空军军医大学学报2025，Vol.46Issue(11)：1456-1464,9.DOI:10.13276/j.issn.2097-1656.2025.11.009
艾曲波帕安全性评估:来自FAERS数据库的真实世界不良事件分析
Safety assessment of eltrombopag:real-world adverse event analysis from the FAERS database
摘要
Abstract
Objective To detect and analyze the signals of spontaneously reported adverse drug events(ADE)in the post-marketing clinical application of eltrombopag by data mining technology,so as to deepen the systematic understanding of the safety characteristics of eltrombopag.Methods This study conducted a systematic search of the Food and Drug Administration Adverse Event Reporting System database operated by the US Food and Drug Administration from the date of entry(December 31,2008)to June 30,2024.After standardizing the data,four non-proportional methods,namely reporting odds ratio(ROR),proportional reporting ratio,Bayesian confidence propagation neural network and multi-item gamma Poisson shrinker,were used to evaluate the correlation between eltrombopag and ADE,and Weibull shape parameter was used to analyze the characteristics of the onset time curve to explore the ADE signals of eltrombopag.Results There were 17 230 ADE reports of eltrombopag.A total of 182 preferred terms(PT)showed significant disproportionality across all four algorithms and seven system organ classes(SOC)showed significant disproportionality across any four algorithms.SOC disproportionate analysis found that"general disorders and administration site conditions"were significant and ranked first in the total number of ADE cases(n=8 985,ROR=1.28).PT analysis revealed high-intensity ADE signals associated with eltrombopag,such as decreased platelet count and elevated platelet count.Some ADE signals were found to be highly consistent when compared with drug instructions and Side Effect Resource databases,while some new ADE signals were also found.Conclusion More attention should be paid to the risks of"thrombocytopenia"and"anemia"when taking eltrombopag.At the same time,we should also be alert to cerebral infarction and myocardial infarction events caused by thrombosis due to increased platelets,as well as ADE signals not mentioned in the instructions,such as"antiphospholipid syndrome"and"increased reticulocyte count",to ensure the medication safety of patients.关键词
艾曲波帕/FAERS数据库/不良事件信号/不成比例分析/真实世界研究/免疫性血小板减少症Key words
eltrombopag/FAERS database/adverse event signal/disproportionate analysis/real-world research/immune thrombocytopenia分类
医药卫生引用本文复制引用
刘婕,陈抒鹏,高姚,章美玲,伍振辉,曾英坚..艾曲波帕安全性评估:来自FAERS数据库的真实世界不良事件分析[J].空军军医大学学报,2025,46(11):1456-1464,9.基金项目
国家自然科学基金(82260914) （82260914）
江西省自然科学基金面上项目(20192BAB205100) （20192BAB205100）
江西省中医药管理局中医优势病种培育项目(赣财社指[2023]70) （赣财社指[2023]70）
江西中医药大学大学生创新创业训练计划项目(202410412256) （202410412256）
