麝香保心丸治疗不稳定型心绞痛的系统评价和Meta分析

A Systematic Review and Meta-analysis of Shexiang Baoxin Pill for the Treatment of Unstable Angina Pectoris

目的从循证医学的角度系统评价麝香保心丸治疗不稳定型心绞痛的疗效和安全性。方法广泛搜集麝香保心丸治疗不稳定型心绞痛的随机对照试验,运用Cochrane图书馆系统评价方法,对纳入研究进行质量评价和Meta分析。结果 9个随机对照试验纳入系统评价,均为Jadad评分<2的低质量研究。Meta分析结果提示麝香保心丸联合常规治疗在整体临床症状和心电图的改善方面均优于单纯使用常规治疗。整体临床疗效比较OR值为2.76,95%IC为(1.83,4.15);心电图改善情况比较OR值为2.51,95%IC为(1.68,3.76)。5个研究报告了应用麝香保心丸带来的轻度不良反应。结论麝香保心丸联合常规治疗用于不稳定型心绞痛可能取得较单纯常规治疗更好的效果,且安全性良好,但由于纳入的研究方法学质量低,存在发生偏倚的高度可能性,需更多设计合理的高质量的临床试验加以验证。

Objective To systematically appraise the effectiveness and safety of Shexiang Baoxin pill for the treatment of Unstable Angina Pectoris（UAP）,thus to provide an evidence based guidance for clinical practice.Methods Reports of clinical trials on Shexiang Baoxin pill for the treatment of UAP were extensively retrieved.Cochrane library systematic review method was applied to analyze the quality and quantity of included trials.Results Nine randomized controlled trials were included in the systematic review.All the 9 studies were concluded as poor-quality ones by the methodological quality appraisal.A Meta-analysis showed that the combination of Shexiang Baoxin pill and conventional treatment had better effectiveness on both overall clinical manifestations and ECG than the regular conventional treatment had.The odds ratio（OR）and 95% confidence interval（95%CI）of the comparison of the improvement on overall clinical manifestations were 2.76（1.83,4.15）,and the OR and 95% CI of comparison of the improvement on ECG were 2.51（1.68,3.76）.Five studies reported mild adverse events due to administration of Shexiang Baoxin pill.Conclusion The combination of Shexiang Baoxin pill and conventional treatment may have better effectiveness and safety for UAP than the regular conventional treatment had.Nevertheless,because of the unclear methodological quality of the included studies,the results of our Meta-analysis may possibly be of much bias.Further well-designed clinical studies are required for the evaluation of Shexiang Baoxin pill for the treatment of UAP.