Effect of an Herbal-Based Injection on 28-Day Mortality in Patients With Sepsis
Authors: Liu Songqiao , Yao Chen , Xie Jianfeng , Liu Hong , Wang Hongliang , Lin Zhaofen , Qin Bingyu , Wang Difen , Lu Weihua , Ma Xiaochun , Liu Yan , Liu Ling , Zhang Chi , Xu Lei , Zheng Ruiqiang , Zhou Feihu , Liu Zhongmin , Zhang Guoqiang , Zhou Lixin , Liu Jian , Fei Aihua , Zhang Guoxiu , Zhu Yimin , Qian Kejian , Wang Ruilan , Liang Yafeng , Duan Meili , Wu Dawei , Sun Rongqing , Wang Ying , Zhang Xijing , Cao Quan , Yang Mingshi , Jin Minggen , Song Yan , Huang Ling , Zhou Fachun , Chen Dechang , Liang Qun , Qian Chuanyun , Tang Zhongzhi , Zhang Zhong , Feng Qiming , Peng Zhiyong , Sun Renhua , Song Zhenju , Sun Yunbo , Chai Yanfen , Zhou Lihua , Cheng Chen , Li Li , Yan Xiaoyan , Zhang Junhua , Huang Yingzi , Guo Fengmei , Li Chuan , Yang Yi , Shang Hongcai , Qiu Haibo ,   EXIT-SEP Investigators, Liu Wenxue , Shang Meixia , Han Jibin , Li Ming , Ma Linhao , Li Yunpeng , Liu Yuanyi , Yu Tao , Li Xin , Lu Xing , Chen Qihong , Yang Yimin , Li Yan , Guo Weiguang , Dou Zhimin , Gao Chengjin , Li Dahuan , Han Xiaotong , Shao Qiang , Xie Yun , Li Xiaoli , Lin Jin , Li Zhi , Gao Min , Song Yunxi , Su Binxiao , Liu Yun , Peng Yue , Cui Qingsong , Yu Huichao , Fu Baocai , Lin Shihui , Huang Yanxia , Cao Xuedan , Wang Xiao , Fang Qing , Huang Ruolan , Yang Kaichao , Feng Ying , Gong Fangxiao , Yin Jun , Cai Shixia , Li Shixin , Wang Jingchao , Zheng Wenke 
Published: May 2023

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 &amp;lt; .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.

Trial Registration

ClinicalTrials.gov Identifier: NCT03238742