Polyunsaturated phosphatidyl-choline and interferon alpha for treatment of chronic hepatitis B and C: a multi-center, randomized, double-blind, placebo-controlled trial. Leich Study Group.

摘要: BACKGROUND/AIMS Polyunsaturated phospatidyl-choline (PPC) has been shown to reduce serum aminotransferases in experimental hepatitis. This multi-center, randomized, double-blind, placebo-controlled trial evaluated the effects of PPC patients with chronic hepatitis B and C combination interferon alpha 2a or 2b. The diagnosis viral was based on an abnormal alanine aminotransferase (ALT) value (more than twice upper normal), replication found liver biopsy. METHODOLOGY Patients received 5 million I.U. (Hepatitis B) 3 (hepatitis C) s.c. thrice weekly for 24 weeks, respectively, were randomly assigned additional oral medication either 6 capsules (total daily dose: 1.8 g) placebo per day weeks. Biochemical response therapy defined as a reduction ALT by more 50% pre-treatment values. responders treated further weeks after cessation placebo. RESULTS 176 completed study protocol (per-protocol population: 92 84 group). A biochemical (> reduction) seen 71% who PPC, but only 56% (p < 0.05). increased rate particular C: those responded group versus 51% Prolonged given beyond tended increase sustained at week 48 (41% 15% control group; p = 0.064). In contrast, did not alter B. accelerate elimination HBV-DNA, HBeAg HCV-RNA. CONCLUSIONS conclusion, may be recommended termination order high relapse rate. contrast IFN other antiviral agents does carry major risks is tolerated very well.