Abstract: Objective To analyze the characteristics of autoantibodies in patients suffering from chronic drug-induced liver injury(DILI) and identify the key factors influencing their prognosis. Methods Between March 2019 and March 2022, 358 patients diagnosed with chronic DILI at our institution were retrospectively analyzed and categorized based on their prognosis six months post-treatment into two groups: those with a poor prognosis (108 cases) and those with a good prognosis (250 cases). Autoantibody screening was conducted for all patients, dividing them into autoantibody-positive(145 cases) and autoantibody-negative groups (213 cases). All subjects underwent biochemical therapy. Results In this cohort of 358 patients with chronic DILI, more than ten types of drugs were identified as causes, with traditional Chinese medicine being the most common (31.0%), followed by antipyretic and analgesic drugs (12.3 % ), antitumor drugs (11.7 %), antibiotics (9.2 %), and subsequently hormones, cardiovascular medications, and nutraceuticals. Autoantibody analysis revealed that 42.74 % (153/358) of patients were positive for antinuclear antibodies(ANA). Of the toatl patient cohort, 145 were found to be positive for autoantibodies while 213 were negative. It was observed that the autoantibody-postive group had a higher proportion of females and older individuals compared to the negative group. Furthermore, within the entire cohort of 358 patients, those aged ≥60 years or with non-hepatocellular types of DILI exhibited a significantly higher risk of poor prognosis. Elevated levels of alanine aminotransferase (ALT)[ (519.7±90.6) U/L vs. (330.8±88.9) U/L], aspartate aminotransferase (AST)[(410.4±91.3) U/L vs. (269.7±80.5) U/], total bilirubin (TBil)[ (44.0±11.8) μmol/L vs. (31.9±13.5) μmol/L] , direct bilirubin (DBil)[(33.4±11.8) μmol/L vs. (27.8±9.0) μmol/L] correlated with a poor prognosis, while lower slbumin (Alb) levels[(46.0±14.9) g/L vs. (60.1±18.1) g/L] were indicative of a better prognosis. Further analysis highlighted that, for the entire patient population, being aged ≥60 years, having a non-hepatocellular DILI type, and presenting with elevated ALT, AST, TBil, DBil, and decreased Alb levels were risk factors for a poor prognosis in chronic DILI (OR=1.618, 1.996, 1.632, 1.602, 1.600, 1.747, 1.929, respectively, all P<0.05). Conclusion Identified risk factors for poor prognosis in patients with chronic DILI include being over 60 years of age, having a non-hepatocellular type, and presenting with elevated biochemical markers such as ALT levels≥435.4 U/L, AST levels≥325.2 U/L, TBil levels≥38.6 μmol/L, DBil levels≥29.2 μmol/L, and reduced Alb levels≤52.2 U/L. Given these findings, regular monitoring of these indicators is imperative, Implementing corresponding intervention measures based on these parameters is crucial for enhaning patient outcomes and improving prognosis.

Key words: Chronic drug-induced liver injury, Autoantibody characteristics, Prognosis, Influencing factor