第八章 药品超说明书用药评价指南
Chapter 8 Guideline for Evaluation of Off-label Uses
伍俊妍 1朱建红 1何志超 1张梅 1邱凯锋 1郑志华2
作者信息
- 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
- 折叠
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.
Abstract
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Key words
off-label uses/evidence-based medicine/evaluation guidelines引用本文复制引用
出版年
2024
NETL
NSTL
万方数据