首页|第八章 药品超说明书用药评价指南

第八章 药品超说明书用药评价指南

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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。
Chapter 8 Guideline for Evaluation of Off-label Uses
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.

off-label usesevidence-based medicineevaluation guidelines

伍俊妍、朱建红、何志超、张梅、邱凯锋、郑志华

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中山大学孙逸仙纪念医院 药学部,广州 510000

广东省药学会,广州 510000

药品超说明书用药 循证医学 评价指南

2024

临床药物治疗杂志
北京药学会

临床药物治疗杂志

CSTPCD
影响因子:1.07
ISSN:1672-3384
年,卷(期):2024.22(z1)