益气养阴法治疗缓慢性心律失常疗效和安全性的Meta分析

A Meta-analysis of efficacy and safety of Tonifying-qi and Nourishing-yin method in the treatment of chronic arrhythmias

目的:系统评价益气养阴法治疗缓慢性心律失常的临床疗效和安全性。方法:计算机检索万方数据、中国知网、中国生物医学文献服务系统、维普数据库、Pubmed、EMbase、The Cochrane Library、Web of Science、Medline共9个数据库,检索时限均为建库至2022年5月,检索关于益气养阴法治疗缓慢性心律失常的临床随机对照试验文献,根据纳入和排除标准进行筛选后,对文献质量进行评价,运用Revman 5.4软件对试验数据进行分析。结果:最终纳入临床随机对照试验45项,纳入样本共4047例。Meta分析示:①在临床有效率方面,益气养阴中药组优于对照组(西医常规治疗或使用安慰剂),差异具有统计学意义[相对危险度(RR)=1.43,95%置信区间(CI)(1.33,1.54),P<0.00001)];②在改善心率方面,益气养阴中药组较对照组(西医常规治疗或使用安慰剂)可显著提高24 h平均心率[标准化均数差(SMD)=2.33,95%CI(1.58,3.08),P<0.00001)]、24 h总心搏数(SMD=2.18,95%CI(1.00,3.36),P<0.00001)及24 h最慢心率(SMD=0.45,95%CI(0.23,0.67),P<0.0001),差异具有统计学意义;③在不良反应发生率方面,益气养阴中药组低于对照组(西医常规治疗或使用安慰剂),差异具有统计学意义(RR=0.35,95%CI(0.26,0.47),P<0.00001)。结论:益气养阴中药或合并西医常规治疗较仅西医常规治疗或使用安慰剂能明显提高缓慢性心律失常患者的临床疗效,提高24 h平均心率、最慢心率并增加总心搏数,且不良反应发生率显著低于西医常规治疗或使用安慰剂。

Objective:To evaluate the clinical efficacy and safety of Tonifying-qi and Nourishing-yin Method(益气养阴法)in the treatment of chronic arrhythmia systematically.Methods:Computer retrieval of 9 databases including Wanfang data,CNKI,China Biomedical Literature Service System,VIP database,Pubmed,EMbase,The Cochrane Library,Web of Science and Medline was made.The retrieval time was from the establishments of the databases to May 2022.The clinical randomized controlled trial liter ature on Tonifying-qi and Nourishing-yin Method in the treatment of chronic arrhythmia was retrieved,and the quality of the literature was evaluated according to the inclusion and exclusion criteria.The data was statistically analyzed using Revman 5.4 software.Results:A total of 45 randomized controlled clinical trials with 4047 cases were finally included.Meta-analysis results showed that:①In terms of clinical efficiency,the Tonifying-qi and Nourishing-yin Method group was better than the control group(took western conventional treatment or placebo),and the difference was statistically significant[RR=1.43,95%CI(1.33,1.54),P<0.00001];②In terms of improving heart rate,the Tonifying-qi and Nourishing-yin Method group could significantly increase 24 h mean heart rate[SMD=2.33,95%CI(1.58,3.08),P<0.00001],24 h total heart beat count(SMD=2.18,95%CI(1.00,3.36),P<0.00001)and 24 h slowest heart rate(SMD=0.45,95%CI(0.23,0.67),P<0.0001)compared with the control group(took western conventional treatment or placebo),and the difference was statistically significant;③In terms of the incidence of adverse reactions,the Tonifying-qi and Nourishing-yin Method group was lower than the control group(took western conventional treatment or placebo),the differences were statistically significant(RR=0.35,95%CI[0.26,0.47],P<0.00001).Conclusion:Tonifying-qi and Nourishing-yin Method or Tonifying-qi and Nourishing-yin Method combined with conventional western medical treatment can significantly improve the clinical efficacy of patients with chronic arrhythmia,increase the 24 h mean heart rate,24 h total heart beat count and 24 h slowest heart rate,and the incidence of adverse effects is significantly lower than that of conventional western medical treatment or placebo.