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基于FAERS数据库对奥法妥木单抗及利妥昔单抗治疗多发性硬化的不良事件分析

Identifying Adverse Events of Ofatumumab and Rituximab in the Treatment of Multiple Sclerosis Based on the FAERS Database
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摘要 目的基于美国食品药品监督管理局不良事件报告系统数据库挖掘奥法妥木单抗及利妥昔单抗治疗多发性硬化(multiple sclerosis,MS)时的不良事件信号,以期为这2种药物临床安全应用提供更多参考。方法提取奥法妥木单抗与利妥昔单抗上市后的不良事件报告形成分析数据集,采用比例失衡法结合贝叶斯法进行不良事件信号监测,筛选出满足阈值条件的不良事件并进行总结分析。结果奥法妥木单抗组采集到不良事件报告72310条,有325个阳性信号,涵盖24个系统器官分类(system organ class,SOC),主要涉及“全身性疾病及给药部位各种反应”“各类神经系统疾病”“各种肌肉骨骼及结缔组织疾病”;利妥昔单抗组采集到不良事件报告23203条,有311个阳性信号,涵盖25个SOC,主要涉及“各类损伤、中毒及操作并发症”“感染及侵染类疾病”“各类神经系统疾病”。除“胃肠系统疾病”及“眼器官疾病”外,这2种药物每个SOC级别内不良事件的分布均有显著差异。结论奥法妥木单抗与利妥昔单抗在治疗MS时的不良事件发生风险有较大差异,临床应用时应注意用药监测。由于基于真实世界的研究难以进行定量分析,以上结论还需大样本的队列研究进行验证。 OBJECTIVE To investigate adverse event signals associated with ofatumumab and rituximab in the treatment of multiple sclerosis(MS),provide more evidences for the clinical safe medication based on the U.S.food and drug administration's adverse event reporting system(FAERS)data.METHODS Postmarking adverse event reports of ofatumumab and rituximab were extracted to form an analysis dataset.Disproportionality analysis combined with bayesian confidence propagation neural nework(BCPNN)was conducted for adverse event signal monitoring.Adverse events meeting threshold conditions were selected and summarized for analysis.RESULTS The ofatumumab group collected a total of 72310 adverse event reports,of which 325 showed positive signals,covering 24 system organ classes(SOCs),involving“infections and infestations”“nervous system disorders”and“musculoskeletal and connective tissue disorders”.The rituximab group collected 23203 adverse event reports,with 311 showing positive signals,covering 25 SOC,involving“injury,poisoning and procedural complications”“infections and infestations”and“nervous system disorders”.Except for“gastrointestinal disorders”and“eye disorders”,both drugs exhibited significant differences in each SOC.CONCLUSION There are substantial differences in the risk of adverse events between ofatumumab and rituximab in the treatment of MS.Therefore,medication monitoring is required during the treatment.Due to the limitations of real-world studies for quantitative analysis,the above conclusions need to be validated through large-scale cohort studies.
作者 李莹 关茗元 段冉冉 康建 LI Ying;GUAN Mingyuan;DUAN Ranran;KANG Jian(Department of Pharmacy,The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China;Henan Drug Clinical Comprehensive Evaluation Center,Zhengzhou 450052,China;Department of Neurology,The First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China)
出处 《中国药学杂志》 CAS CSCD 北大核心 2024年第9期845-851,共7页 Chinese Pharmaceutical Journal
基金 国家自然科学基金项目资助(81703738)。
关键词 奥法妥木单抗 利妥昔单抗 报告系统 不良事件 多发性硬化 ofatumumab rituximab reporting system adverse event multiple sclerosis
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  • 1陈锋,杨世民.我国药物不良反应监测体系建设现状与存在的问题[J].医药导报,2006,25(5):486-488. 被引量:58
  • 2JONES J K. The role of data mining technology in the identification of signals of possible adverse drug reactions: value and limitations [ J ]. Current Therapeutic Research,2001,62 (9) :664-672.
  • 3HAUBEN M,ZHOU X F. Quantitative methods in pharmacovigilance : focus on signal detection [ J ]. Drug Safety,2003,26 ( 3 ) : 159 -186.
  • 4EGBERTS A C, MEYBOOM R H, van PUIJENBROEK E P. Use of measures of disproportionality in phannacovigilance : three dutch exampies[ J]. Drug Safety,2002,25(6) :453-458.
  • 5EVANS S J W, WALLER P C, DAVIS S. Use of proportional reporting ratios(PRRs) for signal generation from spontaneous adverse drug reaction reports [J]. Pharmacoepidemiol Drug Safety, 2001,10 (6) :483-486.
  • 6BATE A, LINDQUIST M, EDWARDS I R, et al. A Bayesian neural network method for adverse drug reaction signal generation [ J]. European doumal of Clinical Pharmacology,1998,54(4) :315-321.
  • 7BATE A, LINDQUIST M, EDWARDS I R, et al. A data mining approach for signal detection and analysis[J]. Drug Safety,2002,25 (6) : 393 -397.
  • 8国家食品药品监督管理局药品安全监管司,国家药品不良反应监测中心.药品不良反应报告和监测工作手册[R].2005.
  • 9Wei Qiu,De-Hui Huang,Shi-Fang Hou,Mei-Ni Zhang,Tao Jin,Hui-Qing Dong,Hua Peng,Chao-Dong Zhang,Gang Zhao,Yi-Ning Huang,Dong Zhou,Wei-Ping Wu,Bao-Jun Wang,Ji-Mei Li,Xing-Hu Zhang,Yan Cheng,Hai-Feng Li,Ling Li,Chuan-Zhen Lu,Xu Zhang,Bi-Tao Bu,Wan-Li Dong,Dong-Sheng Fan,Xue-Qiang Hu,Xian-Hao Xu.Efficacy and Safety of Teriflunomide in Chinese Patients with Relapsing Forms of Multiple Sclerosis: A Subgroup Analysis of the Phase 3 TOWER Study[J].Chinese Medical Journal,2018(23):2776-2784. 被引量:10
  • 10Lublin FD,Reingold SC,Cohen JA,李海峰.多发性硬化基于病程的分型(2013版)简介[J].中国神经免疫学和神经病学杂志,2014,21(4):303-304. 被引量:21

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