Randomised efficacy and safety study of two 3-day artesunate rectal capsule/mefloquine regimens versus artesunate alone for uncomplicated malaria in Ecuadorian children
Randomised efficacy and safety study of two 3-day artesunate rectal capsule/mefloquine regimens versus artesunate alone for uncomplicated malaria in Ecuadorian children
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DOI：
10.1016/j.actatropica.2003.09.003
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发表时间：
2003-12-01
期刊：
影响因子：
2.7
通讯作者：
Cambon, N
中科院分区：
文献类型：
--
作者：
Gomez, EA;Jurado, MH;Cambon, N
青蒿琥酯和甲氟喹的组合是对抗多重抗药性恶性疟疾的最有效的治疗方法之一。然而，儿童的经验有限。本研究的目的是比较两种青蒿琥酯/甲氟喹组合与青蒿琥酯单药治疗厄瓜多尔儿童的疗效和安全性。随机选择了150名2至12岁的儿童，经证实患有单纯性恶性疟疾，并将其分为三个治疗组，每组50名患者。第1组仅接受50 mg直肠胶囊（总剂量40 mg/kg）给药6天。第2组接受50 mg直肠胶囊（30 mg/kg总剂量）3天，第1天联合甲氟喹（20 mg/kg总剂量）。第3组用50 mg直肠胶囊（30 mg/kg总剂量）治疗3天，第1天和第3天联合甲氟喹（15-17 mg/kg总剂量）。对患者进行连续随访，并通过临床和实验室检查控制7天以及第14、21和28天。在治疗后2个月进行额外的寄生虫检查。治疗组间寄生虫血症的清除率相当。第1、2和3组分别为9.2、9.2和8.3 h。第28天的治愈率分别为76、96和94%，2个月后分别为60、88和80%。研究期间未报告不良事件（AE）。生命体征和实验室检查显示无临床相关性变化。青蒿琥酯直肠胶囊与甲氟喹联合应用安全有效。在第1天开始合并给药耐受性良好。与青蒿琥酯单药治疗相比，这种联合治疗显著降低了复发率。比较两种测试的青蒿琥酯/甲氟喹方案，20 mg/kg的甲氟喹总剂量似乎比15-17 mg/kg的总剂量更有效。看来还需要进一步研究。(C)2003 Elsevier B. V.保留所有权利。
The combination of artesunate and mefloquine is one of the most effective treatments against multidrug-resistant falciparum malaria. Experience in children is however limited. The objective of this study was to compare the efficacy and safety of two artesunate/mefloquine combinations with artesunate monotherapy in Ecuadorian children. A total of 150 children with an age between 2 and 12 years, confirmed to have uncomplicated falciparum malaria, were randomly selected and divided in three treatment groups of 50 patients each. Group 1 received 50 mg rectal capsules alone (40 mg/kg total dose) administered over 6 days. Group 2 received 50 mg rectal capsules (30 mg/kg total dose) for 3 days combined with mefloquine (20 mg/kg total dose) on day 1. Group 3 was treated with 50 mg rectal capsules (30 mg/kg total dose) for 3 days, combined with mefloquine on days 1 and 3 (15-17 mg/kg total dose). Patients were continuously followed up and controlled by clinical and laboratory examinations for 7 days as well as on days 14, 21 and 28. An additional parasite examination was performed at 2 months following therapy. Clearance of parasitaemia was comparable between treatment groups. These were 9.2, 9.2 and 8.3 h for Groups 1, 2 and 3, respectively. Cure rates at day 28 were 76, 96 and 94% and after 2 months 60, 88 and 80%, respectively. There were no adverse events (AEs) reported during the study. Vital signs and laboratory examinations revealed no changes of clinical relevance. It can be concluded that the combination of artesunate rectal capsules with mefloquine is effective and safe. Starting concomitant administration already on day 1 is well tolerated. This combination significantly reduces the incidence of recrudescence compared to artesunate monotherapy. Comparing the two tested artesunate/mefloquine regimens, a total mefloquine dose of 20 mg/kg seems to be more effective compared to a total dose of 15-17 mg/kg. Further studies seem to be warranted. (C) 2003 Elsevier B.V. All rights reserved.