基于FAERS数据库的利司那肽不良事件信号挖掘与分析  

Signals mining and analysis of adverse drug events of lixisenatide based on FAERS database

作　　者：戴金琳 刘岩 杨天绎 李皎月 黄子凡 罗云鹏 李萍[1] 赵琦瑶 张力[4] 杨晓晖[1] DAI Jinlin;LIU Yan;YANG Tianyi;LI Jiaoyue;HUANG Zifan;LUO Yunpeng;LI Ping;ZHAO Qiyao;ZHANG Li;YANG Xiaohui(Department of Nephrology and Endocrinology,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China;Key Laboratory of Chinese Internal Medicine of Ministry of Education,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China;Rutgers University,New Brunswick,New Jersey 08901,USA;Department of Scientific Research,Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100078,China)

机构地区：[1]北京中医药大学东直门医院肾病内分泌科,北京100700 [2]北京中医药大学东直门医院中医内科学教育部重点实验室,北京100700 [3]美国罗格斯大学,美国新泽西州新布朗斯维克08901 [4]北京中医药大学东方医院科研处,北京100078

出　　处：《药物流行病学杂志》2024年第12期1325-1335,共11页Chinese Journal of Pharmacoepidemiology

基　　金：国家自然科学基金面上项目(81974541)。

摘　　要：目的挖掘利司那肽上市后的不良事件(ADE)信号,为临床安全用药提供指导。方法利用报告比值比法和贝叶斯置信区间递进神经网络法,对美国食品药品管理局(FDA)不良事件报告系统(FAERS)数据库中2013年第1季度至2024年第2季度的利司那肽ADE报告数据进行挖掘与信号检测。结果经数据清理后,共收集到5162份以利司那肽为首要怀疑药品的ADE报告,两种统计分析方法共识别出85个ADE信号,涉及14个系统/器官分类,ADE信号主要集中在损伤、中毒及操作并发症(25.88%),各类检查(14.12%),全身性疾病及给药部位各种反应(14.12%),胃肠系统疾病(9.41%),各类神经系统疾病(5.88%)。胰腺炎、视觉损害、色盲等28个ADE信号未被药品说明书记载。结论使用利司那肽时,除了需注意低血糖、胃肠道和神经系统反应等胰高血糖素样肽-1受体激动剂常见的ADE,还应关注胰腺相关疾病、眼器官疾病等潜在的ADE,以确保安全用药。Objective To investigate post-marketing adverse drug event(ADE)signals associated with lixisenatide,and to provide guidance for safe clinical use.Methods The ADE reporting data of lixisenatide ADE were mined and the signals were detected from the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database from the first quarter 2013 to the second quarter 2024 using the reporting odds ratio(ROR)method and Bayesian confidence propagation neural network(BCPNN)method.Results After data cleaning,a total of 5162 ADE reports with lixisenatide as the primary suspected drug were collected.The 85 ADE signals identified by the two statistical analysis methods,affected 14 system-organ classes(SOC).They were primarily concentrated in injuries,poisonings,and procedural complications(25.88%),various examinations(14.12%),systemic diseases and reactions at administration sites(14.12%),gastrointestinal diseases(9.41%),and various neurological diseases(5.88%).There were 28 ADE signals such as pancreatitis,visual impairment,and color blindness,that were not included in the drug instructions.Conclusion In addition to monitoring for common ADE associated with GLP-1 receptor agonists such as hypoglycemia,gastrointestinal,and neurological effects,clinicians should also be vigilant for underlying ADE like pancreatic-related diseases,eye toxicity reaction when using lixisenatide to ensure safe and rational medication use.

关 键 词：利司那肽 胰高血糖素样肽-1受体激动剂 药品不良事件 FAERS数据库 信号挖掘 药物警戒 

分 类 号：R969[医药卫生—药理学]