A Prospective Randomized Multicenter Controlled Trial on Salvianolate for Treatment of Unstable Angina Pectoris in A Chinese Elderly Population

Hua CUI; Xiao-ying LI; Xue-wen GAO; Xiang LU; Xiu-ping WU; Xiao-fei WANG; Xiang-qing ZHENG; Kui HUANG; Feng LIU; Zhi LUO; Hui-shu YUAN; Gang SUN; Jian KONG; Xiao-hong DU; Jin ZHENG; Hong-ying LIU; Wen-ju ZHANG

doi:10.1007/s11655-019-2710-x

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A Prospective Randomized Multicenter Controlled Trial on Salvianolate for Treatment of Unstable Angina Pectoris in A Chinese Elderly Population

Original Article | Updated：2021-08-27

- A Prospective Randomized Multicenter Controlled Trial on Salvianolate for Treatment of Unstable Angina Pectoris in A Chinese Elderly Population
- A Prospective Randomized Multicenter Controlled Trial on Salvianolate for Treatment of Unstable Angina Pectoris in A Chinese Elderly Population
- Chinese Journal of Integrative Medicine 2019年25卷第10期页码：728-735
- Affiliations：
  
  1.Department of Geriatric Cardiology, the General Hospital of the People's Liberation Army, Beijing (100853), China
  2.Department of Geriatric Clinic, Inner Mongolia People's Hospital, Hohhot (010017), China
  3.Department of Cardiology, the Second Affiliated Hospital of Nanjing Medical University, Nanjing (210011), China
  4.Second Department of Cadre's Ward, the First Affiliated Hospital of Harbin Medical University, Harbin (150001), China
  5.Department of Cadre Health Care, Tianjin First Central Hospital, Tianjin (300192), China
  6.Department of Cardiovascular Medicine, Chongqing General Hospital, Chongqing (400013), China
  7.Department of Geriatrics, Shenyang Red Cross Hospital, Shenyang (110063), China
  8.Department of Geriatric Cardiology, Guangzhou First People's Hospital, Guangzhou (510180), China
  9.Department of Cardiology, Beijing Geriatric Hospital, Beijing (100095), China
  10.the Second Department of Cardiology, the Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine, Harbin (150009), China
  11.Department of Cardiology, Guizhou Province Hospital of Traditional Chinese Medicine, Guiyang (550001), China
  12.Department of Cadre's Ward, the First Bethune Hospital of Jilin University, Changchun (130021), China
  13.Department of Cadre Health Care, the First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province (325000), China
  14.Medical Department, Shanghai Green Valley Pharmaceutical Co., Ltd., Shanghai (201203), China
  15.China Health Promotion Foundation, Beijing (100161), China
- Author bio：
  
  Correspondence to: Dr. LI Xiao-ying, Tel: 86-10-66876271, E-mail: xyli301@163.com
- Funds：
  
  Science and Technology Commission of Shanghai Municipality(15DZ1900300)
- DOI：10.1007/s11655-019-2710-x
  中图分类号：
- 纸质出版日期：2019-10-01，
  
  录用日期：2019-07-22
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Hua CUI, Xiao-ying LI, Xue-wen GAO, 等. A Prospective Randomized Multicenter Controlled Trial on Salvianolate for Treatment of Unstable Angina Pectoris in A Chinese Elderly Population[J]. Chinese Journal of Integrative Medicine, 2019,25(10):728-735.

Hua CUI, Xiao-ying LI, Xue-wen GAO, et al. A Prospective Randomized Multicenter Controlled Trial on Salvianolate for Treatment of Unstable Angina Pectoris in A Chinese Elderly Population[J]. Chinese Journal of Integrative Medicine, 2019,25(10):728-735.
Hua CUI, Xiao-ying LI, Xue-wen GAO, 等. A Prospective Randomized Multicenter Controlled Trial on Salvianolate for Treatment of Unstable Angina Pectoris in A Chinese Elderly Population[J]. Chinese Journal of Integrative Medicine, 2019,25(10):728-735. DOI： 10.1007/s11655-019-2710-x.

Hua CUI, Xiao-ying LI, Xue-wen GAO, et al. A Prospective Randomized Multicenter Controlled Trial on Salvianolate for Treatment of Unstable Angina Pectoris in A Chinese Elderly Population[J]. Chinese Journal of Integrative Medicine, 2019,25(10):728-735. DOI： 10.1007/s11655-019-2710-x.

摘要

Abstract

Objective:

To evaluate the efficacy and safety of salvianolate in elderly patients with unstable angina pectoris (UAP).

Methods:

A prospective double-blind randomized placebo-controlled multicenter trial in elderly patients with UAP from 13 third-grade class-A hospitals in China was performed. A total of 318 patients were randomly allocated in a 1:1 ratio to an experimental group (160 patients) and a control group (158 patients). The experimental group was treated with salvianolate for 14 days on the basis of conventional medicine

and the control group was given a placebo for 14 days with the same criteria. Follow-up was lasted 28 days in both groups. The primary endpoint was biweekly frequency of angina pectoris attacks. The secondary endpoints included biweekly dosage of nitroglycerin

the Seattle Angina Questionnaire

angina pectoris severity and duration

myocardial injury markers

high-sensitivity C-reactive protein (hs-CRP) and N-terminal pro-B-type natriuretic peptide (NT-proBNP)

as well as major adverse cardiovascular events (MACEs). Safety was assessed according to adverse events and serious adverse events.

Results:

Baseline characteristics were similar between treatment groups. Compared with those in the control group

the frequency of biweekly angina attacks (2.92 vs . 4.08

=0.025)

the biweekly dosage of nitroglycerin

as well as the severity and duration of angina attacks (

0.01) were reduced by salvianolate. The Seattle Angina Questionnaire score was also significantly improved in the experimental group than in the control group (

0.05). No significant differences were observed between the two groups with respect to the incidence of MACEs. Salvianolate was well tolerated.

Conclusions:

Salvianolate appear to have efficacy and well tolerated for elderly patients with UAP. [ClinicalTrials.gov identifier: NCT03037047]

关键词

Keywords

Salvianolateunstable angina pectoriselderlyefficacy

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