Mueller Edgar A, van Vugt Michele, Kirch Wilhelm, Andriano Kim, Hunt Philip, de Palacios Patricia Ibarra
Institute for Clinical Pharmacology, Public Health Research Association Saxony, Medical Faculty, Technical University, Fiedlerstrasse 27, D-01307 Dresden, Germany.
Acta Trop. 2006 Nov;100(1-2):41-53. doi: 10.1016/j.actatropica.2006.09.007. Epub 2006 Oct 12.
To demonstrate the superiority of the six-dose over the four-dose regimen of artemether-lumefantrine (co-artemether, Coartem) in patients >12 years, data from 11 randomized clinical trials were pooled and analyzed. A total of 1368 patients with uncomplicated Plasmodium falciparum malaria (six-dose: 598; four-dose: 770) were included in the analysis, together with 717 patients treated with comparators. Analysis of the 28-day cure rate based on the ITT and evaluable populations yielded corrected cure rates for the six-dose regimen of 87% and 97% compared with 74% and 87%, respectively, with the four-dose regimen (P<0.0001, for both comparisons). For mefloquine/artesunate, the most frequently used comparator, cure rates were 87% and 99%, respectively. The six-dose regimen was well tolerated and not markedly different to the four-dose regimen. The main finding of our analysis is that the six-dose regimen of co-artemether is more effective than the four-dose regimen in adolescents and adults without compromising safety.
为了证明蒿甲醚-本芴醇（复方蒿甲醚，Coartem）六剂疗法相对于四剂疗法在12岁以上患者中的优越性，我们汇总并分析了11项随机临床试验的数据。共有1368例非复杂性恶性疟原虫疟疾患者（六剂疗法组：598例；四剂疗法组：770例）纳入分析，另有717例接受对照治疗的患者。基于意向性分析（ITT）人群和可评估人群对28天治愈率进行分析，结果显示六剂疗法组的校正治愈率分别为87%和97%，而四剂疗法组分别为74%和87%（两组比较P均<0.0001）。对于最常用的对照药物甲氟喹/青蒿琥酯，治愈率分别为87%和99%。六剂疗法耐受性良好，与四剂疗法无明显差异。我们分析的主要发现是，复方蒿甲醚六剂疗法在青少年和成人中比四剂疗法更有效，且不影响安全性
