Objective:To evaluate the clinical efficacy of Ganxian recipe (GXR) and lamivudine (LVD) in a two-year treatment of chronic hepatitis B (CHB).Methods: One hundred and twenty patients with CHB were randomly divided into the combinedly treated group (combined group) of 40 CHB patients who were treated with GXR combined with LVD. Another 40 CHB patients were treated with LVD alone (WM group)

and still another 40 CHB patients were treated with GXR alone (TCM group). All these cases were randomly controlled and observed for two years.Results: Comprehensive efficacy: Total effective rate of the combined group (complete response and partial response) was 92.5%

while that of the WM group was 67.5% and TCM group 57.5%

respectively

with the difference between them was significant (P<0.01); after treatment

the hepatic functions (AST

ALT

SB) of the three groups were all reduced

and the reduction in the combined group was particularly significant in comparison with the WM group or TCM group

P< 0.05 orP<0.01 respectively

suggesting that the effect in the combined group was better than that in the other two groups; the rate of tyrosine-methionine-aspartate-aspartate (YMDD) virus mutation: it was 7.5% in the combined group

40.0% in the WM group

and 5.0% in the TCM group; liver fibrosis improvement parameter: after treatment

the results in the combined group got better than those in the other two groups.Conclusion: GXR could inhibit the appearance of YMDD after long-term application of LVD

and combined use has marked synergism.