Abstract: Objective To observe the clinical efficacy of combination of entecavir（ETV） and immunotherapy in the treatment of hepatitis B virus carriers. Method 66 hepatitis B virus carriers were randomly assigned into treatment group and control group with 33 in each group. Individuals in the treatment group were treated by ETV and hepatitis B vaccine,rIL-2,and G-CSF,and those in the control group were treated with ETV alone. The regimen lasted for three years in both groups. Before and after the treatment,serum level of ALT,HBV DNA,HBeAg,HBeAb,HBsAg were detected routinely. Results At the end of the treatment,negative rate of serum HBeAg in the treatment group was 33.3%,significantly higher than that in the control group（12.1%,P<0.05）;the seroconversion rate of HBeAg to anti-HBe was 24.2% in the treatment group,significantly higher than that in the controls（6.0%,P<0.05）;the serum HBV DNA loss in treatment group was 75.7%,significant higher than that in the control group（51.5%,P<0.05）;At the end of six months after the discontinuation of the treatment,the negative rate of serum HbeAg was 42.4%,the seroconversion of HbeAg to anti-HBe rate was 27.2%,and the serum HBV DNA loss was 78.7% in the treatment group,all significantly higher than those in the controls（12.1%,6.0% and 45.4%,respectively,P<0.05）;serum levels of ALT were elevated in 42.3% of individuals in treatment group, significantly higher than that in the controls（9.0%,P<0.05）. Conclusion The clinical efficacy of combination therapy with nucleoside analogues and immune-modulating agents are promising,which might break the state of immune tolerance in some hepatitis B virus carriers.

Key words: Hepatitis B virus carriers, Entecavir, Immune tolerance, Immune-modulating agents