基于FAERS数据库的利奈唑胺不良事件信号挖掘

Data mining for adverse events signal of linezolid based on FAERS database

目的了解利奈唑胺在真实世界中的药物不良事件发生情况,并评估利奈唑胺的用药安全性,基于美国FDA不良事件自发呈报系统(FDA adverse event reporting system,FAERS)数据库的数据对利奈唑胺不良事件信号进行挖掘,为临床药物治疗监测提供参考。方法从FAERS数据库中筛选2018年第1季度至2023年第3季度共23个季度的利奈唑胺不良事件报告数据,完成数据清洗后使用报告比值比(reporting odds ratio,ROR)法和英国药品和健康产品管理局(Medicines and Healthcare Products Regulatory Agency,MHRA)综合法进行不良事件信号挖掘,以ROR值和比例报告比值(proportional reporting ratio,PRR)衡量不良事件的相关性。结果获得以利奈唑胺为首要怀疑药物的不良事件报告26075例次,挖掘出不良事件信号619个。利奈唑胺不良事件信号涉及全身性疾病及给药部位各种反应、感染及侵染类疾病、血液和淋巴系统疾病以及各类检查。结果发现,信号较强的不良事件为最低抑菌浓度[ROR 95%置信区间(confidence interval,CI)下限=598.04,PRR=1904.92]、铁粒幼红细胞性贫血(ROR 95%CI下限=515.20,PRR=1108.32)及纵隔积液(ROR 95%CI下限=369.74,PRR=1904.92),同时也挖掘出毛舌(ROR 95%CI下限=97.39,PRR=144.43)、脉络膜炎(ROR 95%CI下限=200.02,PRR=306.90)及门静脉海绵样变性(ROR 95%CI下限=180.90,PRR=507.98)等在说明书中未提到的不良事件信号。结论利奈唑胺在临床使用过程中需密切监测治疗效果不佳、血液系统相关的不良事件/反应,本研究结果亦提醒医务人员在药物治疗监测过程中应关注信号值较强的不良事件新信号,保障临床用药的安全性及有效性。

Objective To understand the occurrence of adverse events of linezolid in the real world and evaluate its medication safety,and mine adverse event signals of linezolid based on the data from the FDA Adverse Event Reporting System(FAERS)database,to provide reference for clinical drug treatment monitoring.Methods A total of 23 quarters of linezolid adverse event report data from the first quarter of 2018 to the third quarter of 2023 were screened from the FAERS database.After data cleaning,Medicines and Healthcare Products Regulatory Agency(MHRA)comprehensive method.The correlation of adverse events was measured using ROR values and proportional reporting ratio(PRR).Results A total of 26075 adverse event reports with linezolid as the primary suspected drug were obtained,and 619 adverse event signals were mined.The adverse event signals of linezolid involved systemic diseases and reactions at the administration site,infections and infectious diseases,the blood and lymphatic system diseases,and various examinations.Adverse events with strong signals were found to be minimum inhibitory concentration[ROR 95% confidence interval(CI)lower limit=598.04,PRR=1904.92],sideroblastic anemia(ROR 95%CI lower limit=515.20,PRR=1108.32)and mediastinal effusion(ROR 95%CI lower limit=369.74,PRR=1904.92).At the same time,adverse event signals such as trichoglossia(ROR 95%CI lower limit=97.39,PRR=144.43),choroiditis(ROR 95%CI lower limit=200.02,PRR=306.90)and cavernous transformation of portal vein(ROR 95%CI lower limit=180.90,PRR=507.98)were also identified that were not mentioned in the instructions.Conclusion Linezolid needs to be closely monitored for poor treatment efficacy and adverse events/reactions related to the blood system during clinical use.The results of this study also remind medical personnel to pay attention to new adverse event signals with strong signal values during drug treatment monitoring to ensure the safety and effectiveness of clinical medication.