丹参多酚酸盐治疗不稳定型心绞痛的Meta分析

Meta-analysis of Salvianolate on Unstable Angina Pectoris

目的:从循证医学的角度系统评价丹参多酚酸盐治疗不稳定型心绞痛的疗效和安全性。方法:通过全面检索与丹参多酚酸盐相关的随机对照研究文献,进行质量评价,纳入合格文献进行Meta分析。结果:9个随机对照实验纳入系统评价,均为Jadad评分小于等于3分的低质量研究。Meta分析结果显示丹参多酚酸盐联合常规治疗在整体临床症状、心电图的改善和舒缩血管因子水平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4.37,95%可信区间为2.71～7.03;心电图改善情况比较OR值为3.56,95%可信区间为2.22～5.69。改善血清NO和ET水平分别为[WMD=16.78,95%CI(14.62,18.93),P<0.00001]和[WMD=24.76,95%CI(19.08,30.44),P<0.00001]。结论:丹参多酚酸盐联合常规治疗用于冠心病不稳定型心绞痛可能取得较单一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,尚需更多设计合理的高质量临床试验加以验证。

Objective： To systematically appraise the effect and the safety of salvianolate on unstable angina pectoris.Methods： Comprehensively search the reports about randomized controlled trials of salvianolate,and evaluate the researching quality.Then the Meta-analysis would be carried out for those reports satisfying some criteria.Results： 9 randomized controlled trials,with equal or lesser than 3 Jadad scores,were included for the systematic review.A Meta-analysis showed that the combination of salvianolate and conventional treatment had better efficacy on both overall clinical manifestations and ECG than the conventional monotherapy.The odds ratio（OR） and 95% confidence interval（95% CI） from the comparison of the improvement on overall clinical manifestations were 4.37 and 2.71-7.03 respectively.The OR and 95% CI of comparison of the improvement of ECG were 3.56 and 2.22-5.69 respectively.The results of improving levels of serum NO and ET were the following：VMD=16.78,95%CI（14.62-18.93）,P〈0.00001;and WMD=24.76,95%CI（19.08-30.44）,P〈0.00001,respectively.Conclusion： The combination of salvianolate and conventional treatment may have better effectiveness and safety for unstable angina pectoris than the regular conventional treatment does.Nevertheless,because of the unclear methodological quality of the included studies,the results of our Meta-analysis may be of much bias.Further well-designed clinical studies are required for the evaluation of salvianolate for the treatment of unstable angina pectoris.