摘要
背景导管消融已作为持续性心房颤动(房颤)节律管理的重要手段, 但术后仍有较高复发率。如何降低消融术后复发率是当前研究热点。传统中药参松养心胶囊治疗室性心律失常安全有效, 且对阵发性心房颤动消融术后也有益处。参松养心胶囊对经射频消融持续性房颤患者预后的研究有待完善。基本原理参松养心胶囊根据中医脉络学说指导研制, 由多种中药成分组成。基础研究已证实参松养心胶囊可调节心房结构重构、电重构和自主神经功能, 降低房颤的易感性。临床上已用于阵发性房颤患者维持窦性心律, 并且可降低射频消融术后阵发性房颤患者复发风险。设计方案本试验将920例(年龄18~75岁)经射频消融持续性房颤患者按1∶1比例用区组随机化方法分为服用参松养心胶囊组或安慰剂组, 随访观察1年。主要终点是射频消融术后房颤1年复发率。次要终点:治疗后3、6、12个月时房颤负荷的变化;首次发生心房扑动/房颤的时间;治疗后1年的心脏电复律发生率、经胸超声心动图指标变化;治疗后6个月和1年时脑卒中和血栓栓塞的发生率;治疗后1年内健康调查简表(SF-36)评分。结论本研究预期结果将证实参松养心胶囊可减少持续性房颤消融术后1年内复发率, 降低房颤负荷, 提高患者生活质量并具有良好的安全性。
Background Catheter ablation has been used as a curative treatment for rhythm management of persistent atrial fibrillation(AF),but its recurrence rate is high.How to reduce the recurrence rate of AF after radiofrequency catheter ablation(RFCA)is a current research hotspot.Traditional Chinese medicine ShensongYangxin capsules(SSYX)is safe and effective in the treatment of ventricular arrhythmia.There are also clinical benefits for patients with paroxysmal AF after catheter ablation.However,there is no large-scale clinical study of SSYX on the prognosis of patients with persistent AF after RFCA.Rationale SSYX was developed under the guidance of the meridian theory and is composed of a variety of traditional Chinese medicine ingredients.Basic studies have confirmed that SSYX can regulate atrial structural remodeling,electrical remodeling and autonomic nervous function,and reduce the susceptibility to AF.SSYX has been used clinically to maintain sinus rhythm for patients with paroxysmal AF and reduce the risk of recurrence in patients with paroxysmal AF after RFCA.Design This trial will be conducted with a total of 920 participants diagnosed with persistent AF who received RFCA.The participants will be randomized(1∶1)into groups receiving either SSYX or Placebo for 1 year.The primary endpoint would be recurrence of AF within 1 year after RFCA.The secondary outcome measures include changes of AF load at 3 months,6 months,and 1 year after treatment,the time of first atrial flutter/AF,the incidence of cardioversion 1 year after treatment,changes of transthoracic echocardiographic parameters 1 year after treatment,the incidence of stroke and thromboembolism at 6 months and 1 year after treatment,the score of SF-36 within 1 year after treatment.Safety outcomes will also be assessed.Conclusion The results of this study are expected to confirm that SSYX can reduce recurrence rates,reduce AF burden,improve quality of life,and have good safety within 1 year following radiofrequency ablation of persistent AF.
作者
黄鹤
黄从新
唐艳红
王晞
刘育
孔彬
胡丹
帅维
杨宏杰
孟泓
Huang He;Huang Congxin;Tang Yanhong;Wang Xi;Liu Yu;Kong Bin;Hu Dan;Shuai Wei;Yang Hongjie;Meng Hong(Department of Cardiology,Renmin Hospital of Wuhan University,Cardiovascular Research Institute,Wuhan University,Hubei Key Laboratory of Cardiology,Wuhan 430060,China)
出处
《中华心律失常学杂志》
2023年第2期166-170,共5页
Chinese Journal of Cardiac Arrhythmias
基金
国家重点研发计划(2017YFC1700504)。
关键词
心房颤动
参松养心胶囊
持续性心房颤动
随机对照试验
临床方案
Atrial fibrillation
ShensongYangxin capsules
Persistent atrial fibrillation
Randomized controlled trial
Clinical protocols
