A randomized, controlled study of a simple, once-daily regimen of dihydroartemisinin-piperaquine for the treatment of uncomplicated, multidrug-resistant falciparum malaria
A randomized, controlled study of a simple, once-daily regimen of dihydroartemisinin-piperaquine for the treatment of uncomplicated, multidrug-resistant falciparum malaria
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DOI：
10.1086/432011
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发表时间：
2005-08-15
影响因子：
11.8
通讯作者：
Nosten, F
中科院分区：
文献类型：
--
作者：
Ashley, EA;McGready, R;Nosten, F
背景双氢青蒿素-哌喹（DP）是一种固定复方抗疟药，在东南亚越来越多地使用。目前的方案包括在3天内给予4剂。简化的剂量方案应促进治疗的依从性，从而提高有效性。在泰国西北边境进行的一项随机、对照、3组试验中，将DP（DP 4）的标准4剂量疗程与每日一次方案（DP 3）的等效剂量以及甲氟喹-青蒿琥酯（MAS 3）的标准治疗进行了比较。共有499名患者被纳入研究。所有组的发热和寄生虫清除时间相似。治疗开始后第63天，MAS 3、DP 4和DP 3的PCR基因分型调整治愈率分别为95.7%（95%置信区间[ 95% CI]，92.2%-98.9%）、100%和99.4%（95% CI，98.1%-100%）。DP 4和DP 3的治愈率显著高于MAS 3（分别为和）。Pp. 008页03所有方案均耐受良好。有3例死亡（1例在MAS 3组，2例在DP 3组），认为所有死亡均与给药无关。其他不良事件的发生率在两组之间相当，但腹泻除外，腹泻在DP 4组中更常见（与MAS 3组相比）。Pp. 05结论。每日一次、3剂DP方案是治疗多重耐药恶性疟疾的高效疗法。这种简单、安全且相对便宜的固定组合可能成为恶性疟疾的首选治疗方法。
Background. Dihydroartemisinin-piperaquine (DP) is a fixed-combination antimalarial drug increasingly deployed in Southeast Asia. The current regimen involves 4 doses given over 3 days. Simplification of the dose regimen should facilitate treatment adherence and thereby increase effectiveness.Methods. In a randomized,controlled, 3-arm trial conducted along the northwestern border of Thailand, the standard 4-dose course of DP (DP4) was compared to an equivalent dose given as a once-daily regimen (DP3) and to the standard treatment of mefloquine-artesunate (MAS3).Results. A total of 499 patients were included in the study. Times to fever and parasite clearance were similar in all groups. The PCR genotyping-adjusted cure rates at day 63 after treatment initiation were 95.7% (95% confidence interval [ 95% CI], 92.2%-98.9%) for MAS3, 100% for DP4, and 99.4% (95%CI, 98.1%-100%) for DP3. The DP4 and DP3 cure rates were significantly higher than that for MAS3 ( and, respectively). Pp. 008 Pp. 03 All regimens were well tolerated. There were 3 deaths ( 1 in the MAS3 group and 2 in the DP3 group), all of which were considered to be unrelated to treatment. Rates of other adverse events were comparable between the groups, except for diarrhea, which was more common in the DP4 group ( vs. the MAS3 group). Pp. 05Conclusions. A once-daily, 3-dose regimen of DP is a highly efficacious treatment for multidrug-resistant falciparum malaria. This simple, safe, and relatively inexpensive fixed combination could become the treatment of choice for falciparum malaria.