Wei Yongfang, Yan Meihui, Chen Rumeng, Ding Yining, Xu Shuling, Li Haigang, Wang Zhiyu, Bao Meihua, He Binsheng, Li Sen
School of Pharmacy, Changsha Medical University, Changsha, China.
Hunan Provincial Key Laboratory of the Research and Development of Novel Pharmaceutical Preparations, Changsha Medical University, Changsha, China.
Medicine (Baltimore). 2025 May 2;104(18):e41779. doi: 10.1097/MD.0000000000041779.
Bradyarrhythmia is a form of arrhythmia commonly seen in clinical settings. This study aims to investigate the efficacy and safety of the Shenfu injection (SFI) in the treatment of bradyarrhythmia.
A comprehensive search was conducted in seven databases for randomized controlled trials (RCTs) related to SFI and the treatment of bradyarrhythmia. Primary outcome in this meta-analysis included the overall response rate in clinical symptom improvement. The risk of bias was evaluated utilizing the Cochrane Collaboration's tool.
A total of 28 studies, involving 2143 patients with bradyarrhythmia, were included. The meta-analysis results suggest that SFI treatment is superior to conventional medication alone. Further sensitivity analysis demonstrated that the total response rate in the SFI group was significantly higher than that in the conventional medication group (RR = 1.29; 95% CI: 1.22-1.37; P < .00001). Moreover, the improvement in heart rate in the SFI group was significantly better than that in the conventional medication group (MD = 5.17; 95% CI: 3.77-6.58; P < .00001). In terms of safety, the incidence of adverse events was lower in the SFI treatment group (5.25%, 19/362) compared to the conventional medication alone group (34.04%, 113/332) (RR = 0.20; 95% CI: 0.08-0.51; P < .001).
SFI demonstrates significant improvement in the overall response rate and safety for patients with bradyarrhythmia compared to conventional basic therapy. However, due to the presence of potential bias in the included studies, well-designed RCT trials are needed to confirm the efficacy and safety of adjuvant SFI therapy for the treatment of bradyarrhythmia.
缓慢性心律失常是临床常见的心律失常类型。本研究旨在探讨参附注射液（SFI）治疗缓慢性心律失常的有效性和安全性。
在七个数据库中全面检索与SFI和缓慢性心律失常治疗相关的随机对照试验（RCT）。本荟萃分析的主要结局包括临床症状改善的总体有效率。采用Cochrane协作网的工具评估偏倚风险。
共纳入28项研究，涉及2143例缓慢性心律失常患者。荟萃分析结果表明，SFI治疗优于单纯常规药物治疗。进一步的敏感性分析显示，SFI组的总有效率显著高于常规药物组（RR = 1.29；95%CI：1.22 - 1.37；P <.00001）。此外，SFI组心率改善情况明显优于常规药物组（MD = 5.17；95%CI：3.77 - 6.58；P <.00001）。在安全性方面，SFI治疗组不良事件发生率低于单纯常规药物组（5.25%，19/362）（34.04%，113/332）（RR = 0.20；95%CI：0.08 - 0.51；P <.001）。
与传统基础治疗相比，SFI在缓慢性心律失常患者的总体有效率和安全性方面有显著改善。然而，由于纳入研究存在潜在偏倚，需要设计良好的RCT试验来证实SFI辅助治疗缓慢性心律失常的有效性和安全性。
