Xuebijing injection, an herbal-based intravenous (IV) infusion, is associated with significantly lower risk of mortality compared with placebo among patients with sepsis. These study results were published in JAMA Internal Medicine.
The Efficacy of Xuebijing Injection in Patients With Sepsis (EXIT-SEP), a randomized, double-blind, placebo-controlled clinical trial, took place at 45 intensive care units in China from October 2017 to June 2019. Eligible patients (n=1817) included those with sepsis and Sequential Organ Failure Assessment (SOFA) scores between 2 and 13. Patients were randomly assigned 1:1 to receive either an IV infusion (100 mL) of Xuebijing injection (n=911) or volume-matched saline placebo (n=906) every 12 hours for 5 days. The primary outcome was all-cause mortality 28 days after treatment allocation. The primary outcome was analyzed using a generalized linear model with a binomial distribution and identity link.
Among patients included in the analysis, the mean age (SD) was 56.5 (13.5) years, 66.0% were men, and 1760 (96.9%) completed the trial. For patients in both groups, the mean SOFA score at baseline was approximately 7.1, the mean time between sepsis diagnosis to treatment allocation was 1.4 days, and approximately half of the population (n=830) had septic shock at baseline.
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In the 48 hours prior to treatment allocation, 95.6% of patients in the Xuebijing group and 95.1% in the placebo group received antimicrobial therapy.
At 28 days, the rate of all-cause mortality was lower among patients in the treatment group compared with those in the placebo group (18.8% vs 26.1%, respectively; P <.001), with an absolute risk difference of 7.3% (95% CI, 3.4-11.2).
Sensitivity analyses showed similar results.
During the 28-day follow-up period, the incidence of adverse events (AEs) was lower among patients in the Xuebijing group compared with those in the placebo group (22.9% vs 25.3%, respectively). The most common AEs among patients who received Xuebijing injection included increased alanine (5.8%) and aspartate (4.4%) aminotransferase levels and high leukocyte counts (4.1%).
Overall, there were no reports of treatment-related severe AEs or discontinuations due to drug toxicity.
Limitations of this study include the number of patients who were lost to follow-up, the administration of antimicrobial therapy prior to treatment allocation, and the lack of patients with severe sepsis. Further, long-term survival outcomes were not evaluated.
“Every year, 250,000 patients are treated with XBJ [Xuebijing injection] in China,” the researchers noted.
Reference
Liu S, Yao C, Xie J, et al. Effect of an herbal-based injection on 28-day mortality in patients with sepsis. JAMA Intern Med. Published online May 1, 2023. doi:10.1001/jamainternmed.2023.0780
This article originally appeared on Infectious Disease Advisor
