Association of Shenfu Injection with Reduced 28-Day Mortality in Critically Ill Patients with Sepsis: a Retrospective Propensity Score-matched Cohort Study

Objective We aimed to investigate the association between the combination of shenfu injection (SFI) and sepsis bundle therapy and clinical outcomes in critically ill patients with sepsis in China. Methods This was a retrospective cohort study based on the Electronic Health Record at Ruijin Hospital affiliated with Shanghai Jiaotong University School of Medicine. Adult critically ill patients with sepsis between January 2013 and December 2023 were included in the analysis. The SFI was administered to the patients according to the decision of the attending physician. The primary outcome was 28-day mortality. Secondary outcomes included ventilation-free days, vasopressor-free days, procalcitonin clearance rate, lactate clearance rate, intensive care unit (ICU) length of stay (LOS), hospital LOS, ICU mortality, and in-hospital mortality. The COX proportional hazards and logistic regression model were used to assess the association between SFI and outcomes. Propensity score matching was used to minimize bias when comparing patients treated with the SFI to those without. Results Following adjustment for confounding variables via a propensity score model, 154 paired patients were derived from patients who received SFI and those who did not. The infusion of SFI were associated with a lower rate of 28-day mortality rate (9.74% [15/154] vs. 22.73% [35/154]; P  = 0.002), prolonged vasopressor-free days (19.35 ± 6.86 vs. 16.64 ± 8.91; P  = 0.030) and significantly lower D-dimer levels (3.13 ± 4.25 vs. 4.19 ± 5.11; P  = 0.050). No significant difference was found in procalcitonin clearance rate ( P  = 0.316) or the lactate clearance rate at 72 hours. Conclusion Among critically ill patients with sepsis, adjuvant SFI infusion was associated with improvements in 28-day mortality and organ function recovery. The results need to be verified in further randomized controlled trials.