基于FAERS数据库的阿仑单抗不良事件信号挖掘与分析  

Data mining and analysis of adverse events signals of alemtuzumab based on FAERS database

作　　者：赵尹瑜 谢昊 曹明浩[1,2,3] 陈晨 陈力[1,2] ZHAO Yin-yu;XIE Hao;CAO Ming-hao;CHEN Chen;CHEN Li(Department of Pharmacy/Evidence-Based Pharmacy Center,West China Second Hospital of Sichuan University,Chengdu 610041;Key Laboratory of Birth Defects and Related Disease of Women and Children,Sichuan University,Ministry of Education,Chengdu 610041;School of Pharmacy,West China,Sichuan University,Chengdu 610041)

机构地区：[1]四川大学华西第二医院药学部/循证药学中心,成都610041 [2]出生缺陷与相关妇儿疾病教育部重点实验室,成都610041 [3]四川大学华西药学院,成都610041

出　　处：《中南药学》2021年第8期1706-1710,共5页Central South Pharmacy

基　　金：四川省科技厅项目(No.2019JDR0163)。

摘　　要：目的通过对阿仑单抗不良事件(AEs)进行信号挖掘与分析,为临床合理用药提供依据。方法通过提取美国食品药品监督管理局不良事件报告系统数据库中2016年第一季度至2020年第四季度共20个季度的ASCII数据,采用比例失衡法中的报告比值比法和综合标准法对阿仑单抗AEs报告进行挖掘分析。结果检测到首要怀疑药物为阿仑单抗的AEs报告共10 237份,对数据进行分析处理后得到有效信号930个,主要集中在胃肠系统疾病、各类神经系统的损害、全身性疾病及给药部位各种反应等器官系统分类。结论本研究获得的AEs信号与阿仑单抗说明书和文献研究基本一致,证明本研究的可靠性。在临床应用过程中,应重点进行尿液分析和肌酐监测,防止出现泌尿系统严重的AEs。Objective To provide reference for clinical rational drug use by mining and analyzing the adverse event(AE)signals of alemtuzumab.Methods ASCII data from the first quarter of 2016 to the fourth quarter of 2020 in the US FDA adverse event reporting system database were collected,The report odds ratio and medicines and healthcare products regulatory agency were used to mine and analyze the AE reports.Results Totally 10237 single of AE reports were detected,930 of which were effective signals after data analysis and processing,mainly focusing on gastrointestinal diseases,various nervous system damage,systemic diseases and various reactions of drug delivery sites.Conclusion Common ADR signals and systems involved in this study are consistent with the instructions.In clinical application,we should pay attention to urine analysis and creatinine monitoring to prevent serious AEs of the urinary system.

关 键 词：阿仑单抗 信号挖掘 药物不良事件 

分 类 号：R969.3[医药卫生—药理学]