Objective To observe the efficacy and safety of Fuzheng Jiedu Xiaoji Decoction（扶正解毒消积方） combined with western medicine in the treatment of patients of hepatitis B-related primary liver cancer with the syndrome of deficiency of qi and yin

and acummulation of toxin and stasis. Methods A total of 163 patients were randomly divided into an integrated traditional Chinese and a western medicine group（80 cases） and a western medicine group（83 cases）. The western medicine group was given anti-viral treatment

comprehensive internal medicine treatment and hepatic artery chemoembolization（TACE） treatment

and the integrated medicine group was orally given modified Fuzheng Jiedu Xiaoji Decoction on the basis of the western medicine group

1 dose per day. Both groups were treated for 52 weeks and followed up for 52 weeks. The 1-year and 2-year survival rates of the 2 groups were compared

and the efficacy of solid tumors was judged. Liver function indexes including alanine aminotransferase（ALT）

aspartame aminotransferase（AST）

total bilirubin（TBiL）

albumin（ALB）

alkaline phosphatase（ALP）

γ-glutamyl transpeptidase（GGT）

blood creatinine（Scr） and alpha-fetoprotein（AFP） were measured before treatment and at the 12 th

24 th

36 th

and 52 th weeks of treatment

and adverse reactions were recorded. Results The 2-year survival rate of patients of stage A in Barcelona clinic liver cancer（BCLC） of the integrated medicine group was 86.5%

which was higher than 65.0% of the western medicine group; the 1-year survival rate of patients of stage B was 80.0%

which was higher than 66.7% of the western medicine group（P<0.05）. The curative effect remission rate of solid tumors in the integrated medicine group was 46.6%

and the stable rate was 78.1%

both higher than the 30.1% and 56.2% in the western medicine group（P<0.05）. After 12

24

36

52 weeks of treatment

the levels of ALT

AST

TBiL

ALP

GGT

and AFP in both groups were lower than those in the group before treatment（P<0.05 or P<0.01）

and at 36 th and 52 th week of treatment

the indicators of the integrated medicine group were lower than that of the western medicine group（P<0.05 or P<0.01）. There were no drug-related adverse reactions in both groups. Conclusion Modified Fuzheng Jiedu Xiaoji Decoction combined with western medicine treatment could improve the survival rate of hepatitis B-related primary liver cancer patient in BCLC stage A and B with the syndrome of deficiency of qi and yin

and acummulation of toxin and stasis

improving liver function

better than simple western medicine treatment with good safty.