Data mining for adverse events signal of linezolid based on FAERS database
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 26 075 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=1 904.92],sideroblastic anemia(ROR 95％CI lower limit=515.20,PRR=1108.32)and mediastinal effusion(ROR 95％CI lower limit=369.74,PRR=1 904.92).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.
NETL
NSTL
万方数据
