药品不良反应发生时间信号检测法在药品安全性监测中的应用

中国药物警戒 ›› 2017, Vol. 14 ›› Issue (6): 350-352.

• 统计学在药物警戒中的应用专栏 • 上一篇下一篇

药品不良反应发生时间信号检测法在药品安全性监测中的应用

严心远^1,2,王胤丞^1,2,张天一¹,叶小飞¹,侯永芳³,吴桂芝³,贺佳^1,*

¹ 第二军医大学卫勤系卫生统计学教研室，上海 200433；
² 第二军医大学卫勤系学员队，上海 2004333；
³ 国家食品药品监督管理总局药品评价中心，北京 100045

收稿日期:2017-05-17 修回日期:2017-08-17 出版日期:2017-06-20 发布日期:2017-08-17
通讯作者: 贺佳，女，教授，博导，药物流行病学及新药评价的统计分析。E-mail：hejia@smmu.edu.cn
作者简介:严心远，男，本科在读，卫生事业管理。
基金资助:
国家自然科学基金（81373105）：贝叶斯倾向性评分方法研究及其在药品不良反应信号检测中的应用；上海市公共卫生重点学科（815GWZK0901）：循证公共卫生与卫生经济学；上海市卫计委科研课题（201440379）：药品不良反应信号检测中混杂因素控制的倾向性评分方法研究。

Application of Time-to-onset in Drug Safety Surveillance

YAN Xin-yuan^1,2, WANG Yin-cheng^1,2, ZHANG Tian-yi¹, YE Xiao-fei¹, HOU Yong-fang³, WU Gui-zhi³, HE Jia^1,*

¹ Department of Health Statistics, Faculty of Health Service, Second Military Medical University, Shanghai 200433, China;
² Undergraduate Student, Faculty of Health Service, Second Military Medical University, Shanghai 200433, China;
³ Center for Drug Reevaluation,CFDA, Beijing 100045, China

Received:2017-05-17 Revised:2017-08-17 Online:2017-06-20 Published:2017-08-17

摘要/Abstract

摘要： 目的传统的信号检测方法主要基于不相称理论，这些方法主要基于观测与理论频数之比来识别信号。最近有学者最新提出药品不良反应发生时间（TTO）信号检测法，通过药品不良反应发生时间的分布来发现信号，本文对该方法原理及应用现状做一介绍。方法通过文献检索，对TTO的原理、特点、信号检测能力等诸多方面进行回顾与综述。结果既往研究表明TTO 方法在药品不良反应信号检测中发挥了一定的作用，然而TTO 方法在不同数据库中表现效果存在差异。结论 TTO方法可以作为传统不相称测定分析的一种重要补充手段应用于信号检测中。

关键词: 药品不良反应发生时间, 药品不良反应, 信号检测, 不相称测定分析

Abstract: Objective Disproportionality analysis is the main method for signal detection and disproportionality analysis is based on the observed and expected values. Recently, time-to-onset (TTO) has been proposed as an effective tool in the adverse drug reactions surveillance. In this study, we aimed to introduce the principle and application of TTO method. Methods We discussed the theory, characteristic, signal detection performance of TTO method through literature review. Results TTO method has played role in signal detection, however, the performance result differed in different studies. Conclusion TTO method could act as an important complementary tool of disproportionality analysis for signal detection.

Key words: time-to-onset, adverse drug reaction, signal detection, disproportionality analysis

中图分类号:

R994.11

严心远,王胤丞,张天一,叶小飞,侯永芳,吴桂芝,贺佳. 药品不良反应发生时间信号检测法在药品安全性监测中的应用[J]. 中国药物警戒, 2017, 14(6): 350-352.

YAN Xin-yuan, WANG Yin-cheng, ZHANG Tian-yi, YE Xiao-fei, HOU Yong-fang, WU Gui-zhi, HE Jia. Application of Time-to-onset in Drug Safety Surveillance[J]. Chinese Journal of Pharmacovigilance, 2017, 14(6): 350-352.

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药品不良反应发生时间信号检测法在药品安全性监测中的应用

Application of Time-to-onset in Drug Safety Surveillance

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