温肾活血法治疗冠心病心绞痛有效性及安全性的Meta分析

A Meta-analysis of the effectiveness and safety of the warming kidney and activating blood circulation method in the treatment of angina pectoris in coronary heart disease

目的:系统评价温肾活血法治疗冠状动脉粥样硬化性心脏病(简称冠心病)心绞痛的有效性及安全性,为临床应用温肾活血法治疗冠心病心绞痛提供理论依据,并且通过挖掘处方开拓新药研发思路。方法:计算机检索中国知网、万方数据库、维普数据库、中国生物医学文献数据库、PubMed、Embase、Cochrane Library、Web of Science等数据库,检索时限从建库至2022年3月,筛选关于温肾活血法治疗冠心病心绞痛的临床随机对照试验。采用Cochrane风险偏倚评估工具对纳入研究的文献进行质量评价,使用RevMan 5.3软件进行Meta分析,运用Microsoft Office Excel对中药频数、频率进行统计,应用SPSS Statistics 21.0软件进行聚类分析。结果:最终共纳入10篇随机对照试验研究,共计924例患者。Meta分析结果显示:与对照组相比,研究组能有效提高心绞痛疗效、心电图疗效、中医症状总疗效,缩短心绞痛发作持续时间,降低中医证候总积分(均有P<0.0001)。两组在减少心绞痛发作频率方面的差异无统计学意义(P=0.09),且两组在不良反应方面的差异无统计学意义(P=0.43)。频数统计结果显示:排名居前7位的依次是丹参、淫羊藿、川芎、三七、黄芪、山茱萸、熟地黄。聚类分析得到3组药物组合。结论:温肾活血法在治疗冠心病心绞痛方面具有良好的临床疗效,但对冠心病心绞痛的安全性高低不确定。数据挖掘获得的药物组合功效、机制明确,其应用于临床治疗冠心病心绞痛具有一定的借鉴意义。因纳入本研究的文献质量及数量的限制,上述结论仍需使用临床设计更符合循证医学规范且更严谨、高质量、大样本的临床随机对照双盲试验予以验证。

Objective:To systematically evaluate the effectiveness and safety of the warming kidney and activating blood circulation method in the treatment ofangina pectoris in coronary heart disease,providing a theoretical basis for clinical application of the warming kidney and activating blood circulation method in treating angina pectoris in coronary heart disease and exploring new medicine research ideas by mining prescriptions.Methods:In databases such as CNKI,Wanfang,VIP,CBMdisc,O PubMed,Embase,Cochrane Library and Web of Science,the clinical randomized controlled trials of treating angina pectoris in coronary heart disease by the warming kidney and activating blood circulation method from the establishment of each database to March 2022 were retrieved.Cochrane risk bias assessment tool was used to evaluate the quality of the included literature.A Meta-analysis was performed by RevMan 5.3 software.Microsoft Office Excel was used to count the frequency of TCM medicines.SPSS Statistics 21.0 software was used to perform a cluster analysis.Results:A total of 10 studies on randomized controlled trials with 924 cases were eventually included.The Meta-analysis showed that compared with the control group,the study group could effectively ameliorate the angina pectoris efficacy,ECG efficacy,and total TCM symptom efficacy,shorten the duration of angina pectoris,and reduce the total score of TCM syndromes(all P<0.0001).There was no statistically significant difference between the two groups in reducing the frequency of angina pectoris(P=0.09),and there was no statistically significant difference between the two groups in adverse reactions(P=0.43).The results of frequency statistics showed that the top 7 medicines were Danshen(Radix et Rhizoma Salviae Miltiorrhizae),Yinyanghuo(Herbaa Epimedii),Chuanxiong(Rhizoma Chuanxiong),Sanqi(Radix Notoginseng),Huangqi(Radix Astragali),Shanzhuyu(Radix Astragali)and Shu Dihuang(Radix Rehmanniae Praeparata)in order.The cluster analysis obtained 3 groups of medicine combinations.Conclusion:The warming kidney and activating blood circulation method shows a good clinical effect on angina pectoris in coronary heart disease,but its safety level is uncertain.The efficacy and action mechanism of medicine combinations obtained from data mining are clear,and their application in the clinical treatment of angina pectoris in coronary angina pectoris shows a certain referent significance.Due to the limitation of the quality and quantity of the literature included in this study,the above conclusions still need to be verified by clinical randomized controlled double-bling trials with a more rigorous,high-quality and large sample clinical design that is more consistent with evidence-based medical norms.