抗肿瘤药物警戒研究进展  

Research Progress of Antitumor Pharmacovigilance

作　　者：孙雯娟[1] 胡扬[1] 徐燕[2] 张波[1] Wenjuan SUN;Yang HU;Yan XU;Bo ZHANG(Department of Pharmacy,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100730,China;Department of Respiratory and Critical Care Medicine,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100730,China)

机构地区：[1]中国医学科学院,北京协和医学院,北京协和医院,药剂科,北京100730 [2]中国医学科学院,北京协和医学院,北京协和医院,呼吸与危重症医学科,北京100730

出　　处：《中国肺癌杂志》2022年第7期541-545,共5页Chinese Journal of Lung Cancer

基　　金：中国医学科学院医学与健康科技创新工程项目资助(No.2021-I2M-C&T-B-014)资助。

摘　　要：2019年我国新修订的《药品管理法》首次提出国家建立药物警戒制度,2021年我国首部《药物警戒质量管理规范》发布。药物警戒的提出和实施在我国为初始阶段,从体制、监测机制、数据库建设等方面需不断完善。我国肿瘤患者新发病例数量位居全球首位,近年来,新型抗肿瘤药物上市速度加快,临床试验繁多,抗肿瘤药物警戒工作势在必行。本文从药物警戒起源、临床实践目标、流程与方法、抗肿瘤药物警戒难点及我国药物警戒现行特点等方面归纳总结,旨在为抗肿瘤药物警戒的开展提供参考。In 2019,Drug Administration Law of China was first time proposed that the country should establish pharmacovigilance system.In 2021,the first Pharmacovigilance Quality Management Standard of China was released.The proposal and implementation of pharmacovigilance were the initial stage in China,and it needed to improve the aspects of pharmacovigilance include institution,monitoring mechanism and database construction.The number of new diagnosed cancer patients in China ranked first in the world.In recent years,the marketing speed of novel antitumor drugs was accelerated,and there were many clinical trials.Therefore,antitumor pharmacovigilance was imperative.In this article,we summarized pharmacovigilance of the origin,clinical practice objectives,procedures,methods.We described the difficulties in antitumor pharmacovigilance and current characteristics of pharmacovigilance in China,aiming to provide reference for the development of antitumor pharmacovigilance.

关 键 词：抗肿瘤药物 药物警戒 监测模式 目标 

分 类 号：R979.1[医药卫生—药品]