桂枝甘草龙骨牡蛎汤治疗心律失常疗效及安全性的系统评价

A Systematic Review of the Clinical Efficacy and Safety about Guizhi Gancao Longgu Muli Decoction(桂枝甘草龙骨牡蛎汤) in the Treatment of Arrhythmia

目的:系统评价桂枝甘草龙骨牡蛎汤治疗心律失常的临床疗效与安全性。方法:计算机检索Cochrance Library、Pub Med、EMbase、中国生物医学文献光盘数据库(CBM)、中国期刊全文数据库(CNKI)、万方数据库,维普全文电子期刊(VIP),筛查后纳入桂枝甘草龙骨牡蛎汤治疗心律失常的随机对照试验(RCTs)。分别采用Review Manager 5.2软件、Stata14软件及GRADE-profiler3.6软件对数据进行偏倚风险评估、Meta分析和质量整体评价。结果:共纳入17项研究,1,451例研究对象,文献整体质量偏低,Meta分析显示治疗组中医证候疗效[OR=3.13,95%CI(2.16,14.53)]、早搏临床疗效[OR=12.46,95%CI(1.65,3.67)]、动态心电图早搏总数[WMD=-517.96,95%CI(-715.94,-319.98),P<0.000,01]、中医证候积分[WMD=-5.48,95%CI(-5.90,-5.06),P<0.000,01]以及不良反应发生率[RR=0.45,95%CI(0.24,0.85),P=0.01]方面均优于对照组。结论:基于目前证据,桂枝甘草龙骨牡蛎汤治疗心律失常疗效好且安全。但纳入研究整体质量偏低,对于该方治疗心律失常的疗效和安全性还需更多的临床证据证实。

Objective： To evaluate the clinical efficacy and safety about Guizhi Gancao Longgu Muli decoction in the treatment of arrhythmia. Methods： The Cochrane library, Pub Med, EMbase, CBM, CNKI, Wan Fang Data and VIP were searched, and randomized controlled trials（RCTs） about Guizhi Gancao Longgu Muli decoction in treating arrhythmias were recruited. Review 5.2 Manager software, stata14 software, GRADE-profiler3.6.1 software were used to conduct the bias risk assessment, Meta-analysis, and quality evaluation of the studies.Results： A total of 17 RCTs involving 1,451 patients were included into the study. The overall quality of studies is low. Meta analysis showed that in the clinical curative effect of TCM [OR=3.13, 95% CI（2.16,14.53）], the clinical curative effect of premature [OR =12.46, 95% CI（1.65,3.67）], the total number of dynamic ECG beats[WMD=-517.96, 95% CI（-715.94,-319.98, P〈0.000,01], the TCM syndrome score [WMD=-5.48, 95% CI（-5.90,-5.06）, P 0.000,01] and the rate of adverse reactions [RR =0.45 95% CI（0.24,0.85）, P =0.01] in the treatment group is better than those in the control group. Conclusion： Based on the current evidence, Guizhi Gancao Longgu Mu Li decoction is safe and effective in the treatment of arrhythmia. Because of the low methodological quality of the included clinical trials, the efficacy and safety of the treatment are needed.