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作者

Jianfeng Wu, Fei Pei, Lixin Zhou, Weiqin Li, Renhua Sun, Yimin Li, Zheng Wang, Zhijie He, Xiaofei Zhang, Xiaodong Jin, Yun Long, Wei Cui, Chunting Wang, Erzhen Chen, Jun Zeng, Jing Yan, Qinhan Lin, Feihu Zhou, Lei Huang, You Shang, Meili Duan, Wei Zheng, Duming Zhu, Qiuye Kou, Shihong Zhang, Yin Liu, Chen Yao, Meixia Shang, Sui Peng, Qian Zhou, Kar Keung Cheng, Xiangdong Guan  TESTS study collaborator group

作者单位

Affiliations ¹ Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong province, China. ² Guangdong Clinical Research Center for Critical Care Medicine, Guangzhou, Guangdong province, China. ³ Clinical Trials Unit, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China. ⁴ Department of Critical Care Medicine, The First People's Hospital of Foshan, Foshan, Guangdong province, China. ⁵ Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, Nanjing, Jiangsu province, China. ⁶ Emergency and Critical Care Center, Intensive Care Unit, Zhejiang Provincial People's Hospital (Affiliated People's Hospital, Hangzhou Medical College), Hangzhou, Zhejiang province, China guanxd@mail.sysu.edu.cn. ⁷ Department of Critical Care Medicine, State Key Laboratory of Respiratory Diseases, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province, China. ⁸ Department of Hepatobiliary Surgery, Department of Surgical Intensive Care Unit, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi province, China. ⁹ Department of Critical Care Medicine, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong province, China. ¹⁰ Department of Intensive Care Unit, The Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong province, China. ¹¹ Department of Critical Care Medicine, West China Hospital of Sichuan University, Chengdu, Sichuan Province, China. ¹² Department of Critical Care Medicine, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China. ¹³ Department of Critical Care Medicine, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang province, China. ¹⁴ Department of Critical Care Medicine, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong province, China. ¹⁵ Department of Emergency, Ruijin Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China. ¹⁶ Department of Critical Care Medicine, Guangzhou First People's Hospital, Guangzhou, Guangdong province, China. ¹⁷ Department of Intensive Care, Zhejiang Hospital, Hangzhou, Zhejiang province, China. ¹⁸ Department of Critical Care Medicine, Affiliated Qingyuan Hospital, The Sixth Clinical Medical School, Guangzhou Medical University, Qingyuan People's Hospital, Qingyuan, Guangdong Province, China. ¹⁹ Department of Critical Care Medicine, The First Medical Centre, Chinese PLA General Hospital, Beijing, China. ²⁰ Department of Critical Care Medicine, Peking University Shenzhen Hospital, Shenzhen, Guangdong Province, China. ²¹ Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei province, China. ²² Department of Critical Care Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China. ²³ Department of Critical Care Medicine, Zhuhai People's Hospital, Zhuhai, Guangdong Province, China. ²⁴ Department of Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China. ²⁵ Department of Critical Care Medicine, Foersea Life insurance Guangzhou General Hospital, Guangzhou, Guangdong province, China. ²⁶ Department of Laboratory Medicine, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong province, China. ²⁷ Peking University First Hospital, Beijing, China. ²⁸ Department of Applied Health Sciences, College of Medicine and Health, University of Birmingham, Birmingham, UK. ²⁹ Department of Critical Care Medicine, The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, Guangdong province, China guanxd@mail.sysu.edu.cn.

刊名

BMJ (Clinical research ed.)

年份

2025

卷号

Vol.388

页码

e082583

ISSN

1756-1833

摘要

Objective: To evaluate whether the immunomodulatory drug thymosin α1 reduces mortality in adults with sepsis. Design: Multicentre, double blinded, placebo controlled phase 3 trial. Setting: 22 centres in China, September 2016 to December 2020. Participants: 1106 adults aged 18-85 years with a diagnosis of sepsis according to sepsis-3 criteria and randomly assigned in a 1:1 ratio to receive thymosin α1 or placebo . A stratified block method was used for randomisation, and participants were strat...更多

Objective: To evaluate whether the immunomodulatory drug thymosin α1 reduces mortality in adults with sepsis. Design: Multicentre, double blinded, placebo controlled phase 3 trial. Setting: 22 centres in China, September 2016 to December 2020. Participants: 1106 adults aged 18-85 years with a diagnosis of sepsis according to sepsis-3 criteria and randomly assigned in a 1:1 ratio to receive thymosin α1 or placebo . A stratified block method was used for randomisation, and participants were stratified by age and centre. Interventions: Subcutaneous injection of thymosin α1 or placebo every 12 hours for seven days unless discontinued owing to discharge from the intensive care unit, death, or withdrawal of consent. Main outcome measure: The primary outcome was 28 day all cause mortality after randomisation. All analyses were based on a modified intention-to-treat set, including participants who received at least one dose of study drug. Results: Of 1106 adults with sepsis enrolled in the study, 1089 were included in the modified intention-to-treat analyses . 28 day all cause mortality occurred in 127 participants in the thymosin α1 group and 132 in the placebo group . No secondary or safety outcome differed statistically significantly between the two groups. The prespecified subgroup analysis showed a potential differential effect of thymosin α1 on the primary outcome based on age and diabetes . Conclusions: This trial found no clear evidence to suggest that thymosin α1 decreases 28 day all cause mortality in adults with sepsis.收起

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