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首页> 外文期刊>The American Journal of Tropical Medicine and Hygiene >Artesunate and mefloquine given simultaneously for three days via a prepacked blister is equally effective and tolerated as a standard sequential treatment of uncomplicated acute Plasmodium falciparum malaria: randomized, double-blind study in Thaila
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Artesunate and mefloquine given simultaneously for three days via a prepacked blister is equally effective and tolerated as a standard sequential treatment of uncomplicated acute Plasmodium falciparum malaria: randomized, double-blind study in Thaila

机译：通过预先包装的水泡同时给予青蒿琥酯和甲氟喹三天，与简单的急性恶性疟原虫疟疾的标准序贯治疗方法一样有效且可耐受：在Thaila进行的随机，双盲研究

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The combination of artesunate and mefloquine is currently one of the most effective treatments against multidrug-resistant Plasmodium falciparum malaria. To improve patient compliance to such a combination, the two agents have been combined in a prepacked single blister. Patients were instructed to simultaneously co-administer the drugs once a day for three days. In the present randomized, double-blind, parallel group, comparative, single center study in Thailand, this concept was investigated in 204 adults and children with acute, uncomplicated P. falciparum malaria. Patients were randomized into two treatment groups and received once a day over a three-day period the following: Group A received artesunate, 4-5 mg/kg/day, and mefloquine, total dose = 25 mg/kg, approximately 8.5 mg/kg/day, simultaneously. Group B received artesunate, 4-5 mg/kg/day, and mefloquine, total dose = 25 mg/kg, sequentially (i.e., no mefloquine dose on the first day, 15 mg/kg on the second day, and 10 mg/kg on the third day). Both treatment groups showed no relevant differences in baseline demographic and clinical characteristics. Intent-to-treat analysis revealed a cure rate at day 28 (primary endpoint) of 100% in group A and 99% in group B (difference not significant). The secondary endpoints of mean time to fever clearance (group A = 34 hours, group B = 31 hours) and mean time to parasite clearance (group A = 44 hours group B = 48 hours) were similar between groups (both differences not significant). Tolerability was good in both treatment groups, with no difference in the overall incidence of adverse events. There was a low incidence of nausea/vomiting (4.9% in both groups) and central nervous system side effects (4.9% in group A versus 8.8% in group B). These were comparable between groups and generally of a mild nature. The three-day combination of artesunate and mefloquine (Artequin, Mepha, Ltd., Aesch, Switzerland) with the introduction of mefloquine on day 1 offers a practical dosing regimen that is highly effective and well tolerated in patients of different ages with uncomplicated P. falciparum malaria. It is likely that the prepacked blister approach translates clinically into a better patient compliance, thereby contributing to limit the development of drug resistance.
机译：青蒿琥酯和甲氟喹的组合目前是对抗多重耐药性恶性疟原虫疟疾最有效的治疗方法之一。为了提高患者对这种组合的依从性，已将两种药剂合并在预包装的单泡罩中。指示患者每天一次同时服用药物，持续三天。在泰国目前的随机，双盲，平行组，比较，单中心研究中，对204名成年和未患恶性疟原虫疟疾的成人和儿童进行了研究。将患者随机分为两个治疗组，并在三天的时间内每天接受以下药物：A组接受青蒿琥酯，4-5 mg / kg /天和甲氟喹，总剂量= 25 mg / kg，约8.5 mg /公斤/天，同时。 B组依次接受4-5 mg / kg /天的青蒿琥酯和甲氟喹，总剂量= 25 mg / kg（即，第一天无甲氟喹剂量，第二天为15 mg / kg，10 mg / kg）。公斤（第三天）。两个治疗组在基线人口统计学和临床​​特征方面均无相关差异。意向治疗分析显示，第28天（主要终点）治愈率在A组为100％，在B组为99％（差异不显着）。各组平均发烧清除时间（A组= 34小时，B组= 31小时）和平均寄生虫清除时间（A组= 44小时B组= 48小时）的次要终点相似（两组差异均无统计学意义） 。两个治疗组的耐受性均良好，不良事件的总发生率无差异。恶心/呕吐的发生率较低（两组均为4.9％）和中枢神经系统副作用（A组为4.9％，B组为8.8％）。这些在各组之间是可比的，并且通常是温和的。青蒿琥酯和甲氟喹的三天组合（瑞士阿伊斯汀，阿法汀，Mepha，Ltd。，瑞士埃斯）在第1天开始使用甲氟喹，提供了一种实用的给药方案，对于不同年龄的单纯性P患者，该方案高度有效且耐受性良好。恶性疟疾。预包装的泡罩方法可能在临床上转化为更好的患者依从性，从而有助于限制耐药性的发展。

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