To study the effects of compound Kushen injection in prevention and treatment of primary hepatic cellular carcinoma (HCC) and the effect on serum P53 antibody, vascular endothelial growth factor (VEGF), transforming growth factor β1 (TGF-β1) and Ki67 levels. Methods:A total of 72 patients with primary HCC who were admitted to our hospital between July 2014 and July 2016 were randomly divided into two groups according to the order of admission, with 36 cases in each group. The control group was treated with chemotherapy alone, while the observation group was treated with compound Kushen injection on the basis of the control group. The clinical efficacy and safety were compared between the two groups. Results:The total effective rate of treatment was significantly higher in the observation group than the control group (4722% vs 2500%) (P<005). After treatment, the levels of CD3, CD4 and CD4/CD8 in the observation group[(5815±925)%, (4441±563)%, (171±056)] were significantly higher than those in the control group[(5114±654)%, (3266±429)%, (106±026)] (P<005). The levels of serum P53 antibody, VEGF, TGF-β1 and Ki67 in the observation group[(15329±3185) pg/mL, (21439±3128) pg/mL, (1647±193) ng/mL, (7134±627)%] were significantly lower than those in the control group[(18994±4421) pg/mL, (35287±4367) pg/mL, (2563±426) ng/mL, (8237±712)%] (P<005). The incidence rates of fever and bone marrow suppression in the observation group (556%, 278%) were significantly lower than those in the control group (2778%, 3611%) (P<005). Conclusion:Compound Kushen injection combined with chemotherapy can effectively control recurrence and metastasis of HCC by reducing the levels of serum markers and inducing cancer cell withering. The incidence of clinical adverse reactions is low.