摘要
目的:挖掘和分析艾曲泊帕相关药品不良事件(ADE)信号,为临床安全用药提供参考。方法:应用比值失衡法中的报告比值比法(ROR)和比例报告比值法(PRR),借助在线药物警戒工具OpenVigil,对美国食品药品监督管理局不良事件报告系统(FAERS)数据库中2008年第1季度至2022年第3季度共59个季度的艾曲泊帕相关ADE进行数据挖掘及分析。结果:在FAERS数据库中共收集到艾曲泊帕相关ADE报告8 858份,发现阳性信号共216个。其中,骨髓网状纤维化、网硬蛋白升高、骨髓纤维化、出血、血小板增多症等相关性较高。ADE涉及系统器官分类共22个,主要为各类检查、血管与淋巴管类疾病、恶性及性质不明的肿瘤(包括囊状和息肉状)等。发现了如免疫反应降低、新型冠状病毒感染、肝脏感染、脓毒症、血铁升高、发育不全、眼睛颜色变化、黄疸、听觉减退等多个新的ADE。结论:基于FAERS数据库可对艾曲泊帕上市后的ADE进行全面挖掘分析,其结果能为临床安全用药提供参考。
OBJECTIVE:To explore and analyze the signal of eltrombopag-related adverse drug events(ADE),so as to provide reference for clinical safe drug use.METHODS:Reporting ratio method(ROR)and Ratio reporting ratio method(PRR)in measures of dis-proportionality was used,online pharmacovigilance tool OpenVigil was adopted,data mining and analysis were performed for 59 quarters(from the first quarter of 2008 to the third quarter of 2022)of eltrombopag-related ADE in the Food and Drug Administration Adverse Event Reporting System(FAERS)database.RESULTS:A total of 8858 ADE reports were collected from the FAERS database,and 216 positive signals were found.Among them,bone marrow reticulofibrosis,elevated reticulin,myelofibrosis,hemorrhage and thrombocythemia were highly correlated.ADE involved a total of 22 system organ classifications,mainly for various examinations,vascular and lymphatic diseases,malignant and tumors of undetermined nature(including cystic and polypoid).Several new ADE were identified,such as decreased immune response,COVID-19,liver infection,sepsis,elevated blood iron,hypoplasia,eye color change,jaundice and hearing loss.CONCLUSIONS:Based on FAERS database,the ADE after marketing of eltrombopag can be comprehensively mined and analyzed,and the results can provide reference for clinical safety of drug use.
作者
闫阔
成晓玲
张楠
杨慧鹃
陆红柳
杨啸白
夏文斌
YAN Kuo;CHENG Xiaoling;ZHANG Nan;YANG Huijuan;LU Hongliu;YANG Xiaobai;XIA Wenbin(Dept.of Pharmacy,Beijing Chuiyangliu Hospital,Beijing 100022,China;Dept.of Pharmacy,Beijing Children’s Hospital,Capital Medical University,Beijing 100045,China)
出处
《中国医院用药评价与分析》
2023年第10期1264-1267,1272,共5页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
首都临床特色应用研究项目(No.Z181100001718125)
首都卫生发展科研专项项目(No.首发2022-2Z-2099)。
