Omari A A A, Gamble C, Garner P
Countess of Chester Hospital, NHS Foundation Trust, Paediatric Department, Countess of Chester Health Park, Liverpool Road, Chester, Cheshire, UK, CH2 1UL.
Cochrane Database Syst Rev. 2007 Jul 18;2003(2):CD003125. doi: 10.1002/14651858.CD003125.pub2.
Artemether-lumefantrine is being recommended by the World Health Organization for treating uncomplicated malaria. It is expensive. We sought evidence of its superiority over existing treatment regimens.
To compare artemether-lumefantrine with other antimalarial drugs for treating uncomplicated falciparum malaria.
We searched the Cochrane Infectious Diseases Group specialized trials register (May 2005), CENTRAL (The Cochrane Library Issue 2, 2005), MEDLINE (1966 to May 2005), EMBASE (1988 to May 2005), conference proceedings, and reference lists of articles. We contacted experts in malaria research and the pharmaceutical company that manufactures artemether-lumefantrine.
Randomized and quasi-randomized trials comparing artemether-lumefantrine administered orally with standard treatment regimens (single drug or combination).
Two reviewers independently applied inclusion criteria to potentially relevant trials, assessed trial quality, and extracted data. Parasitaemia on day 28 (day 42 for sulfadoxine-pyrimethamine and day 63 for mefloquine) was the primary outcome. Adverse event information was collected from the studies.
Six trials (1698 participants) tested a four dose regimen. Failure rates for artemether-lumefantrine tended to be higher (comparisons included sulfadoxine-pyrimethamine, halofantrine, and mefloquine; difference statistically significant for mefloquine). When compared with chloroquine, artemether-lumefantrine was better in two studies, but the failure rate for chloroquine at these sites was over 50%. Two trials (419 participants) tested a six dose regimen against mefloquine plus artesunate. Artemether-lumefantrine was associated with higher failure rates but the studies were small.
AUTHORS' CONCLUSIONS: The four dose regimen of artemether-lumefantrine seems to be less effective than most other current antimalarial regimens. The six dose regimen is largely untested. The authors are aware that some recently published trials may change the results of this review, and are preparing an update. These trials are referenced in 'Studies awaiting assessment'.
世界卫生组织推荐蒿甲醚-本芴醇用于治疗非复杂性疟疾。其价格昂贵。我们探寻其相较于现有治疗方案具有优越性的证据。
比较蒿甲醚-本芴醇与其他抗疟药物治疗非复杂性恶性疟的效果。
我们检索了Cochrane传染病学组专业试验注册库(2005年5月)、Cochrane系统评价数据库(2005年第2期)、医学索引数据库(1966年至2005年5月)、荷兰医学文摘数据库(1988年至2005年5月)、会议论文集以及文章的参考文献列表。我们联系了疟疾研究领域的专家以及生产蒿甲醚-本芴醇的制药公司。
比较口服蒿甲醚-本芴醇与标准治疗方案(单一药物或联合用药)的随机和半随机试验。
两名评价员独立对可能相关的试验应用纳入标准,评估试验质量并提取数据。第28天的疟原虫血症(磺胺多辛-乙胺嘧啶为第42天,甲氟喹为第63天)为主要结局指标。从研究中收集不良事件信息。
六项试验(1698名参与者)测试了四剂疗法。蒿甲醚-本芴醇的失败率往往更高(比较药物包括磺胺多辛-乙胺嘧啶、卤泛群和甲氟喹;与甲氟喹比较差异有统计学意义)。与氯喹相比,在两项研究中蒿甲醚-本芴醇效果更好,但这些研究地点氯喹的失败率超过50%。两项试验(419名参与者)测试了六剂疗法与甲氟喹加青蒿琥酯的对比。蒿甲醚-本芴醇的失败率更高,但研究规模较小。
蒿甲醚-本芴醇的四剂疗法似乎比目前大多数其他抗疟方案效果更差。六剂疗法基本未经测试。作者意识到一些最近发表的试验可能会改变本综述的结果,正在准备更新。这些试验在“等待评估的研究”中被引用。