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. 2023 Jul 1;183(7):647-655.
doi: 10.1001/jamainternmed.2023.0780.

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

Songqiao Liu  1 , Chen Yao  2 , Jianfeng Xie  1 , Hong Liu  3 , Hongliang Wang  4 , Zhaofen Lin  5 , Bingyu Qin  6 , Difen Wang  7 , Weihua Lu  8 , Xiaochun Ma  9 , Yan Liu  10 , Ling Liu  1 , Chi Zhang  11 , Lei Xu  12 , Ruiqiang Zheng  13 , Feihu Zhou  14 , Zhongmin Liu  15 , Guoqiang Zhang  16 , Lixin Zhou  17 , Jian Liu  18 , Aihua Fei  19 , Guoxiu Zhang  20 , Yimin Zhu  21 , Kejian Qian  22 , Ruilan Wang  23 , Yafeng Liang  24 , Meili Duan  25 , Dawei Wu  26 , Rongqing Sun  27 , Ying Wang  28 , Xijing Zhang  29 , Quan Cao  30 , Mingshi Yang  31 , Minggen Jin  32 , Yan Song  33 , Ling Huang  34 , Fachun Zhou  35 , Dechang Chen  36 , Qun Liang  37 , Chuanyun Qian  38 , Zhongzhi Tang  39 , Zhong Zhang  40 , Qiming Feng  41 , Zhiyong Peng  42 , Renhua Sun  43 , Zhenju Song  44 , Yunbo Sun  45 , Yanfen Chai  46 , Lihua Zhou  47 , Chen Cheng  48 , Li Li  49 , Xiaoyan Yan  2 , Junhua Zhang  50 , Yingzi Huang  1 , Fengmei Guo  1 , Chuan Li  48 , Yi Yang  1 , Hongcai Shang  10 , Haibo Qiu  1 ; EXIT-SEP Investigators
Collaborators, Affiliations

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

Songqiao Liu et al. JAMA Intern Med. .

Abstract

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.

Trial registration: ClinicalTrials.gov Identifier: NCT03238742.

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Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure 1.
Figure 1.. Flow of the Participants in the Efficacy of Xuebijing Injection for Sepsis (EXIT-SEP) Trial
CONSORT flow diagram to show participant recruitment and follow-up. XBJ indicates Xuebijing injection.
Figure 2.
Figure 2.. Probability of Survival From Randomization Through Day 28
Patients with unknown survival status at 28 days (n = 57) were censored on the last day they were known to be alive. XBJ indicates Xuebijing injection.
See this image and copyright information in PMC

Comment in

References

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