甲氨蝶呤误用风险分析及对药物警戒的启示  

Misuse Risk Analysis of Methotrexate and Enlightenment to Pharmacovigilance

作　　者：李岚[1] 夏东胜[1] 田春华[1] 

机构地区：[1]国家食品药品监督管理总局药品评价中心,北京100045

出　　处：《中国药物警戒》2017年第9期538-540,共3页Chinese Journal of Pharmacovigilance

摘　　要：目的分析甲氨蝶呤误用风险及探讨《药品不良反应信息通报》(第75期)对药物警戒的启示。方法对甲氨蝶呤基本情况、用药错误相关国内外文献资料、国内外监管措施等资料进行整理与分析。结果国内外均有甲氨蝶呤用药错误的文献报道,对此国外药品监管部门多次发布警示信息,我国也发布《药品不良反应信息通报》(第75期),此次通报是我国首次针对药品误用问题发布。结论医务人员应了解该药品的误用风险,做好患者的用药指导。同时提示《药品不良反应信息通报》可作为开展药物警戒的重要措施。Objective To analyze the misuse risk of methotrexate and the enlightenment for pharmacovigilance. Methods This article summarized the basic situation of methotrexate, domestic and foreign literature about medication error of methotrexate and domestic and foreign regulatory measures. Results Both domestic and foreign literatures were reported about medication error of methotrexate. The foreign drug regulatory authorities issued a number of warnings. CFDA also issued Chinese Adverse Drug Reaction Information Bulletin （No.75）. It is the first time to remind the problem of drug misuse in Bulletin. Conclusion Medical personnel should be aware of the misuse risk of methotrexate and give medication guidance for patients. Chinese Adverse Drug Reaction Information Bulletin could be an important management measure for pharmacovigilance.

关 键 词：药品不良反应信息通报 甲氨蝶呤 用药错误 药物警戒 

分 类 号：R965[医药卫生—药理学]