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传统草药治疗心律失常的疗效和安全性：一项随机对照临床试验的系统评价和荟萃分析。

Effectiveness and safety of traditional herbal medicine on cardiac arrhythmic condition: A systematic review and meta-analysis of randomized control clinical trial.

机构信息

Department of Korean Internal Medicine, College of Korean Medicine, Wonkwang University, 460, Iksan-daero, South Korea.

Department of Diagnostics, College of Korean Medicine, Wonkwang University, 460, Iksan-daero, South Korea.

出版信息

Medicine (Baltimore). 2024 Jun 7;103(23):e38441. doi: 10.1097/MD.0000000000038441.

DOI:10.1097/MD.0000000000038441
PMID:38847675
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11155608/
Abstract

INTRODUCTION

The prevalence of cardiac arrhythmia, which can lead to cardiac death, heart failure, and cardioembolic stroke, is increasing. Although various Western medicines for cardiac arrhythmias have been developed, there are still various difficulties in the management of arrhythmias. Traditional herbal medicines (THM) are widely used to manage arrhythmia in East Asia. Therefore, this study aimed to assess the effectiveness and safety of THM in the treatment of arrhythmia.

METHOD

Using a systematic review methodology, we searched for randomized clinical trials on herbal medicines for arrhythmia without complications in 4 databases up to September 2022. The literature search was carried out again, targeting papers published until April 2024.We conducted a risk-of-bias assessment and meta-analysis. This study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

RESULTS

Eighty-two randomized clinical trials were included in this meta-analysis. Total effective rate was significantly better in unspecified arrhythmia (risk ratio [RR]: 1.20, 95% confidence interval [CI]: 1.13-1.26), premature ventricular contraction (RR: 1.29, 95% CI: 1.29-1.33), sinus bradycardia (RR: 1.26, 95% CI: 1.17-1.36), tachycardia (RR: 1.23 95% CI: 1.15-1.32), and atrial fibrillation (RR: 1.17, 95% CI: 1.07-1.27). No severe adverse events were associated with THM. The overall risk of bias was relatively high. The total effective rate was the most frequently assessed clinical outcome variable. Most outcomes were surrogates and not clinical endpoints.

CONCLUSION

THM, alone or in combination with Western medicine, has therapeutic effects on cardiac arrhythmic diseases. However, additional disease-specific clinical outcome variables are required for further studies on THM. Owing to the low quality of the included studies and their small sample sizes, additional large-scale, long-term follow-up, and well-designed randomized controlled clinical trials are required.

SYSTEMATIC REVIEW REGISTRATION NUMBER

Details of the protocol for this systematic review and meta-analysis were registered on the Open Science Framework (OSF. io). (https://osf.io/7r8kn/).

摘要

简介

心律失常的患病率不断增加，可导致心源性死亡、心力衰竭和心源性卒中。尽管已经开发出各种治疗心律失常的西药，但心律失常的管理仍存在各种困难。传统草药（THM）在东亚被广泛用于治疗心律失常。因此，本研究旨在评估 THM 治疗心律失常的有效性和安全性。

方法

使用系统评价方法，我们在 4 个数据库中检索了截至 2022 年 9 月无并发症的草药治疗心律失常的随机临床试验。再次进行文献检索，针对截至 2024 年 4 月发表的论文进行检索。我们进行了风险偏倚评估和荟萃分析。本研究根据系统评价和荟萃分析的首选报告项目进行。

结果

这项荟萃分析共纳入 82 项随机临床试验。不明原因心律失常（风险比 [RR]：1.20，95%置信区间 [CI]：1.13-1.26）、室性早搏（RR：1.29，95% CI：1.29-1.33）、窦性心动过缓（RR：1.26，95% CI：1.17-1.36）、心动过速（RR：1.23，95% CI：1.15-1.32）和心房颤动（RR：1.17，95% CI：1.07-1.27）的总有效率明显更好。THM 不与严重不良事件相关。总体偏倚风险相对较高。总有效率是最常评估的临床结局变量。大多数结局都是替代指标，而不是临床终点。

结论

THM 单独或与西药联合使用对心律失常性疾病具有治疗作用。然而，THM 的进一步研究需要特定疾病的临床结局变量。由于纳入研究的质量较低且样本量较小，需要进行更多的大型、长期随访和设计良好的随机对照临床试验。

系统评价注册编号

本系统评价和荟萃分析的方案详情已在开放科学框架（OSF. io）上注册（https://osf.io/7r8kn/）。

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