中文摘要：

目的：检测口服盐酸特比萘芬引起听力障碍的药品不良反应信号。方法：AERS-DM是对美国不良反应报告系统AERS数据进行去重、标准化与知识聚合的不良反应数据库,本研究在AERS-DM中进行数据挖掘,计算不良反应信号比例报告比值比（proportional ADR reporting ratio,PRR）和报告比值比（reporting odds ratio,ROR）。PRR的判定标准为：当药物引起不良反应例数〉3,PRR≥2,四格表χ^2≥4,则提示生成不良反应信号。ROR的判定标准为：当ROR95%可信区间下限〉1则提示生成不良反应信号。结果：检测到PRR和ROR不良反应信号。PRR=3.77〉2,χ^2=20.39〉4,药物引起不良反应例数〉3,提示生成不良反应信号;ROR=3.78,ROR的95%可信区间（2.03,7.03）,下限〉1,提示生成不良反应信号。结论：基于AERS-DM数据检测不良反应信号结果表明口服盐酸特比萘芬与听力障碍具有相关性。

英文摘要：

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 data. This study used the method of proportional reporting ratio,reporting odds ratio for data mining. Using the PRR,a signal is detected if the number of co-occurrences is 3 or more and the PRR is 2 or more with an associated χ~2value 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 adverse event signals PRR and ROR are detected. The PRR = 3. 77 〉2,χ~2= 20. 39 〉 4,the number of co-occurrences is more than3,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.