参松养心胶囊辅助治疗稳定型心绞痛的Meta分析与试验序贯分析

Shensong Yangxin Capsules in the adjuvant treatment of stable angina pectoris:a Meta-analysis and trial sequential analysis

系统评价参松养心胶囊辅助治疗稳定型心绞痛的疗效和安全性,旨在为临床用药提供循证参考。通过计算机检索PubMed、EMbase、Cochrane Library、中国生物医学文献数据库、中国知网、维普、万方数据库等,收集参松养心胶囊联合西医常规治疗(试验组)对比西医常规治疗(对照组)治疗稳定型心绞痛的随机对照研究(RCT)。筛选文献、提取数据并采用Cochrane 5. 1. 0偏倚风险评估工具对纳入研究质量进行评价,后采用Rev Man 5. 3统计软件进行Meta分析;采用倒漏斗图法和Egger’s检验评估发表偏倚;采用TSA 0. 9软件对心绞痛临床总有效率进行试验序贯分析。最终纳入15项RCT,共计1 316例患者。Meta分析结果显示,试验组患者心绞痛症状改善的总有效率(RR=1. 15,95%CI[1. 09,1. 21],P<0. 001)显著高于对照组,心电图改善的总有效率(RR=1. 10,95%CI[0. 94,1. 29],P=0. 25)高于对照组但差异无显著性,治疗后试验组的24 h总缺血时间(SMD=-1. 21,95%CI[-1. 97,-0. 45],P=0. 002)、ST段压低幅度(SMD=-1. 30,95%CI[-1. 52,-1. 09],P<0. 001)、心绞痛发作持续时间(SMD=-1. 16,95%CI[-1. 36,-0. 95],P<0. 001)、每周的心绞痛发作次数(SMD=-0. 80,95%CI[-1. 10,-0. 50],P<0. 001)、每周硝酸甘油用量(SMD=-0. 72,95%CI[-1. 05,-0. 39],P<0. 001)显著低于对照组,试验组在改善血脂和高敏C反应蛋白(hs-CRP)水平方面均优于对照组,漏斗图法和Egger’s线性回归分析提示不存在发表偏倚,敏感性分析提示结果稳定、可信。2组患者均未见明显的不良反应。试验序贯分析提示,参松养心胶囊辅助治疗稳定型心绞痛的疗效证据确切。尚可认为参松养心胶囊联合西医常规治疗方案,治疗稳定型心绞痛可提高患者心绞痛总有效率,降低24 h总缺血时间、ST段压低幅度、心绞痛发作持续时间、心绞痛发作次数和硝酸甘油用量,还能改善患者血脂和hs-CRP水平。

To systemically evaluate the benefits and side effects of Shensong Yangxin Capsules( SYC) in the adjuvant treatment of stable angina pectoris( SAP). Chinese and English databases( PubMed,EMbase,the Cochrane Library,CBM,CNKI,VIP,Wan Fang database) were retrieved to collect the randomized controlled trials( RCTs) about therapeutic efficacy of SYC combined with routine drug( trial group) vs routine drug( control group) in the treatment of SAP. The methodological quality of the RCTs was evaluated based on the cochrane risk of bias assessment tool. The data were extracted and Meta-analyzed by Reviewer Manager 5. 3. TSA 0. 9 software was used for trial sequential analysis( TSA) of the total effective rate of symptoms improvement. A total of 15 RCTs with 1 316 participants were included. Results of Meta-analysis showed that the total effective rate of angina symptoms improvement( RR = 1. 15,95% CI[1. 09,1. 21],P<0. 001) of trial group were significantly higher than those of control group,with statistical significance,the total effective rate of electrocardiograms( ECG) improvement( RR = 1. 10,95% CI[0. 94,1. 29],P = 0. 25) of trial group were significantly higher than those of control group,but the difference was not statistically significant. After treatment,the improvement of the total time of 24 h general ischemia( SMD =-1. 21,95%CI[-1. 97,-0. 45],P = 0. 002),the ST-segment depression amplitude( SMD =-1. 30,95%CI [-1. 52,-1. 09],P<0. 001),the duration of angina pectoris attack( SMD =-1. 16,95% CI[-1. 36,-0. 95],P< 0. 001),the angina pectoris attack every week( SMD =-0. 80,95%CI[-1. 10,-0. 50],P<0. 001),the onsumption of nitroglycerin every week( SMD=-0. 72,95%CI[-1. 05,-0. 39],P<0. 001) in the trial group were better than that of the control group,and the difference was statistically significant. Besides,the improvement of the blood lipid and high sensitivity C reactive protein( hs-CRP) in the trial group were better than those of the control group after treatment,and the difference was statistically significant( P< 0. 001). Funnel plots and Egger’s linear regression showed that there was no publication bias. By sensitivity analysis,it showed that the results of this study were stable and reliable. No obvious adverse drug reactions were observed in all studies. TSA analysis showed that the evidence of Meta-analysis was reliable. SYC combined with routine Western medicine treatment for SAP can improve the total effective rate of angina pectoris,reduce 24 h total ischemia time,ST segment depression amplitude,duration of angina pectoris attack,frequency of angina pectoris attack and nitroglycerin dosage,and also can improve blood lipid and hs-CRP levels.