Abstract: Objective To investigate the clinical characteristics and prognostic factors of patients with drug-induced liver injury (DILI), so as to provide early warning for patients with high risk of DILI deterioration and reduce the risk of death. Methods Patients diagnosed with DILI by liver biopsy who were hospitalized to Beijing You An Hospital at Capital Medical University between March 2013 and January 2024 were collected. The social demographic information, clinical data, and patient outcomes were recorded and the patients were split into two groups: an improvement group and a deterioration group. Comparisons were made then between the social demographic information and clinical features of the two groups. The risk factors associated with DILI prognosis were analyzed by univariate and multifactorial analysis, and the rate of deterioration in patients with different risk factors was compared. Methods A total of 360 patients with a median age of 49.00 (37.00, 57.00) years were enrolled in this study, the clinical manifestations of enrolled patients were non-specific. Most of the patients were females (240 cases, 66.70%). Among the suspicious drugs used, the majority of patients were single drug use (314 cases, 87.22%), and the proportion of traditional Chinese medicine/proprietary Chinese medicine was the highest (53.90%). In this study, there were 347 patients in the improvement group and 13 patients in the deterioration group. When compared with the improvement group, the white blood cell count (WBC), alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin (TBil) in the deterioration group were significantly increased, cholinesterase (CHE), albumin (ALB), prothrombin time activity (PTA) and Delta-TBil were significantly decreased, and the number of hospital days was shorter. Univariate analysis and multivariate analysis showed that PTA (OR 0.716 (0.535,0.960), P=0.025) and Delta-TBil (OR 0.970 (0.941,0.999), P=0.044) were independent risk factors for the prognosis of DILI. PTA and Delta-TBil were processed as categorical variables. It was found that the deterioration rate of 100.00% in patients with 2 risk factors (PTA≤51 and Delta-TBil≤-37.8) was significantly higher than that in patients with ≥1 risk factor (PTA≤51 or/and Delta-TBil≤-37.8) and patients without risk factors. Conclusion The risk variables influencing DILI prognosis are PTA and Delta-TBil. To lower the mortality, patients with these two risk factors should have their disease surveillance reinforced and be placed in the liver transplant waiting list as soon as possible.

Key words: drug-induced liver injury, clinical features, prognosis, risk factor