在中国应用依达拉奉治疗急性脑梗死临床疗效的Meta分析

目的评价国内重要文献数据库的资料中依达拉奉治疗急性脑梗死的临床疗效。方法计算机检索中国学术期刊全文数据库（CNKI）、中国生物医学文献数据库（CBMdisc）、Pubmed、eBASE（截止至2008年12月）及其参考文献，筛选所有使用依达拉奉治疗急性脑梗死的随机对照试验（RCT），对照组为采用常规治疗的急性脑梗死患者。检索时限定研究对象为急性脑梗死患者，语种为中、英文。采用Jadad7分评分法评价所纳入文献的质量。疗效评价指标采用治疗结束后神经功能缺损评分变化或神经功能缺损改善率，安全性评价指标为不良反应发生率。由两名评价员独直检索和评价质量，采用RevMan4．2软件进行Meta分析。结果共检出符合标准的应用依达拉奉治疗急性脑梗死的RCT文献169篇，筛选出采用中国卒中量表（CSS）评分并行临床疗效判定的55篇文献（依达拉奉治疗组为2281例，对照组为2262例）。其中2篇Jadad评分为4分，属高质量文献；7篇为3分，16篇为2分，其余得分均为1分，均属低质量文献。其中49篇为阴性对照（依达拉奉治疗组为1957例，对照组为1958例），合并效应值OR=2．81，95％CI：2．45～3．21，与阴性对照组比较，用依达拉奉治疗急性脑梗死疗效显著，两组间差异有统计学意义依达拉奉治疗组有效率为61．52％（1024／1957），对照组有效率为37．64％（737／1958）；P〈0．00001]；另6篇为胞二磷胆碱阳性对照（依达拉奉治疗组为324例，对照组为304例），合并效应值OR=2．16，95％CI：1．55～3．00。认为与阳性对照组比较，用依达拉奉治疗急性脑梗死疗效显著，两组间差异有统计学意义依达拉奉治疗组有效率为61．73％（200／324），对照组有效率为43．75％（133／304）；P〈0．00001]。结论中国现有数据库的临床资料显示，依达拉奉可改善急性脑梗死后神经功能缺损评分和转归。

Meta-analysis on the clinical effects of edaravone in the treatment of acute cerebral infarction in China

Objective To assess the clinical effect of edaravone in treatment of patients with acute cerebral infarction（ACI） according to domestic and overseas medical literatures. Methods We searched the China National Knowledge Infrastructure （CNKI） , the China Biological Medicine Database（ CBMdisc） ,Pubmed , eBASE （all till Dec. 2008） and the reference lists of related articles. The object of research was confined to the ACI patients and the languages were Chinese and English. Change of nervous functional defect score and improvement rate of nervous function defect were used to evaluate clinical curative effect. The incidence rate of adverse drug reactions was used to evaluate the safety of drug. Two appraisers assessed the quality of studies and data independently. The Rev Man 4.2 software was used for statistical analysis. Results We identified 169 randomized controlled trials about treating ACI by edaravone complying with the standard and selected 55 randomized control tests by CSS （ Chinese stroke scale） Score and clinical effect , which included 2281 cases in treatment group and 2262 cases in control group. To review the document quality using the method of Jadad 7 score, 2 papers got 4 score,7 papers got 3 score, 16 papers got 2 score and others got 1 score. Among them,49 papers including 1957 cases in treatment group and 1958 cases in control group were negative control. The clinical effective rate was 61.52% in treatment group and 37.64% in control group OR = 2.81,95% CI （2.45 - 3.21 ） ）. Another 6 papers including 324 cases in treatment group and 304 cases in control group, were cytidine diphosphate choline positive controls. The rates of clinical efficiency were 61.73% in treatment group and 43.75% in control group OR = 2.16,95% CI（ 1.55 -3.00）1- Meta-analysis showed that the neurological deficits in treatment group showed significant difference compared with that in control group（ P 〈 0. 000 01 ）. The funnel graph was almost symmetrical, but , not funnel plot. Maybe it was related to publication bias analysis, unpublished negative results and low quality of documents. Conclusion The Meta-analysis results from databases indicated that edaravone injection can provide effective improvements for neurological deficits in ACI and it has instructive meanings to clinical use of edaravone .