Background Drug-induced liver injury (DILI) is one of the most serious adverse drug reactions and the incidence has been increasing rapidly. Accumulating evidence suggested that the immune activation and systemic inflammatory responses play a significant role in the progression of DILI. Corticosteroids are often used in DILI, but clinical usefulness remain 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 (TBIL) ≥171 μmol/L presented to Fifth Medical Center of PLA General Hospital, Beijing from 1/1/2015 to 31/12/2019 were randomized into prednisolone group and control group. The primary endpoints were proportion of subjects with resolution of SDILI defined as decrease in TBIL by at least 35 μmol/L to below 171 μmol/L and overall survival at 6 months. Patients in prednisolone group received prednisolone 60 mg/day therapy for the first 7 days. Patients reaching the primary endpoint or achieved decrease in TBIL by more than 35 umol/L on day 8 would continue on tapering doses of prednisolone, otherwise prednisolone would be discontinued.
Results On day 8, 50.7% (34/67) and 26.5% (18/68) of the subjects in the prednisolone group and control group achieved the primary endpoint respectively, p=0.002. However, there was no significant difference in overall survival at 6 months, 95.52% (64/67) vs 91.2% (62/68), p= 0.2. All deaths in both groups occurred in patients who failed to achieve SDILI resolution on day 8.
Conclusions Prednisolone therapy may accelerate recovery of SDILI and shorten hospitalization.