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双氢青蒿素哌喹与青蒿琥酯阿莫地喹治疗越南中部非复杂性恶性疟原虫疟疾的开放标签随机对照研究

Open label randomized comparison of dihydroartemisinin-piperaquine and artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in central Vietnam.

作者信息

Thanh Nguyen Xuan, Trung Trieu Nguyen, Phong Nguyen Chinh, Thien Nguyen Xuan, Dai Bui, Shanks G Dennis, Chavchich Marina, Edstein Michael D

机构信息

Military Institute of Hygiene and Epidemiology, Hanoi, Vietnam.

出版信息

Trop Med Int Health. 2009 May;14(5):504-11. doi: 10.1111/j.1365-3156.2009.02269.x. Epub 2009 Mar 19.

Abstract

OBJECTIVE

Artesunate-amodiaquine (AAQ) is efficacious for the treatment of uncomplicated Plasmodium falciparum malaria in Africa, but little is known about its efficacy in Southeast Asia. We compared the efficacy of dihydroartemisinin-piperaquine (DHP) and AAQ against falciparum malaria in central Vietnam.

METHODS

Open, randomized clinical trial of 116 patients (36 children aged 6-14 years, 80 adults aged 15-60 years) were randomly allocated a 3-day course of either DHP (approximately 2.3 mg/kg dihydroartemisinin plus approximately 18.5 mg/kg of piperaquine per day) or AAQ (approximately 4.4 mg/kg of artesunate plus approximately 10.6 mg/kg of amodiaquine per day). The follow-up period was 42 days.

RESULTS

The two drug combinations were well tolerated by all age groups with no obvious drug associated adverse events. Of the patients who completed 42 days of follow-up, 49 were on DHP (15 children, 34 adults) and 49 were on AAQ (14 children, 35 adults). The 42 day cure rates adjusted for reinfection identified by PCR genotyping for the two groups were similar [100% (49/49) and 98% (48/49) for DHP and AAQ, respectively]. With fewer reinfections, DHP appears to possess greater post-treatment prophylactic activity than AAQ.

CONCLUSION

AAQ, an inexpensive artemisinin-based combination, could be an additional option to DHP for the treatment of multidrug-resistant falciparum malaria in Vietnam.

摘要

目的

青蒿琥酯-阿莫地喹(AAQ)对非洲非复杂性恶性疟原虫疟疾的治疗有效,但对其在东南亚的疗效了解甚少。我们比较了双氢青蒿素-哌喹(DHP)和AAQ在越南中部治疗恶性疟的疗效。

方法

对116例患者(36例6至14岁儿童,80例15至60岁成人)进行开放、随机临床试验,将其随机分配接受为期3天的DHP疗程(约2.3毫克/千克双氢青蒿素加约18.5毫克/千克哌喹每日)或AAQ疗程(约4.4毫克/千克青蒿琥酯加约10.6毫克/千克阿莫地喹每日)。随访期为42天。

结果

所有年龄组对这两种药物组合耐受性良好,无明显药物相关不良事件。完成42天随访的患者中,49例接受DHP治疗(15例儿童,34例成人),49例接受AAQ治疗(14例儿童,35例成人)。通过PCR基因分型确定的两组经再感染调整后的42天治愈率相似[DHP和AAQ分别为100%(49/49)和98%(48/49)]。由于再感染较少,DHP似乎比AAQ具有更大的治疗后预防活性。

结论

AAQ作为一种廉价的青蒿素类联合用药,可能成为越南治疗多重耐药恶性疟的DHP之外的另一种选择。

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