第八章 药品超说明书用药评价指南  

Chapter 8 Guideline for Evaluation of Off-label Uses

作　　者：伍俊妍[1] 朱建红[1] 何志超[1] 张梅 邱凯锋[1] 郑志华 WU Junyan;ZHU Jianhong;HE Zhichao;ZHANG Mei;QIU Kaifeng;ZHENG Zhihua(Department of Pharmacy,Sun Yat-sen Memorial Hospital,Sun Yat-sen University,Guangzhou 510000,China;Guangdong Pharmaceutical Association,Guangzhou 510000,China)

机构地区：[1]中山大学孙逸仙纪念医院药学部,广州510000 [2]广东省药学会,广州510000

出　　处：《临床药物治疗杂志》2024年第S1期46-51,72,共7页Clinical Medication Journal

摘　　要：基于循证医学的进展、说明书更新不及时、患者特殊治疗需求的原因,临床会出现超说明书用药的情况。如何对药品超说明书用药开展评价,建立评价标准,最大限度地保证药品的尽责使用和合理使用是亟待解决的重要问题。本章介绍了药品超说明书用药现状;拟定了药品超说明书用药评价流程;并采用循证评价的方法,对药品超说明书用药的安全性、有效性、经济性、体内药动学等方面需要评价和重点关注的内容进行了阐述,旨在规范药品超说明用药评价,为临床治疗提供重要的决策依据。Due to the progress of evidence-based medicine,the lack of timely update of instructions,and the special treatment needs of patients,off-label uses of drugs become inevitable in clinical practice.How to evaluate off-label uses,establish evaluation standards,and ensure the maximum responsible and rational use of drugs is an urgent issue.This chapter introduces the current situation of off-label uses and developed the evaluation process of off-label uses.The safety,effectiveness,economy,and pharmacokinetics of off-label uses,which are needed to be evaluated and focused on,are described by using the method of evidence-based evaluation.The aim is to standardize the evaluation of off-label uses of drugs and provide important decision basis for clinical treatment.

关 键 词：药品超说明书用药 循证医学 评价指南 

分 类 号：R95[医药卫生—药学]