Abstract: Objective The aim of this study was to summarize clinical feature of patients with serum anti-nuclear antibody (ANA) positive drug-induced liver injury (DILI). Methods 64 patients with DILI were admitted to the First Affiliated Hospital, Anhui Medical University between December 2019 and April 2023, and all patients underwent liver biopsies to exclude autoimmune hepatitis (AIH). Serum ANA was found positive in 31 patients and negative in 33 patients. Results Of the 64 patients with DILI, the blamed medicines included herbal medicine in 59.4%, antibiotics in 10.9% and nonsteroidal antiinflammatory drugs in 4.7%; the hepatocellular injury type accounted for 65.6%, cholestatic type for 17.2% and mixed type for 17.2%; of patients with serum ANA positive , the hepatocellular injury type, cholestatic type and mixed type accounted for 77.4%, 6.5% and 16.1%, not significantly different as compared to 54.5%, 5.2% and 30.3% in those with serum ANA negative (P>0.05); serum globulin and Ig G levels in DILI patients with serum ANA positive were 26.1(22.2, 29.9)g/L and 13.6(12.1, 17.7)g/L, both significantly higher than [22.9(21.6, 25.2)g/L and 11.5(9.4, 12.9)g/L, respectively, P＜0.05] in those with serum ANA negative; all patients in the two groups recovered, except for one in serum ANA positive group, who ultimately transferred to drug-induced autoimmune hepatitis (DI-AIH) and two also with serum ANA positive, who transferred to immune mediated drug-induced liver injury (IM-DILI), and the three patients got their liver function tests recovered after oral steroid administration. Conclusion DILI patients with serum ANA positive could recover smoothly, some of them might switch to DI-AIH or IM-DILI, and needs steroid therapy.

Key words: Drug-induced liver injury, Anti-nuclear antibody, Clinical feature, Prognosis