Meremikwu Martin, Alaribe Ambrose, Ejemot Regina, Oyo-Ita Angela, Ekenjoku John, Nwachukwu Chukwuemeka, Ordu Donald, Ezedinachi Emmanuel
Calabar Institute of Tropical Disease Research & Prevention, GPO Box 1211, Calabar, Nigeria.
Malar J. 2006 May 16;5:43. doi: 10.1186/1475-2875-5-43.
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.
Children aged 6 to 59 months with uncomplicated P. falciparum infection and parasite density 1,000 to 200,000 parasites/microL enrolled following informed consent by parents.
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.
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.
Artemether-lumenfantrine and artesunate plus amodiaquine have high and comparable cure rates and tolerability among under-five children in Calabar, Nigeria.
在尼日利亚一个恶性疟原虫对氯喹和磺胺多辛-乙胺嘧啶具有高度抗性的地区，评估了青蒿琥酯加阿莫地喹和蒿甲醚/本芴醇的治疗效果。
年龄在6至59个月、患有非复杂性恶性疟原虫感染且寄生虫密度为每微升1000至200000个寄生虫的儿童，经父母知情同意后入组。
符合条件的儿童被随机分配接受为期3天的青蒿琥酯（4毫克/千克）加阿莫地喹（10毫克/千克）疗程，或在三天内接受6剂次的蒿甲醚/本芴醇（20/120毫克片剂）疗程。按照世界卫生组织标准的体内抗疟药物测试方案，对患者进行临床和实验室评估随访至第14天。
总共119名符合条件的儿童入组，但111名完成了研究。蒿甲醚-本芴醇（AL）组和青蒿琥酯+阿莫地喹（AAMQ）组的充分临床和寄生虫学反应（ACPR）分别为47例（87.0%）和47例（82.5%）（比值比0.7，95%置信区间0.22至2.22）。接受AAMQ治疗的一名参与者（1.8%）出现早期治疗失败，但接受AL治疗的参与者中无人出现。AL组有两名（3.7%）患者出现晚期临床失败，AAMQ组无人出现。接受AAMQ和AL治疗的患者中，分别有9例（15.8%）和5例（9.3%）出现晚期寄生虫学失败。没有参与者发生严重不良事件。
在尼日利亚卡拉巴尔，蒿甲醚-本芴醇和青蒿琥酯加阿莫地喹在五岁以下儿童中具有较高且相当的治愈率和耐受性。
