参松养心胶囊治疗心动过缓疗效的荟萃分析

Effects of shensongyangxin capsule on bradycardia：a meta-analysis

目的 评价参松养心胶囊治疗心动过缓的临床疗效.方法检索中国期刊全文数据库、万方数据库、维普数据库、Pubmed数据库中自建库至2015年12月所有评价参松养心胶囊治疗心动过缓的文献.对纳入的文献进行Jadad质量评分,采用Rev Man 5.3软件进行统计学分析,以临床症状、心率变化、室性早搏（室早）作为评价指标,评价参松养心胶囊的疗效和安全性.结果共纳入21项研究,患者总数1 972例,治疗组1 041例,对照组931例.荟萃分析结果显示：参松养心胶囊可以改善心动过缓患者的临床症状（OR=7.72,95％ CI：4.94～12.07,P〈0.05）、动态心电图评价（OR=8.31,95％ CI：3.63～19.06,P〈0.05）、治疗前后的平均心率变化[加权均数差（WMD）=-8.11,95％ CI：-10.07～-6.15,P〈0.05）和合并室早的变化（OR=3.17,95％ CI：2.06～4.89,P〈0.05）.文献记录的药物不良反应发生率：治疗组11.80％,对照组14.85％,两组比较差异无统计学意义（χ2=2.631,P=0.105）.结论参松养心胶囊对心动过缓患者有明显的疗效,且不良反应小.由于纳入的研究数量较少,并发症报道量也不大,且存在一定的偏倚风险,故仍需更多高质量大样本的随机双盲对照试验来证实其疗效及安全性.

ObjectiveTo evaluate the clinical effects of shensongyangxin capsule on bradycardia.MethodsThe related literatures of shensongyangxin capsule in treatment of bradycardia were searched from China National Knowledge Infrastructure,Wanfang database,Weipu database,Pubmed database from inception to December 2015.All of included trials were chosen to make a quality score with Jadad,and then make a meta-analysis with Rev Man 5.3.We evaluated efficiency and safety of shensongyangxin capsule by these indices such as clinical symptoms,heart rate changes,and premature ventricular contractions.ResultsA total of 1 972 cases from 21 studies were included,the treatment group with 1 041 cases,and the control group with 931 cases.Meta analysis showed that shensongyangxin capsule was beneficial to bradycardia patients,for example,clinical symptoms（OR=7.72,95％ CI：4.94-12.07,P〈0.05）,electrocardiogram evaluation（OR=8.31,95％ CI：3.63-19.06,P〈0.05）,average heart rate changes before and after treatment（WMD=-8.11,95％ CI：-10.07——6.15,P〈0.05）,and premature ventricular contractions changes before and after treatment（OR=3.17,95％ CI：2.06-4.89,P〈0.05）.The incidence of adverse drug reactions of two groups were not statistically significant（χ2=2.631,P=0.105）,which were 11.80％ in the treatment group and 14.85％ in the control group.Conclusion Shensongyangxin capsule has obvious effect in patients with bradycardia,and less adverse reaction.More high-quality,large sample randomized,double-blind controlled trials are needed to confirm it＇s efficacy and safety.