Abstract: Objective To determine the role of Pre-S1 protein in diagnosing viral replication,hepatic inflammation and fibrosis in patients with chronic hepatitis B. Methods 103 consecutive patients with chronic hepatitis B were included in the study,and liver biopsies were performed in all patients. Serial serum samples were studied with the quantitative determination of HBV DNA by a quantitative PCR assay,and determination of Pre-S1 protein by ELISA. The degrees of hepatic inflammation were divided into G1,G2,G3,G4,and degrees of hepatic fibrosis were divided into S1,S2,S3,S4. Results HBV DNA>10³copies/ml as positive criteria for diagnosing viral replication. The rate between Pre-S1 protein and HBV DNA detection was 88.1%;The rates between Pre-S1 protein and HBV DNA detection were 88.1%,96.3%,92.9%,83.3% in G1,G2,G3,G4 grading;The rates between Pre-S1 protein and HBV DNA detection were 84.2%,91.7%,90.9%,75.0% in S1,S2,S3,S4 staging. Conclusion The efficiency and sensitivity of Pre-S1 test were higher than of HBeAg,more sensitive than HBeAg test in diagnosing viral replication in patients with chronic hepatitis B.And Pre-S1 protein as a good sign in diagnosing degrees of of hepatic inflammation and fibrosis.

Key words: Hepatitis B, Pre-S1 protein, Hepatitis B e antigen, Hepatic inflammation, Hepatic fibrosis