Juma Elizabeth A, Obonyo Charles O, Akhwale Willis S, Ogutu Bernhards R
Kenya Medical Research Institute, Centre for Global Health Research, PO Box 1578, 40100 Kisumu, Kenya.
Malar J. 2008 Dec 22;7:262. doi: 10.1186/1475-2875-7-262.
Artemether/lumefantrine (AL) has been adopted as the treatment of choice for uncomplicated malaria in Kenya and other countries in the region. Six-dose artemether/lumefantrine tablets are highly effective and safe for the treatment of infants and children weighing between five and 25 kg with uncomplicated Plasmodium falciparum malaria. However, oral paediatric formulations are urgently needed, as the tablets are difficult to administer to young children, who cannot swallow whole tablets or tolerate the bitter taste of the crushed tablets.
A randomized, controlled, open-label trial was conducted comparing day 28 PCR corrected cure-rates in 245 children aged 6-59 months, treated over three days with either six-dose of artemether/lumefantrine tablets (Coartem) or three-dose of artemether/lumefantrine suspension (Co-artesiane) for uncomplicated falciparum malaria in western Kenya. The children were followed-up with clinical, parasitological and haematological evaluations over 28 days.
Ninety three percent (124/133) and 90% (121/134) children in the AL tablets and AL suspension arms respectively completed followed up. A per protocol analysis revealed a PCR-corrected parasitological cure rate of 96.0% at Day 28 in the AL tablets group and 93.4% in the AL suspension group, p = 0.40. Both drugs effectively cleared gametocytes and were well tolerated, with no difference in the overall incidence of adverse events.
The once daily three-dose of artemether-lumefantrine suspension (Co-artesiane(R)) was not superior to six-dose artemether-lumefantrine tablets (Coartem) for the treatment of uncomplicated malaria in children below five years of age in western Kenya.
蒿甲醚/本芴醇（AL）已被肯尼亚及该地区其他国家用作非复杂性疟疾的首选治疗药物。六剂次的蒿甲醚/本芴醇片剂对治疗体重在5至25千克之间的患有非复杂性恶性疟原虫疟疾的婴幼儿和儿童非常有效且安全。然而，由于片剂难以给幼儿服用，这些幼儿无法整片吞咽或耐受碾碎片剂的苦味，因此急需口服儿科制剂。
开展了一项随机、对照、开放标签试验，比较245名6至59个月大儿童的第28天PCR校正治愈率，这些儿童在肯尼亚西部接受了为期三天的治疗，分别使用六剂次的蒿甲醚/本芴醇片剂（科泰复）或三剂次的蒿甲醚/本芴醇混悬液（可阿特健）来治疗非复杂性恶性疟。对这些儿童进行了为期28天的临床、寄生虫学和血液学评估随访。
蒿甲醚/本芴醇片剂组和蒿甲醚/本芴醇混悬液组分别有93%（124/133）和90%（121/134）的儿童完成了随访。一项符合方案分析显示，蒿甲醚/本芴醇片剂组在第28天的PCR校正寄生虫学治愈率为96.0%，蒿甲醚/本芴醇混悬液组为93.4%，p = 均数差异检验的概率值0.40。两种药物均能有效清除配子体，耐受性良好，不良事件的总体发生率无差异。
对于肯尼亚西部五岁以下儿童的非复杂性疟疾治疗，每日一次的三剂次蒿甲醚-本芴醇混悬液（可阿特健）并不优于六剂次的蒿甲醚-本芴醇片剂（科泰复）。
