Abstract: Objective To observe the clinical efficacy of Fufang Biejia Ruangan tablet （FBR） combined with entecavir （ETV） in the treatment of patients with chronic hepatitis B （CHB）. Methods A total of 138 patients with CHB were enrolled and divided into two groups（73 in FBR plus ETV group，and 65 patients in ETV monotherapy group）. Liver functions，HBV serological indicators，HBV DNA quantification，liver fibrosis markers，results of abdominal ultrasound and adverse drug reactions were recorded. Results The liver functions in both groups had been improved after 48-weeks treatment compared with those before treatment. ALT levels before and after treatment in patients of combination group were[（118.7±70.9） U/L vs. （32.6±21.5） U/L，P<0.01] and ALB before and after treatment in combination group were [（38.5±3.8） g/L vs. （43.2±4.5） g/L，P<0.01]；No significant difference was seen between the two groups in serum clearance rate of HBV DNA and negative conversion rate of HBeAg [85.33% （64/73） vs. 86.15% （56/65），and 27.78% vs. 15.15%，respectively，P>0.05 for both]； Serum hyaluronic acid （HA） and length of spleen in combination group reduced remarkably after 48-weeks treatment compared with those before treatment [（172.40±58.16） μg/L vs. （365.17±119.07） μg/L for HA， P<0.01 and （10.15±0.12） cm vs. （12.08±0.16） cm for the length of spleen，P<0.05]. Conclusion ETV combined with FBR provides better efficacy than ETV alone in the treatment of patients with CHB.

Key words: Hepatitis B, Fufang Biejia Ruangan tablet, Enticavir, Liver fibrosis, Clinical efficacy