Efficacy, safety and tolerability of artesunate-mefloquine in the treatment of uncomplicated Plasmodium falciparum malaria in four geographic zones of Nigeria
Efficacy, safety and tolerability of artesunate-mefloquine in the treatment of uncomplicated Plasmodium falciparum malaria in four geographic zones of Nigeria
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DOI：
10.1186/1475-2875-7-172
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发表时间：
2008-09-09
期刊：
影响因子：
3
通讯作者：
Aina, Olugbenga O.
中科院分区：
文献类型：
--
作者：
Agomo, Philip U.;Meremikwu, Martin M.;Aina, Olugbenga O.
背景：据报道，青蒿琥酯联合甲氟喹对尼日利亚报道的耐多药恶性疟原虫疟疾有效。这项多中心研究的目的是评估青蒿琥酯和甲氟喹复合包装制剂在两个体重组（分别为15 -29公斤和>= 30公斤）中治疗无并发症疟疾的有效性、安全性和耐受性。方法：试验在尼日利亚东北部、中北部、西南部和东南部的农村社区进行。遵循了世卫组织抗疟疾药物检测规程。入选的门诊患者除其他标准外，寄生虫密度为b> = 1000亩。在第0、1和2天分别以青蒿琥酯（4 mg/kg体重/天）和甲氟喹（25 mg/kg体重/天）的剂量给药3天。随访28 d，分别于第1、2、3、7、28天进行寄生虫学指标评估。结果：446例（446）患者入组，431例完成研究。第28天，两组患者的治愈率均为90%。治疗组和治疗组的平均寄生虫清除时间分别为40.1和42.4小时。青蒿琥酯与甲氟喹联用具有良好的杀配子活性（治疗ⅰ组和治疗ⅱ组配子细胞清除时间分别为42.0和45.6小时）。无严重不良事件发生。观察到的其他不良事件包括头痛、头晕、呕吐和腹部不适。血液学、生化指标无明显变化。结论：青蒿琥酯+甲氟喹（Artequin， TM）共包装制剂疗效高、安全性好、耐受性好。在尼日利亚，推荐用于治疗无并发症的恶性疟原虫疟疾。
Background: The combination of artesunate and mefloquine has been reported to be effective against multidrug resistant Plasmodium falciparum malaria, which has been reported in Nigeria. The objective of this multicentre study was to evaluate the efficacy, safety and tolerability of the co-packaged formulation of artesunate and mefloquine in the treatment of uncomplicated malaria in two weight groups: those between 15 -29 kg and >= 30 kg respectively.Methods: The trial was conducted in rural communities in the north-east, north-central, south-west and southeastern parts of Nigeria. The WHO protocol for testing antimalarial drugs was followed. Outpatients having amongst other criteria, parasite density of >= 1,000 mu l were enrolled. The co-packaged drugs were administered for 3 days at a dosage of artesunate, 4 mg/kg body wt/day and mefloquine, 25 mg/kg/body wt total) on days 0, 1 and 2. Patients were followed up for 28 days with the assessment of the parasitological parameters on days 1, 2, 3, 7, and 28.Results: Four hundred and forty-six (446) patients were enrolled and 431 completed the study. Cure rates in both treatment groups was > 90% at day 28. The mean parasite clearance times in treatment groups I and II were 40.1 and 42.4 hours respectively. The combination of artesunate and mefloquine showed good gametocidal activity, (gametocyte clearance time of 42.0 & 45.6 hours in treatment groups I and II respectively). There were no serious adverse events. Other adverse events observed were headache, dizziness, vomiting and abdominal discomfort. There was no significant derangement in the haematological and biochemical parameters.Conclusion: This co-packaged formulation of artesunate + mefloquine (Artequin (TM)) is highly efficacious, safe and well-tolerated. It is recommended for the treatment of uncomplicated P. falciparum malaria in Nigeria.