药品不良反应信号的验证和统计分析研究方法的探索————基于克林霉素注射剂致肾毒性的不良反应监测数据

中国药物警戒 ›› 2013, Vol. 10 ›› Issue (4): 222-227.

药品不良反应信号的验证和统计分析研究方法的探索————基于克林霉素注射剂致肾毒性的不良反应监测数据

路长飞,田春华^2*,田月洁¹,刘翠丽²,谢彦军¹

1.山东省药品不良反应监测中心,山东济南250013；
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:2016-03-09 修回日期:2016-03-09 出版日期:2013-04-08 发布日期:2016-03-09
通讯作者: 田春华,女,副主任药师,药品不良反应监测。 E-mail: tianchunhua@cdr.gov.cn
作者简介:路长飞,男,药师,药品不良反应监测与评价。

Exploration on Adverse Drug Reaction Signal Detection, Validation and Statistics Analysis Methods: Based on the Clindamycin Injection's Renal Toxicity Adverse Reaction Monitoring Data.

LU Chang-fei¹, TIAN Chun-hua^2* ,TIAN Yue-jie¹, LIU Cui-li² ,XIE Yan-jun¹

1.Shandong Centre for ADR Monitoring, Shandong Jinan 250013, China;
2.Centre for Drug Reevaluation, SFDA, Beijing 100045, China

Received:2016-03-09 Revised:2016-03-09 Online:2013-04-08 Published:2016-03-09

摘要/Abstract

摘要： 目的探索自愿报告药品不良反应信号的提取、验证及分析研究方法和模式。方法利用比例失衡法和单因素分析方法,对国家药品不良反应数据库中有关克林霉素注射剂肾毒性的不良反应数据,进行信号的提取、验证和分析。结果克林霉素注射剂致肾损害的ROR值为65.0,盐酸盐和磷酸酯致肾损害的ROR 值分别为114.0、14.7；调整年龄、单次给药剂量后,盐酸克林霉素注射剂致肾损害的风险分别是克林霉素磷酸酯注射剂的6.6 倍和5.5 倍（ P<0.001）；药品不良反应评价流程包括药品不良反应信号的提取、药品不良反应信号的验证、药品不良反应信号的分析研究3个流程。结论克林霉素注射剂与肾毒性不良反应存在关联性,盐酸克林霉素注射剂致肾损害风险高于克林霉素磷酸酯注射剂,但其机制仍需要进一步研究分析；综合运用数据挖掘和统计方法,可在药品不良反应信号提取、验证和分析研究中提供更有利的证据。

关键词: 克林霉素, 不良反应, 信号, 挖掘, 统计

Abstract: Objective To establish the model of adverse drug reaction signal detection, validation and statistics analysis methods. Methods Using the measures of disproportionality and stratified analysis to establish the model of adverse drug reaction signal detection, validation and analysis research by the clindamycin injection's renal toxicity adverse reaction monitoring data. Results The ROR of clindamycin injection, clindamycin hydrochloride injection and clindamycin phosphate injection were 65.0, 114.0 and 14.7, respectively. The risks of renal damage of clindamycin hydrochloride injection were 6.6 times and 5.5 times than clindamycin phosphate injection after adjusting the age and single drug dose( P<0.001). It has been successfully established the model of adverse drug reaction signal detection, validation and analysis research. Conclusion There is strong relevance between clindamycin and renal toxicity adverse reaction, and the risk of renal damage of clindamycin hydrochloride injection was higher than clindamycin phosphate injection, but more researches are needed to verify it. The integrated use of data mining and statistics Methods can make more favorable evidence for adverse drug reaction signal detection, validation and analysis research.

Key words: clindamycin, adverse reaction, signal, mining, statistics

中图分类号:

R954

路长飞,田春华,田月洁,刘翠丽,谢彦军 . 药品不良反应信号的验证和统计分析研究方法的探索————基于克林霉素注射剂致肾毒性的不良反应监测数据[J]. 中国药物警戒, 2013, 10(4): 222-227.

LU Chang-fei, TIAN Chun-hua ,TIAN Yue-jie, LIU Cui-li ,XIE Yan-jun . Exploration on Adverse Drug Reaction Signal Detection, Validation and Statistics Analysis Methods: Based on the Clindamycin Injection's Renal Toxicity Adverse Reaction Monitoring Data. [J]. Chinese Journal of Pharmacovigilance, 2013, 10(4): 222-227.

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