摘要Background and aims:Drug-induced liver injury(DILI)is one of the most serious adverse drug reactions and its incidence has been increasing rapidly.Accumulating evidence suggests that immune activation and systemic inflammatory responses are very important in the progression of DILI.Corticosteroids are often used in DILI,but their clinical usefulness remains controversial.We therefore conducted a prospective,randomized controlled study to investigate whether corticosteroid therapy can accelerate recovery and reduce mortality in severe DILI(SDILI).Methods:SDILI patients with total bilirubin ≥171 pmol/L who presented to the Fifth Medical Center of Chinese PLA General Hospital,Beijing from 2016 to 2019 were randomly allocated to prednisolone and control groups.The endpoints were resolution of SDILI,defined as a decrease in total bilirubin of at least 35 pmol/L to＜171 pmol/L,and overall survival at 6 months.Patients in the prednisolone group received prednisolone 60 mg/day therapy for the first 7 days.Patients with a decrease in total bilirubin of more than 35 pmol/L on day 8 continued on tapering doses of prednisolone;otherwise,prednisolone was discontinued.Results:On day 8,50.75％(34/67)and 26.47％(18/68)of the participants in the prednisolone and control groups,respectively,achieved the primary endpoint(p=0.002).However,there was no significant difference in overall survival at 6 months:95.52％(64/67)vs.91.18％(62/68)in the prednisolone and control groups,respectively(p=0.3).All deaths in both groups occurred in patients who failed to achieve SDILI resolution on day 8.Conclusion:Prednisolone therapy may accelerate the recovery of SDILI.