目的 系统评价稳心颗粒联合常规治疗方案治疗心肌病合并心律失常的有效性和安全性。方法 计算机检索PubMed、Cochrane Library、中国知网、万方、维普等数据库，搜集稳心颗粒治疗心肌病合并心律失常的相关随机对照试验（randomized controlled trials，RCTs），检索时限从建库至2024年2月。由2名研究者独立筛选文献、提取相关资料并评估纳入研究的偏倚风险后，采用Review Manager 5.4软件进行Meta分析。结果 共纳入23个RCTs，包括2 169例患者。Meta分析结果显示，在常规治疗方案基础上联用稳心颗粒可显著提升综合临床疗效 [OR＝3.96, 95% CI (3.03, 5.17), P＜0.000 01]，增加24 h超声心动图治疗有效率 [OR＝2.79, 95% CI (1.73, 4.50), P＜0.000 1]，有效改善左心室射血分数（left ventricular ejection fraction，LVEF）[MD＝3.37, 95% CI (0.79, 5.96), P＝0.01] 和心率（heart rate，HR）[MD＝-7.93, 95% CI (-15.09,-0.77), P＝0.03]，并降低总体不良反应发生率 [OR＝0.44, 95% CI (0.30, 0.64), P＜0.000 1]。结论 稳心颗粒联合常规治疗方案治疗心肌病合并心律失常可提高临床疗效，且安全性较高。受纳入研究的数量和质量的限制，研究结果尚需开展更多高质量研究予以证实。

Objective To systematically evaluate the efficacy and safety of Wenxin Granules (稳心颗粒, WXKL) in combination with western medical treatment (WMT) for the treatment of cardiomyopathy combined with arrhythmias. Methods Randomized controlled trials (RCTs) of WXKL for the treatment of cardiomyopathy combined with arrhythmia were searched in PubMed, Cochrane Library, CNKI, Wanfang and VIP databases from the inception to February 2024. Two evaluators independently performed article screening, data extraction, and study quality assessment. Data analysis was performed using Review Manager 5.4. Results A total of 23 RCTs with 2 169 patients were included. Meta-analysis showed that compared with WMT, WXKL can improve the clinical efficacy better [OR = 3.96, 95% CI (3.03, 5.17), P < 0.000 01] and increase efficacy of dynamic electrocardiography [OR = 2.79, 95% CI (1.73, 4.50), P < 0.000 1], and effectively improve left ventricular ejection fraction (LVEF) [(MD = 3.37, 95% CI (0.79, 5.96), P = 0.01)] and heart rate (HR) [(MD = -7.93, 95% CI (-15.09, -0.77), P = 0.03)], and reduce the incidence of adverse events [OR = 0.44, 95% CI (0.30, 0.64), P < 0.000 1]. Conclusion WXKL can improve the clinical efficacy and have a high safety profile in patients with cardiomyopathy combined with arrhythmia. Due to the limitations of the number and quality of included studies, more high-quality studies are needed to confirm the conclusions of this study.

R285.64

2023科技创新专项（DZMKJCX-023-027）