基于美国FAERS数据库的艾曲泊帕药品不良事件信号挖掘  

Data mining of adverse drug events signals for eltrombopag based on FAERS database

作　　者：杨琰茗 李惠英[1] 任丹阳[1] 翁稚颖 杨国宁[3] YANG Yanming;LI Huiying;REN Danyang;WENG Zhiying;YANG Guoning(Department of Pharmacy,Kunming Children’s Hospital,Kunming 650000;School of Pharmaceutical Sciences,Kunming Medical University,Kunming 650000;Department of Otolaryngology,Baoshan People’s Hospital,Baoshan Yunnan 678000,China)

机构地区：[1]昆明市儿童医院药剂科,昆明650000 [2]昆明医科大学药学院,昆明650000 [3]保山市人民医院耳鼻喉科,云南保山678000

出　　处：《临床与病理杂志》2023年第12期2125-2132,共8页Journal of Clinical and Pathological Research

摘　　要：目的:艾曲泊帕是一种小分子非肽类促血小板生成素受体激动剂(thrombopoietin receptor agonists,TPORA)。本研究对艾曲泊帕药品不良事件(adverse drug event,ADE)进行信号挖掘,总结相关ADE临床特征和用药风险,为临床安全用药提供参考。方法:基于美国药品食品监督管理局不良事件报告系统(Food and Drug Administration Adverse Event Reporting System,FAERS)数据,运用比值失衡测量法中报告比值比法(reporting odds ratio,ROR)和比例报告比值法(proportional reporting ratio,PRR)对艾曲泊帕的ADE进行数据挖掘。结果:在FAERS数据库中共收集到以艾曲泊帕为首要怀疑药物的报告18135份,共涉及ADE 48640条(1份报告可能涉及多个ADE),阳性信号中以血小板计数降低、死亡、血小板计数升高等较为常见,网硬蛋白升高、骨髓网状纤维化、克隆进化等ADE信号强度较高,与艾曲泊帕的使用具有强相关。结论:临床在使用艾曲泊帕时,应密切关注患者的血小板计数、网硬蛋白、骨髓网状纤维化,保证患者用药的安全性和有效性。Objective:Eltrombopag is a small molecule non-peptide thrombopoietin receptor agonist(TPO-RA).This study aims to mine and analyze the adverse drug event(ADE)signals associated with eltrombopag and summarize the clinical characteristics and medication risks related to these ADEs,providing reference for safe clinical medication.Methods:Based on the US Food and Drug Administration Adverse Event Reporting System(FAERS)database,the reporting odds ratio(ROR)and proportional reporting ratio(PRR)were used to mine ADEs related to eltrombopag.Results:A total of 18135 reports with eltrombopag as the primary suspect drug were collected in the FAERS database,involving 48640 ADEs(one report may involve multiple ADEs).Common ADEs in positive signals included decreased platelet count,death,and elevated platelet count.High-intensity ADE signals such as increased reticular protein,bone marrow reticular fibrosis,and clonal evolution were highly correlated with the use of eltrombopag.Conclusion:The platelet count,reticulin,and bone marrow reticular fibrosis of patients should be closely monitored in the clinical use of eltrombopag to ensure the safety and effectiveness of the drug.

关 键 词：艾曲泊帕 药品不良反应 美国食品药品监督管理局不良事件报告系统 信号挖掘 

分 类 号：R95[医药卫生—药学]