihydroartemisinin-piperaquine (DP) could be an alternative to artemether-lumefantrine (AL), the efficacy and the tolerability of the two products for the treatment of uncomplicated falciparum malaria in sub-Saharan Africa have been compared.
A multicentric open randomized controlled clinical trial of three-day treatment of DP against AL for the treatment of two parallel groups of patients aged two years and above and suffering from uncomplicated falciparum malaria was carried out in Cameroon, Côte d'Ivoire and Senegal. Within each group, patients were randomly assigned supervised treatment. DP was given once a day for three days and AL twice a day for three days. Follow-up visits were performed on day 1 to 4 and on day 7, 14, 21, 28 to evaluate clinical and parasitological results. The primary endpoint was the recovery rate by day 28.
Of 384 patients enrolled, 197 were assigned DP and 187 AL. The recovery rates adjusted by genotyping, 99.5% in the DP group and 98.9% in the AL group, were not statistically different (p=0.538). No Early Therapeutic Failure (ETF) was observed. At day 28, two patients in the DP group and five in AL group had recurrent parasitaemia with Plasmodium falciparum. In the DP group, after PCR genotyping, one of the two recurrences was classified as a new infection and the other as recrudescence. In AL group, two recurrences were classified after correction by PCR as recrudescence. All cases of recrudescence were classified as Late Parasitological Failure (LPF). In each group, a rapid recovery from fever and parasitaemia was noticed. More than 90% of patients did no longer present fever or parasitaemia 48 hours after treatment. Both drugs were well tolerated. Indeed, no serious adverse events were reported during the follow-up period. Most of the adverse events which developed were moderate and did not result in the treatment being stopped in either treatment group.
Dihydroartemisinin-piperaquine was as effective and well-tolerated as artemether-lumefantrine in the treatment of uncomplicated falciparum malaria. In addition, dihydroartemisinin-piperaquine, a single daily dose, could be an advantage over artemether-lumefantrine in Africa because of better treatment observance.
选择合适的青蒿素类复方疗法取决于多个因素（成本、疗效、安全性、再感染率和给药简便性）。为评估二氢青蒿素-哌喹（DP）能否替代青蒿琥酯-甲氟喹（AL），对这两种药物治疗撒哈拉以南非洲地区无并发症恶性疟的疗效和耐受性进行了比较。
在喀麦隆、科特迪瓦和塞内加尔进行了一项为期 3 天的 DP 与 AL 治疗无并发症恶性疟的多中心、开放性、随机对照临床试验，比较两组年龄在 2 岁及以上的无并发症恶性疟患者。在每组内，患者均接受有监督的治疗。DP 每日 1 次，共 3 天；AL 每日 2 次，共 3 天。在第 1 至 4 天及第 7、14、21、28 天进行随访，以评估临床和寄生虫学结果。主要终点为第 28 天的恢复率。
384 例患者中，197 例接受 DP 治疗，187 例接受 AL 治疗。DP 组和 AL 组经基因分型校正后的恢复率分别为 99.5%和 98.9%，差异无统计学意义（P=0.538）。未观察到早期治疗失败（ETF）。在第 28 天，DP 组有 2 例患者和 AL 组有 5 例患者出现疟原虫复燃。在 DP 组中，2 例复燃病例经 PCR 基因分型后，1 例为新感染，1 例为复发。在 AL 组中，PCR 校正后，2 例复燃病例被归类为复发。所有复发病例均归类为晚期寄生虫学失败（LPF）。两组患者发热和寄生虫血症均迅速恢复。治疗后 48 小时，超过 90%的患者不再发热或存在寄生虫血症。两种药物均具有良好的耐受性。事实上，在随访期间未报告严重不良事件。大多数发生的不良事件为中度，且未导致任何一组患者停止治疗。
二氢青蒿素-哌喹与青蒿琥酯-甲氟喹治疗无并发症恶性疟的疗效相当，且耐受性良好。此外，二氢青蒿素-哌喹每日 1 剂，在非洲地区可能优于青蒿琥酯-甲氟喹，因为其治疗依从性更好。
