| 摘要: |
| 目的:探索真实世界中<18 岁儿童使用度普利尤单抗的安全性,为药品上市后研究和临床合理用药提供参考。方法:收
集美国食品药品监督管理局不良事件报告系统(FAERS)2017 年3 月28 日至2024 年3 月31 日以度普利尤单抗为首要怀疑药
物的<18 岁儿童患者药品不良事件(ADE)报告,通过使用报告比值比(ROR) 与综合标准法(MHRA) 对儿童使用度普利尤单抗
相关ADE 风险信号进行挖掘;挖掘与研究儿童长期使用度普利尤单抗的ADE 与严重ADE。结果:收集以度普利尤单抗为首要
怀疑药物的<18 岁儿童ADE 报告共20 515 份,共挖掘得到ADE 信号164 个,累及14 个器官系统,ADE 主要集中于皮肤及皮下
组织类疾病、全身性疾病及给药部位各种反应、眼器官疾病等系统,发现部分药品说明书未载ADE;不同年龄组部分高频次
ADE 存在差异;将881 例ADE 发生时间在13 周以上的ADE 报告纳入儿童长期用药安全性研究;获得严重ADE 报告共1 070
份,部分严重ADE 报告已有相关文献报道。结论:儿童在应用度普利尤单抗前应做好相关筛查,严格监测相关不良反应,并警
惕严重不良反应发生。 |
| 关键词: 儿童 用药安全 度普利尤单抗 不良事件 数据挖掘 食品药品监督管理局不良事件报告系统 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2025.04.003 |
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| 基金项目: |
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| Analysis of Adverse Events of Dupilumab in Children Based on the U. S. Food and Drug AdministrationAdverse Event Reporting System Database |
| Zhou Jing, Wang Wei, Chen Huijuan, Liu Jinfa |
| ((Ningde Hospital Affiliated to Ningde Normal University, Fujian Ningde
352100, China)) |
| Abstract: |
| Objective: To explore the safety of dupilumab in children aged <18 years in the real world, and provide reference for postmarketing
studies and rational clinical use of the drugs. Methods: Adverse drug event (ADE) reports of children <18 years with
dupilumab as primary suspect were collected from the U. S. Food and Drug Administration Adverse Event Reporting System (FAERS)
database from Mar. 28th , 2017 to Mar. 31st , 2024. Risk signals of ADE associated with dupilumab in children were mined by using
reported odds ratio (ROR) and Mantel-Haenszel risk adjustment (MHRA) methods. ADE and severe ADE of long-term use of
dupilumab in children were explored. Results: A total of 20,515 ADE reports were collected from children aged < 18 years with
dupliuzumab as the primary suspect drugs. A total of 164 ADE signals were mined, including 14 organ systems. ADE were primarily
concentrated in diseases of the skin and subcutaneous tissue, systemic diseases, various reactions at the site of administration, and
diseases of the eye. Some ADE were found not to be listed in the drug instructions. Differences in high-frequency ADE were observed
among different age groups. Totally 881 ADE reports with ADE more than 13 weeks were included in the long-term drug safety study.
And 1,070 severe ADE reports were obtained, with some severe ADE already reported in relevant literature. Conclusion: It is necessary to do
a good job in screening children before using dupilumab, strictly monitor the related ADE, and be alert to the occurrence of severe ADE. |
| Key words: children medication safety dupilumab adverse drug events data mining Food and Drug Administration Adverse Event
Reporting System Database |
