<italic style="font-style: italic">Dingchan Granule</italic> （定颤颗粒） for Paroxysmal Atrial Fibrillation with Syndrome of <italic style="font-style: italic">Qi</italic> Stagnation and Blood Stasis：A Randomized，Double-Blinded，Placebo-Controlled Clinical Trial

CHENG Xiaozhen; CHEN Xingjuan; LI Weina; XIAO Lu; WANG Yunhan; XU Yun; NIU Yueyue; FENG Ling

doi:10.13288/j.11-2166/r.2025.12.008

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Dingchan Granule （定颤颗粒） for Paroxysmal Atrial Fibrillation with Syndrome of Qi Stagnation and Blood Stasis：A Randomized，Double-Blinded，Placebo-Controlled Clinical Trial

更新时间：2025-06-13

- Dingchan Granule （定颤颗粒） for Paroxysmal Atrial Fibrillation with Syndrome of Qi Stagnation and Blood Stasis：A Randomized，Double-Blinded，Placebo-Controlled Clinical Trial
- Journal of Traditional Chinese Medicine Vol. 66, Issue 12, Pages: 1233-1240(2025)
- 作者机构：
  
  1.中国中医科学院广安门医院，北京市西城区北线阁5号，100053
  2.河南省中医院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2025.12.008
  CLC：
- Received：03 December 2024，
  
  Revised：2025-02-15，
  
  Published：17 June 2025
- 稿件说明：
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程晓振,陈兴娟,李维娜等.定颤颗粒治疗气滞血瘀证阵发性心房颤动的随机、双盲、安慰剂对照临床试验[J].中医杂志,2025,66(12):1233-1240.

CHENG Xiaozhen,CHEN Xingjuan,LI Weina,et al.Dingchan Granule （定颤颗粒） for Paroxysmal Atrial Fibrillation with Syndrome of Qi Stagnation and Blood Stasis：A Randomized，Double-Blinded，Placebo-Controlled Clinical Trial[J].Journal of Traditional Chinese Medicine,2025,66(12):1233-1240.
程晓振,陈兴娟,李维娜等.定颤颗粒治疗气滞血瘀证阵发性心房颤动的随机、双盲、安慰剂对照临床试验[J].中医杂志,2025,66(12):1233-1240. DOI： 10.13288/j.11-2166/r.2025.12.008.

CHENG Xiaozhen,CHEN Xingjuan,LI Weina,et al.Dingchan Granule （定颤颗粒） for Paroxysmal Atrial Fibrillation with Syndrome of Qi Stagnation and Blood Stasis：A Randomized，Double-Blinded，Placebo-Controlled Clinical Trial[J].Journal of Traditional Chinese Medicine,2025,66(12):1233-1240. DOI： 10.13288/j.11-2166/r.2025.12.008.

摘要

目的

观察定颤颗粒治疗气滞血瘀证阵发性心房颤动（阵发性房颤）的临床疗效与安全性。

方法

采用随机、双盲、安慰剂对照研究方法，将90例气滞血瘀证阵发性房颤患者分为治疗组和对照组各45例。两组均给予西医常规治疗，治疗组在西医常规治疗基础上加用定颤颗粒，对照组加用定颤颗粒模拟剂，均每次8 g，每日2次口服。两组均治疗8周。比较两组患者临床疗效、中医证候疗效和房颤转复率；于治疗前后比较两组患者房颤发作次数和持续时间、中医证候积分、房颤症状分级、24小时平均心室率、匹兹堡睡眠质量指数（PSQI）、焦虑指数、抑郁指数，并进行安全性评价。

