Artemether-lumefantrine versus artesunate plus amodiaquine for treating uncomplicated childhood malaria in Nigeria: randomized controlled trial
Artemether-lumefantrine versus artesunate plus amodiaquine for treating uncomplicated childhood malaria in Nigeria: randomized controlled trial
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DOI：
10.1186/1475-2875-5-43
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发表时间：
2006-05-16
期刊：
影响因子：
3
通讯作者：
Ezedinachi, Emmanuel
中科院分区：
文献类型：
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作者：
Meremikwu, Martin;Alaribe, Ambrose;Ezedinachi, Emmanuel
背景：在恶性疟原虫对氯喹和磺胺二甲胺嘧啶耐药水平较高的尼日利亚地区，对青蒿琥酯联合阿莫地喹和蒿甲醚/鲁米芬的治疗效果进行了评估。参与者：在父母知情同意的情况下，6~59个月龄恶性疟原虫感染和寄生虫密度为1,000~200,000条/亩的儿童进入L。方法：符合条件的儿童被随机分配到接受青蒿琥酯(4 mg/kg)加阿莫地喹(10 mg/kg)或6剂蒿甲醚/鲁米芬(20/120 mg片剂)为期3天的疗程。对患者进行临床和实验室评估，直到第14天，使用标准的WHO体内抗疟疾药物测试方案。结果：共有119名符合条件的儿童入选，其中111名完成了研究。蒿甲醚-鲁米芬(AL)和青蒿琥酯+阿莫地喹(AAMQ)的临床和寄生虫学反应(ACPR)分别为47例(87.0%)和47例(82.5%)(OR 0.7，95%可信区间0.22~2.22)。接受AAQ治疗的一名参与者(1.8%)出现早期治疗失败(ETF)，而接受AL治疗的患者中没有一人发生早期治疗失败。AL组有2例(3.7%)患者晚期临床失败，AAQ组无一例。AAQ组和AL组分别有9例(15.8%)和5例(9.3%)晚期寄生虫学失败。所有受试者均未发生严重不良事件。结论：在尼日利亚卡拉巴尔的5岁以下儿童中，蒿甲醚-鲁门凡三联和青蒿琥酯联合阿莫地喹有较高的治愈率和耐受性。
Background: The therapeutic efficacy of artesunate plus amodiaquine and artemether/ lumefantrine were assessed in an area of Nigeria with high levels of Plasmodium falciparum resistance to chloroquine and sulphadoxine-pyrimethamine.Participants: Children aged 6 to 59 months with uncomplicated P. falciparum infection and parasite density 1,000 to 200,000 parasites/mu L enrolled following informed consent by parents.Methods: Eligible children were randomly assigned to receive either a 3-day course of artesunate ( 4 mg/kg) plus amodiaquine ( 10 mg/kg) or 6-dose course of artemether/ lumefantrine (20/120 mg tablets) over three days. Patients were followed up with clinical and laboratory assessments until day 14 using standard WHO in-vivo antimalarial drug test protocol.Results: A total 119 eligible children were enrolled but 111 completed the study. Adequate clinical and parasitological response (ACPR) was 47 (87.0%) and 47 (82.5%) for artemether-lumefantrine (AL) and artesunate + amodiaquine (AAMQ) respectively ( OR 0.7, 95% confidence interval 0.22 to 2.22). Early treatment failure (ETF) occurred in one participant (1.8%) treated with AAQ but in none of those with AL. Two (3.7%) patients in the AL group and none in the AAQ group had late clinical failure. Late parasitological failure was observed in 9 (15.8) and 5 (9.3%) of patients treated with AAQ and AL respectively. None of participants had a serious adverse event.Conclusion: Artemether-lumenfantrine and artesunate plus amodiaquine have high and comparable cure rates and tolerability among under-five children in Calabar, Nigeria.