冠心丹参滴丸改善冠心病PCI术后并发焦虑或抑郁患者的生活质量和心血管预后（GLAD研究）：一项随机双盲安慰剂对照研究

WANG Cheng-long; HUAN Na; WANG Pei-li; GENG Qing-shan; MA Wen-lin; MA Li-hong; JIANG Hong-yan; MENG Xiao-ping; ZHANG Da-wu; GOU Xiao-jiang; HU Da-yi; CHEN Ke-ji

doi:10.1007/s11655-022-3688-3

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冠心丹参滴丸改善冠心病PCI术后并发焦虑或抑郁患者的生活质量和心血管预后（GLAD研究）：一项随机双盲安慰剂对照研究

Original Article | Updated：2023-02-22

- 冠心丹参滴丸改善冠心病PCI术后并发焦虑或抑郁患者的生活质量和心血管预后（GLAD研究）：一项随机双盲安慰剂对照研究
- Guanxin Danshen Dripping Pills Improve Quality of Life and Cardiovascular Prognoses of CHD Patients after PCI with Anxiety or Depression (GLAD Study): A Randomized Double-Blind Placebo-Controlled Study
- 中国结合医学杂志（英文版） 2023年29卷第3期页码：195-204
- Affiliations：
  
  1.Department of Cardiovascular Disease, Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences, Beijing(100091), China
  2.National Clinical Research Center for Chinese Medicine Cardiology, Beijing(100091), China
  3.Department of Cardiovascular Disease, Guangdong Provincial People's Hospital, Guangzhou (510055), China
  4.Department of Cardiovascular Disease, Shanghai Tongji Hospital, Shanghai(200065), China
  5.Department of Cardiovascular Disease, Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing(100037), China
  6.Department of Cardiovascular Disease, Beijing First Hospital of Integrated Chinese and Western Medicine, Beijing(100020), China
  7.Department of Cardiovascular Disease, Affiliated Hospital of Changchun University of Chinese Medicine, Changchun (130021), China
  8.Department of Cardiovascular Disease, People's Hospital of Peking University, Beijing(100044), China
- Author bio：
  
  Prof. CHEN Ke-ji, E-mail: kjchenvip@163.com
- Funds：
- DOI：10.1007/s11655-022-3688-3
  中图分类号：
- 纸质出版日期：2023-03，
  
  网络出版日期：2022-10-27，
  
  录用日期：2022-07-22
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冠心丹参滴丸改善冠心病PCI术后并发焦虑或抑郁患者的生活质量和心血管预后（GLAD研究）：一项随机双盲安慰剂对照研究[J]. 中国结合医学杂志（英文版）, 2023,29(3):195-204.

WANG Cheng-long, HUAN Na, WANG Pei-li, et al. Guanxin Danshen Dripping Pills Improve Quality of Life and Cardiovascular Prognoses of CHD Patients after PCI with Anxiety or Depression (GLAD Study): A Randomized Double-Blind Placebo-Controlled Study[J]. Chinese Journal of Integrative Medicine, 2023,29(3):195-204.
冠心丹参滴丸改善冠心病PCI术后并发焦虑或抑郁患者的生活质量和心血管预后（GLAD研究）：一项随机双盲安慰剂对照研究[J]. 中国结合医学杂志（英文版）, 2023,29(3):195-204. DOI： 10.1007/s11655-022-3688-3.

WANG Cheng-long, HUAN Na, WANG Pei-li, et al. Guanxin Danshen Dripping Pills Improve Quality of Life and Cardiovascular Prognoses of CHD Patients after PCI with Anxiety or Depression (GLAD Study): A Randomized Double-Blind Placebo-Controlled Study[J]. Chinese Journal of Integrative Medicine, 2023,29(3):195-204. DOI： 10.1007/s11655-022-3688-3.

摘要

目的:

评价冠心丹参滴丸 (GXDS) 治疗冠心病患者经皮冠状动脉介入治疗 (PCI) 后抑郁或焦虑的疗效和安全性.

