Abstract: Objective To investigate the efficacy of ursodeoxycholic acid combined with S-adenosyl-L-methionine therapy in drug-induced cholestatic liver injury.Methods A retrospective analysis of 84 patients with drug-induced cholestatic liver injury from January 2013 to May 2015 in our hospital was conducted. Patients were divided into two groups depending on therapeutic regimen, including 46 patients receiving ursodesoxycholic acid and S-adenosyl-L-methionine combination therapy for 4 weeks in treatment group, and 38 patients receiving S-adenosyl-L-methionine in control group. All patients were followed up for 24 weeks, and the clinical outcomes were accessed.Results After 4-week treatment, patients in treatment group had higher response rate than those in control group (97.83% vs 84.21%, P=0.02). Furthermore, the liver function indexes, including total bilirubin, direct bilirubin, alkaline phosphatase and gamma-glutamyl transpeptidase, were all significantly improved in treatment group compared with those in control group (all P<0.05). During 24-week follow-up, two patients in control group were re-hospitalized due to abnormal liver function, including one patient with positive autoantibody and histopathologically diagnosed of drug induced liver injury-associated-autoimmune hepatitis. However, no similar case was observed in treatment group. No adverse effect was observed in both groups during and after treatment.Conclusion Ursodeoxycholic acid and S-adenosyl-L-methionine combination therapy might be more effective than S-adenosyl-L-methionine monotherapy for drug-induced cholestatic liver injury. Ursodeoxycholic acid might putatively contribute to prevention of autoimmune hepatitis, which needs to be further investigated.

Key words: Ursodeoxycholic acid, S-adenosyl-L-methionine, Drug-induced liver injury, Cholestasis, Drug- induced liver injury-associated-autoimmune hepatitis