德曲妥珠单抗在晚期或转移性乳腺癌治疗中的快速卫生技术评估  

Rapid health technology evaluation of trastuzumab deruxtecan in the treatment of advanced or metastatic breast cancer

作　　者：姜伊 张卓[1] 刘倩欣 张志琪 刘晓[1] 周颖[1] JIANG Yi;ZHANG Zhuo;LIU Qian-xin;ZHANG Zhi-qi;LIU Xiao;ZHOU Ying(Department of Pharmacy,Peking University First Hospital,Beijing 100034,China;School of Basic Medicine and Clinical Pharmacy,China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]北京大学第一医院药剂科,北京100034 [2]中国药科大学基础医学与临床药学学院,南京211198

出　　处：《中国新药杂志》2025年第1期102-109,共8页Chinese Journal of New Drugs

基　　金：国家卫生健康委医院管理研究所医疗质量(循证)管理研究项目(YLZLXZ23G030);中央高水平医院临床科研业务费资助北京大学第一医院院内交叉临床研究专项基金资助项目(2022CR36)。

摘　　要：目的:评价德曲妥珠单抗(trastuzumab deruxtecan, T-DXd)在晚期或转移性乳腺癌治疗中的有效性、安全性和经济性。方法:系统检索中英文数据库及卫生技术评估(health technology assessment, HTA)相关网站,遴选相关研究并提取数据,进行描述性统计分析。结果:共纳入5篇HTA报告、19篇Meta分析/系统综述和14篇经济学研究。在人表皮生长因子受体2(human epidermal growth factor receptor 2,HER2)阳性晚期或转移性乳腺癌的二线治疗中,T-DXd对比恩美曲妥珠单抗(trastuzumab emtansine, T-DM1)有效性更佳。T-DXd常见不良事件包括胃肠道反应、血液毒性、疲劳、脱发等,特殊不良事件主要为间质性肺病。由于药品价格限制,对于中国支付者,T-DXd相比T-DM1和化疗方案均不具成本效益。结论:T-DXd有效性良好、安全性可控,暂不具备经济性。Objective:To evaluate the efficacy,safety and pharmacoeconomic of trastuzumab deruxtecan(T-DXd)in the treatment of advanced or metastatic breast cancer.Methods:Databases in Chinese/English and websites on health technology assessment(HTA)were systematically searched.Two reviewers independently identified the studies,extracted data,and accessed the quality.Descriptive statistical analysis was conducted.Results:5 HTA reports,19 Meta-analyses/systematic reviews,and 14 economic studies were included.In the second-line treatment of human epidermal growth factor receptor 2 positive advanced or metastatic breast cancer,T-DXd demonstrated superior efficacy compared to trastuzumab emtansine(T-DM1).Common adverse events associated with T-DXd included gastrointestinal reactions,hematologic toxicity,fatigue,and alopecia.Notably,interstitial lung disease was a specific adverse event.Due to drug price restrictions,T-DXd was not cost-effective compared with T-DM1 or chemotherapy for Chinese payers.Conclusion:T-DXd has favorable efficacy and controllable safety,but is not economical at present.

关 键 词：德曲妥珠单抗 乳腺癌 有效性 安全性 经济性 快速卫生技术评估 

分 类 号：R956[医药卫生—药学]