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阿特金与青蒿琥酯-甲氟喹治疗急性非复杂性恶性疟的开放随机临床试验。

An open randomized clinical trial of Artekin vs artesunate-mefloquine in the treatment of acute uncomplicated falciparum malaria.

作者信息

Tangpukdee N, Krudsood S, Thanachartwet W, Chalermrut K, Pengruksa C, Srivilairit S, Silachamroon U, Wilairatana P, Phongtananant S, Kano S, Looareesuwan S

机构信息

Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.

出版信息

Southeast Asian J Trop Med Public Health. 2005 Sep;36(5):1085-91.

PMID:16438129
Abstract

Malaria remains a major cause of morbidity and mortality in tropical countries and subtropical regions in the world. Southeast Asia has the most resistant malaria parasites in the world, which has limited treatment options in this region. In response to this situation, short-course artemisinin-based combination therapies (ACTs) have been developed. The combination of dihydroartemisinin (DHA) and piperaquine (PQP) in the form of Artekin has been developed as an alternative to established combinations, such as artesunate-mefloquine, primarily to reduce treatment costs and toxicity. We conducted a study comparing a standard treatment for acute uncomplicated falciparum malaria (artesunate 4 mg/kg/day together with mefloquine 8 mg/kg/day oral route once a day for 3 days) (Group A) and a combination of dihydroartemisinin 40 mg and piperaquine 320 mg in the form of Artekin given once a day for 3 days (Group B) to determine safety, efficacy, and tolerability. One hundred and eighty patients were randomly enrolled at the ratio of 1:2 into groups A:B. All patients had rapid initial clinical and parasitological responses. There were no significant differences in fever clearance time or parasite clearance time between both groups. The 28-day cure rates were high, at 100% and 99%, in groups A and B, respectively. We conclude that Artekin was as effective and well-tolerated as artesunate-mefloquine, and can be used alternatively as the current treatment for multidrug-resistant P. falciparum malaria.

摘要

疟疾仍然是世界上热带国家和亚热带地区发病和死亡的主要原因。东南亚拥有世界上耐药性最强的疟原虫,这限制了该地区的治疗选择。针对这种情况,已开发出基于青蒿素的短疗程联合疗法(ACTs)。以Artekin形式存在的双氢青蒿素(DHA)和哌喹(PQP)组合已被开发出来,作为已确立的联合疗法(如青蒿琥酯-甲氟喹)的替代方案,主要是为了降低治疗成本和毒性。我们进行了一项研究,比较急性非复杂性恶性疟的标准治疗方法(青蒿琥酯4mg/kg/天,与甲氟喹8mg/kg/天联合,口服,每天一次,共3天)(A组)和以Artekin形式存在的双氢青蒿素40mg与哌喹320mg的组合,每天一次,共3天(B组),以确定安全性、有效性和耐受性。180名患者按1:2的比例随机分为A组和B组。所有患者最初均有快速的临床和寄生虫学反应。两组之间的退热时间或寄生虫清除时间无显著差异。A组和B组的28天治愈率分别高达100%和99%。我们得出结论,Artekin与青蒿琥酯-甲氟喹一样有效且耐受性良好,可作为目前多药耐药恶性疟原虫疟疾的替代治疗方法。

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