URSODEOXYCHOLIC ACID THERAPY FOR CHRONIC TYPE-C HEPATITIS - A MULTICENTER, DOSE-FINDING TRIAL

Orsodeoxycholic acid (UDCA) was administered orally for 12 weeks to 40 patients with chronic type C hepatitis. Patients were randomly assign ed to receive UDCA 150 mg/day (n = 20) or 450 mg/day (n = 20). In the 450-mg group, alanine aminotransferase (ALT) decreased significantly ( P ( 0.05) during treatment but increased (P < 0.05) 4 weeks after the drug was withdrawn, In contrast, in the 150-mg group, ALT showed no si gnificant decrease during treatment. In the 450-mg group, aspartate am inotransferase (AST) at weeks 8 and 12 and ALT at week 12 were signifi cantly decreased compared with the 150-mg dose group (P < 0.01). No si gnificant difference between groups was observed in gamma-glutamyltran sferase (GGT) levels, although in both groups GGT significantly decrea sed (P < 0.05). The UDCA fraction to serum bile acid ratio increased t o 29 mol% in the 150-mg group and to 47 mol% in the 450-mg group. Ther e was a good correlation between the increase in the serum UDCA fracti on and the decrease in ALT and GGT levels. These results suggest that in chronic type C hepatitis, UDCA at a dose of 450 mg/day significantl y improves AST, ALT, and GGT levels and that these improvements are as sociated with an increase in the serum UDCA fraction.