基于FAERS数据库的肾上腺色腙安全信号挖掘与分析  

A Real-World Study Leveraging US FAERS System of Carbazochrome

作　　者：马小磊[1] 李轶凡[1] 冯欣[1] MA Xiao-lei;LI Yi-fan;FENG Xin(Beijing Obstetrics and Gynecology Hospital,Capital Medical University/Beijing Maternal and Child Health Care Hospital,Beijing 100026,China)

机构地区：[1]首都医科大学附属北京妇产医院/北京妇幼保健院,北京100026

出　　处：《中国药学杂志》2022年第12期981-985,共5页Chinese Pharmaceutical Journal

基　　金：北京市医院管理中心临床医学发展专项经费资助(ZYLX202119)。

摘　　要：目的挖掘美国食品药品监督管理局不良事件呈报系统(FAERS)数据库中肾上腺色腙上市后安全警戒信号,探讨其潜在的不良反应,为临床安全用药提供参考。方法采用比例失衡分析法中的报告比值比法(ROR)和比例报告比值比法(PRR)同时检测信号。检索FAERS数据库中2014年1季度至2020年4季度数据进行数据挖掘分析。结果1829份不良事件(ADE)报告中,经ROR法和PRR法共得到肾上腺色腙ADE信号620个,排除用药错误和无法判断的ADE信号(例如产品问题,良性、恶性及性质不明的肿瘤),最终得到ADE信号214个,其中95.34%的ADE说明书中未提及。共累及15个系统器官,报告例数最多的前5项系统器官分类(SOC)分别为感染及侵染类疾病(51例)、全身性疾病及给药部位各种反应(40例)、各类损伤、中毒及操作并发症(20例)、各种肌肉骨骼及结缔组织疾病(18例)、呼吸系统、胸及纵隔疾病(18例)。其中检测出信号最强的5个ADE分别为左心室衰竭、玻璃体出血、龈炎、胃肠感染、椎体压缩骨折。结论目前上市药品说明书中对其药物不良反应表述较少,与FAERS中真实世界数据所反映情况相差较大,且目前该药品临床应用较为广泛,同时较新的临床研究较少,本研究旨在提示临床应用肾上腺色腙时应充分关注其左心室衰竭、玻璃体出血等不良反应的发生,药师在患者用药前应对患者进行充分的用药教育,建议相关生产企业对肾上腺色腙片剂的说明书信息进行核实同时进行相应的临床试验与观察积累临床资料及时修订药品说明书保障临床用药安全。OBJECTIVE Based on the U.S.food and drug administration′s adverse event reporting system(FAERS)database,mining adrenal hydrazone post-marketing safety warning signals to provide references for clinical safe medication.METHODS Reporting odds ratio(ROR)and proportional reporting ratios(PRR)were used for risk signal detection.The data from the first quarter of 2014 to the fourth quarter of 2020 in the FAERS database for data mining were analyzed.RESULTS The FAERS database contains 1829 related ADE reports and 620 signals,excluding medication errors and unjudgeable ADE signals,and finally 214 ADE signals are obtained,of which 95.34%of the ADE instructions are not mentioned.A total of 15 SOCs are involved,and the top five SOCs with the largest number of reported cases are infection and infective diseases(51 cases),systemic diseases and various reactions at the site of administration(40 cases),various injuries,poisoning and manipulation complications(20 cases),various musculoskeletal and connective tissue diseases(18 cases),respiratory system,chest and mediastinal diseases(18 cases).The five ADEs with the strongest signals were left ventricular failure,vitreous hemorrhage,gingivitis,gastrointestinal infection,and vertebral compression fracture.CONCLUSION At this stage,there are few expressions of adverse drug reactions in the drug inserts,which are quite different from the real-world data in FAERS.At present,the drug is widely used in clinical applications,and there are few newer clinical studies.This study aims to prompt clinical trials.When applying carbazochrome,full attention should be paid to the occurrence of adverse reactions such as left ventricular failure and vitreous hemorrhage.The pharmacist should give the patient sufficient medication education before taking the drug.It is recommended that relevant manufacturers verify the information on the instructions of carbazochrome tablets at the same time carry out corresponding clinical trials and observations to accumulate clinical data and timely revise the dr

关 键 词：肾上腺色腙 不良事件报告 美国食品药品监督管理局不良事件呈报系统 数据挖掘 

分 类 号：R95[医药卫生—药学]