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参松养心胶囊治疗持续性心房颤动的疗效与安全性:一项随机对照试验的系统评价与Meta分析

Efficacy and safety of shensong yangxin capsules for persistent atrial fibrillation: a Systematic Review and meta-analysis of randomized controlled trials.

作者信息

Chen Yifan, Wang Liuding, Li Yuying, A Runa, OuYang Jiahui, Jiang Zhonghui, Gao Zhuye

机构信息

Department of Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

Department of Neurology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

出版信息

Front Pharmacol. 2025 Jun 18;16:1620340. doi: 10.3389/fphar.2025.1620340. eCollection 2025.

Abstract

BACKGROUND

Shensong Yangxin (SSYX), a standardized Chinese preparation, is widely utilized in arrhythmia treatment. This research sought to assess the clinical advantages of SSYX for persistent atrial fibrillation (PsAF).

METHODS

We searched seven databases and two registries to identify randomized controlled trials (RCTs) assessing SSYX as an adjunctive treatment for PsAF. We assessed methodological quality with the Cochrane Risk of Bias Tool 2.0, and conducted meta-analyses with RevMan 5.4.

RESULTS

The meta-analysis incorporated ten RCTs enrolling 1,713 patients with PsAF. SSYX combined with conventional treatments (CTs) significantly lowered the recurrence of AF compared to CTs alone (risk ratio [] = 0.65, 95% conffdence interval [] 0.56 to 0.75, < 0.001). The results also showed that SSYX contributed to the reduction of left atrial diameter ( = -1.41, 95% -2.48 to -0.34, < 0.001) and P-wave dispersion ( = -10.37, 95% -17.23 to -3.5, = 0.003). Safety analysis revealed that the combination of SSYX and CTs decreased adverse reaction incidence ( = 0.54, 95% 0.32 to 0.90, = 0.02). The certainty of evidence was graded as moderate to low.

CONCLUSION

SSYX showed potential in preventing AF recurrence in PsAF patients. Nevertheless, these preliminary findings require validation through more rigorously designed trials, given methodological limitations impacting evidence certainty.

SYSTEMATIC REVIEW REGISTRATION

https://www.crd.york.ac.uk/PROSPERO/view/CRD420251008974, identifier CRD420251008974.

摘要

背景

参松养心(SSYX)是一种标准化的中药制剂,广泛应用于心律失常的治疗。本研究旨在评估参松养心治疗持续性房颤(PsAF)的临床优势。

方法

我们检索了七个数据库和两个注册库,以识别评估参松养心作为PsAF辅助治疗的随机对照试验(RCT)。我们使用Cochrane偏倚风险工具2.0评估方法学质量,并使用RevMan 5.4进行荟萃分析。

结果

荟萃分析纳入了10项RCT,共1713例PsAF患者。与单纯常规治疗(CT)相比,参松养心联合CT显著降低了房颤复发率(风险比[] = 0.65,95%置信区间[] 0.56至0.75,<0.001)。结果还显示,参松养心有助于减小左心房直径(= -1.41,95% -2.48至-0.34,<0.001)和P波离散度(= -10.37,95% -17.23至-3.5,= 0.003)。安全性分析显示,参松养心与CT联合使用可降低不良反应发生率(= 0.54,95% 0.32至0.90,= 0.02)。证据的确定性等级为中到低。

结论

参松养心在预防PsAF患者房颤复发方面显示出潜力。然而,鉴于影响证据确定性的方法学局限性,这些初步发现需要通过更严格设计的试验进行验证。

系统评价注册

https://www.crd.york.ac.uk/PROSPERO/view/CRD420251008974,标识符CRD420251008974

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/34c7/12213544/0c020bfece2c/fphar-16-1620340-g001.jpg

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