常用药品不良反应信号检测方法比较研究

中国药物警戒 ›› 2011, Vol. 8 ›› Issue (6): 356-359.

常用药品不良反应信号检测方法比较研究

任经天^1,2, 王胜锋¹, 侯永芳², 杜晓曦², 李立明¹

1. 北京大学公共卫生学院流行病与卫生统计,北京 100191;
2. 国家食品药品监督管理局药品评价中心,北京 100045

收稿日期:2015-08-27 修回日期:2015-08-27 出版日期:2011-06-10 发布日期:2015-08-27
通讯作者: 李立明,男,教授,博士生导师,流行病学。E-mail:lmlee@vip.163.com;杜晓曦,女,研究员,药品评价与药品不良反应监测。E-mail:duxiaoxi@cdr.gov.cn
作者简介:任经天,男,副研究员,在读博士研究生,药品再评价与药品风险管理。

Comparative Study on the Common Signal Detection Methods of Adverse Drug Reaction

REN Jing-tian^1,2, WANG Sheng-feng¹, HOU Yong-fang², DU Xiao-xi², LI Li-ming¹

1. Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Center, Beijing 100191, China;
2. Center for Drug Reevaluation, SFDA, Beijing 100045, China

Received:2015-08-27 Revised:2015-08-27 Online:2011-06-10 Published:2015-08-27

摘要/Abstract

摘要： 通过对报告比值比、比例报告比、信息成分法、（多项）伽玛泊松分布缩减法4种常用药品不良反应信号检测方法进行了分析比较,提出在我国开展信号检测研究的建议。

关键词: 药品不良反应, 信号检测, 比较研究

Abstract: This paper aims to put forward some suggestions for signal detection research in China via comparative study on the common used signal detection Methods, such as the Reporting Odd Ratio, Proportional Reporting Ratio, Information Component and Gamma-Poisson Shrinker.

Key words: adverse drug reaction(ADR), signal detection, comparative study

中图分类号:

R954

任经天, 王胜锋, 侯永芳, 杜晓曦, 李立明. 常用药品不良反应信号检测方法比较研究[J]. 中国药物警戒, 2011, 8(6): 356-359.

REN Jing-tian, WANG Sheng-feng, HOU Yong-fang, DU Xiao-xi, LI Li-ming. Comparative Study on the Common Signal Detection Methods of Adverse Drug Reaction[J]. Chinese Journal of Pharmacovigilance, 2011, 8(6): 356-359.

参考文献

[1] Matsushita, Y, Y. Kuroda, S. Niwa, et al. Criteria revision and performance comparison of three methods of signal detection applied to the spontaneous reporting database of a pharmaceutical manufacturer[J]. Drug Saf,2007, 30(8):715-726.
[2] van Puijenbroek, E.P., A. Bate, H.G. Leufkens, et al. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions[J]. Pharmacoepidemiol Drug Saf,2002, 11(1): 3-10.
[3] Kubota, K, D. Koide T. Hirai. Comparison of data mining metho-dologies using Japanese spontaneous reports[J]. Pharmacoep-idemiol Drug Saf,2004,13(6): 387-394.
[4] Stahl, M, M. Lindquist, I.R. Edwards, et al. Introducing triage logic as a new strategy for the detection of signals in the WHO Drug Monitoring Database[J]. Pharmacoepidemiol Drug Saf, 2004,13(6):355-363.
[5] Roux, E, F Thiessard, A. Fourrier, et al. Evaluation of statistical association measures for the automatic signal generation in pharmacovigilance[J]. IEEE Transactions On Information Technology In Biomedicine:A Publication Of The IEEE Engineering In Medicine And Biology Society,2005, 9(4): 518-527.
[6] Almenoff, J , J M Tonning, A L Gould, et al. Perspectives on the use of data mining in pharmacovigilance[J]. Drug Saf,2005,28(11): 981-1007.
[7] Rothman, K J, S Lanes,S T Sacks. The reporting odds ratio and its advantages over the proportional reporting ratio[J]. Pharmacoe-pidemiol Drug Saf, 2004,13(8): 519-523.
[8] van der Heijden P G, E P van Puijenbroek. On the assessment of adverse drug reactions from spontaneous reporting systems: the influence of under-reporting on odds ratios[J]. Stat Med, 2002,21(14): 2027-2044.
[9] Ye, X Z Fu, H Wang, et al. A computerized system for signal detection in spontaneous reporting system of Shanghai China[J]. Pharmacoepidemiol Drug Saf, 2009,18(2):154-158.
[10] FDA. Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment[EB/OL].2010-01-27[2011-03-01].http://www.fda.gov/downloads/RegulatoryInforma-tion/Guidances/UCM126834.pdf:
[11] Almenoff, J S, K K La Croix, et al. Comparative performance of two quantitative safety signalling methods: implications for use in a pharmacovigilance department[J]. Drug Saf,2006,29(10):875-887.
[12] Hauben, M, S. Horn,L Reich. Potential use of data-mining algorithms for the detection of 'surprise' adverse drug reactions[J]. Drug Saf,2007,30(2):143-155.
[13] Hochberg, A M, M Hauben, R K Pearson, etal. An evaluation of three signal-detection algorithms using a highly inclusive reference event database[J]. Drug Saf, 2009,32(6):509-525.
[14] Cesana, M, R Cerutti, E Grossi, etal. Bayesian data mining techniques: the evidence provided by signals detected in single-company spontaneous reports databases[J]. Drug Inf J,2007, 41(1):11-21.
[15] 李婵娟, 王素珍, 王陵, 等. 基于模拟数据库的药品不良反应信号检测方法比较[J]. 中国卫生统计,2009,02:124-127.
[16] Li, C, J Xia, J Deng, et al. A comparison of measures of disproportionality for signal detection on adverse drug reaction spontaneous reporting database of Guangdong province in China[J]. Pharmac-oepidemiol Drug Saf, 2008,17(6): 593-600.
[17] van Puijenbroek, E, W Diemont,K van Grootheest. Application of quantitative signal detection in the Dutch spontaneous reporting system for adverse drug reactions[J]. Drug Saf, 2003, 26(5): 293-301.
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