超适应证用药——临床用药中的“尴尬”与应对

摘要

Unregistered drug use,also called off-label drug use,has become a universal phenomenon in clinical practice worldwide.At present,there is still no definite laws and regulations in the field of off-label medication in China.The article gives an overview about the current criterion for prescription in China,the definition of off-label use,analysis of this situation and causes,how to regulate this practice to protect the patient's rights and safety,and also doctor's rights of prescription.%“药品未注册用法”又称“超适应证用药”,在全球范围内的临床实践过程中已经成为一种普遍现象.目前中国没有明确的法律或者法规性文件就药品超适应证用药进行相应的规定,本文就中国现有的临床医师用药规范,“超适应证用药”的定义、产生原因,如何合理规范进行“超适应证用药”,保障患者的利益和用药安全,以及医师的权益,结合国内外现状,对这一现象进行述评.