Objective To observe the efficiency and safety of Thymosin-al for treatment of anti-HBe- and HBV DNA-positive chronic hepatitis B. Methods 56 patients were randomly divided into group A and B, and the baseline were co...Objective To observe the efficiency and safety of Thymosin-al for treatment of anti-HBe- and HBV DNA-positive chronic hepatitis B. Methods 56 patients were randomly divided into group A and B, and the baseline were comparable between group A and B (P>0.05). The patients in group A received Thymosin-α1 1.6 mg subcutaneous injection twice a week for 6 months, and the patients in group B received Interferon a 3-5 Mu each day for 15 days, then thrice a week for 6 months. All the patients were followed up for 6 months. Another 30 patients without Thymosin-al and Interferon alpha therapy as control were followed up for 12 months. Proportions of complete response at the end of therapy and follow-up were compared between group A, B and control. Complete response was defined as serum ALT normalization and HBV DNA loss. Results At the end of treatment, proportions of complete response were 30.8% (8/26) in group A and 46.7% (14/30) in group B, there was no evident difference between them (χ^2=1.47, P>0.05). At the end of follow-up, proportions of complete response were 42.3%% (11/26) in group A and 23.3%% (7/30) in group B, there was no evident difference between them (χ^2=2.29, P>0.05). At 6 months and 12 months of follow-up, proportions of complete response were 3.3% (1/30) and 3.3% (1/30). The proportion of complete response in group B at the end of treatment was significantly higher than that in control at 6 months of follow-up (χ^2=15.02, P<0.01), and the proportion of complete response in group A at the end of follow-up was significantly higher than that in control at 12 months of follow-up (χ^2=12.60, P<0.01). Unlike Interferon alpha, Thymosin-α1 was well tolerated in all patients, and no side effect was observed. Conclusions Thymosin-α1 for anti-HBe- and HBV DNA-positive chronic hepatitis B is effective and safe, and Thymosin-al can reduce HBV replication persistently in patients with anti-HBe-positive chronic hepatitis B.展开更多
文摘Objective To observe the efficiency and safety of Thymosin-al for treatment of anti-HBe- and HBV DNA-positive chronic hepatitis B. Methods 56 patients were randomly divided into group A and B, and the baseline were comparable between group A and B (P>0.05). The patients in group A received Thymosin-α1 1.6 mg subcutaneous injection twice a week for 6 months, and the patients in group B received Interferon a 3-5 Mu each day for 15 days, then thrice a week for 6 months. All the patients were followed up for 6 months. Another 30 patients without Thymosin-al and Interferon alpha therapy as control were followed up for 12 months. Proportions of complete response at the end of therapy and follow-up were compared between group A, B and control. Complete response was defined as serum ALT normalization and HBV DNA loss. Results At the end of treatment, proportions of complete response were 30.8% (8/26) in group A and 46.7% (14/30) in group B, there was no evident difference between them (χ^2=1.47, P>0.05). At the end of follow-up, proportions of complete response were 42.3%% (11/26) in group A and 23.3%% (7/30) in group B, there was no evident difference between them (χ^2=2.29, P>0.05). At 6 months and 12 months of follow-up, proportions of complete response were 3.3% (1/30) and 3.3% (1/30). The proportion of complete response in group B at the end of treatment was significantly higher than that in control at 6 months of follow-up (χ^2=15.02, P<0.01), and the proportion of complete response in group A at the end of follow-up was significantly higher than that in control at 12 months of follow-up (χ^2=12.60, P<0.01). Unlike Interferon alpha, Thymosin-α1 was well tolerated in all patients, and no side effect was observed. Conclusions Thymosin-α1 for anti-HBe- and HBV DNA-positive chronic hepatitis B is effective and safe, and Thymosin-al can reduce HBV replication persistently in patients with anti-HBe-positive chronic hepatitis B.
