Objective: To evaluate the antiviral therapeutic effects and safety of Bushen Qingtou prescription to hepatitis B virus(HBV) carriers with positive e antigen. Method: With the multi-center

randomized

double-blinded and placebo-controlled methods

300 cases of HBV carriers with positive e antigen were double-blinded randomized into 2 groups

with 200 cases in treated group and 100 cases in controlled group. During the 52-week treatments

Bushen Qingtou prescription was applied in treated group and Bushen Qingtou placebo prescription was adopted in controlled group. All the drugs above were granular formulation

one dose twice per day taken with water. During the treatments

the DNA quantitative of serum HBV and the two pairs of semi-hepatitis B quantitative were tested and the occurrence of adverse effects was observed. Result: At the 52nd week

the DNA levels of serum HBV in treated group were remarkably decreased

with significant difference compared with that at the 0 week respectively. The ratio of decreasing over 1 lg and over 2 lg was 41.36% and 19.37% in treated group

which were more compared with that of 15.96% and 4.26% in Controlled Group. During the treatments

the average values of HBeAg in treated group were continuously decreasing. At the 52nd week

the average values of HBeAg in treated group were obviously decreased compared with that in the placebo Controlled Group

with significant difference

while the average values of HBsAg in treated group were not better. The ratio of HBsAg decreasing over 0.5 lg was 27.23% in treated group

which was superior to that of 8.51% in Controlled Group

with significant difference. At the 52nd week

in two groups

the decreasing of DNA level of serum HBV over 3 lg and negative-transmission ratio

the HBeAg negative-transmission ratio

the HBeAg seroconversion ratio and the HBsAg decreasing over 1 lg and over 2 lg and negative-transmission ratio were almost the same without significant difference. There was no case of serious adverse effects during the treatments. Conclusion: Bushen Qingtou prescription has the function of HBV inhibition

which have the tendency of time-dependence.