Abstract: Objective To analyze the clinical characteristics and related influencing factors of drug-induced liver injury (DILI). Methods A total of 302 patients diagnosed with DILI at Shanghai Public Health Clinical Center from January 2020 to January 2025 were enrolled. Data including medical history, clinical manifestations and classification, laboratory test indicators, disease severity and mortality were collected. Statistical analyses were performed using t-test, one-way ANOVA, Mann-Whitney U test, Kruskal-Wallis H test and logistic regression model. Results Most patients were middle-aged and elderly (72%), with a female predominance. Among the drugs causing DILI, traditional Chinese medicine (TCM) accounted for 128 cases (42.38%), mainly including polygonum multiflorum and gynura segetum; western medicine accounted for 174 cases (57.6%), mainly anti-tuberculosis drugs (30.79%).Compared with the western medicine group, the TCM group had significantly higher rates of skin jaundice, anorexia and dark urine (all P<0.001, P<0.004, P<0.001, respectively), but a lower rate of rash (P<0.004).Peak serum levels of ALT, AST, ALP, TBil and DBil were significantly higher in the TCM group (all P<0.001, P<0.001, P<0.015, P<0.001, P<0.001, respectively), while the peak percentage of eosinophils was significantly higher in the western medicine group.In total, 98.7% of DILI patients were cured or improved, and 1.3% had no recovery. Conclusion Herbal medicines and anti-tuberculosis drugs are the main suspicious agents causing DILI. DILI is more common in middle-aged and elderly women, mostly presenting as hepatocellular injury. The prognosis of most DILI patients is favorable after drug withdrawal.

Key words: Drug-induced liver injury, Traditional Chinese medicine, Western medicine, Clinical features, Prognosis