空军军医大学学报2025，Vol.46Issue(11)：1450-1455,6.DOI:10.13276/j.issn.2097-1656.2025.11.008
基于FAERS的帕博利珠单抗不良事件信号挖掘研究
Data mining of adverse drug event signals for pembrolizumab based on FAERS
摘要
Abstract
Objective To mine and analyze the adverse drug event signals of pembrolizumab,so as to provide reference for safe medication in clinic.Methods Adverse event reports from Q4 2014 to Q4 2022 were extracted from the Food and Drug Administration Adverse Event Reporting System database,and data mining was conducted using reporting odds ratio method and Medicines and Healthcare Products Regulatory Agency method.Results A total of 853 adverse event signals were obtained in the reports of pembrolizumab as the primary suspect drug after screening,and the signals with the highest intensity were immune-mediated hypothyroidism,immune-mediated kidney disease,and immune-mediated gastritis.The top 50 adverse events for signal strength involved a total of 17 systems,including diseases of the hepatobiliary system,endocrine system,and immune system.Conclusion The study finds a variety of adverse event signals not reported by the drug label,such as immune-mediated cystitis,adrenocorticotropic hormone deficiency,and tumour hyperprogression,which can provide references for clinical safe drug use.关键词
比例失衡法/帕博利珠单抗/药品不良事件/信号挖掘Key words
disproportional analysis/pembrolizumab/adverse drug events/signal mining分类
药学引用本文复制引用
崔钰,王素珍,高誉轩,于莉莉..基于FAERS的帕博利珠单抗不良事件信号挖掘研究[J].空军军医大学学报,2025,46(11):1450-1455,6.基金项目
国家自然科学基金面上项目(81872719) （81872719）
潍坊医学院附属医院科技发展项目(2023FYZ015) （2023FYZ015）
