OBJECTIVE： To observe therapeutic efficacy and safety of cinobufacini capsules combined with paclitaxel and cisplatin in the treatment of middle and advanced cervical cancer. METHODS： A total of 92 patients with middle and advanced cervical cancer were randomly divided into observation group（46 cases） and control group（46 cases）. Both groups received pelvic intensity-modulated radiotherapy （IMRT）+interstitial brachytherapy. Control group was additionally given Paclitaxel injection 135 mg/m2，d1+Cisplatin injection 75 mg/m2，d1，21 d as a treatment course， and received chemotherapy for 2 cycles since the first day of radiotherapy. Observation group was additionally given Cinobufacini capsules 0.5 g orally since the first day of radiotherapy， 3 times a day， until the end of radiotherapy. Clinical efficacies as well as platelet count， KPS score， body weight， pain relief and the recovery of platelet abnormality were observed in 2 groups， and the occurrence of toxic reaction was recorded. RESULTS： The complete remission rate， the rate of platelet count abnormality recovery as well as remission rate and total remission rate of pain after 3 weeks of treatment in observation group were significantly higher than control group， with statistical significance （P＜0.05）. There was no statistical significance in the total response rate and remission rate after 4， 5 weeks of treatment between 2 groups （P＞0.05）. After treatment， platelet count of 2 groups were significantly lower than before， and the observation group was significantly lower than the control group； KPS score of 2 groups and body weight of observation group were significantly higher than before treatment； body weight of control group was significantly lower than before， and the observation group was significantly higher than the control group， with statistical significance （P＜0.05）. The incidence of grade Ⅲ-Ⅳ neutropenia， nausea and vomiting， grade Ⅰ-Ⅱ diarrhea in observation group were significantly lower than control group， with statistical significance （P＜0.05）. CONCLUSIONS： Based on conventional treatment， cinobufacini capsules combined with paclitaxel and cisplatin show significantly therapeutic efficacy for middle and advanced cervical cancer， improve blood hypercoagulation and survival quality， relieve pain and reduce the occurrence of toxic reaction.