[1]李爱国,陈湘磊.基于FAERS数据库进行伊布替尼药物不良事件信号挖掘[J].医学信息,2025,38(08):27-32.[doi:10.3969/j.issn.1006-1959.2025.08.005]
　LI Aiguo,CHEN Xianglei.Adverse Drug Event Signals Mining of Ibrutinib Based on FAERS Database[J].Journal of Medical Information,2025,38(08):27-32.[doi:10.3969/j.issn.1006-1959.2025.08.005]
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基于FAERS数据库进行伊布替尼药物不良事件信号挖掘()
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医学信息[ISSN:1006-1959/CN:61-1278/R]

卷:
38卷
期数:
2025年08期
页码:
27-32
栏目:
药学信息学
出版日期:
2025-04-15

文章信息/Info

Title:
Adverse Drug Event Signals Mining of Ibrutinib Based on FAERS Database
文章编号:
1006-1959（2025）08-0027-06
作者:
李爱国1; 陈湘磊2
潍坊市益都中心医院输血科1，血液科2，山东 青州 262500
Author(s):
LI Aiguo1;  CHEN Xianglei2
Department of Blood Transfusion1, Department of Hematology2, Yidu Central Hospital of Weifang, Qingzhou 262500, Shandong, China
关键词:
伊布替尼; 美国食品药品监督管理局不良事件报告系统; 药物不良事件
Keywords:
Ibrutinib;  The Food and Drug Administration Adverse Event Reporting System;  Adverse drug event
分类号:
R979.1
DOI:
10.3969/j.issn.1006-1959.2025.08.005
文献标志码:
A
摘要:
目的 利用美国食品药品监督管理局（FDA）不良事件报告系统（FAERS）挖掘伊布替尼药物不良事件（ADE）信号，为临床合理用药提供参考。方法 调取FAERS中2014年第一季度至2023年第一季度的伊布替尼数据，采用报告比值比法和贝叶斯可信区间递进神经网络法进行信号挖掘，分析其ADE发生情况。结果 共检测到58 380份以伊布替尼为首要怀疑药物的ADE报告，伊布替尼不良反应的中位发生时间为143 d，主要发生在用药治疗的早期，ADE上报呈逐年上升趋势。ADE信号为580个，涉及到25个系统器官分类（SOC）。结论 在真实世界中，伊布替尼存在药品说明书以外的ADE，应提高对此类ADE发生的警惕性，更好地保障患者用药安全。
Abstract:
Objective To explore the adverse drug event (ADE) signals of ibutinib by using the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), and to provide reference for clinical rational drug use. Methods The data of ibutinib from the first quarter of 2014 to the first quarter of 2023 in FAERS were collected. The reporting odds ratio method and Bayesian confidence interval progressive neural network method were used for signal mining to analyze the occurrence of ADE. Results A total of 58 380 reports of adverse events with ibutinib as the primary suspected drug were detected. The median occurrence time of adverse reactions of ibutinib was 143 days, mainly in the early stage of drug treatment, and ADE reporting showed an increasing trend year by year. ADE signals were 580, involving 25 system organ classification (SOC). Conclusion In the real world, ibrutinib has adverse events other than drug labels, and vigilance for such adverse events should be improved to better ensure the safety of patients.

参考文献/References:

