中国药物评价2016,Vol.33Issue(1):51-54,4.
口服盐酸特比萘芬与听力障碍相关性数据挖掘研究
Data Mining of Association between Oral Terbinafine Hydrochloride and Hearing Impairment
摘要
Abstract
Objective: To detect the adverse event signal between oral terbinafine hydrochloride and hearing impairment.Methods:AERS-DM is a knowledge-aggregated database of the adverse events after de-duplicating, normalizing the FDA AERS da-ta.This study used the method of proportional reporting ratio, reporting odds ratio for data mining.Using the PRR, a signal is de-tected if the number of co-occurrences is 3 or more and the PRR is 2 or more with an associated χ2 value of 4 or more.For the ROR, a signal is detected, if the lower limit of the 95% two-sided confidence interval exceeds 1.Results: The result shows ad-verse event signals PRR and ROR are detected.The PRR=3.77>2,χ2 =20.39 >4,the number of co-occurrences is more than 3, a signal is detected.The ROR=3.78, the 95% two-sided confidence interval is (2.03,7.03), the lower limit exceeds 1, a signal is detected.Conclusion:The result shows there is association between oral terbinafine hydrochloride and hearing impairment in AERS-DM by detecting the adverse event signal.关键词
盐酸特比萘芬/听力障碍/AERS-DM/不良反应信号/数据挖掘Key words
Terbinafine hydrochloride/Hearing impairment/AERS-DM/Adverse reactions signal/Data mining分类
医药卫生引用本文复制引用
李梅,曹玉莹,王丽伟..口服盐酸特比萘芬与听力障碍相关性数据挖掘研究[J].中国药物评价,2016,33(1):51-54,4.基金项目
吉林省教育厅“十二五”社会科学研究项目(项目编号吉教科文合字[2014]第 B020号);吉林大学基本科研业务费项目 ()