中国药物警戒 ›› 2019, Vol. 16 ›› Issue (2): 81-87.

• 法规与管理研究 • 上一篇    下一篇

美国FDA哨点系统的应用及启示

王琳琳, 杨悦, 王淑玲*   

  1. 沈阳药科大学工商管理学院,辽宁 沈阳 110016
  • 收稿日期:2019-03-12 修回日期:2019-03-12 出版日期:2019-02-25 发布日期:2019-03-12
  • 作者简介:王琳琳,女,在读硕士,药事管理。

Application of the US FDA Sentinel System and Enlightenment

WANG Linlin, YANG Yue, WANG Shuling*   

  1. School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China
  • Received:2019-03-12 Revised:2019-03-12 Online:2019-02-25 Published:2019-03-12
  • Contact: *王淑玲,女,硕士,副教授·硕导,药事管理。E-mail：405861417@qq.com

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摘要： 目的 介绍美国FDA哨点系统相关内容及应用案例,为我国医药产品的安全性监测提供参考。方法 通过介绍美国FDA哨点系统的背景、组织框架、安全风险信号的要素与评估过程,并以肾素-血管紧张素-醛固酮系统相关药物与血管性水肿信号的评估为例,为我国建立完整的电子数据库监测系统提供参考。结果 与结论 在借助中国医院药物警戒系统（CHPS）平台的基础上,继续扩大哨点监测范围与哨点单位数量,积极开展不良反应的主动监测。同时,探索并开发新的数据管理模式,为数据的处理与分析提供支持。

关键词: 美国食品药品管理局（FDA）, 哨点系统, 血管性水肿

Abstract: Objective To introduce the relevant content and application cases of the US sentinel system, so as to provide reference for the safety monitoring of medical products in China. Methods The background, organizational framework, safety risk signal elements and evaluation process of the US FDA sentinel system were introduced, and the evaluation of renin-angiotensin-aldosterone system(RAAS) related drugs and angioedema signals were taken as an example to provide reference for the establishment of a complete electronic database monitoring system in China. Results and Conclusion On the basis of the Chinese Hospital Pharmacovigilance System (CHPS) platform, the number of sentinel surveillance areas and the number of sentinel units continue to be expanded, and active monitoring of adverse reactions is actively carried out. At the same time, explore and develop new data management models to support data processing and analysis.

Key words: US FDA, sentinel system, angioedema

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