循证医学视角下的超说明书用药分级管理研究

Research on Classification Management of Off-label Drug Use on Evidence-based Medicine

目的为促进临床合理用药,保障患者用药安全,对超说明书用药进行分级管理。方法以循证医学证据为分级管理依据,启动了全院临床科室超说明书用药的备案评审工作。结果在406条备案药物中,抗肿瘤药物超说明书用药占78.8%,依据国际指南用法的比例最高,占48.8%,其次为其他循证支持用法占36.4%,再次为国内指南用法占11.1%。结论超说明书用药的管理应重点集中于证据等级较低、药物不良反应发生率较高,且曾发生过医患纠纷的药物。

Objective To implement the classification management of off-label drug use to regulate off-label drug use,in order to promote the clinical rational drug use and to ensure the safety of patients＇ drug use. Methods Implementing the record review work of off-label drug use by classification management based on the evidence-based medicine. Results Of the 406 registration drugs,antineoplastic drugs accounted for 78.8%,according to the international guidelines for the usage of the highest proportion, accounting for 48.8%, followed by other evidence-based support usage（including literature reported） accounted for 36.4%,and 11.1% for domestic usage guidelines. Conclusion The management of off-label drug use should focus on the drugs which have low level of evidence,higher incidence of adverse drug reactions,and ever lead to medical disputes.