A Randomized Controlled Trial of Thymosin–α1 Versus Interferon Alfa Treatment in Patients With Hepatitis B E Antigen Antibody—And Hepatitis B Virus Dna—Positive Chronic Hepatitis B

作者：Pietro Andreoné, Carmela Cursaro, Annagiulia Gramenzi, Claudio Zavaglia, Indira Rezakovic, Emanuele Altomare, R Severini, J S Franzone, Ottavio Albano, Gaetano Ideo, Mauro Bernardi, Antonio Gasbarrini · 发表于：Hepatology · 年份：1996 · DOI：10.1002/hep.510240404 · 被引用次数：68 · 研究领域：Hepatitis B Virus Studies、Hepatitis C virus research、Viral Infections and Outbreaks Research

It has recently been shown that thymosin-alpha1(T-alpha1), a synthetic polypeptide of thymic origin, is able to promote disease remission and inhibition of hepatitis B virus (HBV) replication in patients affected by hepatitis B e antigen (HBeAg)-positive chronic active hepatitis. We evaluated the efficacy and safety of T-alpha1 treatment in patients with hepatitis B e antibody (anti-HBe) and HBV-DNA-positive chronic hepatitis. Thirty-three patients were randomly assigned to receive either T-alpha1 900 microg/m2 body surface area twice weekly (17 patients) or 5 MU of interferon alfa (IFN-alpha) three times weekly (16 patients) for 6 months. At baseline, both groups were comparable concerning age, sex, liver histology, and alanine transaminase (ALT) levels. At the end of treatment, complete response (defined as ALT normalization and HBV-DNA loss) occurred in 5 of 17 (29.4%) in the T-alpha1 group and in 7 of 16 (43.8%) in the IFN-alpha group (P = not significant). After a follow-up period of 6 months, a complete response was observed in 7 of 17 (41.2%) in the T-alpha1 group and in 4 of 16 (25%) in the IFN-alpha group (P = n.s.). Compared with the results observed in a group of 15 patients never treated with IFN-alpha and followed for 12 months, the rate of complete response was significantly higher in the IFN-alpha group at the end of therapy (1 of 15 vs. 7 of 16, respectively; P < .05) and in the T-alpha1 group at the end of follow-up (1 of 15 vs. 7 of 17, respectively; P < .05...