Dihydroartemisinin-Piperaquine Versus Chloroquine in the Treatment of Plasmodium vivax Malaria in Thailand: A Randomized Controlled Trial
Dihydroartemisinin-Piperaquine Versus Chloroquine in the Treatment of Plasmodium vivax Malaria in Thailand: A Randomized Controlled Trial
复制标题
DOI：
10.1093/cid/cir631
复制
发表时间：
2011-11-15
影响因子：
11.8
通讯作者：
Nosten, Francois
中科院分区：
文献类型：
--
作者：
Phyo, Aung Pyae;Lwin, Khin Maung;Nosten, Francois
背景资料。在泰国西北部边境，氯喹治疗间日疟的疗效正在下降。这项对500名成人和儿童进行的随机对照试验表明，双氢青蒿素-哌喹是一种安全有效的替代治疗方法。我们进行了一项随机对照研究，比较了CQ和双氢青蒿素哌喹(DP)治疗泰国西北部边境500例成人和儿童急性间日疟的疗效和耐受性。两种药物的耐受性都很好。CQ组的发热和寄生虫清除时间比DP组慢(P<；.001)。到第28天，接受CQ治疗的207人中有18人出现复发感染，而接受DP治疗的230人中有5人出现复发感染(相对危险度为4.0；95%可信区间为1.51-10.58；P=0.0046)。接受CQ治疗的患者9周时间日疟复发的累积风险为79.1%(95%CI，73.5%-84.8%)，而接受DP治疗的患者为54.9%(95%CI，48.2%-61.6%)(风险比[HR]，2.27；95%CI，1.8-2.9；P<；.001)。5岁以下儿童间日疟原虫复发风险(74.4%；95%CI，63.2%-85.6%)高于老年患者(55.3%[95%CI，50.2%-60.4%]；HR，1.58[95%CI，1.1-2.2]；P=0.005)。体外药敏试验显示，13%的受试菌对CQ的半数抑制浓度为&100nmol/L，表明其敏感性降低。在泰缅边境，CQ治疗间日疟原虫感染的疗效正在下降。DP是一种有效的替代疗法。临床试验注册。ISRCTN87827353。
Background. The efficacy of chloroquine in the treatment of Plasmodium vivax malaria is declining on the Northwestern border of Thailand. This randomized controlled trial in 500 adults and children shows that dihydroartemisinin-piperaquine is a safe and effective alternative treatment.Methods. We conducted a randomized controlled study to compare the efficacy and the tolerability of CQ and dihydroartemisinin-piperaquine (DP) in 500 adults and children with acute vivax malaria on the Northwestern border of Thailand.Results. Both drugs were well tolerated. Fever and parasite clearance times were slower in the CQ than in the DP group (P < .001). By day 28, recurrent infections had emerged in 18 of 207 CQ recipients compared with 5 of 230 treated with DP (relative risk, 4.0; 95% confidence interval [CI], 1.51-10.58; P = .0046). The cumulative risk of recurrence with P. vivax at 9 weeks was 79.1% (95% CI, 73.5%-84.8%) in patients treated with CQ compared with 54.9% (95% CI, 48.2%-61.6%) in those receiving DP (hazard ratio [HR], 2.27; 95% CI, 1.8-2.9; P < .001). Children < 5 years old were at greater risk of recurrent P. vivax infection (74.4%; 95% CI, 63.2%-85.6%) than older patients (55.3% [95% CI, 50.2%-60.4%]; HR, 1.58 [95% CI, 1.1-2.2]; P = .005). In vitro susceptibility testing showed that 13% of the tested isolates had a CQ median inhibitory concentration > 100 nmol/L, suggesting reduced susceptibility.Conclusions. The efficacy of CQ in the treatment of P. vivax infections is declining on the Thai-Myanmar border. DP is an effective alternative treatment.Clinical Trials Registration. ISRCTN87827353.