结果

治疗组临床疗效

总有效率为82.22%（37/45）优于对照组的60.00%（27/45，

＜0.05）；治疗组中医证候疗效总有效率为88.89%（40/45）优于对照组的66.67%（30/45，

＜0.05）；治疗组房颤转复率为26.67%（12/45）优于对照组的6.67%（3/45，

＜0.05）。治疗后两组房颤发作次数和持续时间均较治疗前明显降低（

＜0.01），且治疗组房颤发作次数和持续时间均低于对照组（

＜0.01）。两组治疗后中医证候积分均较治疗前明显降低（

＜0.01），且治疗组低于对照组（

＜0.05）。治疗后两组房颤症状严重程度、房颤症状分级均较治疗前好转（

＜0.01），治疗组症状改善程度优于对照组（

＜0.01）。治疗后两组24小时平均心室率均较治疗前明显降低（

＜0.01）。治疗后治疗组PSQI、焦虑指数、抑郁指数均较治疗前降低（

＜0.01），对照组PSQI、焦虑指数均较治疗前降低（

＜0.01或

＜0.05），且治疗组PSQI、焦虑指数、抑郁指数均低于对照组（

＜0.05或

＜0.01）。两组均未发生不良事件，血、尿、大便常规，肝肾功能，凝血功能指标均未见异常。

结论

定颤颗粒可缓解气滞血瘀证阵发性房颤患者临床症状，改善中医症状积分，提高房颤转复率，稳定平均心室率，亦可显著改善睡眠质量，缓解焦虑、抑郁不良情绪，且安全性良好。

Abstract

Objective

To observe the clinical effectiveness and safety of

Dingchan Granule

（定颤颗粒） for paroxysmal atrial fibrillation with syndrome of

stagnation and blood stasis.

Methods

Using a randomised， double-blind， placebo controlled study method， 90 patients with paroxysmal atrial fibrillation with

stagnation and blood stasis syndrome were divided into 45 cases each in the treatment group and the control group. Both groups were given conventional western medicine treatment， and the treatment group was additionally treated with

Dingchan Granule

， while the control group was treated with

Dingchan Granule

placebo， both of which were taken orally for 8 g each time twice a day. Both groups were treated for 8 weeks. We compared the clinical effectiveness， the improvement of traditional Chinese medicine （TCM） symptoms and the recovery rate of atrial fibrillation between the two groups. We compared the number and duration of atrial fibrillation episodes， TCM sy

mptoms score， atrial fibrillation symptom classification， 24-hour average ventricular rate， Pittsburgh Sleep Quality Index （PSQI）， anxiety index， depression index before and after treatment， and evaluated the safety of the two groups.

Results

The total clinical effectiveness rate in the treatment group was 82.22% （37/45）， which was better than 60.00% （27/45） in the control group （

＜0.05）. The total effective rate of TCM syndrome effectiveness in the treatment group was 88.89% （40/45）， which was better than 66.67% （30/45） in the control group （

＜0.05）； and the rate of atrial fibrillation regression in the treatment group was 26.67% （12/45）， better than 6.67% （3/45） in the control group （

＜0.05）. The number and duration of atrial fibrillation episodes in both groups were significantly decreased （

＜0.01）， and the number and duration of atrial fibrillation episodes in the treatment group were lower than those in the control group （

＜0.01）. The TCM syndrome scores of both groups after treatment were significantly lower than before treatment （

＜0.01）， and the scores of the treatment group was lower than those of the control group （

＜0.05）. The severity of atrial fibrillation symptoms and the grading of atrial fibrillation symptoms in both groups after treatment were improved （

＜0.01）， and the degree of symptom improvement in the treatment group was better than that in the control group （

＜0.01）. The 24-hour average ventricular rate of both groups after treatment was significantly lower （

＜0.01）. The PSQI， anxiety index and depression index of the treatment group were all lower than before treatment （

＜0.01）， while the PSQI and anxiety index of the control group were both lower than before treatment （

＜0.01 or

＜0.05）， the PSQI， anxiety index and depression index of the tr

eatment group being lower than those of the control group （

＜0.05 or

＜0.01）. No adverse events occurred in both groups， and no abnormalities were observed in blood， urine， stool routine， liver and kidney function， and coagulation function indexes.

Conclusion

Dingchan Granule

for paroxysmal atrial fibrillation with

stagnation and blood stasis syndrome can alleviate clinical symptom， improve TCM symptom scores， increase atrial fibrillation recovery rate， stabilise the average ventricular rate， and significantly improve the quality of sleep， alleviate the anxiety and depression， with a good safety profile.

关键词

Keywords

references

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Dingchan Granule （定颤颗粒） for Paroxysmal Atrial Fibrillation with Syndrome of Qi Stagnation and Blood Stasis：A Randomized，Double-Blinded，Placebo-Controlled Clinical Trial

DOI：10.13288/j.11-2166/r.2025.12.008

摘要

Abstract

关键词

Keywords

references