冠心舒通胶囊辅助治疗不稳定型心绞痛疗效的Meta分析与试验序贯分析

Guanxin Shutong Capsule in the Adjuvant Treatment of Unstable Angina Pectoris:A Meta-analysis and Trial Sequential Analysis

目的:系统评价冠心舒通胶囊辅助治疗不稳定型心绞痛的临床疗效,为临床治疗不稳定型心绞痛提供循证参考。方法:计算机检索PubMed、Embase、Cochrane图书馆、中国生物医学文献数据库、中国知网、维普网、万方数据,检索时限均为建库起至2018年10月11日,收集冠心舒通胶囊联合西医常规治疗(试验组)对比西医常规治疗(对照组)治疗不稳定型心绞痛的随机对照试验(RCT),对符合标准的文献进行资料提取并采用Cochrane偏倚风险评估工具5.1.0进行质量评价后,采用Rev Man 5.2统计软件对心绞痛总有效率、心电图总有效率、血脂水平[总胆固醇(TC)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)、三酰甘油(TG)]、高敏C反应蛋白(hs-CRP)水平进行Meta分析;采用TSA 0.9软件对心绞痛总有效率和心电图总有效率进行试验序贯分析。结果:共纳入11项RCT,合计946例患者。Meta分析结果显示,试验组患者的心绞痛总有效率[RR=1.24,95%CI(1.16,1.32),P<0.001]和心电图总有效率[RR=1.22,95%CI(1.11,1.34),P<0.001]均显著高于对照组,试验组患者TC[SMD=-1.55,95%CI(-1.81,-1.29),P<0.001]、TG[SMD=-0.84,95%CI(-1.08,-0.60),P<0.001]、HDL-C[SMD=0.15,95%CI(0.06,0.25),P=0.001]、LDL-C[SMD=-0.62,95%CI(-0.76,-0.48),P<0.001]、hs-CRP[SMD=-2.54,95%CI(-3.88,-1.88),P<0.001]改善程度均优于对照组;试验序贯分析结果提示证据可靠。结论:冠心舒通胶囊联合西医常规治疗方案治疗不稳定型心绞痛可提高患者心绞痛总有效率、心电图有效率,改善患者血脂和hs-CRP水平。

OBJECTIVE:To evaluate clinical efficacy of Guanxin shutong capsule(GSC)in the adjuvant treatment of unstable angina pectoris(UAP),and to provide evidence-based reference for clinical treatment of UAP.METHODS:Retrieved from PubMed,Embase,Cochrane library,CBM,CNKI,VIP and Wanfang database,randomized controlled trials(RCTs)about routine treatment(trial group)of GSC combined with western medicine versus western medicine routine treatment(control group)in the treatment of UAP were collected during database establishment to Oct.11th,2018.After data extraction of included literatures and quality evaluation with Cochrane bias risk evaluation tool 5.1.0,Meta-analysis of total response rate of angina pectoris,total response rate of ECG,blood lipid levels(TC,HDL-C,LDL-C,TG),the level of hs-CRP were performed by using Rev Man 5.2 statistical software.TSA 0.9 software was used for trial sequential analysis(TSA)of the total response rate of angina pectoris and response rate of ECG.RESULTS:A total of 11 RCTs were included,involving 946 patients.Results of Meta-analysis showed that total response rate of angina pectoris [RR=1.24,95%CI(1.16,1.32),P<0.001] and total response rate of ECG [RR=1.22,95%CI(1.11,1.34),P<0.001] in trial group were significantly higher than control group.The improvement of TC [SMD=-1.55,95%CI(-1.81,-1.29),P<0.001],TG [SMD=-0.84,95%CI(-1.08,-0.60),P<0.001],HDL-C [SMD=0.15,95%CI(0.06,0.25),P=0.001],LDL-C [SMD=-0.62,95%CI(-0.76,-0.48),P<0.001] and hs-CRP [SMD=-2.54,95%CI(-3.88,-1.88),P<0.001] in trial group were better than control group.TSA analysis showed that the evidence of Meta-analysis was reliable.CONCLUSIONS:GSC combined with western medicine routine treatment can improve total response rate of angina pectoris,total response rate of ECG,blood lipid and hs-CRP level of UAP patients.