药品未注册用药现状及在神经肿瘤化疗中的应用

Off-label Use of Anticancer Drugs in Neuro-oncology

药品未注册用药是指药品使用的适应症、适应人群、给药方法或剂量不在药品说明书之内的用法。药品未注册用药现象普遍存在于抗肿瘤治疗中,并成为一个越来越突出的有争议的问题。本文介绍国内外药品未注册用药的现状及存在问题,并探讨神经肿瘤化疗领域药品未注册用药的意义和注意事项,以及非注册临床研究的重要性。

Off-label drug use includes the uses of a drug product in indications,patient populations,routes of administration or doses that are not reflected health administration-approved product labeling.Off-label use of drugs to treat cancer is particularly common,and is becoming a subject with much debate.This article introduced the current status and debate about off-label drug use,indicating the significance in chemotherapy of nervous system neoplasms and the importance of non-registration clinical studies.