方法:

采用随机数表法将200名参与者随机分为实验组 (GSDX

100例) 和对照组 (100名) . GXDS和对照组分别给予GXDS和安慰剂

每次0.4 g

每天3次

持续12周. 主要治疗指标为PHQ-9、GAD-7和SAQ) 的得分. 次要指标包括SF-12评分、首次发病时间和主要不良心血管事件 (MACEs) 发生率.

结果:

在全分析集 (200例) 分析中

GXDS组治疗后PHQ-9和GAD-7评分显著低于对照组 (

0.05) . 与基线值相比

实验组和对照组的PHQ-9总分分别下降3.97和1.18. 两组之间的校正平均差为-2.78 (95% CI: -3.47

-2.10;

0.001) . GXDS组的GAD-7总分与基线水平相比下降了3.48%

而对照组下降了1.13%. 两组间的校正平均值差为-2.35 (95% CI: -2.95

-1.76;

0.0001)

GXDS组内皮素和hs-CRP水平显著高于对照组

两组之间的差异具有统计学意义 (

0.05) . 本研究观察到3例不良事件

未发生严重不良事件.

结论:

GXDS对冠心病患者PCI后抑郁或焦虑的治疗有效

可以显著缓解抑郁和焦虑

缓解心绞痛症状

提高生活质量. (注册号: ChiCTR1800014291)

Abstract

Objective:

To assess the efficacy and safety of Guanxin Danshen Dripping Pills (GXDS) in the treatment of depression or anxiety in patients with coronary heart disease (CHD) after percutaneous coronary intervention (PCI).

Methods:

From September 2017 to June 2019

200 CHD patients after PCI with depression and anxiety were included and randomly divided into GXDS (100 cases) and placebo control groups (100 cases) by block randomization and a random number table. Patients in the GXDS and control groups were given GXDS and placebo

respectively

0.4 g each time

3 times daily for 12 weeks. The primary outcomes were scores of Patient Health Questionnaire-9 (PHQ-9)

Generalized Anxiety Scale (GAD-7) and the Seattle Angina Pectoris Scale (SAQ). The secondary outcomes included 12 Health Survey Summary Form (SF-12) scores and the first onset time and incidence of major adverse cardiovascular events (MACEs). Other indices including blood pressure

blood lipids

microcirculation and inflammatory-related indices

etc. were monitored at baseline

week 4

and week 12.

Results:

In the full analysis set (200 cases)

after treatment

the PHQ-9 and GAD-7 scores in the GXDS group were considerably lower than those in the control group (

0.05). Compared with the baseline

the total PHQ-9 scores of the experimental and control groups decreased by 3.97 and 1.18

respectively. The corrected mean difference between the two groups was –2.78 (95% CI: –3.47

–2.10;

0.001). The total GAD-7 score in the GXDS group decreased by 3.48% compared with the baseline level

while that of the placebo group decreased by 1.13%. The corrected mean difference between the two groups was –2.35 (95% CI: –2.95

–1.76;

0.001). The degree of improvement in SAQ score

SF-12 score

endothelin and high-sensitive C-reactive protein levels in the GXDS group were substantially superior than those in the placebo group

and the differences between the two groups were statistically significant (

0.05). Similar results were obtained in the per protocol population analysis of 177 patients. Three cases of MACES were reported in this study (1 in the GXDS group and 2 in the placebo group)

and no serious adverse events occurred.

Conclusions:

GXDS can significantly alleviate depression and anxiety

relieve symptoms of angina

and improve quality of life in patients with CHD after PCI. (Registration No. ChiCTR1800014291)

关键词

冠心病经皮冠状动脉介入治疗抑郁和焦虑状态随机对照试验临床疗效

Keywords

Chinese medicinecoronary heart diseasepercutaneous coronary interventiondepression and anxiety stateclinical efficacy

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