Objective:To investigate the clinical efficacy of Jieyu Ganshu capsules (JGC) plus adefovir dipivoxil tablets and bifendate tablets for treating patients with chronic hepatitis B (CHB) and the effect on immunoregulatory function. Method: One hundred and three patients (liver-stagnation and spleen-deficiency syndrome) were randomly divided into observation group (n=52) and control group (n=51). Control group was given adefovir dipivoxil tablets

10 mg daily;bifendate tablets

25-50 mg each time

tid

and withdrawal after 4 weeks for liver function was normal. JGC was added to observation group

3 capsules each time

tid. All patients were received treatment for after 24 weeks accordingly. Hepatitis be antigen (HbeAg)

alanine aminotransferase (ALT)

hepatitis B virus-DNA (HBV-DNA)

T cell subset and serum immunoglobulin were tested

and score of liver-stagnation and spleen-deficiency syndrome was observed. Result: The level of HBV-DNA and ALT in both groups after the treatment were lower than those before

and the post-treatment HBV-DNA level of observation group was more lower compared with that in control group after 24 weeks (P<0.01). The post-treatment level of ALT of observation group was lower than those in control group after 12

24 weeks (P<0.01). The post-treatment complex rule number of ALT of observation group were superior to those in control group after 12

24 weeks (P<0.05). The post-treatment HBV-DNA negative number in observation group was superior compared with that in control group (P<0.05). CD3+

CD4+ and CD4+/CD8+ in observation group were increased obviously and higher than those in control group

and CD8+ was dramatic declined and lower than that in control group(P<0.05

P<0.01). The level of IgG

IgA and IgM in observation group were declined obviously and lower than those in control group (P<0.01). Bloating

distending pain in hypochondrium

abdominal distension

poor appetite and indigestion

depressed mood

preference for sighing

syndrome score of liver-stagnation and spleen-deficiency in observation group after treatment were lower compared with those in control group (P<0.01). Conclusion: JGC plus adefovir dipivoxil tablets and bifendate tabletes can resist HBV

protect liver function

relieve the clinical symptoms

and the mechanism of action may be related with regulating cellular immunity and humoral immunity function.