【摘要】 目的通过比较国内外利巴韦林批准情况及药品说明书等,并对某省利巴韦林儿童药品不良反应(ADR)报告数据挖掘,分析我国儿童利巴韦林临床应用风险来源,以期为该药说明书修改、临床应用及监管等提供建议。方法比较分析国内外利巴韦林批准信息、使用情况及药品说明书;采用回顾性方法对某省2003年1月至2016年12月利巴韦林儿童ADR报告数据分析。结果国内外利巴韦林批准剂型、适应证差异明显,我国利巴韦林儿科临床应用中联合用药不当、超适应证使用等不合理用药现象严重。结论建议修订完善药品说明书,对利巴韦林未批适应证和未批剂型予以关注,规范其儿科临床应用。更多还原

【Abstract】 Objective Through comparatively analyzing the approval, application and instructions of ribavirin at home and abroad, to conduct the risk analysis of domestic children ribavirin clinical use based on the ribavirin’s children ADR report data in a certain province, so as to provide suggestions on the modification of instructions, clinical application,regulation and so on. Methods The risk of ribavirin was analyzed by means of comparing ribavirin’s approval, application and instructions at home and abroad,and analyzing ribavirin’s children ADR reports collected by a certain province from January 2003 to December 2016. Results The approval and application of ribavirin were different significantly between China and abroad, the phenomenons of irrational drug combination and off-label use are common during clinical application in children. Conclusion It is suggested that regulatory authority, manufactures and healthcare providers should pay attention to unapproved indications and dosage form of ribavirin, while revising and improving instruction for more standardized application.更多还原