Abstract: Objective The aim of this study was to investigate the risk factors for drug-induced liver injury (DILI) in critically ill patients with severe infections during tigecycline antimicrobial therapy, and to provide evidence for safe clinical use. Methods 67 patients with severe bacterial infection were encountered in our hospital between January 2023 and December 202, and all received tigecycline with or without other antibiotic treatment for severe infections. Univariate and multivariate Logistic regression analysis were applied to determine independent risk factors for DILI occurrence. Results Of the 67 patients with severe infections, DILI was diagnosed in 32 cases (47.8%) during tigecycline treatment; ages, concomitant diabetes, liver cirrhosis and sepsis, ICU stay and SOFA score in DILI group were much greater or higher than in those without DILI(P<0.05); doses and course of tigecycline, other antibiotic combination, anti-fungus and steroid therapy in DILI group were(143.8±48.5)mg·d^-1, (10.5±4.2)d, 53.1%, 40.6% and 84.4%, all significantly greater or higher than [(118.6±36.2)mg·d^-1, (7.8±3.6)d, 28.6%, 14.3% and 25.7%, respectively, P<0.05] in those without DILI; liver injuries, decreased serum albumin level, increased INR, C-reactive protein (CRP), procalcitonin (PCT) and lactic acid levels were common in DILI group (P<0.05); multivariate Logistic regression analysis showed that liver cirrhosis, dose and course of tigecycline, combination of anti-fungus medicine and steroid, increased serum CRP and PCT levels were all the independent risk factors for DILI occurrence(P<0.05). Conclusion In critically ill patients with severe bacterial infections, DILI could happen easily during tigecycline antimicrobial therapy, and appropriate prevention and managements should be given to improve the prognosis of patients in this setting.

Key words: Drug-induced liver injury, Sepsis, Tigecycline, Risk factors