利用Meta分析法系统评价心可舒片治疗冠心病合并抑郁症的“双心”疾病的疗效及安全性。计算机检索中国期刊全文数据库（CNKI）、万方数字化期刊全文数据库、中国生物医学文献数据库（CBM）、Embase、Pubmed、Cochrane Library，收集1979—2015年发表的心可舒治疗冠心病合并抑郁症的“双心”疾病的随机对照临床试验文献。对纳入文献进行质量评价和资料提取，数据采用Review Manager 5.1软件进行Meta分析。共纳入10项研究，包含1 184例患者。文献质量评估结果显示文献质量总体不高。Meta分析结果显示心可舒片联合常规化学药治疗对冠心病合并抑郁症的“双心”病人的冠心病临床疗效及抑郁症临床疗效均优于常规化学药治疗组，危险比（RR）及95%可信区间（95% CI）分别为1.15（1.07，1.23）和1.39（1.07，1.79）。常规西医治疗基础上加用心可舒片治疗冠心病合并抑郁症的“双心”疾病有显著疗效，但尚需更多大样本、高质量的临床试验对其疗效和安全性加以证实。

To evaluate the clinical effect and safety of Xinkeshu Tablets on the double heart disease in coronary heart disease with depression systematically. The relative randomized controlled trials about Xinkeshu Tablets in the treatment of double heart disease in coronary heart disease with depression from 1979 to 2015 were searched in database like CNKI, WanFang data, CBM, Embase, Pubmed, and Cochrane Library. Studies were screened, data were extracted, and methodological quality was evaluated. Meta-analysis was then performed using Review Manager 5.1 software. Totally 11 kinds of studies and 961 patients were involved in this study. Xinkeshu Tablets combined with conventional Western medicine therapy was superior to pure conventional Western medicine therapy in clinical effect of coronary heart disease and improve of HAMD scores with the RR of 1.15 (1.07, 1.23) and 1.39 (1.07, 1.79) respectively. On the basis of available evidence, Xinkeshu Tablets combined with conventional Western medicine therapy has a certain effect on the double heart disease in coronary heart disease with depression, but more clinical study with big samples and high quality should be done to confirm the efficacy and safety.

国家重大新药创制重大专项课题：中药复方药理学研究与药效评价关键技术（2009ZX09502-015）；山东省重大产业专项：国家基药大品种心可舒片二次深度开发（2015ZDZX07002）；山东省自主创新和成果转化课题：药物安全性评价和适宜于抗肿瘤及缺血性脑血管疾病多靶点和复方新药成药性评价关键技术研究（2014ZZCX02104）；泰山学者工程专项经费资助（Ns201511107）