Komkova I.I.¹, Tkachenko P.E.^1,, Maevskaya M.V.¹, Ivashkin V.T.¹

Background and aim: Severe alcoholic hepatitis (AH) is a life-threatening alcoholic liver disease with a potential of 30-40% mortality at 1 month. While steroids remain to be a first line therapy, there is a need in alternative treatment. The aim of the study is to compare efficacy and safety of budesonide and prednisolone in treatment of severe AH and to determine predictors of none-response, predictors of short-term mortality. Methods: 37 patients with severe AH were randomized in 2 groups and enrolled in the prospective trial. Group 1 (n=17) patients received budesonide 9 mg/daily per os, group 2 (n=20) patients were managed with prednisolone 40 mg/daily per os. Treatment duration was 28 days. Response criteria – Lille model. Results: There were no significant differences in short-term survival (р = 0,857). In group 2 adverse events were statistically more frequently than in group 1 (70% vs. 26,7%, р = 0,011). Hepatorenal syndrome occurred more frequently in group 2 (р = 0,033). Predictors of non-response were MELD score (р = 0,009), ABIC score (р = 0,011), hepatic encephalopathy (p=0,035), total bilirubin (p=0,016). Predictors of mortality were Lille score (p=0,018), serum glucose (p=0,017), total bilirubin level at the 7th day of the therapy (p=0,030). Conclusions: Budesonide therapy for patients with severe alcoholic hepatitis showed same efficacy as prednisolone treatment with significantly less adverse events. Budesonide appears to be effective in prevention of hepatorenal syndrome.

severe alcoholic hepatitis, prednisolone, budesonide, hepatorenal syndrome