患者报告结局在药品不良反应报告中的应用和思考.pdfVIP

中国药物警戒第11卷第6期 2014年6月 June,2014,Vol.11,No.6 中图分类号：R994.11 文献标识码：A 文章编号：1672-8629（2014 ）06-0340-04 患者报告结局在药品不良反应报告中的应用和思考 王春婷 （国家食品药品监督管理局药品评价中心，北京100045） 摘要：目的 探索患者报告结局在药品不良反应报告中的应用。方法 通过文献回顾的方法，对国外药品安全性研究 中纳入患者报告结局的背景、驱动因素、当前监管情况进行了全面综述。结果 目前数据收集的局限性、患者和医务 人员间的不一致、通过患者能获取更丰富的信息等多个因素的驱动，且美国、英国等国家对此制定了监管措施，有效 推动了患者报告结局在药品安全性研究中的应用。 患者报告结局以患者为中心，为药品使用的效益、风险和结 结论 局的全面分析提供了丰富而宝贵的信息，可用作目前药物警戒和上市后研究的补充内容，为我国将患者报告结局的 方法纳入药品安全性研究提供重要参考。 关键词：患者报告结局；药品不良反应；文献回顾 Thought and Application of Patient-reported Outcome in the Adverse Drug Reaction Report WANG Chun-ting (Center for Drug Reevaluation, CFDA, Beijing 100045, China) Abstract ：Objective To explore the application of the patient-reported outcome in adverse drug reaction report. Methods Through the method of literature review, the background, drivers, current regulatory framework of patient- reported outcome adoption in foreign drugs safety studies are comprehensively reviewed. Results Limitations with current data collection, discordance between patients and prescribers, better patient context drive the adoption of patient-report outcome effectively, as well as the regulatory measures formulated by many countries such as America and Britain. Conclusion Patient-reported outcome with patient-centered, which provides a rich and valuable information for comprehensive analysis of the effectiveness, risks and outcomes of drug use, can be used as a supplement to the current pharmacovigilance and post-marketing studies, and provides an important reference for our country to adopt patient-reported outcome in drug safety studies. Key words ：patient-reported outcome; adverse