Barennes Hubert, Nagot Nicholas, Valea Innocent, Koussoubé-Balima Tatiana, Ouedraogo Albert, Sanou Thérèse, Yé Suzanne
Unité d'Epidémiologie d'Intervention Centre Muraz, Bobo Dioulasso, Burkina Faso.
Trop Med Int Health. 2004 Apr;9(4):438-44. doi: 10.1111/j.1365-3156.2004.01224.x.
Combining artesunate (AR) with existing antimalarial drugs may improve cure rates, delay emergence of resistance and reduce parasite clearance time. In order to investigate the latter, we conducted a randomized clinical trial testing the AR plus amodiaquine (AQ) combination for the treatment of uncomplicated Plasmodium falciparum malaria in Burkina Faso. Children aged 1-15 years were randomly assigned to either AQ (10 mg/kg) or AR (4 mg/kg first day then half dose) or AQ + AR (AQAR) as a single daily dose under supervision for three consecutive days for all groups. Follow-up lasted 28 days. Primary endpoints were parasite and fever clearance time. Eighty-seven children were evaluated: 27 received AQ, 27 AR and 33 AQAR. Using an intention to treat analysis, fever clearance time was similar in the three groups. However, it was significantly faster in the AR (1.21 days; P = 0.02) and AQAR groups (1.19 days; P < 0.01) than in the AQ group (1.46 days) when excluding other concomitant causes of fever. Parasite clearance time was faster in AR (1.13 days; P = 0.008) and AQAR groups (1.13 days; P < 0.01) than in the AQ group (1.6 days). All children cleared their parasites by day 14, including the child with Late Parasitological Failure (LPF) at day 7 after rescue treatment. Only one child (4%) from the AR group and one (4%) from the AQ group presented with asymptomatic parasitaemia at day 7 and day 21, respectively (LPF). Gametocyte carriage was not detectable in any group during follow-up nor was any adverse reaction observed. While resistance to first-line treatment (chloroquine) is already established in the country, AQ and AR used alone or in combination therapy proved highly efficacious in our study. Burkina Faso stands in a very good situation for an internationally recommended switch to AR-containing combination as first-line treatment for uncomplicated malaria. Including AQ in this regimen seems the best option.
将青蒿琥酯（AR）与现有的抗疟药物联合使用可能会提高治愈率、延缓耐药性的出现并缩短寄生虫清除时间。为了研究后者，我们在布基纳法索进行了一项随机临床试验，测试AR加阿莫地喹（AQ）联合用药治疗单纯性恶性疟原虫疟疾的效果。1至15岁的儿童被随机分为三组，分别接受AQ（10毫克/千克）、AR（首日4毫克/千克，之后减半）或AQ + AR（AQAR）治疗，所有组均在监督下每日单次给药，连续三天。随访持续28天。主要终点指标为寄生虫清除时间和退热时间。共评估了87名儿童：27名接受AQ治疗，27名接受AR治疗，33名接受AQAR治疗。采用意向性分析，三组的退热时间相似。然而，排除其他发热伴随原因后，AR组（1.21天；P = 0.02）和AQAR组（1.19天；P < 0.01）的退热时间显著快于AQ组（1.46天）。AR组（1.13天；P = 0.008）和AQAR组（1.13天；P < 0.01）的寄生虫清除时间快于AQ组（1.6天）。所有儿童在第14天前均清除了寄生虫，包括在抢救治疗后第7天出现晚期寄生虫学失败（LPF）的儿童。AR组仅有一名儿童（4%）在第7天出现无症状寄生虫血症，AQ组有一名儿童（4%）在第21天出现无症状寄生虫血症（LPF）。随访期间，任何组均未检测到配子体携带情况，也未观察到任何不良反应。虽然该国已出现对一线治疗药物（氯喹）的耐药性，但在我们的研究中，单独使用或联合使用AQ和AR均显示出高效性。布基纳法索在国际上推荐将含AR的联合用药作为单纯性疟疾的一线治疗方案方面处于非常有利地位。在此方案中加入AQ似乎是最佳选择。
