Objective:To evaluate the efficacy and safety of Huqi Zhengxiao Decoction(HQZX)combined with lenvatinib in the treatment of stage Ⅲ hepatitis B related liver cancer.Methods:A practical randomized control method was used.Eighty-two patients with stage Ⅲ hepatitis B related liver cancer were enrolled and randomly di-vided into the treatment group and the control group,with 41 patients in each group.The control group was trea-ted with lenvatinib(body weight＜60 kg,8 mg/d,body weight≥60 kg,12 mg/d).The treatment group was treated with a combination of HQZX on the basis of the control group's medication.Both groups were treated con-tinuously for 24 weeks and followed up for 24 weeks.The main endpoint of the study was progression free surviv-al(PFS),while secondary endpoints included overall survival(OS),quality of life symptom score before and after treatment,Traditional Chinese Medicine syndrome score,and safety.Results:There was no significant difference in baseline characteristics between the two groups.The treatment group prolonged the PFS of patients with stageⅢ hepatitis B related liver cancer(8.7 months vs 7.2 months,P=0.007),and OS did not benefit significantly(14.8 months vs 13.8 months,P=0.147).The combination treatment of HQZX can improve the Traditional Chinese Medicine syndrome score and the quality of life scores in the three dimensions of abdominal distension(P=0.010),jaundice(P=0.007),and nutritional changes(P=0.004)in the EORTC QLQ-HCC-18 scale.It can also reduce adverse reactions to hand and foot syndrome(P=0.040),hypertension(P=0.004)and fa-tigue(P=0.013).Conclusion:HQZX combined with lenvatinib treatment can significantly improve the PFS of patients with stage Ⅲ hepatitis B related liver cancer,and improve the quality of life with good safety.
关键词
乙肝相关肝癌/槲芪癥消汤/中医治疗/实用性随机对照试验
Key words
hepatitis B related liver cancer/Huqi Zhengxiao Decoction/Traditional Chinese Medicine treat-ment/practical randomized controlled trial
维普
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