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

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

作者机构：Department of Geriatric Cardiology the General Hospital of the People's Liberation Army Beijing (100853) China the Second Department of Cardiology the Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine Harbin (150009) China Department of Cardiology Guizhou Province Hospital of Traditional Chinese Medicine Guiyang (550001) China Department of Cadre's Ward the First Bethune Hospital of Jilin University Changchun (130021) China Department of Cadre Health Care the First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang Province (325000) China Medical Department Shanghai Green Valley Pharmaceutical Co. Ltd. Shanghai (201203) China China Health Promotion Foundation Beijing (100161) China Department of Geriatric Clinic Inner Mongolia People's Hospital Hohhot (010017) China Department of Cardiology the Second Affiliated Hospital of Nanjing Medical University Nanjing (210011) China Second Department of Cadre's Ward the First Affiliated Hospital of Harbin Medical University Harbin (150001) China Department of Cadre Health Care Tianjin First Central Hospital Tianjin (300192) China Department of Cardiovascular Medicine Chongqing General Hospital Chongqing (400013) China Department of Geriatrics Shenyang Red Cross Hospital Shenyang (110063) China Department of Geriatric Cardiology Guangzhou First People's Hospital Guangzhou (510180) China Department of Cardiology Beijing Geriatric Hospital Beijing (100095) China 

出 版 物：《Chinese Journal of Integrative Medicine》 (中国结合医学杂志（英文版）)

年 卷 期：2019年第25卷第10期

页      面：728-735页

核心收录：

学科分类：10[医学] 

基　　金：Supported by Science and Technology Commission of Shanghai Municipality(15DZ1900300) 

主　　题：Salvianolate unstable angina pectoris elderly efficacy 

摘      要：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 angi na attacks(2.92 vs. 4.08, P =0.025), th e biweekly dosage of nitroglycerin, as well as the severity and duration of angina attacks(P 0.01) were reduced by salvianolate. The Seattle Angina Questionnaire score was also significantly improved in the experimental group than in the control group(P 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.