Combination of Activating Blood Circulation and Detoxifying Chinese Medicines Played an Anti-Inflammatory Role in Unstable Angina Patients after Percutaneous Coronary Intervention:A Multicenter, Open-Labeled, Randomized Controlled Trial<sup>*</sup>

Xiao-juan MA; Wen-hui DUAN; Ying ZHANG; Jie GAO; Bao-yi GUAN; Ke-ji CHEN; Da-zhuo SHI

doi:10.1007/s11655-021-2878-8

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Combination of Activating Blood Circulation and Detoxifying Chinese Medicines Played an Anti-Inflammatory Role in Unstable Angina Patients after Percutaneous Coronary Intervention:A Multicenter, Open-Labeled, Randomized Controlled Trial^*

Original Article | Updated：2021-11-05

- Combination of Activating Blood Circulation and Detoxifying Chinese Medicines Played an Anti-Inflammatory Role in Unstable Angina Patients after Percutaneous Coronary Intervention:A Multicenter, Open-Labeled, Randomized Controlled Trial^*
- Chinese Journal of Integrative Medicine Vol. 27, Issue 11, Pages: 803-810(2021)
- Affiliations：
  
  1.National Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing (100091), China
  2.Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing (100091), China
- Author bio：
  
  Prof. SHI Da-zhuo, E-mail: shidztcm@163.com
- Funds：
- DOI：10.1007/s11655-021-2878-8
  CLC：
- Published：01 November 2021，
  
  Published Online：16 September 2021，
  
  Accepted：22 February 2021
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Xiao-juan MA, Wen-hui DUAN, Ying ZHANG, et al. Combination of Activating Blood Circulation and Detoxifying Chinese Medicines Played an Anti-Inflammatory Role in Unstable Angina Patients after Percutaneous Coronary Intervention:A Multicenter, Open-Labeled, Randomized Controlled Trial^*. [J]. Chinese Journal of Integrative Medicine 27(11):803-810(2021)
DOI：

Xiao-juan MA, Wen-hui DUAN, Ying ZHANG, et al. Combination of Activating Blood Circulation and Detoxifying Chinese Medicines Played an Anti-Inflammatory Role in Unstable Angina Patients after Percutaneous Coronary Intervention:A Multicenter, Open-Labeled, Randomized Controlled Trial^*. [J]. Chinese Journal of Integrative Medicine 27(11):803-810(2021) DOI： 10.1007/s11655-021-2878-8.

摘要

目的:

观察活血解毒中药配伍联合西医常规对不稳定性心绞痛介入后患者炎症介质水平的影响.

方法:

采用多中心、随机对照、开放性临床试验设计

纳入154例不稳定性心绞痛患者

随机分为活血组和活血解毒组: 活血组在常规西药治疗基础上

加用冠心丹参滴丸 (0.4 g

每日三次) ; 活血解毒组在常规西药治疗基础上

加用冠心丹参滴丸 (服法同上) 和穿心莲片 (0.2 g

每日三次)

两组皆治疗4周. 主要疗效指标为血清hs-CRP水平; 次要疗效指标包括: ①肿瘤坏死因子α (TNFα) 、白介素-6 (IL-6) 、抗原CD40配体 (sCD40L) 和血栓调节蛋白 (TM) 等. ②心绞痛计分改善情况. ③血瘀证计分改善情况. ④中医症状计分改善情况

分别与入组时和4周治疗结束时进行检测.

结果:

共有144例患者完成观察 (活血组70例

活血解毒组74例) . 两组患者的性别、年龄、疾病史和用药情况等基线资料无显著差异 (

0.05) . 治疗4周后

与活血组比较

活血解毒组发挥了更好的抑制炎症因子的作用

尤其是在降低hs-CRP(

0.05) 、IL-6 (

0.01) 和TNFα(

0.01) 的表达方面. 两组患者治疗后的血瘀证计分、心绞痛计分和中医症状计分均比治疗前有显著改善 (

0.05)

且活血解毒组患者血瘀证计分和心绞痛计分显著低于活血组 (

0.05) .

结论:

在西医常规治疗基础上加用活血解毒中药 (冠心丹参滴丸+穿心莲片) 治疗不稳定性心绞痛介入后患者

较单纯应用活血化瘀中药 (冠心丹参滴丸) 能更好的降低炎症因子水平.

Abstract

Objective:

To investigate the combined anti-inflammatory effect of activating blood circulation and detoxifying Chinese medicines in unstable angina (UA) patients.

Methods:

This study was an open-labeled

randomized controlled trial conducted in 5 centers in Beijing. A total of 154 patients were randomized into two groups at a 1:1 ratio by random numbers. Based on the conventional treatment

patients in the activating blood circulation (ABC) group were treated with Guanxin Danshen Droping Pill (冠心丹参滴丸

0.4 g

thrice daily)

and patients in the activating blood circulation and detoxifying (ABCD) group were treated with Guanxin Danshen Droping Pill (0.4 g

thrice daily) and Andrographis tablet (0.2 g

thrice daily) for 4 weeks. The primary outcome was the serum level of high sensitive C reaction protein (hs-CRP)

and the secondary outcome index included the serum levels of tumor necrosis factor α (TNF-α)

interleukin 6 (IL-6)

soluble CD40 ligand (sCD40L)

thrombomodulin (TM)

the score of angina pectoris

the score of blood stasis syndrome

and the score of Chinese medicine symptoms

observed at week 0 and week 4.

Results:

A total of 144 patients completed the trial (ABC group

=70; ABCD group

=74). There were no significant differences in the clinical baseline characteristics between the two groups. When compared with the ABC group

ABCD group showed better performance in reducing the level of inflammatory factors

especially hs-CRP (

0.05)

IL-6 (

0.01) and TNF-α (

0.01). In term of clinical symptoms

ABCD group played a better role in improving the scores of angina pectoris and blood stasis syndrome than ABC group (all

0.05).

Conclusions:

The combination of Guanxin Danshen Dropping Pill and Andrographis tablet exert significant anti-inflammatory effect on UA patients

which is superior to single Guanxin Danshen Dropping Pill. (Registration No. ChiCTR-TRC-13004072)

关键词

Keywords

Chinese medicineunstable anginainflammationrandomized controlled trial

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Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Institute of Dermatology, Shanghai Academy of Traditional Chinese Medicine

Department of Integrated Traditional Chinese and Western Medicine, Shanghai Skin Disease Hospital, Tongji University School of Medicine

Department of Endocrinology, Guangdong Provincial Hospital of Chinese Medicine

The Second Clinical College of Guangzhou University of Chinese Medicine

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