| 摘要: |
| 目的:探讨乌司奴单抗在儿童患者中潜在的药品不良事件(ADE),为临床合理用药提供参考。方法:基于美国食品药品
监督管理局不良事件报告系统(FAERS),采用报告比值比(ROR) 法和比例报告比值(PRR) 法对FAERS 中2015-2023 年上报
的乌司奴单抗为首要怀疑ADE 进行数据挖掘和分析,按国际医学用语词典( MedDRA) 的首选术语( PT) 和系统-器官分类
(SOC)进行统计分析。结果:共检索到乌司奴单抗儿童ADE 报告1 050 例,以女性患儿为主(568 例,54. 1%),0~ 5 岁81 例
(7. 7%),>5~11 岁129 例(12. 3%),>11~17 岁840 例(80. 0%)。主要上报国家为美国(774 例,73. 7%),报告者职业以卫生专
业人员为主(295 例,28. 1%),报告数量在2019 年达到峰值。共检索到乌司奴单抗PT 554 个,经ROR 法和PRR 法得到66 个
ADE 信号,涉及15 个SOC。对有信号的PT 按照报告数和信号强度排序,常见的ADE 为速发严重过敏反应(ROR=3. 25,95%CI
1. 95~5. 41)、难辨梭状芽孢杆菌感染(ROR=11. 88,95%CI 7. 00~20. 18)、治疗反应减弱(ROR=5. 79,95%CI 3. 42~9. 81)。相
关性最高的ADE 为肠脓肿(ROR= 46. 03,95%CI 16. 70~126. 88)、闪光幻觉(ROR=31.28,95%CI 9.82~99.61)、血铁降低(ROR=
12. 36,95%CI 3. 94~38. 73)。新的潜在ADE 包括闪光幻觉、脱发、难辨梭状芽孢肝菌感染、盗汗、传染性单核细胞增多症、早产
儿等。结论:乌司奴单抗在儿童患者中常见ADE 信号与药品说明书具有一致性,但仍有药品说明书中未记载的新的SOC 和新
的ADE 信号出现,提示儿童与成人使用乌司奴单抗的ADE 发生情况存在差异,需更多的研究来确定其安全性。 |
| 关键词: 乌司奴单抗 药品不良事件 美国 食品药品监督管理局不良事件报告系统 信号挖掘 儿童 银屑病 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2025.04.002 |
|
| 基金项目:自贡市重点科技计划项目,编号2022ZCYKY04。 |
|
| Safety Signal Mining and Analysis for Ustekinumab Used in Children Based on the U. S. Food and DrugAdministration Adverse Event Reporting System Database |
| Zhang Xuanyi, Kong Wenqiang, Zhou Yilu, Zhong Hong |
| ((Zigong First People’ s Hospital, Sichuan Zigong 643000,
China)) |
| Abstract: |
| Objective: To probe into the potential adverse drug events (ADE) of ustekinumab in children, and to provide reference for
clinical rational drug use. Methods: Based on the U. S. Food and Drug Administration Adverse Event Reporting System (FAERS)
database, the reporting odds ratio (ROR) and proportional reporting ratio (PRR) methods were used to mine and analyze the data on
ustekinumab as the primary suspect ADE reported in the system from 2015 to 2023. Statistical analysis was performed according to the
preferred terms (PT) and system organ class (SOC) of the International Dictionary of Medical Terms (MedDRA). Results: A total of
1,050 reports of ADE related to ustekinumab in children were retrieved, with ADE reports predominantly from females (568 cases,
54. 1%), and the majority of reports were children aged from 0 to 5 years (81 cases, 7. 7%), >5 to 11 years (129 cases, 12. 3%), and >11 to 17 years (840 cases, 80. 0%). The top reporting countries were the United States (774 cases, 73. 7%), with healthcare
professionals being the main reporters (295 cases, 28. 1%), and the highest number of reports was reported in 2019. A total of 554
ustekinumab PT were retrieved, and 66 ADE signals were obtained by ROR and PRR methods, including 15 SOC. The PT with signals
were sorted by signal intensity and occurrence frequency. The most common ADE were rapid severe allergic reactions (ROR = 3. 25,
95%CI 1. 95 to 5. 41), Clostridium difficile infection (ROR = 11. 88, 95%CI 7. 00 to 20. 18), and decreased therapeutic response
(ROR=5. 79, 95%CI 3. 42 to 9. 81). The ADE with the highest signal intensity was intestinal abscess intestinal (ROR=46. 03, 95%
CI 16. 70 to 126. 88), photopsia (ROR = 31. 28, 95%CI 9. 82 to 99. 61), decreased blood iron (ROR = 12. 36, 95%CI 3. 94 to
38. 73). New potential ADE included photopsia, alopecia, C. difficile infection, night sweats, infectious mononucleosis, and premature
infants. Conclusion: The common ADE signals of ustekinumab in children is consistent with the drug instructions, yet there are still new
SOC and new ADE signals. The results suggest that there is a difference in the occurrence of ADE between children and adults using
ustekinumab, and more studies are needed to determine the medication safety. |
| Key words: ustekinumab adverse drug events the U. S. A Food and Drug Administration Adverse Event Reporting System signal
mining children psoriasis |
