基于FAERS数据库的苯二氮[艹卓]类药物的不良反应分析

Adverse reactions of benzodiazepines based on FAERS database

目的 利用美国食品药品监督管理局(FDA)不良事件报告系统(FDA adverse event reporting system, FAERS)数据库2004年3月1日至2020年9月30日的数据,挖掘与使用苯二氮[艹卓]类药物相关的潜在信号,并对劳拉西泮进行二次筛选分析,从而更好地指导该类药物的科学合理使用。方法 利用频数法,通过计算校正的卡方值(χ^(2)_(Yates))、PRR和ROR的95%置信区间的下限(ROR_(025))挖掘与苯二氮[艹卓]类药物相关的信号。结果 与阿普唑仑、氯巴占、氯硝西泮、二钾氯氮、地西泮、艾司唑仑、氟西泮、劳拉西泮、奥沙西泮、夸西泮、替马西泮、三唑仑相关的信号数分别为1 345、582、1 532、430、1430、216、312、1 699、618、98、1 027、330个,其中劳拉西泮经二次筛选分析得到的信号数为58个。结论通过该研究,发现与各苯二氮[艹卓]类药物相关的信号位居前10位的事件大多已在药品说明书中载明,然而经二次筛选的劳拉西泮的相关信号较多尚未在药品说明书中载明,提示在劳拉西泮的用药中应对此类信号予以格外关注。

Objective To analyze benzodiazepines-related signals based on the data(1Mar2004-30Sep2020) from the Food and Drug Administration Adverse Event Reporting System(FAERS), and to screen lorazepam a second time in order to contribute to rational use of the drug. Methods Using the frequency method, benzodiazepines-related signals were mined via the Chi-Squared test with Yates’ correction(χ^(2)_(Yates)), proportional reporting ratio(PRR) and the lower limit of the 95%confidence interval of the reporting odds ratio(ROR_(025)). Results The number of signals related to alprazolam, clobazam,clonazepam, clorazepate, diazepam, estazolam, flurazepam, lorazepam, oxazepam, quazepam, temazepam and triazolam was 1 345, 582, 1 532, 430, 1 430, 216, 312, 1 699, 618, 98, 1 027 and 330, respectively. Fifty-eight signals were obtained by the second analysis of lorazepam. Conclusion Most of the top 10 benzodiazepine-related signals have been described in drug labels, but most of the lorazepam-related signals mined in the second analysis have not been described in drug labels,so more attention should be paid to such signals in the subsequent use of lorazepam to reduce the side effects of the drug.