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首页> 外文期刊>Transactions of the Royal Society of Tropical Medicine and Hygiene >Efficacy and safety of artemether-lumefantrine (Coartem((R))) tablets (six-dose regimen) in African infants and children with acute, uncomplicated falciparum malaria.
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Efficacy and safety of artemether-lumefantrine (Coartem((R))) tablets (six-dose regimen) in African infants and children with acute, uncomplicated falciparum malaria.

机译：Artemether-lumefantrine（Coartem（R））片剂（六剂方案）在非洲婴儿和患有急性单纯性恶性疟疾的儿童中的疗效和安全性。

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摘要

Approximately one million children die from malaria each year. A recently approved artemisinin-based tablet, Coartem (co-artemether), comprising artemether 120mg plus lumefantrine 20mg, given in four doses, provides effective antimalarial treatment for children in many sub-Saharan countries. However, this regimen is considered insufficient for non-immune infants and in areas where multidrug-resistant Plasmodium falciparum predominates. This open-label study assessed the efficacy and safety of co-artemether administered to 310 African children weighing 5-25kg, with acute, uncomplicated falciparum malaria. Six doses of co-artemether were given over 3 days, with follow-up at 7, 14 and 28 days. Treatment rapidly cleared parasitemia and fever. The overall 28-day cure rate was 86.5%, and 93.9% when corrected by PCR for reinfection. Cure rates at 7 and 14 days exceeded 97.0% (uncorrected) and, on day 28, were similar in infants (5-<10kg) previously exposed to malaria infection (partially immune: 88.6% uncorrected; 93.3% corrected), and in those who were non-immune (82.5% uncorrected; 95.0% corrected). Adverse events were mostly mild. There was no electrocardiographic evidence of cardiotoxicity. The co-artemether six-dose regimen, treating acute uncomplicated falciparum malaria in African children, achieved rapid parasite clearance and a high cure rate. Treatment was generally safe and well tolerated.
机译：每年约有100万儿童死于疟疾。最近批准的基于青蒿素的片剂复方蒿甲醚（复方蒿甲醚），包括青蒿素120mg加卢美汀20毫克，分四剂服用，为许多撒哈拉以南国家的儿童提供有效的抗疟疾治疗。但是，对于非免疫婴儿以及在多药耐药性恶性疟原虫占主导地位的地区，该方案被认为不足。这项开放性研究评估了共310例体重5至25公斤的非洲儿童患有急性，简单的恶性疟疾的联合蒿甲醚的有效性和安全性。在3天内给予了6剂共蒿甲醚，并在7、14和28天进行了随访。治疗迅速清除了寄生虫病和发烧。 28天的总治愈率为86.5％，经PCR校正再感染后为93.9％。在第7天和第14天的治愈率超过97.0％（未纠正），并且在第28天，以前接触过疟疾感染的婴儿（5- <10kg）相似（部分免疫：未纠正的88.6％;已纠正的93.3％），而在这些患者中非免疫接种者（82.5％未纠正; 95.0％纠正）。不良事件多为轻度。没有心电图证据表明有心脏毒性。联合蒿甲醚六剂量方案治疗非洲儿童的急性单纯性恶性疟疾，实现了快速的寄生虫清除和高治愈率。治疗通常是安全的，耐受性良好。

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