清开灵注射液治疗急性中风的Meta分析

背景：中医药学几千年来各界了许多治疗中风有产的疗法和方药，如清开灵注射液（）简称清开灵）等，但因临床研究对方法学的重视仍不够，影响了研究结论的推广和国外医学界的承认。循证医学及系统分析的方法和结果日益得到了国际医学界和卫生决策部门的认可与重视，利用循证医学，系统分析的方法，拿出Ｍｅｔａ分析等数据，将极寺地促进中医药走向世界。目的：在严格的质量评价的基础上，对清开灵的临床疗与安全性进行系统评价。

Meta-analysis of Qingkailing Injection for Treating Acute Stroke

Backgrounds:Many therapeutics and remedies of traditional Chinese medicine(TCM) claimed effective for stroke through thousands of years of practice,such as Injection QingKaiLing(QKL).However, most are methodologically weak in clinical research,and this affects their application and acceptance.The methods and results of evidence_based medicine(EBM)and systematic review(SR)are accepted and highly praised by more and more professionals and medical decision_makers.It will greatly enhance the exchanges between TCM and western/modern medicine to utilize the methods of EBM and SR,and present data such as the synthesized OR in Meta_analysis.Objective: To systematically assess the efficacy and safety of QKL based on strict quality evaluation of reports of the clinical trials.Methods: All the reports of clinical trials that use OKL as the main intervention to treat acute stroke were retrieved and collected and random_effect model of Meta_analysis was preformed by using the statistical software Review Manager(RevMan 3.1.1 ) on the basis of strict quality evaluation; sensitivity analysis were carried out between various inclusion criteria;funnel_plot was used to identify the publication bias.Results:Synthesized efficacy(Odds Ratio,OR)of QKL were as follow:OR of recovered and nearly recovered between groups was 2.10,95% CI 1.62,2.72 ];OR of reuction of death rate was 0.46,95% CI 0.17,1.29 ].Adverse drug reaction(ADR) was not found.Funnel_plot showed the possible existence of publication bias.Conclusion:It initially proved that QKL has positive efficacy on acute stroke,and has trend to reduce mortality rate of acute stroke.Discussion: multi_center,double_blinded randomized controlled trials(RCT)should be carried out to give more strong evidence.Many questions exist in clinical trials that need to be resolved,such as really and strictly randomizing,application of blinding method,choice of outcome indicators,observation of follow_up and ADR,the publication bias and the standardization of reports of clinical trials.