目的对温胆汤治疗心律失常的疗效及安全性进行评价。方法全面收录温胆汤加减方治疗心律失常的临床随机对照试验和半随机对照试验,按照纳入排除标准对符合条件的研究提取资料并进行严格的质量评价后,采用RevMan5.2软件进行Meta分析,并进行敏感性分析和偏倚性分析。结果共纳入10项研究,均为中文文献,总计908例患者,治疗组492例,对照组416例。Meta分析结果显示:温胆汤与对照组相比,治疗心律失常的临床总有效率有统计学意义,表明温胆汤治疗心律失常在临床总有效率方面优于对照组。温胆汤加规范西药与规范西药相比,治疗心律失常的临床总有效率、症状改善总有效率、心电图改善总有效率有统计学意义,表明温胆汤加规范西药治疗心律失常在临床总有效率、症状改善总有效率、心电图改善总有效率等方面均优于单纯规范西药(均P〈0.00001或P〈0.05)。漏斗图分析结果显示不排除发表性偏倚的可能性。结论温胆汤能够有效治疗心律失常,改善心律失常的临床症状和心电图,但是由于纳入的研究质量和数量有限,上述结论尚需更多高质量、大样本、长期随访的临床随机对照试验的验证。
Objective: To evaluate the clinical efficacy and safety of Wendan decoction on arrhythmia. Methods: Randomized controlled trials and semi-controlled trials were included about Wendan decoction on Arrhythmia. According to the inclusion of exclusion criteria,the research data in line with the conditions was extracted,and the strict quality evaluation was carried on,after which,RevMan5.2 software was used to make Meta-analysis,as well as sensitivity analysis and bias analysis. Results: 10 selected trials were Chinese. 908 patients were divided into the treatment group of 492 cases and the control group of 416 cases. Meta-analysis results showed that in the comparison with the control group,the clinical total effective rate of the treatment group had statistical significance,and the treatment group with Wendan decoction was superior to the control group. In the comparison with Western Medicine in the control group,the clinical total effective,the symptom improvement efficiency and the electrocardiogram improvement efficiency rate of Wendan decoction in the treatment group had statistical significance,and Wendan decoction combined with Western medicine was superior to only Western medicine(P〈0.00001 or P〈0.05). The funnel plot analysis pointed out that there might be publication bias. Conclusion:Wendan decoction is effective on arrhythmia and can improve the clinical symptoms and electrocardiogram of arrhythmia. But because the quality and quantity of the research are limited,further confirmation with clinical randomized controlled trials of high quality,large sample and long-term follow-up are needed.