两种青蒿琥酯直肠胶囊/甲氟喹三日疗法与单用青蒿琥酯治疗厄瓜多尔儿童单纯性疟疾的随机疗效和安全性研究。

Randomised efficacy and safety study of two 3-day artesunate rectal capsule/mefloquine regimens versus artesunate alone for uncomplicated malaria in Ecuadorian children.

作者信息

Gomez E A, Jurado M H, Cambon N

机构信息

Medical Sciences Faculty, Institute of Biomedicine, Catholic University, P.O. Box 593 04 4671, Guayaquil, Ecuador.

出版信息

Acta Trop. 2003 Dec;89(1):47-53. doi: 10.1016/j.actatropica.2003.09.003.

DOI:10.1016/j.actatropica.2003.09.003

PMID:14636982

Abstract

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.

摘要

青蒿琥酯和甲氟喹联合用药是治疗耐多药恶性疟最有效的方法之一。然而，针对儿童的经验有限。本研究的目的是比较两种青蒿琥酯/甲氟喹联合用药方案与青蒿琥酯单药治疗在厄瓜多尔儿童中的疗效和安全性。总共随机选择了150名年龄在2至12岁之间、确诊为非复杂性恶性疟的儿童，并将其分为三个治疗组，每组50名患者。第1组仅接受50毫克直肠胶囊（总剂量40毫克/千克），分6天给药。第2组接受50毫克直肠胶囊（总剂量30毫克/千克），连用3天，并在第1天联合使用甲氟喹（总剂量20毫克/千克）。第3组接受50毫克直肠胶囊（总剂量30毫克/千克），连用3天，并在第1天和第3天联合使用甲氟喹（总剂量15 - 17毫克/千克）。对患者进行连续7天以及第14、21和28天的临床和实验室检查随访及监测。治疗后2个月进行额外的寄生虫检查。各治疗组间的疟原虫血症清除情况相当。第1、2和3组的疟原虫血症清除时间分别为9.2、9.2和8.3小时。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未发现具有临床意义的变化。可以得出结论，青蒿琥酯直肠胶囊与甲氟喹联合用药是有效且安全的。从第1天开始联合给药耐受性良好。与青蒿琥酯单药治疗相比，这种联合用药显著降低了复发率。比较两种测试的青蒿琥酯/甲氟喹方案，总剂量20毫克/千克的甲氟喹似乎比总剂量15 - 17毫克/千克更有效。似乎有必要进行进一步研究。