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Efficacy and safety of Shuxuening injection in patients with unstable angina: a multicenter, randomized, placebo-controlled trial

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收录情况： ◇ SCIE

作者：
Yu, Lintong[1,2] * ; Tao, Shiyi[1,3] ; Lin, Qian[4,*1] ; Gao, Sheng[5] ; Hu, Xitian[6] ; Li, Xiaoping[7] ; Wang, Xiaofeng[8] ; Chen, Huijun[9] ; Ji, Xianyou[10] ; Lian, Qiufang[11] ; Jin, Daoqun[12] ; Xu, Jingyu[13] ; Feng, Jun[14] ; Qu, Yanling[15] ; An, Deying[16] ; Qi, Chunmei[17] ; Chen, Ling[18] ; Zheng, Mingqi[19] ; Cao, Guiqiu[20] ; Liu, Jing[21] ; Gao, Dongmei[22] ; Ma, Mingfeng[23] ; Song, Shujiang[24] ; Wang, Yuesong[25] ; Zhao, Lizhi[26] ; Zhu, Zhongsheng[27] ; Zhang, Yigang[28] ; Xiao, Wei[29] ; Sun, Yuanyuan[30] ; Zou, Ting[31] ; Li, Helin[32] ;
机构： [1]Beijing Univ Chinese Med, Grad Sch, Beijing, Peoples R China [2]China Acad Chinese Med Sci, Xiyuan Hosp, Dept Cardiol, Beijing 100091, Peoples R China [3]China Acad Chinese Med Sci, Dept Cardiol, Guanganmen Hosp, Beijing 100053, Peoples R China [4]Beijing Univ Chinese Med, Dongzhimen Hosp, Dept Cardiol, Beijing 100700, Peoples R China [5]ITCWM Nankai Hosp, Tianjin Hosp, Dept Cardiol, Tianjin 300100, Peoples R China [6]Shijiazhuang City Peoples Hosp, Dept Cardiol, Shijiazhuang 050000, Hebei, Peoples R China [7]Inner Mongolia Autonomous Reg Int Mongolian Med Ho, Dept Cardiol, Hohhot 010000, Inner Mongolia, Peoples R China [8]Xinjiang Uygur Autonomous Reg Hosp Tradit Chinese, Dept Cardiol, Urumqi 830000, Xinjiang Uygur, Peoples R China [9]Heilongjiang Zhongyiyaodaxue, Dept Cardiol, Fushu Dier Yiyuan, Harbin 150001, Heilongjiang, Peoples R China [10]Daqing People Hosp, Dept Cardiol, Daqing 163711, Heilongjiang, Peoples R China [11]Yanan Univ, Dept Cardiol, Xianyang Hosp, Xianyang 712000, Shaanxi, Peoples R China [12]Huangshi Cent Hosp, Dept Cardiol, Hungshi 435000, Hubei, Peoples R China [13]Heilongjiang Univ Chinese Med, Affiliated Hosp 1, Dept Cardiol, Harbin 150040, Heilongjiang, Peoples R China [14]Hefei Second Peoples Hosp, Dept Cardiol, Hefei 230000, Anhui, Peoples R China [15]Shanxi Yuncheng Cent Hosp, Dept Cardiol, Yuncheng 044000, Shanxi, Peoples R China [16]Gansuwuwei Tumour Hosp, Dept Cardiol, Wuwei 733000, Gansu, Peoples R China [17]Xuzhou Min Grp, Dept Cardiol, Gen Hosp, Xuzhou 221006, Jiangsu, Peoples R China [18]Shaanxi Univ Tradit Chinese Med, Dept Cardiol, Affiliated Hosp, Xianyang 712000, Shaanxi, Peoples R China [19]Hebei Med Univ, Dept Cardiol, Hosp 1, Shijiazhuang 050023, Hebei, Peoples R China [20]Xinjiang Med Univ, Dept Cardiol, Affiliated Hosp 5, Urumqi 830001, Xinjiang Uygur, Peoples R China [21]First Peoples Hosp Yinchuan, Dept Cardiol, Yinchuan 750001, Ningxia Hui Aut, Peoples R China [22]Xingtai Med Coll, Dept Cardiol, Affiliated Hosp 2, Xingtai 054000, Hebei, Peoples R China [23]Shanxi Prov Fenyang Hosp, Dept Cardiol, Fenyang 032200, Shanxi, Peoples R China [24]Hebei Univ, Affiliated Hosp, Dept Cardiol, Baoding 071000, Hebei, Peoples R China [25]Maanshan Peoples Hosp, Dept Cardiol, Maanshan 243000, Anhui, Peoples R China [26]Southwest Med Univ, Affiliated Hosp Tradit Chinese Med, Dept Cardiol, Luzhou 646000, Sichuan, Peoples R China [27]Shanghai Pudong Hosp, Dept Cardiol, Shanghai 200000, Peoples R China [28]Xuzhou Cent Hosp, Dept Cardiol, Xuzhou 221000, Jiangsu, Peoples R China [29]Harbin Kangsi Med Technol Dev Co LTD, Harbin 150001, Heilongjiang, Peoples R China [30]China Assoc Tradit Chinese Med, Cardiovasc Dis Drug Res Comm, Beijing, Peoples R China [31]China Assoc Tradit Chinese Med, Chinese & Western Combined Drug Res & Dev Working, Beijing 100061, Peoples R China [32]Beijing Yaohai Ningkang Pharmaceut Technol Co LTD, Beijing 100101, Peoples R China
出处：
DOI： 10.1016/j.phymed.2025.156916
ISSN：

