目的 评价芪参胶囊辅助治疗冠心病病人的疗效和安全性.方法 中文文献检索中国知网数据库(CNKI)、万方数据库、重庆维普中文科技期刊数据库(VIP)、中国生物医学文献数据库(CBM),外文文献检索PubMed和Cochrane图书馆.文献检索年限从建库到2016年10月20日,检索语种为中文、英文.纳入芪参胶囊治疗冠心病的随机对照试验(RCT)文献.使用Cochrane系统评价手册的偏倚风险评估标准进行评估,采用RevMan 5.3软件进行Meta分析.通过比较不同的效应模型结果进行敏感性分析,若Meta分析研究个数在10个及以上时,采用倒漏斗图分析检验是否存在发表偏倚.结果 共纳入13项研究1 310例冠心病病人,试验方法学质量普遍偏低.芪参胶囊辅助治疗冠心病,与基础治疗组比较显示:临床症状改善率RR(95％ CI)为1.27(1.20,1.34);异常心电图改善率RR(95％ CI)为1.28(1.17,1.40);心绞痛症状改善率RR(95％ CI)为1.47(1.15,1.88);血清同型半胱氨酸SMD(95％ CI)为-0.38(-0.75,-0.01).8项研究报道病人治疗前后未出现不良反应,5项研究未提及不良反应.结论 芪参胶囊治疗冠心病可能缓解病人临床症状,改善心电图情况,提高心绞痛疗效,降低病人血清同型半胱氨酸水平,且不良反应少.%Objective To evaluate the efficacy and safety of adjuvant therapy of Qishen capsule for coronary heart diseases (CHD).Methods China National Knowledge Infrastructure Database (CNKI),Wangfang Database,Chongqing VIP Database (VIP),China Biology Medicine Database (CBM),MEDLINE (PubMed),and Cochrane Library were retrieved with the deadline on October 20,2016.The inclusion trials of CHD were Qishen capsule together with basic treatment to basic treatment or placebo with basic treatment.The risk of bias of cochrene handbook and RevMan 5.3 were conducted by authors.Sensitivity analysis was constructed by using two different effect models.Besides,a funnel plot was created to analyze potential publication bias.Results One thousand,three hundreds and ten patients from eleven studies were included,in which the quality of methodology was low.As for Qishen capsule together with basic treatment to basic treatment,the relative risk (RR) and 95％ confidence interval (CI) of improvement of clinical symptoms,improvement of abnormal electrocardiogram,and improving symptoms of angina pectoris were 1.28(1.20,1.36),1.28 (1.17,1.40) and 1.47 (1.15,1.88),rsspectively,and the standardized mean difference (SMD) and 95％ confidence interval (CI) of homocysteine was-0.38(-0.75,-0.01).Eight trials were no adverse reaction and five trials there were no mention of adverse reaction.Conclusion Qishen capsules may release clinical syndromes,improve the electrocardiogram,improve the clinical effect of angina pectoris of patients with CHD,lower homocysteine levels,and the adverse reaction is small.
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