曲妥珠单抗超药品说明书用药临床研究进展  

Clinical Research Progress of Trastuzumab Off-label Use

作　　者：谢梦棋 张婷华 陈璿瑛[3] 胡锦芳[3] XIE Mengqi;ZHANG Tinghua;CHEN Xuanying;HU Jinfang(School of Pharmacy,Nanchang University,Nanchang Jiangxi 330006,China;Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine,Nanchang Jiangxi 330006,China;The First Affiliated Hospital of Nanchang University,Nanchang Jiangxi 330006,China)

机构地区：[1]南昌大学药学院,江西南昌330006 [2]江西中医药大学附属医院,江西南昌330006 [3]南昌大学第一附属医院,江西南昌330006

出　　处：《药品评价》2022年第22期1405-1408,共4页Drug Evaluation

基　　金：江西省卫健委课题(SKJP220212447);江西省卫计委课题(20165175);吴阶平医学基金会临床科研专项资助基金项目(320.6750.2022-19-13)。

摘　　要：超说明书用药指经国家药品监督管理部门批准的药品说明书中未包含的药物使用方式。曲妥珠单抗对人类表皮生长因子受体2(HER2)阳性乳腺癌的一线治疗取得了巨大成功,也获批应用于HER2阳性的胃癌。研究表明HER2在多种人类癌症中扩增,曲妥珠单抗联合化疗超说明书应用于此类疾病,可以极大地改善患者的预后。但是,我国超说明书用药缺乏统一的管理和规范。本文综述了近年来国内外曲妥珠单抗在HER2阳性癌症中超说明书应用的临床研究进展,旨在为临床合理用药提供参考。Off-label use generally refers to any intentional use of a drug not covered by its label approved by the national drug regulatory department.Trastuzumab has achieved great success as first-line treatment for HER2-positive breast cancer and has also been approved for HER2-positive gastric cancer.Studies have shown that HER2 is amplified in a variety of human cancers,and off-label use of trastuzumab combined with chemotherapy in such diseases can greatly improve the prognosis of patients.However,there is a lack of unified management and standardization of off-label use in China.This article reviews the clinical research progress of off-label use of trastuzumab in HER2-positive cancer at home and abroad in recent years,aiming to provide reference for clinical rational drug use.

关 键 词：曲妥珠单抗 超说明书用药 人类表皮生长因子受体2 基因扩增 

分 类 号：R95[医药卫生—药学]