首页|槲芪癥消汤联合仑伐替尼治疗Ⅲ期乙肝相关肝癌93例临床观察

槲芪癥消汤联合仑伐替尼治疗Ⅲ期乙肝相关肝癌93例临床观察

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目的:评价槲芪癥消汤联合仑伐替尼治疗Ⅲ期乙肝相关肝癌的有效性及安全性。方法:采用实用性随机对照方法，纳入Ⅲ期乙肝相关肝癌患者93例，随机分为治疗组48例，对照组45例。对照组采用仑伐替尼治疗(体重＜60 kg，8 mg/次，1次/d;体重≥60 kg，12 mg/次，1次/d)，治疗组在对照组用药基础上联合槲芪癥消汤中医治疗方案。两组均连续治疗24周，随访24周。主要研究终点为无进展生存期(progression-free survival，PFS)，次要研究终点包括总生存期(overall survival，OS)、治疗前后生活质量症状评分、中医证候评分和安全性。结果:两组患者的基线特征差异无统计学意义，治疗组延长了 Ⅲ期乙肝相关肝癌患者的PFS(8。7个月vs。7。2个月，P=0。007)，OS未见显著获益(14。8个月vs。13。8个月，P=0。147)。槲芪癥消汤联合治疗能够改善患者的中医证候评分及腹胀(P=0。010)、黄疸(P=0。007)、营养改变(P=0。004)3个维度的生活质量评分，且能减少手足综合征(P=0。040)、高血压(P=0。004)及疲乏(P=0。013)等不良反应。结论:槲芪癥消汤联合仑伐替尼治疗可提高Ⅲ期乙肝相关肝癌患者的PFS，改善生活质量，且安全性良好。
Clinical study of Huqi Zhengxiao Decoction with lenvatinib in treating 93 patients with stage Ⅲ hepatitis B related liver cancer
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.

hepatitis B related liver cancerHuqi Zhengxiao DecoctionTraditional Chinese Medicine treat-mentpractical randomized controlled trial

姚杨、刘迪、王一同、王雪婧、张旻玥、张纯、郑小勤、汪晓军

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首都医科大学附属北京佑安医院中西医结合中心(北京,100069)

乙肝相关肝癌 槲芪癥消汤 中医治疗 实用性随机对照试验

首都卫生发展科研专项北京市医院管理中心"扬帆"计划诊疗能力提升项目国家中医药局高水平中医药重点学科建设项目

首发2022-2-2186ZLRK202332zyyzdxk-2023002

2024

10.3969/j.issn.1671-038X.2024.03.05

中国中西医结合消化杂志
华中科技大学同济医学院,中国中西医结合学会消化系统疾病专业委员会,中华中医药学会脾胃病专业委员会

中国中西医结合消化杂志

CSTPCD
影响因子：1.363
ISSN：1671-038X
年,卷(期)：2024.32(3)
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