关键词： Unstable angina Shuxuening injection Coronary heart disease Traditional chinese medicine

摘要：
Objective: To determine the efficacy and safety of adjunct Shuxuening Injection (SXN) on conventional therapy in patients with unstable angina (UA) which provides a complementary choice and its evidence for clinical medication for treating UA. Methods: In this multicenter, randomized, double-blind, placebo-controlled trial, 469 patients with UA from 25 hospitals in China who had an episode of angina within 48 hours were randomly assigned 3:1 to SXN and placebo group for 10 days in addition to conventional treatment. The primary outcome is the frequency of angina pectoris attacks after 10 days of intervention. The secondary outcomes are the frequency of angina pectoris attacks on day 30, the duration of angina pectoris symptoms, the visual analogue scale (VAS) score, total score of angina pectoris symptoms, the Global Registry of Acute Coronary Events (GRACE) score, total ischemia burden (TIB), and the level of high-sensitivity C-reactive protein (hs-CRP). Results: A total of 469 participants from 25 hospitals in China were enrolled in this trial. After 10 days of treatment, the frequency and duration of angina pectoris attacks, VAS score, and total score of angina pectoris symptoms exhibited a significant improvement in the SXN group compared to the placebo group both on days 10 and 30 (all p < 0.05). The GRACE risk score classification, TIB, and hs-CRP levels in the SXN group showed no statistically significant decrease compared to the control group on day 10 (all p > 0.05). The medication compliance, concomitant medication, and rates of adverse events were similar between the two groups (p > 0.05). Conclusion: In patients with UA, SXN added on conventional treatment reduced the frequency and duration of angina pectoris attacks, even after discontinuation of the intervention for 20 days.

基金：
High-level Key Department Construction Project of Traditional Chinese Medicine of National Administration of Traditional Chinese Medicine [zyyzdxk-2023253]
语种：
外文
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2026]版：
无
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 药物化学 1 区 全科医学与补充医学 1 区 药学 1 区 植物科学
JCR分区：
出版当年[2025]版：
无
最新[2024]版：
Q1 CHEMISTRY, MEDICINAL Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE Q1 PHARMACOLOGY & PHARMACY Q1 PLANT SCIENCES

影响因子： 最新[2024版] 最新五年平均 出版当年[2025版] 出版当年五年平均 出版前一年[2024版]

第一作者：
第一作者机构： [1]Beijing Univ Chinese Med, Grad Sch, Beijing, Peoples R China [2]China Acad Chinese Med Sci, Xiyuan Hosp, Dept Cardiol, Beijing 100091, Peoples R China
通讯作者：
通讯机构： [4]Beijing Univ Chinese Med, Dongzhimen Hosp, Dept Cardiol, Beijing 100700, Peoples R China [*1]Beijing Univ Chinese Med, Dongzhimen Hosp, Hai Yun Cang 5th Zip, Beijing 100700, Peoples R China
推荐引用方式(GB/T 7714)：
Yu Lintong,Tao Shiyi,Lin Qian,et al.Efficacy and safety of Shuxuening injection in patients with unstable angina: a multicenter, randomized, placebo-controlled trial[J].PHYTOMEDICINE.2025,144:doi:10.1016/j.phymed.2025.156916.
APA：
Yu, Lintong,Tao, Shiyi,Lin, Qian,Gao, Sheng,Hu, Xitian...&Li, Helin.(2025).Efficacy and safety of Shuxuening injection in patients with unstable angina: a multicenter, randomized, placebo-controlled trial.PHYTOMEDICINE,144,
MLA：
Yu, Lintong,et al."Efficacy and safety of Shuxuening injection in patients with unstable angina: a multicenter, randomized, placebo-controlled trial".PHYTOMEDICINE 144.(2025)

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