Objective To observe the efficacy and safety of Tα1 vs.Tα1 combined with IFN-α in the treatment of chronic hepatitis B.Methods Thirty-eight patients with chronic hepatitis B were randomly divided into group A and B.Patients in both groups received Tα1 for six months.However,patients in group A received IFN-α coincidently for six months.Results At the end of treatment,ALT level decreased in the patients of both group A and group B(P=0.0043 and P=0.0036,respectively),which decreased 96.6±38.3IU/L(P=0.00189)in group A and 81.93±56.39IU/L in group B respectirely.HBV DNA level decreased 130±283 mEq/ml(P=0.0019)in group A and 373±825 mEq/ml in group B(P=0.019).Conclusion The Tα1 or Tα1 combined with IFN-α is efficient to treat patients with chronic hepatitis B.