A multi-center randomized double-blind placebo-controlled trial of Xiongshao Capsule (芎芍胶囊) in preventing restenosis after percutaneous coronary intervention: A subgroup analysis of senile patients

Qing-hua Shang; Hao Xu; Xiao-yan Lu; Chuan Wen; Da-zhuo Shi; Ke-ji Chen

doi:10.1007/s11655-011-0843-7

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A multi-center randomized double-blind placebo-controlled trial of Xiongshao Capsule (芎芍胶囊) in preventing restenosis after percutaneous coronary intervention: A subgroup analysis of senile patients

OriginalPaper | Updated：2021-08-27

- A multi-center randomized double-blind placebo-controlled trial of Xiongshao Capsule (芎芍胶囊) in preventing restenosis after percutaneous coronary intervention: A subgroup analysis of senile patients
- A multi-center randomized double-blind placebo-controlled trial of Xiongshao Capsule (芎芍胶囊) in preventing restenosis after percutaneous coronary intervention: A subgroup analysis of senile patients
- 中国结合医学杂志（英文版） 2011年17卷第9期页码：669-674
- Affiliations：
  
  1. Beijing University of Chinese Medicine,Beijing,China
  2. National Integrative Medicine Center for Cardiovascular Diseases, China-Japan Friendship Hospital,Beijing,China
  3. Xiyuan Hospital, China Academy of Chinese Medical Sciences,Beijing,China
- Author bio：
- Funds：
  
  Supported by the grant from National Tenth Five-year Projects Plan (No. 2001BA701A20)
- DOI：10.1007/s11655-011-0843-7
  中图分类号：
- 纸质出版日期：2011，
  
  网络出版日期：2011-9-11，
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Shang, Qh., Xu, H., Lu, Xy. et al. A multi-center randomized double-blind placebo-controlled trial of Xiongshao Capsule (芎芍胶囊) in preventing restenosis after percutaneous coronary intervention: A subgroup analysis of senile patients., Chin. J. Integr. Med. 17, 669 (2011). https://doi.org/10.1007/s11655-011-0843-7

Qing-hua Shang, Hao Xu, Xiao-yan Lu, et al. A multi-center randomized double-blind placebo-controlled trial of Xiongshao Capsule (芎芍胶囊) in preventing restenosis after percutaneous coronary intervention: A subgroup analysis of senile patients[J]. Chinese Journal of Integrative Medicine, 2011,17(9):669-674.
Shang, Qh., Xu, H., Lu, Xy. et al. A multi-center randomized double-blind placebo-controlled trial of Xiongshao Capsule (芎芍胶囊) in preventing restenosis after percutaneous coronary intervention: A subgroup analysis of senile patients., Chin. J. Integr. Med. 17, 669 (2011). https://doi.org/10.1007/s11655-011-0843-7 DOI：

Qing-hua Shang, Hao Xu, Xiao-yan Lu, et al. A multi-center randomized double-blind placebo-controlled trial of Xiongshao Capsule (芎芍胶囊) in preventing restenosis after percutaneous coronary intervention: A subgroup analysis of senile patients[J]. Chinese Journal of Integrative Medicine, 2011,17(9):669-674. DOI： 10.1007/s11655-011-0843-7.

摘要

To evaluate the safety and efficacy of Xiongshao Capsule (芎芍胶囊

XS)

consisting of Chuangxiongol and paeoniflorin

in preventing restenosis after percutaneous coronary intervention (PCI) in senile coronary heart disease (CHD) patients. A multi-center

randomized

double-blind

placebo-controlled trial was conducted. A total of 335 CHD patients were randomly assigned to treatment with oral administration of XS

or a placebo for 6 months after successful PCI. A clinical follow-up was performed at 1

3 and 6 months after PCI and an angiographic follow-up was scheduled at 6 months. The primary endpoint was angiographic restenosis defined as a luminal stenosis ⩾ 50% in follow-up. The secondary endpoints were combined incidence of death

target lesion nonfatal myocardial infarction

repeat target-vessel angioplasty

and coronary artery bypass graft surgery (CABG). The follow-up for the above clinical endpoint events was continued to 1 year after PCI. The subgroup analysis of 152 senile patients (68 cases angiographic follow-up) showed that the restenosis rates tended to reduce in the XS group as compared with that in the placebo group (24.32% vs. 38.71%

P > 0.05)

and the minimum lumen diameter (MLD) significantly increased in the follow-up (2.15 ± 0.84 for XS vs. 1.73 ± 0.91 for placebo

P < 0.05). The incidence of recurrent angina at 3 and 6 months after PCI was also significantly reduced in the XS group (4.11% and 12.33%) as compared with those in the placebo group (17.72% and 43.04%)

but there was no significant difference in the combined incidence of clinical outcomes (6.85% in the XS group vs. 11.39% in the placebo group

P > 0.05). No significant adverse reactions occurred within the 6-month follow-up period in the XS group. Administration of XS in addition to standardized Western medication for 6 months is demonstrated to be safe and effective in reducing post-PCI recurrent angina and inhibiting luminal restenosis after PCI in senile CHD patients.

Abstract

To evaluate the safety and efficacy of Xiongshao Capsule (芎芍胶囊

XS)

consisting of Chuangxiongol and paeoniflorin

in preventing restenosis after percutaneous coronary intervention (PCI) in senile coronary heart disease (CHD) patients. A multi-center

randomized

double-blind

placebo-controlled trial was conducted. A total of 335 CHD patients were randomly assigned to treatment with oral administration of XS

or a placebo for 6 months after successful PCI. A clinical follow-up was performed at 1

target lesion nonfatal myocardial infarction

repeat target-vessel angioplasty

P > 0.05)

and the minimum lumen diameter (MLD) significantly increased in the follow-up (2.15 ± 0.84 for XS vs. 1.73 ± 0.91 for placebo

but there was no significant difference in the combined incidence of clinical outcomes (6.85% in the XS group vs. 11.39% in the placebo group

关键词

coronary heart diseasesenilePercutaneous Coronary InterventionrestenosisXiongshao capsuleactive blood circulation

Keywords

coronary heart diseasesenilePercutaneous Coronary InterventionrestenosisXiongshao capsuleactive blood circulation

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