Cardiovascular Department, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
J Tradit Chin Med. 2024 Dec;44(6):1247-1253. doi: 10.19852/j.cnki.jtcm.2024.06.010.
To evaluate the efficacy of Tongyang Fumai decoction (, TYFM) on the quality of life (QOL) as a complementary therapy for sick sinus syndrome (SSS).
This randomized controlled study involved 224 patients with symptomatic SSS. Patients were randomly assigned to either the TYFM group or the control group (receiving theophylline sustained-release tablets). The primary endpoints included changes in average heart rate, the longest R to R (RR) interval, and the occurrences of long RR intervals. Secondary endpoints comprised the Short Form (SF)-36 questionnaires, the Self-Rating Anxiety Scale (SAS), and the Self-Rating Depression Scale (SDS).
TYFM significantly improved average heart rate (TYFM: 6 bpm control: 3 bpm, 0.01), shortened longest RR interval (TYFM: -0.20 s control: -0.0027 s, 0.05), and reduced numbers of long RR (TYFM: -99 control: -59, 0.01). In SF-36, TYFM enhanced physical and mental components ( 0.01), outperforming the control group. TYFM also improved eight SF-36 dimensions significantly ( 0.05 or 0.01). Regarding SAS and SDS, TYFM reduced scores significantly ( 0.01), while SAS improved in the control group ( 0.01), with no change in SDS. Statistically significant differences ( 0.01) were observed in SAS and SDS between TYFM and control groups post-intervention.
TYFM emerges as a promising alternative strategy for treating SSS, demonstrating favorable therapeutic effects and significant improvements in the quality of life for patients with SSS.
评价通阳复脉汤(TYFM)作为一种治疗病态窦房结综合征(SSS)的补充疗法对生活质量(QOL)的疗效。
这是一项随机对照研究,共纳入 224 例有症状的 SSS 患者。患者被随机分为 TYFM 组或对照组(接受茶碱缓释片治疗)。主要终点包括平均心率、最长 R 到 R(RR)间期的变化以及长 RR 间期的发生。次要终点包括简明健康调查问卷(SF-36)、焦虑自评量表(SAS)和抑郁自评量表(SDS)。
TYFM 可显著提高平均心率(TYFM:6 次/分,对照组:3 次/分, 0.01)、缩短最长 RR 间期(TYFM:-0.20 s,对照组:-0.0027 s, 0.05)、减少长 RR 间期的发生(TYFM:-99 次,对照组:-59 次, 0.01)。在 SF-36 中,TYFM 增强了生理和心理功能( 0.01),优于对照组。TYFM 还显著改善了 8 个 SF-36 维度( 0.05 或 0.01)。在 SAS 和 SDS 方面,TYFM 可显著降低评分( 0.01),而对照组的 SAS 有所改善( 0.01),SDS 则无变化。干预后 TYFM 和对照组在 SAS 和 SDS 方面的差异具有统计学意义( 0.01)。
TYFM 是治疗 SSS 的一种很有前途的策略,对 SSS 患者的治疗效果和生活质量均有显著改善。