Traditional Chinese Medicine Compound (Tongxinluo) and Clinical Outcomes of Patients With Acute Myocardial Infarction

作者：Yuejin Yang, Xiangdong Li, Guihao Chen, Ying Xian, Haitao Zhang, Yuan Wu, Yanmin Yang, Jianhua Wu, Chuntong Wang, Shenghu He, Zhong Wang, Yixin Wang, Zhifang Wang, Hui Liu, Xiping Wang, Minzhou Zhang, Jun Zhang, Jia Li, Tao An, Hao Guan, Lin Li, Meixia Shang, Chen Yao, Yaling Han, Boli Zhang, Runlin Gao, Eric D. Peterson, CTS-AMI Investigators, Yuejin Yang, Jianhua Wu, Chuntong Wang, Shenghu He, Zhong Wang, Yixin Wang, Yongquan Jing, L Liu, Xuxia Zhang, Hanjun Pei, Yuzeng Xue, Guanzhong Zheng, Changyu Wang, Zhongming Zhao, Yanjie Zheng, Baoliang Duan, Gaoxing Zhang, Hui Liu, Zhifang Wang, Zeyuan Fan, Wenzhai Cao, Huanyi Zhang, Xiaoyong Qi, Xiping Wang, Guoqing Wu, Feng Gao, Zidong Bie, Yue Long, Heng Hong, Jun Qian, Bingguang Dai, Weiguang Dou, Liming Yue, Zhongqun Zhan, Man Liu, Gao Xiaohong, Yi-tian Lian, Yi Zheng, Jianwu Zhang, Ronghai Man, Peng Dong, Lianling Wu, Junguo Deng, Yong Guo, Minzhou Zhang, Jia Li, Zheying Wang, Peisheng Dai, Guleng Siri, Qiming Xu, Xinyang Li, Keqing Li, Shengli Han, Huaixin Wang, Xia Li, Ping Yang, Haowen Zhang, Yuesen Liu, Xin Bo, M Zhang, Zhiduo Cao, Meng Zhang, Gang Ma, Lei Wang, Jun Song, Weiguo Li, Hongchun Li, Zhenglu Shang, Ouhua Feng, Hongjun Zhang, Hongtao Gao, Rongqi Bao, Fengshun Wang, Linqing Shang, Lei Qin, Jianping Wang, Genshan Ma, Jiayu Cui, Shixi Wang, Fangzhou Cheng, Shujiang Zhang, Xianshi Liu, Chunxi Cha, Min Sun, Wenbao Han, Hang Lu, Haiying Wang, Hongguang Zhu, Wei Wang, Zhili Wang, Yufeng Guo, Haisheng Zhang, Zhong Shao, Xirong Cui, Changlin Lu, Zhan Lv, Jiyin Zhang, Guangkai Cui, Hongwei Zhang, Ying Han, Wenli Liu, Bingfeng Zhou, Hua Ge, Liqun Zhang, Tai‐Hong Chen, Bingying Niu, Baoxi Mu, Jiao Zhang, Huaimin Guan, Yuhu Chun, Hua Zhang, Fangjiang Li, Shufang Yin, Xu Wang, Zou Xiao, Junshuai Song, Lang Hong, Mingqi Zheng, Bo Jiang, Shuying Liu, Rui Zhu, Wenbo Liu, Jie Zhang, Bing Wu, Zonggui Wu, Quan Fang, Zuyi Yuan, C. Gao, Hong Jiang, Xinli Li, Peili Bu, Wei Gao, Hongxu Liu, Ying Xian, Runlin Gao, Boli Zhang, Yaling Han, Junbo Ge, Eric D. Peterson, Shaoliang Chen, Jielin Pu, Qingshan Zheng, Congxin Huang, Weifeng Shen, Yuan Wu, Chen Yao, Xiaoyan Yan, Meixia Shang, Xiaohan Fan, Huaibing Cheng, Wenlan Chang, Hui Wang, Zhi Li, Wenxuan Zhai, Zhenghui Zhu, Hui Li, Zhi Wang, Tao Jin, Bo Xu, Meiying Sun, Fan Wu, Tongqiang Zou, Yue Chang, Peng Yin, Junyan Shen, Yaxin Zhang, Yunfei Huang, Guihao Chen, Xiangdong Li, Yi Xu, Jingang Yang, Haitao Zhang, Jin Chen, Min Wang · 发表于：JAMA · 年份：2023 · DOI：10.1001/jama.2023.19524 · 被引用次数：159 · 研究领域：Lipid metabolism and disorders、Ginseng Biological Effects and Applications、Biochemical Acid Research Studies

Importance: Tongxinluo, a traditional Chinese medicine compound, has shown promise in in vitro, animal, and small human studies for myocardial infarction, but has not been rigorously evaluated in large randomized clinical trials. Objective: To investigate whether Tongxinluo could improve clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI). Design, Setting, and Participants: Randomized, double-blind, placebo-controlled clinical trial was conducted among patients with STEMI within 24 hours of symptom onset from 124 hospitals in China. Patients were enrolled from May 2019 to December 2020; the last date of follow-up was December 15, 2021. Interventions: Patients were randomized 1:1 to receive either Tongxinluo or placebo orally for 12 months (a loading dose of 2.08 g after randomization, followed by the maintenance dose of 1.04 g, 3 times a day), in addition to STEMI guideline-directed treatments. Main Outcomes and Measures: The primary end point was 30-day major adverse cardiac and cerebrovascular events (MACCEs), a composite of cardiac death, myocardial reinfarction, emergent coronary revascularization, and stroke. Follow-up for MACCEs occurred every 3 months to 1 year. Results: Among 3797 patients who were randomized, 3777 (Tongxinluo: 1889 and placebo: 1888; mean age, 61 years; 76.9% male) were included in the primary analysis. Thirty-day MACCEs occurred in 64 patients (3.4%) in the Tongxinluo group vs 99 patients (5.2%) in the control group...