中医药治疗冠心病PCI术后合并焦虑和(或)抑郁疗效及安全性的Meta分析

Efficacy and safety of traditional Chinese medicine in the treatment of coronary heart disease complicated with anxiety and/or depression after PCI:A systematic review and meta-analysis

目的:系统评价中医药治疗冠心病PCI术后合并焦虑和(或)抑郁的临床疗效与安全性。方法:计算机检索中国知网、万方、维普、中国生物医学文献数据库(CMB)、PubMed、Web of Science、Cochrane Library数据库,纳入自建库至2020年11月前公开发表的中医药治疗冠心病PCI术后合并焦虑和(或)抑郁的中英文随机对照研究(randomized controlled trials,RCTs),运用Cochrane偏倚风险工具和改良后的Jadad量表对纳入文献进行质量评价,采用RevMan 5.3、Stata16.0软件进行Meta分析。结果:共计纳入23篇随机对照试验,包括1837例研究对象,其中中医药治疗组917例,对照组920例,组间基线情况一致,具有可比性。Meta分析结果显示,中医药治疗在提高临床总有效率[OR=2.34,95%CI(1.61,3.40),P<0.00001],中医证候疗效[OR=5.19,95%CI(2.74,9.86),P<0.00001],降低汉密尔顿焦虑量表HAMA评分[SMD=-0.96,95%CI(-1.78,-0.14),P=0.02]、汉密尔顿抑郁量表HAMD评分[SMD=-1.10,95%CI(-1.79,-0.41),P=0.002]、SAS自评量表评分[SMD=-1.20,95%CI(-1.75,-0.65),P<0.0001]及SDS自评量表评分[SMD=-1.14,95%CI(-1.62,-0.65),P<0.00001]等指标上均优于对照组,其差异具有统计学意义(P<0.05)。结论:在术后常规西医治疗方案基础上联用中医药干预可以进一步提高冠心病PCI术后合并焦虑和(或)抑郁患者的临床疗效且具有良好的安全性。限于本研究所纳入的文献质量总体一般,因此上述结论有待今后进一步开展高质量临床随机对照双盲试验加以证实。

Objective:To evaluate the clinical efficacy and safety of traditional Chinese medicine in the treatment of anxiety and/or depression after PCI for coronary heart disease.Methods:We searched the databases of CNKI,Wanfang,VIP,CMB,PubMed,Web of Science,and Cochrane Library.The Chinese and English randomized controlled trials(RCTs)of traditional Chinese medicine in the treatment of anxiety and/or depression after PCI of coronary heart disease published from the database to November 2020 were included.The Cochrane bias risk tool and the modified Jadad scale were used to evaluate the quality of the included literature,and the RevMan 5.3 and Stata 16.0 software were used for meta-analysis.Results:A total of 23 RCTs were selected,including 1837 subjects,917 cases in the treatment group of traditional Chinese medicine,and 920 cases in the control group,and the baseline situation between groups was consistent and comparable.Meta-analysis results show that TCM treatment improves the total clinical effective rate[OR=2.34,95%CI(1.61,3.40),P<0.00001],and the efficacy of TCM syndrome[OR=5.19,95%CI(2.74,9.86),P<0.00001],and reduces Hamilton anxiety scale HAMA score[SMD=-0.96,95%CI(-1.78,-0.14),P=0.02],Hamilton Depression Scale HAMD score[SMD=-1.10,95%CI(-1.79,-0.41),P=0.002],SAS self-rating scale score[SMD=-1.20,95%CI(-1.75,-0.65),P<0.0001],SDS self-rating scale score[SMD=-1.14,95%CI(-1.62,-0.65),P<0.00001]and other indicators,which is better than the control group,and the difference is statistically significant(P<0.05).Conclusion:The combination of traditional Chinese medicine intervention and conventional western medicine treatment can further improve the clinical efficacy of patients with anxiety and/or depression after PCI of coronary heart disease and has good safety.Due to the general quality of the literature included in this study,the above conclusions need to be further confirmed by high-quality randomized controlled double-blind clinical trials.