Military Institute of Hygiene and Epidemiology, Hanoi, Vietnam.
Malar J. 2012 Jun 28;11:217. doi: 10.1186/1475-2875-11-217.
In Vietnam, the artemisinin-based combination therapy (ACT) of dihydroartemisinin-piperaquine is currently used for first-line treatment of uncomplicated Plasmodium falciparum malaria. However, limited efficacy and tolerability data are available on alternative forms of ACT in Vietnam in case there is a reduction in the susceptibility of dihydroartemisinin-piperaquine. A study was conducted to compare the efficacy and tolerability of two fixed-dose formulations of ACT, artemisinin-piperaquine (Artequick®, ARPQ) and artesunate-amodiaquine (Coarsucam™, ASAQ) for the treatment of P. falciparum malaria in south-central Vietnam.
A randomized, open-label trial was conducted comparing the efficacy of a two-day regimen of ARPQ (2.8 mg/kg artemisinin plus ~17.1 mg/kg of piperaquine per day) and a three-day regimen of ASAQ (4.7 mg/kg of artesunate plus ~12.6 mg/kg of amodiaquine per day) for the treatment of children and adults with uncomplicated falciparum malaria. Primary efficacy endpoint was day 42, PCR-corrected, parasitological cure rate. Secondary endpoints were parasite and fever clearance times and tolerability.
Of 128 patients enrolled, 63 were administered ARPQ and 65 ASAQ. Of the patients who completed the 42 days follow-up period or had a recurrence of malaria, 55 were on ARPQ (30 children, 25 adults) and 59 were on ASAQ (31 children, 28 adults). Recrudescent parasitaemia was PCR-confirmed for one patient in each treatment group, with cure rates at day 42 of 98% (95% CI: 88-100) for both forms of ACT. The median parasite clearance time was significantly slower in the ARPQ group compared with the ASAQ group (48 h vs. 36 h, P<0.001) and fever clearance times were shorter in the ASAQ group (12 h vs. 24 h, P=0.07). The two forms of ACT were well tolerated with no serious adverse events.
Both forms of ACT were highly efficacious in the treatment of uncomplicated P. falciparum malaria. Although the two-day course of ARPQ was equally as effective as the three-day course of ASAQ, parasite and fever clearance times were shorter with ASAQ. Further studies are warranted in different regions of Vietnam to determine the nationwide efficacy of ASAQ.
Australian New Zealand Clinical Trials Registry Number, ACTRN12609000816257.
在越南，双氢青蒿素哌喹复方疗法（ACT）目前被用作治疗无并发症恶性疟原虫疟疾的一线药物。然而，在双氢青蒿素哌喹敏感性降低的情况下，有关越南其他形式的 ACT 的疗效和耐受性的数据有限。本研究旨在比较两种固定剂量的 ACT（青蒿琥酯哌喹[Artequick®，ARPQ]和青蒿琥酯阿莫地喹[Coarsucam™，ASAQ]）在治疗越南中南部地区恶性疟原虫疟疾的疗效和耐受性。
采用随机、开放标签试验，比较 2 天疗程的 ARPQ（2.8mg/kg 青蒿琥酯加17.1mg/kg 哌喹/天）和 3 天疗程的 ASAQ（4.7mg/kg 青蒿琥酯加12.6mg/kg 阿莫地喹/天）治疗儿童和成人无并发症恶性疟的疗效。主要疗效终点为第 42 天 PCR 校正后寄生虫学治愈率。次要终点为寄生虫和退热时间以及耐受性。
128 例患者中，63 例接受了 ARPQ 治疗，65 例接受了 ASAQ 治疗。在完成 42 天随访或疟疾复发的 128 例患者中，55 例接受了 ARPQ（30 例儿童，25 例成人）治疗，59 例接受了 ASAQ（31 例儿童，28 例成人）治疗。两组各有 1 例患者经 PCR 确认复燃，ACT 两种剂型的第 42 天治愈率均为 98%（95%CI：88-100）。ARPQ 组的寄生虫清除时间明显慢于 ASAQ 组（48h 比 36h，P<0.001），而 ASAQ 组的退热时间较短（12h 比 24h，P=0.07）。两种 ACT 剂型均耐受良好，无严重不良事件。
两种 ACT 剂型治疗无并发症恶性疟原虫疟疾均具有高度疗效。虽然 ARPQ 两日疗程与 ASAQ 三日疗程同样有效，但 ASAQ 的寄生虫和退热时间更短。需要在越南不同地区进一步研究，以确定 ASAQ 在全国范围内的疗效。
澳大利亚新西兰临床试验注册中心编号，ACTRN12609000816257。
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