The use of sivelestat sodium among patients with acute pancreatitis and early organ failure: a single-center retrospective cohort study.

BACKGROUND: This study aimed to investigate whether neutrophil elastase inhibitor (sivelestat sodium) was associated with decreased duration of organ failure in patients with acute pancreatitis (AP) and early organ failure. METHODS: Between January 2022 and December 2024, patients who were diagnosed with AP and early organ failure were included. The primary outcome was organ failure-free days (OFFD) to Day 14 after admission. Propensity score matching (PSM) analysis was performed to control confounders. Multivariate zero-inflated negative binomial regression model was used to evaluate the association between sivelestat sodium and OFFD. An exploratory mediation analysis was carried out to evaluate whether day 3 C-reactive protein partly accounted for the association. RESULTS: 340 patients were enrolled in this study. After PSM, patients receiving sivelestat sodium had significantly more OFFD than those who did not (median [IQR], 9 [5 to 13] vs. 6 [1 to 10], p = 0.040). Using sivelestat sodium was associated with increased OFFD (Incidence rate ratio = 1.21, p = 0.001) after adjusting for covariates. The exploratory mediation analysis suggested that this association was primarily direct (1.28 days, p = 0.036), with a marginally significant component mediated through day 3 C-reactive protein reduction (0.13 days, p = 0.068). CONCLUSION: Sivelestat sodium use was associated with more organ failure-free days in patients with AP and early organ failure, particularly in those with respiratory failure. These findings require confirmation in future prospective randomized trials.