基于FAERS数据库的艾曲泊帕相关药品不良事件的分析研究  

Analysis of Adverse Drug Events of Eltrombopag Based on FAERS Database

作　　者：闫阔 成晓玲[2] 张楠[1] 杨慧鹃 陆红柳[1] 杨啸白[1] 夏文斌[1] 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)

机构地区：[1]北京市垂杨柳医院药剂科,北京100022 [2]首都医科大学附属北京儿童医院药学部,北京100045

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)。

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.

关 键 词：艾曲波帕 药品不良事件 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：R969.3[医药卫生—药理学] R973[医药卫生—药学]