Utilization of chi-square statistics for screening adverse drug-drug interactions in spontaneous reporting systems
Utilization of chi-square statistics for screening adverse drug-drug interactions in spontaneous reporting systems
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DOI：
10.1007/s00228-017-2233-3
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发表时间：
2017-06-01
影响因子：
2.9
通讯作者：
Hirakawa, Akihiro
中科院分区：
文献类型：
--
作者：
Gosho, Masahiko;Maruo, Kazushi;Hirakawa, Akihiro
目的提出一种统计学标准来检测自发报告系统中引起药物不良反应的药物相互作用，方法通过卡方统计定量测量观察到的不良事件数与预期的不良事件数之间的差异。我们比较了我们的方法与Nor，n等人的性能。（Stat Med 2008; 27（16）：3057-3070）进行了模拟研究。结果当两种药物的组合的事件数等于或小于2时，我们的方法的假阳性率范围为0.01 - 0.08，而Nor，n的方法范围为0.01 ~ 0.06。我们的方法的灵敏度范围从0.09到0.29，而Nor，n的方法的灵敏度范围从0.03到0.24。无论模拟设置如何，我们的方法的受试者工作特征曲线下的面积都显著大于Nor，n方法。所提出的方法也适用于食品和药物管理局不良事件报告系统数据库，和一个公认的药物相互作用detected.Conslusions建议的标准控制假阳性在一个可接受的水平，并有更高的灵敏度比，也没有，n的方法时，事件是罕见的。
Purpose We proposed a statistical criterion to detect drug-drug interactions causing adverse drug reactions in spontaneous reporting systems.Methods The used criterion quantitatively measures the discrepancy between the observed and expected number of adverse events via chi-square statistics. We compared the performance of our method with that of Nor,n et al. (Stat Med 2008; 27 (16): 3057-3070) through a simulation study.Results When the number of events for a combination of two drugs was equal to or lower than two, the false positive rate for our method ranged from 0.01 to 0.08, whereas the rate for Nor,n's method ranged from 0.01 to 0.06. The sensitivity for our method ranged from 0.09 to 0.29, whereas the sensitivity for Nor,n's method ranged from 0.03 to 0.24. The area-under-the-receiver operating characteristic curve for our method was significantly larger than that for Nor,n's methods regardless of simulation settings. The proposed method was also applied to the Food and Drug Administration Adverse Event Reporting System database, and a recognized drug-drug interaction was detected.Conslusions The proposed criterion controlled false positives at an acceptable level and had higher sensitivity than that of Nor,n's method had when events were rare.