血栓通联合常规西药治疗冠心病心绞痛疗效和安全性的Meta分析

Effect and Safety of Xueshuantong Combined with Conventional Western Medicine for Angina Pectoris in Coronary Heart Disease Patients: A Systematic Review

目的系统评价血栓通治疗冠心病心绞痛的疗效及安全性。方法计算机检索Cochrane图书馆临床对照试验资料库(2013年第12期)、Medline(建库至2013年10月)、EMbase(建库至2013年10月)和万方(建库至2013年10月)、维普数据库(建库至2013年10月)、中国知网(建库至2013年10月)、中国生物医学文献服务系统(建库至2013年10月)。搜集血栓通治疗冠心病心绞通的随机对照试验。按照纳入和排除标准,由3名研究者独立筛选试验、提取资料及评估方法学质量。交叉核对后应用Rev Man 5.1软件进行Meta分析。结果共纳入13个随机对照试验,共1 298例患者。Meta分析结果显示在冠心病心绞痛的临床有效性方面,血栓通联合常规西药组(血栓通组)疗效优于单纯常规西药组(对照组),差异有统计学意义[RR=1.22,95%CI(1.16,1.29),P<0.000 01],亚组分析显示血栓通组治疗稳定型心绞痛和不稳定型心绞痛疗效均优于对照组[RR=1.24,95%CI(1.12,1.37),P<0.000 1;RR=1.22,95%CI(1.15,1.29),P<0.000 01];在改善心电图表现方面,血栓通组疗效同样优于对照组,差异有统计学意义[RR=1.21,95%CI(1.13,1.29),P<0.000 01],亚组分析显示血栓通组治疗稳定型心绞痛和不稳定型心绞痛在总体改善心电图方面均优于对照组[RR=1.30,95%CI(1.11,1.51),P=0.000 8;RR=1.18,95%CI(1.10,1.28),P<0.000 1]。在不良反应发生率方面,两组差异无统计学意义[RR=4.50,95%CI(0.99,20.53),P=0.05]。结论血栓通联合常规西药在治疗冠心病心绞痛有效性和改善心电图表现方面均优于单纯常规西药治疗,且尚不能认为两组不良反应发生率有差别。但由于所纳样本量少、方法学质量偏低、存在偏倚风险,有必要开展设计合理、大样本量、多中心的临床随机对照试验以进一步验证血栓通联合常规西药治疗冠心病心绞痛的有效性及安全性。

Objective To evaluate the efficacy and safety of Xueshuantong combined with conventional western medicine for angina pectoris in coronary heart disease （CHD） patients. Methods We searched the Cochrane Library （2013.12）, Medline （2013.10）, EMbase （unlimited-2013.10）, China Nation Knowledge Infrastructure （unlimited-2013.10） and the Wanfang Database （unlimitied-2013.10）, Weipu Database （unlimited-2013.10）, and CBM （unlimited-2013.10） on computers for parallel group randomized controlled trials （RCTs） comparing Xueshuantong and placebo for patients with angina pectoris. Three researchers selected the trials based on the inclusion and exclusion criteria and then extracted the data, assessed the quality of each trial independently. After cross checking, the Cochrane Collaboration＇s RevMan 5.1 software was used to perform Meta-analysis. Results Thirteen RCTs and a total of 1 298 participants were involved. Meta-analysis showed that Xueshuantong combined with the conventional western medicine had better curative effect on angina pectoris for CHD than conventional therapy; stable angina pectoris [RR=1.24, 95%CI （1.12, 1.37）, P 〈 0.000 1];unstable angina pectoris [RR=1.22, 95%CI （1.15, 1.29）, P 〈 0.000 01]. There was also significant difference in total curative effect between the two groups [RR=1.22, 95%CI （1.16, 1.29）, P 〈 0.000 01]. Xueshuantong also had better curative effect on improving performance of electrocardiogtram （ECG）： stable angina pectoris [RR=1.30, 95%CI （1.11, 1.51）, P=0.000 8]; unstable angina pectoris ]RR=1.18, 95%CI （1.10, 1.28）, P 〈 0.000 1]. There was also significant difference in total curative effect on improving performance of ECG between the two groups [RR=I.21, 95%CI （1.13, 1.29）, P 〈 0.000 01]. But there was no significant difference in adverse effects rate between the two groups [RR=4.50, 95%CI （0.99, 20.53）, P=0.05]. Conclusions Compared with conventional therapy, Xueshuantong combined with conventional western medicine has better curative effect with improved performance of ECG. The adverse effect rate between the two groups is not significantly different. But because of the small scale, inferior quality, and bias risk of these trials, large-scale, rational designed, multicenter RCTs are needed to confirm our conclusions.