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Effect of an Herbal-Based Injection on 28-Day Mortality in Patients With Sepsis The EXIT-SEP Randomized Clinical Trial

文献类型：期刊论文

作者Liu, Songqiao50; Yao, Chen49; Xie, Jianfeng50; Liu, Hong48; Wang, Hongliang47; Lin, Zhaofen46; Qin, Bingyu45; Wang, Difen44; Lu, Weihua43; Ma, Xiaochun42
刊名JAMA INTERNAL MEDICINE
出版日期2023-07-01
卷号183期号:7页码:647-655
DOI10.1001/jamainternmed.2023.0780
文献子类Article
英文摘要Importance Previous research has suggested that Xuebijing injection (XBJ), an herbal-based intravenous preparation, may reduce mortality among patients with sepsis.Objective To determine the effect of XBJ vs placebo on 28-day mortality among patients with sepsis.Design, Setting, and Participants The Efficacy of Xuebijing Injection in Patients With Sepsis (EXIT-SEP) trial was a multicenter, randomized double-blind, placebo-controlled trial conducted in intensive care units at 45 sites and included 1817 randomized patients with sepsis (sepsis 3.0) present for less than 48 hours. Patients aged 18 to 75 years with a Sequential Organ Failure Assessment score of 2 to 13 were enrolled. The study was conducted from October 2017 to June 2019. The final date of follow-up was July 26, 2019. Data analysis was performed from January 2020 to August 2022.Interventions The patients were randomized to receive either intravenous infusion of XBJ (100 mL, n = 911) or volume-matched saline placebo (n = 906) every 12 hours for 5 days.Main Outcomes and Measures The primary outcome was 28-day mortality.Results Among the 1817 patients who were randomized (mean [SD] age, 56.5 [13.5] years; 1199 [66.0%] men), 1760 (96.9%) completed the trial. In these patients, the 28-day mortality rate was significantly different between the placebo group and the XBJ group (230 of 882 patients [26.1%] vs 165 of 878 patients [18.8%], respectively; P < .001). The absolute risk difference was 7.3 (95% CI, 3.4-11.2) percentage points. The incidence of adverse events was 222 of 878 patients (25.3%) in the placebo group and 200 of 872 patients (22.9%) in the XBJ group.Conclusions and Relevance In this randomized clinical trial among patients with sepsis, the administration of XBJ reduced 28-day mortality compared with placebo.
WOS关键词XUEBIJING INJECTION ; INJURY
WOS研究方向General & Internal Medicine
语种英语
出版者AMER MEDICAL ASSOC
WOS记录号WOS:000991924100001
源URL[http://119.78.100.183/handle/2S10ELR8/309639]  
专题新药研究国家重点实验室
通讯作者Shang, Hongcai; Qiu, Haibo
作者单位1.Yanbian Univ Hosp, Dept Crit Care Med, Yanji, Jilin, Peoples R China;
2.Tianjin Univ Tradit Chinese Med, Evidence Based Med Ctr, Tianjin, Peoples R China
3.Tianjin Univ Tradit Chinese Med, Teaching Hosp 1, Natl Clin Res Ctr Chinese Med Acupuncture & Moxibu, Tianjin, Peoples R China;
4.Chinese Acad Sci, Shanghai Inst Mat Med, State Key Lab Drug Res, Zhangjiang Hitech Pk, Shanghai, Peoples R China;
5.Inner Mongolia Med Univ, Dept Crit Care Med, Affiliated Hosp, Hohhot, Inner Mongolia, Peoples R China;
6.Tianjin Med Univ Gen Hosp, Dept Emergency, Tianjin, Peoples R China;
7.Affiliated Hosp Qingdao Univ, Dept Crit Care Med, Qingdao, Shandong, Peoples R China;
8.Fudan Univ, Zhongshan Hosp, Dept Emergency, Shanghai, Peoples R China;
9.Zhejiang Prov Peoples Hosp, Dept Crit Care Med, Hangzhou, Zhejiang, Peoples R China;
10.Wuhan Univ, Zhongnan Hosp, Dept Crit Care Med, Wuhan, Hubei, Peoples R China;
推荐引用方式
GB/T 7714		 Liu, Songqiao,Yao, Chen,Xie, Jianfeng,et al. Effect of an Herbal-Based Injection on 28-Day Mortality in Patients With Sepsis The EXIT-SEP Randomized Clinical Trial[J]. JAMA INTERNAL MEDICINE,2023,183(7):647-655.
APA Liu, Songqiao.,Yao, Chen.,Xie, Jianfeng.,Liu, Hong.,Wang, Hongliang.,...&EXIT-SEP Investigators.(2023).Effect of an Herbal-Based Injection on 28-Day Mortality in Patients With Sepsis The EXIT-SEP Randomized Clinical Trial.JAMA INTERNAL MEDICINE,183(7),647-655.
MLA Liu, Songqiao,et al."Effect of an Herbal-Based Injection on 28-Day Mortality in Patients With Sepsis The EXIT-SEP Randomized Clinical Trial".JAMA INTERNAL MEDICINE 183.7(2023):647-655.

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来源：上海药物研究所

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