【摘要】 目的:了解我国药品监督管理部门责令修订药品说明书现状,为临床安全用药提供参考。方法:查询2003～2009年国家食品药品监督管理局(SFDA)网站上修订药品说明书的相关信息,归纳分析主要风险信息和相关风险管理措施。结果与结论:我国已对33种药品(含类别)说明书通过增加警示语、限制适应证、补充药物相互作用、增加治疗建议和安全防护等措施实施风险管理。建议进一步规范说明书修订形式及内容,实现安全用药的目标。更多还原

【Abstract】 OBJECTIVE:To investigate the status quo that drug regulatory agency orders to revise drug package insert in China,and to provide reference for safety of drug use in the clinic.METHODS:Related information on the revision of drug package insert was inquired from State Food and Drug Administration(SFDA) web site.Main risk information and related risk management measures were summarized and analyzed.RESULTS & CONCLUSIONS:Risk management of 33 kinds of drug package insert(including category) has been carried out in China by adding warnings,restricting the indications,supplementing drug interactions,enriching treatment recommendations and security protection measures.It is suggested to further standardize the revision form and content of drug package insert to achieve the goal of safety of drug use.更多还原