基于FAERS的氢氯噻嗪相关非黑色素瘤皮肤癌事件数据挖掘研究  

Data Mining of Hydrochlorothiazide Related Adverse Events of Non-Melanoma Skin Cancer Based on FAERS

作　　者：陈韵西 张恩娟 CHEN Yunxi;ZHANG Enjuan(Department of Pharmacology,Guiqian International General Hospital,Guiyang,Guizhou 550001,China)

机构地区：[1]贵黔国际总医院药学部,贵州贵阳550001

出　　处：《中国药业》2021年第4期81-84,共4页China Pharmaceuticals

基　　金：贵州省卫生健康委科学技术基金[gzwjkj2020-1-208]。

摘　　要：目的为临床安全使用氢氯噻嗪类药物提供参考。方法下载美国食品和药物管理局(FDA)不良事件报告系统(FAERS)2004年至2018年共60个季度的数据,经过MedEx药品名称标准、MedDRA不良事件系统分类等数据清洗后,提取氢氯噻嗪不良事件数据,采用报告比值比法(ROR)和比例报告比值法(PRR)进行信号检测。结果共提取到氢氯噻嗪不良事件报告记录139002条,氢氯噻嗪相关非黑色素瘤皮肤癌事件报告509条(0.37%),其中,基底细胞癌的ROR=2.24,PRR=2.24;皮肤癌的ROR=2.05,PRR=2.05;鲍温病的ROR=2.24,PRR=2.24;角化棘皮瘤的ROR=3.34,PRR=3.34;皮肤原位癌的ROR=3.11,PRR=3.11。结论应重视氢氯噻嗪潜在非黑色素瘤皮肤癌的风险,长期使用该药的患者或高风险人群建议定期检查。Objective To provide a reference for clinical safety of hydrochlorothiazide.Methods Totally 60 quarters of the US Food and Drug Administration(FDA)adverse event reporting system(FAERS)data(from 2004 to 2018)were downloaded,and hydrochlorothiazide-induced adverse event data were extracted after data cleaning such as drug name standardization by MedEx and systematic classification of adverse events by MedDRA,then the report ratio method(ROR)and ratio report ratio method(PRR)were used for signal detection.Results A total of 139002 adverse event case reports of hydrochlorothiazide were extracted,and 509 cases(0.37%)of hydrochlorothiazide related non-melanoma skin cancer(NMSC)events were reported.The ROR and PRR were 2.24 and 2.24 for basal cell carcinoma,2.05 and 2.05 for skin cancer,2.24 and 2.24 for Bowen’s disease,3.34 and 3.34 for keratoacanthoma and 3.11 and3.11 for carcinoma in situ.Conclusion The potential risk of hydrochlorothiazide for NMSC should be taken into account and regular screening should be performed in patients who have been using hydrochlorothiazide for a long time or in high-risk population.

关 键 词：氢氯噻嗪 非黑色素瘤皮肤癌 不良事件 数据挖掘 美国食品和药物管理局不良事件报告系统 

分 类 号：R969.4[医药卫生—药理学] R983.1[医药卫生—药学]