[1]Miklos DB,Abu Zaid M,Cooney JP,et al.Ibrutinib for First-Line Treatment of Chronic Graft-Versus-Host Disease: Results From the Randomized Phase III iNTEGRATE Study[J].J Clin Oncol,2023,41(10):1876-1887.[2]Wang M,Ramchandren R,Chen R,et al.Concurrent ibrutinib plus venetoclax in relapsed/refractory mantle cell lymphoma: the safety run-in of the phase 3 SYMPATICO study[J].J Hematol Oncol,2021,14(1):179.[3]Hou K,Yu Z,Jia Y,et al.Efficacy and safety of ibrutinib in diffuse large B-cell lymphoma: A single-arm meta-analysis[J].Crit Rev Oncol Hematol,2020,152:103010.[4]Ren L,Li L,Zhang L,et al.Ibrutinib in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Retrospective Study[J].Indian J Hematol Blood Transfus,2022,38(1):42-50.[5]中国临床肿瘤学会(CSCO)抗白血病联盟,中国临床肿瘤学会(CSCO)抗淋巴瘤联盟.伊布替尼治疗B细胞恶性肿瘤中国专家共识(2019年版)[J].白血病·淋巴瘤,2019,28(8):449-456.[6]Stephens DM,Byrd JC.How I manage ibrutinib intolerance and complications in patients with chronic lymphocytic leukemia[J].Blood,2019,133(12):1298-1307.[7]李健,陈耀鑫,彭德强,等.基于FAERS数据库的特立帕肽不良事件信号挖掘与分析[J].现代药物与临床,2023,38(1):194-200.[8]Park G,Jung H,Heo SJ,et al.Comparison of Data Mining Methods for the Signal Detection of Adverse Drug Events with a Hierarchical Structure in Postmarketing Surveillance[J].Life (Basel),2020,10(8):138.[9]张婧媛,白羽霞,韩晟,等.数据挖掘方法检测药品不良反应信号的应用研究[J].药物不良反应杂志,2016,18(6):412-416.[10]Guan Y,Qi Y,Zheng L,et al.Data mining techniques for detecting signals of adverse drug reaction of cardiac therapy drugs based on Jinan adverse event reporting system database: a retrospective study[J].BMJ Open,2023,13(1):e068127. [11]Wilson LAB,Zajitschek SRK,Lagisz M,et al.Sex differences in allometry for phenotypic traits in mice indicate that females are not scaled males[J].Nat Commun,2022,13(1):7502.[12]Thandra KC,Barsouk A,Saginala K,et al.Epidemiology of Non-Hodgkin’s Lymphoma[J].Med Sci (Basel),2021,9(1):5.[13]林翼旻,张纾,张玲萍,等.国外药物警戒体系建设现状探究及启示[J].中国药事,2024,38(1):105-110.[14]管绯,高建,张艳.全生命周期药物警戒体系和药物警戒技术实施现状调研[J].中国医药导刊,2023,25(12):1200-1206.[15]Noy A,de Vos S,Thieblemont C,et al.Targeting Bruton tyrosine kinase with ibrutinib in relapsed/refractory marginal zone lymphoma[J].Blood,2017,129(16):2224-2232.[16]Younes A,Sehn LH,Johnson P,et al.Randomized Phase III Trial of Ibrutinib and Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Non-Germinal Center B-Cell Diffuse Large B-Cell Lymphoma[J].J Clin Oncol,2019,37(15):1285-1295.[17]Bye AP,Unsworth AJ,Desborough MJ,et al.Severe platelet dysfunction in NHL patients receiving ibrutinib is absent in patients receiving acalabrutinib[J].Blood Adv,2017,1(26):2610-2623.[18]Rossi D,Gaidano G.Lymphocytosis and ibrutinib treatment of CLL[J].Blood,2014,123(12):1772-1774.[19]Shah RR,Morganroth J.Update on Cardiovascular Safety of Tyrosine Kinase Inhibitors: With a Special Focus on QT Interval, Left Ventricular Dysfunction and Overall Risk/Benefit[J].Drug Saf,2015,38(8):693-710.[20]Tang CPS,McMullen J,Tam C.Cardiac side effects of bruton tyrosine kinase (BTK) inhibitors[J].Leuk Lymphoma,2018,59(7):1554-1564.[21]Mathur K,Saini A,Ellenbogen KA,et al.Profound Sinoatrial Arrest Associated with Ibrutinib[J].Case Rep Oncol Med,2017,2017:7304021.[22]Xu L,Dong Q,Zhang N,et al.Severe Sinus Bradycardia Associated with Ibrutinib: One Rare Case from China[J].Am J Med Sci,2021,361(6):803-805.[23]Tuomi JM,Bohne LJ,Dorey TW,et al.Distinct Effects of Ibrutinib and Acalabrutinib on Mouse Atrial and Sinoatrial Node Electrophysiology and Arrhythmogenesis[J].J Am Heart Assoc,2021,10(22):e022369.[24]Bond DA,Huang Y,Fisher JL,et al.Second cancer incidence in CLL patients receiving BTK inhibitors[J].Leukemia,2020,34(12):3197-3205.

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更新日期/Last Update: 1900-01-01