中国麻风皮肤病杂志 ›› 2024, Vol. 40 ›› Issue (7): 466-470.doi: 10.12144/zgmfskin202407466

• 论著 • 上一篇    下一篇

基于FDA不良事件报告系统的乌帕替尼药物警戒研究

葛素素1,王方海2,孙雨菡3,袁忠1   

  1. 1济南市机关医院药剂科，山东济南，250001；2济南市长清区崮云湖卫生服务中心，山东济南，250300；3济南市机关医院科教科，山东济南，250001
  • 出版日期:2024-07-15 发布日期:2024-06-11

A real-world pharmacovigilance study of FDA Adverse Event Reporting System events for upadacitinib

GE Susu1, WANG Fanghai2, SUN Yuhan3, YUAN Zhong1   

  1. 1 Department of Pharmacy, Jinan Municipal Government Hospital, Jinan 250001, China; 2 Jinan Changqing District Guyun Lake Health Service Center, Jinan 250300, China; 3 Department of Science and Education, Jinan Municipal Government Hospital, Jinan 250001, China
  • Online:2024-07-15 Published:2024-06-11

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摘要： 目的：通过评估来自FDA不良事件报告系统(FAERS)乌帕替尼的不良反应信号，促进乌帕替尼的安全处方。方法：在FAERS中，以“upadacitinib”作为检索词，筛选以乌帕替尼为首要怀疑对象的不良反应事件（ADE），收集从2019年8月至2023年3月的ADE信号。采用报告比值比(ROR)、比例报告比(PRR)、贝叶斯置信传播神经网络(BCPNN)和多项伽马泊松缩减法(MGPS)四种算法。根据《国际医学用语词典》（24.1版）中的系统器官分类（SOC）和首选术语（PT）对ADE报告进行描述和分类。结果：检索到报告期内乌帕替尼ADEs 21 213例，呈递增趋势，其中肿瘤245例、血栓形成78例。通过四种算法共获得357个ADE信号,信号强度排名前4位为类风湿因子阳性、疱疹性湿疹、脊髓感染、口腔扁平苔藓，其中类风湿因子阳性、脊髓感染、口腔扁平苔藓未在说明书中收录。ADE信号报告例次较多的主要涉及关节痛、新型冠状病毒感染、鼻咽炎、尿路感染，其中关节痛、新型冠状病毒感染、尿路感染未在说明书中收录。ADE共涉及15个SOC，主要为感染性疾病（5490例，占37.57%）、肌肉骨骼及结缔组织疾病（3370例，占23.06%）。结论：发现乌帕替尼在新型冠状病毒感染、尿路感染等新的ADE信号，此外，该药在恶性肿瘤、血栓形成方面的风险也不容忽视。

关键词: 乌帕替尼, FAERS, 不良反应事件, 数据挖掘, 黑框警告, 药物警戒

Abstract: Objective: To promote safe upadacitinib prescribing by mining and evaluating the upadacitinib adverse reaction events(ADE) signals from the FDA Adverse Event Reporting System (FAERS). Methods: In the FAERS, “upadacitinib” was used as a search term to screen ADEs. ADE signals were collected from August 2019 to March 2023 and were detected. The analysis method included four algorithms of reporting odd ratio (ROR), proportional reporting ratio (PRR), bayesian configuration promotion neural network (BCPNN), and multi item gamma poisson shrinker (MGPS). ADE reports were described and classified according to the System Organ Class (SOC) and Preferred Term (PT) in the Medical Dictionary for Regulatory Activities (version 24.0). Results: 21 213 ADEs were collected with an upward trend, including 245 cases of tumor and 78 cases of thrombosis. A total of 357 ADE signals were obtained by four methods. The top signal intensities were rheumatoid factor positive, pelvic floor muscle weakness, eczema herpeticum, spinal cord infection, oral lichen planus, of which rheumatoid factor positive, pelvic floor muscle weakness, spinal cord infection, oral lichen planus were not included in the package insert. Reported multiple ADE signals mainly involved arthralgia, novel coronavirus infection, nasopharyngitis, urinary tract infection, of which arthralgia, novel coronavirus infection,  urinary tract infection were not included in the package insert. The ADE signal involved in 15 SOCs, mainly were infections (5490 cases, 37.57%), musculoskeletal and connective tissue diseases (3370 cases, 23.06%). Conclusion: Our research has found new significant ADE signals of upadacitinib such as in COVID-19 and urinary tract infection, etc. In addition, the risk of malignant tumor and thrombosis can not be ignored.

Key words: upadacitinib, FAERS, adverse drug event, data mining, black box warning, pharmacovigilance