临床与病理杂志2023，Vol.43Issue(12)：2125-2132,8.DOI:10.11817/j.issn.2095-6959.2023.230362
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
杨琰茗 1李惠英 1任丹阳 1翁稚颖 2杨国宁3
作者信息
- 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
- 折叠
摘要
Abstract
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 18 135 reports with eltrombopag as the primary suspect drug were collected in the FAERS database,involving 48 640 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Key words
eltrombopag/adverse drug event/U.S.Food and Drug Administration Adverse Event Reporting System/signal mining引用本文复制引用
杨琰茗,李惠英,任丹阳,翁稚颖,杨国宁..基于美国FAERS数据库的艾曲泊帕药品不良事件信号挖掘[J].临床与病理杂志,2023,43(12):2125-2132,8.
