患者报告结局在药品不良反应报告中的应用和思考

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。结论患者报告结局以患者为中心，为药品使用的效益、风险和结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。

Thought and Application of Patient-reported Outcome in the Adverse Drug Reaction Report

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 withcurrent data collection, discordance between patients and prescribers, better patient context drive the adoption ofpatient-report outcome effectively, as well as the regulatory measures formulated by many countries such as Americaand Britain. Conclusion Patient-reported outcome with patient-centered, which provides a rich and valuable informationfor comprehensive analysis of the effectiveness, risks and outcomes of drug use, can be used as a supplement to thecurrent pharmacovigilance and post-marketing studies, and provides an important reference for our country to adoptpatient-reported outcome in drug safety studies.