Abstract: Objective The aim of this study was to analyze the clinical features and influencing factors of drug-induced liver injury (DILI) in patients with severe infection receiving tigecycline therapy. Methods 74 patients with severe infection were encountered in the intensive care unit of our hospital between January and December 2022, and all were treated with tigecycline at 50 mg(n=27) or 100 mg(n=47), intravenously, q12h, for 7-14 days. The multivariate Logistic regression analysis were applied to reveal the risk factors of DILI occurrence, and the receiver operating characteristic curve (ROC) was applied to predict the efficacy. Results During the antibacterial treatment period, the DILI was found in 36 cases (48.6%); the incidence of concomitant diabetes, hypertension and malignant tumors in patients with DILI were 50.0%, 47.2% and 33.3%, all significantly higher than 18.4%, 23.7% and 13.2% (P<0.05) in patients without DILI; the AUC_0-24h of blood tigecycline concentration in patients with DILI was (17.6±6.6) mg·h·L^-1, much higher than in patients without DILI; the multivariate Logistic regression analysis showed that the concomitant diabetes, malignant tumors and AUC_0-24h were all the independent risk factors for the occurrence of DILI (P<0. 05); the ROC analysis showed that when serum tigecycline’s AUC_0-24h=14.78 mg·h·L^-1 was set as the cut-off-value in predicting DILI occurrence, the sensitivity and specificity were 66.7% and 65.8%, respectively. Conclusion The clinicians should take the precipitating factors of DILI into consideration in critically infected patients when the tigecycline is used, and we recommend monitoring blood drug concentration for making a personalized therapeutic plan to reduce DILI occurrence.

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