依达拉奉治疗急性脑梗死的系统评价

Edaravone for Acute Cerebral Infarction: A Systematic Review

目的评价依达拉奉治疗急性脑梗死的疗效及其安全性。方法运用Cochrane系统评价的方法，检索Cochrane图书馆临床对照试验资料库（2005年第2期）、MEDLINE（1966年～2005年8月）、EMBASE（截至2005年8月）、中国生物医学文献数据库（截至2005年8月）和中国卒中临床试验数据库（截止2005年8月）及所获文献的参考文献。筛选所有应用依达拉奉治疗急性脑梗死的随机对照试验（RCT）。由两名评价员独立评价质量和提取资料，用RevMan4．2软件统计分析。结果共检到12个RCT，其中9个（948例）符合纳入标准。方法学质量评价为B级。由于一些研究间的常规治疗不一致，对远期死亡和残疾的改善率和不良反应发生率未行Meta分析。神经功能缺损改善率的Meta分析显示，在治疗期末依达拉奉组高于对照组，其差异有统计学意义[RR1．87，95％CI（1.21，2．89）]。依达拉奉可能的不良反应包括肝功能异常和皮疹。结论现有临床证据表明，依达拉奉有改善急性脑梗死神经功能缺损的趋势，但鉴于目前评价依达拉奉疗效和安全性的临床试验及病例数较少，尚不能作出其是否有效的确切结论。有必要进一步开展高质量、大样本随机对照试验评价其疗效和安全性。

Objective To assess the effectiveness and safety of edaravone for acute cerebral infarction. Methods We searched The Cochrane Central Register of Controlled Trials （ Issue 2, 2005 ）, MEDLINE （ 1966 to Aug. 2005）, EMBASE （ till Aug. 2005 ）, the China Biological Medcine Database （ till Aug. 2005 ）, the Chinese Stroke Clinical Trials Database （ till August 2005 ） and the reference lists of related articles. Two reviewers independently selected studies, assessed quahty of studies and extracted data. The RevMan 4.2 software was used for statistical analysis. Results We identified 12 randomized controlled trials, of which 9 （ n = 948 ） were included. The level of methodology quality was B. Since the conventional therapy was different among some studies, the improvement of disability and long-term death rate and incidence of adverse reactions were not included by meta-analysis. Meta-analysis on the improvement of neurological deficit showed a better effectiveness of edaravone than control with statistical significance [ OR2.98, 95% CI （ 1.39,6.39 ） ]. Possible adverse reactions to edaravone included abnormal liver function and skin rash. Conclusions With relatively poor quality of most included trials and small sample size, insufficient evidence is obtained to support the conclusion that edaravone is safe or effective in the treatment of acute cerebral infarction. Further high quality and large sample randomized controlled trials should be carried out.