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

Zongwen Zhang, 邹鑫森, Yu Guan, Siyu Zhang, Mingfeng Huang, H Lin, Jing Zhou, Lin Gao, Wenjian Mao, Bin Yao, Xiangcheng Zhang, Lu Ke, Zhihui Tong, Yuxiu Liu, Weiqin Li

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.