Clinical Analysis of 654-2 in Treatment of Cholestatic drug-induced Hepatitis

Objective:To evaluate the clinical effect and safety of 654-2 in treatment of cholestatic drug-induced hepatitis.Methods:Fifty-four cholestatic drug-induced hepatitis patients were randomly divided into two group,steroid treatment group(n=24) and 654-2 treatment group(n=30).Two group both give the same foundation treatment:Rest、supplementary energy and vitamin(10% GS 250 ml+ATP 40 mg+CoA 100 U+Vic 3.0+Vikl 30 mg)、10%GS 250 ml+potassium-magnesium Aspartate 40 ml·by intravenous.24 cases of the steroid treatment group was treated with regular treatment plus prednisone 60 mg once daily by orally,TBIL was reduced more than 50%,prednisone was regularil reduced.654-2 treatment group was given the same regular treament plus 654-2 40 mg once daily by intravenous drip.The therapeutic course to both group were 4 weeks and two weeks'follow-up.Hepatic functions,serum ALT,ALP,TBIL and Hemorheology were measured before and after the treatment.Results:After 2 weeks'treatment,effective rate in the two group were 87.5% and 93.3%,After 4 weeks,treatment,Effective rate in the two group were 87.5% and 96.7%.Short-term effect was not significantly different between the two group(P0.05).After treatment,Hemorheology in the 654-2 treatment group were significantly better than that in the steroid treatment group.Two weeks follow-up did not show reverse in the patients with persistent 654-2 administration.The side effect of 654-2 was mild in the who1e process of treatment.Conclusions:Using conventional therapy,combined therapy with 654-2 is more effective in improving the symptom and liver function of patients with cholestatic drug-induced hepatitis.And 654-2 has no evident side efiect in such patients.