中国药物警戒 ›› 2016, Vol. 13 ›› Issue (8): 484-488.

• 安全性评价与合理用药 • 上一篇    下一篇

药品不良反应/事件之“严重（Serious）”与“重度（Severe）”的界定研究

袁丽, 杨悦*   

  1. 沈阳药科大学工商管理学院,辽宁 沈阳110016
  • 收稿日期:2016-09-14 修回日期:2016-09-14 出版日期:2016-08-20 发布日期:2016-09-14
  • 通讯作者: 杨悦,女,博士,教授·博导,药事法规与药品政策。E-mail：yyue315@vip.126.com

Research on the Differences and Correlation Between‘Serious’ and ‘Severe’ Adverse Drug Reactions/Events

YUAN Li, YANG Yue*   

  1. Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China
  • Received:2016-09-14 Revised:2016-09-14 Online:2016-08-20 Published:2016-09-14

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摘要： 目的 厘清“严重”与“重度”不良反应/事件的概念、内涵、意义,明确两者之间的区别与联系,为两者在实际中的准确运用奠定基础。方法 采用文献研究、对比分析的方法 ,对两者的概念、内涵进行介绍并加以比较,总结二者区别联系。结果 严重不良反应/事件是基于患者结局界定药品安全性监测中相关报告职责的指导标准,重度不良反应事件是不良事件按严重性划分为“重度”的一类不良反应。结论 “严重”与“重度”不良反应/事件并非等同的概念,使用时易混淆,前者是更加偏向管理的一个概念,而后者是更加偏向技术的一个概念,二者的存在发挥着不同的作用,使用应加以注意。

关键词: 药品不良反应, 不良事件, 分类

Abstract: Objective To ravel out the concept,connotation and significance of ‘serious’ and ‘severe’ adverse drug reactions (ADRs) /adverse events (AEs), clear out the differences and correlation between the two concepts, and lay a foundation for accurate use in the actual work. Methods Literature research and comparative analysis were introduced to compare and summarize the differences and relationship between the concepts and connotation. Results ‘Serious’ ADR/AE is based on outcome, it is a guidance in determining responsibility in drug safety monitoring, ‘severe’ adverse drug reaction/event is a class of ADR/ADE marked as ‘severe’. Conclusion ‘Serious’ and ‘severe’ ADRs/AEs are not the same and often confused in use, the former is more likely a concept of administration, and the latter is more likely a technical concept. The existence of the two plays a different role, it should be paid attention when use.

Key words: adverse drug reaction, adverse event, classification

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