麝香保心丸治疗冠心病心绞痛有效性和安全性的系统评价

Systematic Review of Efficacy and Safety of Shexiang Baoxin Pills in the Treatment of Coronary Heart Disease and Angina Pectoris

目的:系统评价麝香保心丸治疗冠心病心绞痛的有效性和安全性。方法:通过中国知网、维普数据库、万方数据库和PubMed等数据库,检索麝香保心丸治疗冠心病心绞痛的随机对照试验(研究组患者单独使用麝香保心丸治疗或在常规治疗基础上加用麝香保心丸,对照组患者单独使用单硝酸异山梨酯片治疗或在常规治疗基础上加用单硝酸异山梨酯片),检索时限为从建库至2020年1月,检索词为"麝香保心丸""单硝酸异山梨酯片"和"冠心病心绞痛"等,采用Rev Man 5.3软件进行荟萃分析(Meta分析)。结果:最终纳入16项研究,Meta分析结果显示,研究组患者的临床治疗有效率(OR=3.47,95%CI=2.45~4.91,P<0.00001)、心电图有效率(OR=2.40,95%CI=1.88~3.07,P<0.00001)均明显优于对照组,不良反应发生率明显低于对照组(OR=0.24,95%CI=0.15~0.39,P<0.00001),差异均有统计学意义。结论:与单硝酸异山梨酯片相比,麝香保心丸治疗冠心病心绞痛的疗效显著且不良反应发生率较低。但由于纳入研究的样本量较少、质量较低,该结论需要进一步研究验证。

OBJECTIVE:To systematically evaluate the efficacy and safety of Shexiang Baoxin Pills in the treatment of coronary heart disease and angina pectoris.METHODS:CNKI,VIP database,Wanfang database and PubMed were retrieved to collect the randomized controlled trial of Shexiang Baoxin Pills in the treatment of coronary heart disease and angina pectoris(the study group was treated with Shexiang Baoxin Pills alone or combined with conventional treatment,while the control group received Isosorbide mononitrate tablets alone or combined with conventional treatments).The retrieval time was from the establishment of the database to Jan.2020,and the retrieval terms were"Shexiang Baoxin Pills","Isosorbide mononitrate tablets"and"coronary heart disease and angina pectoris".RevMan 5.3 software was used for Meta-analysis.RESULTS:Totally 16 literature were included.Meta-analysis results showed that the clinical treatment effective rate(OR=3.47,95%CI=2.45-4.91,P<0.00001)and ECG effective rate(OR=2.40,95%CI=1.88-3.07,P<0.00001)in the study group were significantly better than those in the control group,and the incidence of adverse drug reactions was significantly lower than that of the control group(OR=0.24,95%CI=0.15-0.39,P<0.00001),and the differences were statistically significant.CONCLUSIONS:Compared with the treatment of Isosorbide mononitrate tablets,the efficacy of Shexiang Baoxin Pills in the treatment of coronary heart disease and angina pectoris is significant and the incidence of adverse drug reactions is lower.However,due to the small sample size and low quality of the included literature,the conclusion needs to be further verified.