Kinde-Gazard D, Ogouyèmi-Hounto A, Capo-Chichi L, Gbaguidi J, Massougbodji A
Bull Soc Pathol Exot. 2012 Aug;105(3):208-14. doi: 10.1007/s13149-012-0211-7. Epub 2012 Feb 11.
The Ministry of Health recommended in Benin, since 2004, artemisinin-based combination, artemether-lumtefantrine (Coartem®), therapy for the treatment of uncomplicated malaria. To resolve the difficulties related to observance, we are interested in a new combination, artemisinin-naphthoquine (Arco®). A study was conducted to assess and compare the efficacy and tolerability of the fixed combination artemisinin (125 mg)-naphthoquine (50 mg), a single-dose drug, administered one day versus artemether (20 mg)-lumefantrine (120 mg).The clinical assessment was a single-blinded, two-arm, randomized trial comparing Arco® combination as a single-dose regimen and three-day regimen of Coartem® for the treatment of uncomplicated falciparum malaria, from july to october 2008 and may to september 2009, with 28 days of follow-up in children. PCR genotyping was used to classify re-infection or recrudescence. The primary outcome measures for efficacy were cure rates on days 3, 7, 14, 21 and 28. Secondary outcomes included parasite clearance time and fever clearance time. The main outcome measures for safety were incidences of post-treatment clinical and laboratory adverse events. A total of 174 patients (84 in Arco® group and 90 in Coartem® group) were evaluated for clinical and parasitological outcomes. The cure rate was 98.8% for Arco® and 100% for Coartem® on day 28, with no statistically significant difference. Fever clearance was obtained within 24 hours in both groups. The parasite clearance is obtained at 48 hours in Arco® group and at 60 hours in Coartem® group. Both treatments were well tolerated without major side effects. This study therefore concluded that the combination of artemisinin-naphthoquine is as effective and well tolerated as the combination artemether-lumefantrine in the treatment of uncomplicated malaria in Benin children. This medication administered in single dose is therapy of choice to reduce compliance problems during malaria treatment and also to facilitate community-based care of malaria.
自2004年起，贝宁卫生部推荐使用以青蒿素为基础的复方制剂蒿甲醚-本芴醇（科泰复®）治疗非复杂性疟疾。为解决与依从性相关的困难，我们关注一种新的复方制剂青蒿素-萘酚喹（Arco®）。开展了一项研究，以评估和比较固定剂量复方制剂青蒿素（125毫克）-萘酚喹（50毫克）（一种单剂量药物，一日给药一次）与蒿甲醚（20毫克）-本芴醇（120毫克）的疗效和耐受性。临床评估是一项单盲、双臂随机试验，比较Arco®复方制剂单剂量方案和科泰复®三日方案治疗非复杂性恶性疟的效果，研究时间为2008年7月至10月以及2009年5月至9月，对儿童进行28天的随访。采用聚合酶链反应基因分型对再感染或复发进行分类。疗效的主要结局指标为第3、7、14、21和28天的治愈率。次要结局包括寄生虫清除时间和发热清除时间。安全性的主要结局指标为治疗后临床和实验室不良事件的发生率。共对174例患者（Arco®组84例，科泰复®组90例）的临床和寄生虫学结局进行了评估。第28天，Arco®的治愈率为98.8%，科泰复®为100%，无统计学显著差异。两组均在24小时内实现发热清除。Arco®组在48小时实现寄生虫清除，科泰复®组在60小时实现寄生虫清除。两种治疗耐受性均良好，无严重副作用。因此，本研究得出结论，在贝宁儿童非复杂性疟疾治疗中，青蒿素-萘酚喹复方制剂与蒿甲醚-本芴醇复方制剂疗效相当且耐受性良好。这种单剂量给药的药物是减少疟疾治疗期间依从性问题以及促进基于社区的疟疾治疗的首选疗法。
