OBJECTIVE: To observe therapeutic efficacy and safety of Zhenqi fuzheng granules in the adjunctive treatment of cervical cancer. METHODS: 86 patients with cervical cancer were randomly divided into control group (43 cases) and observation group (43 cases). Control group was given intravenous dripping of Diphenhydramine hydrochloride injection 20 mg, Granisetron hydrochloride and glucose injection 5 mg, Cimetidine injection 20 mg at 0.5 h before chemotherapy. After 0.5 h of intravenous dripping, the patients received chemotherapy: Docetaxel injection 40 mg/m2, d1, d8, intravenous dripping; Cisplatin for injection 25 mg/m2, d1-3, intravenous dripping; 21 d as a cycle, a total of 4-6 cycles. On the basis of control group, observation group was additionally given Zhenqi fuzheng granules 5 g, twice 2 day. Clinical efficacies of 2 groups were observed as well as T cell subsets indexes [CD3+,CD4+,CD8+,natural killer cell(NK)], KPS scores, termination, terminal time, the times of chemotherapy and the occurrence of toxic reaction before and after treatment. RESULTS: The total remission rate of observation group was significantly higher than that of control group; the proportion of termination of chemotherapy in observation group was significantly lower than control group; terminal time of chemotherapy was significantly shorter than control group; the times of chemotherapy was significantly more than control group; the incidence of gastrointestinal reaction, anemia, thrombocytopenia and leukopenia were significantly lower than control group, with statistical significance (P<0.05). There was no statistical significance in liver function damage, renal function injury and stomatitis between 2 groups (P>0.05). Before treatment, there was no statistical significance in T cell subsets indexes and KPS scores between 2 groups (P>0.05). After treatment, CD3+, CD4+ and NK cells in observation group were significantly higher than before treatment and control group, while CD8+ was significantly lower than before treatment and control group; KPS scores of 2 groups were significantly higher than before, and the observation group was significantly higher than the control group, with statistical significance (P<0.05). There was no statistical significance in T cell subsets indexes of control group before and after treatment (P>0.05). CONCLUSIONS: On the basis of routine treatment, Zhenqi fuzheng granules can improve therapeutic efficacy, immune function and the quality of life, moreover, reduce toxic reaction in patients with cervical cancer.