| 摘要: |
| 目的:挖掘和评价奥司他韦相关儿童青少年精神病类不良事件信号,为临床安全用药提供参考。 方法:从美国食品药品 监督管理局不良事件报告系统(FAERS)中提取从 2004 年 1 月-2025 年 3 月以奥司他韦作为首要怀疑(PS)药物相关的儿童青 少年精神病类不良事件报告,采用报告比值比法(ROR)、比例报告比值比法(PRR)、多重伽马-泊松分布缩减法(MGPS)和贝叶 斯置信区间传播神经网络(BCPNN)进行分析,当 4 种算法结果均显示阳性,提示生成阳性信号。 结果:经数据清洗后,以系统 器官分类(SOC)“精神病类”对应的不良事件首选术语(PT)查询获得以奥司他韦作为 PS 药物相关儿童青少年精神病类不良事 件报告病例达 1 542 例(41. 02%,1 542 / 3 759),报告例次降序排前 7 位且被识别为具有临床中优先级信号的 PT 为异常行为、幻 觉、谵妄、意识模糊状态、梦魇、攻击性、激越。 按性别、年龄和报告者类型分层分析后,奥司他韦与儿童青少年精神病类不良事 件之间的关联仍然存在。 奥司他韦作为 PS 药物相关儿童青少年精神病类不良事件发生时间在用药后 0 ~ 1 d 占比达 53. 74%。 结论:奥司他韦引发儿童青少年精神病类不良事件风险较高,临床使用时应提前评估并加强早期监测。 |
| 关键词: 奥司他韦 儿童青少年 精神病类不良事件 美国食品药品监督管理局不良事件报告系统 真实世界研究 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2026.06.002 |
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| 基金项目:中国儿科人群临床试验体系建设项目,编号 2017ZX09304029-001-001 |
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| Real-World Study on Oseltamivir-Related Adverse Events of Psychiatric Disorders in Children and Adolescents |
| Zhang Guandong, Yang Yu, Zhao Ruiling |
| (Children’s Hospital of Shanxi, Taiyuan 030013, China) |
| Abstract: |
| Objective: To mine and evaluate the signals of oseltamivir-related adverse events of psychiatric disorders in children and adolescents, and to provide reference for safe clinical medication. Methods: Adverse events of psychiatric disorders in children and adolescents related to oseltamivir as the primary suspected (PS) drug were extracted from the the U. S. Food and Drug Administration Adverse Event Reporting System (FAERS) database from Jan. 2004 to Mar. 2025. When the results of all four algorithms such as the reported odds ratio method (ROR), proportionally reported odds ratio (PRR) method, multiple Gamma-poisson shrinkage estimation (MGPS) method, and the Bayesian confidence propagation neural network (BCPNN) showed positive, a positive signal was generated. Results: After data cleaning, a total of 1,542 cases (41. 02%, 1,542 / 3,759) of “psychiatric disorders” related to oseltamivir as the PS drug in children and adolescents were obtained. The top seven PT reported and identified as priority in clinical were abnormal behavior, hallucinations, delirium, confusion state, nightmares, aggression, and agitation. After stratified analysis by gender, age and reporter type, the association between oseltamivir and adverse events of psychiatric disorders in children and adolescents still existed. Oseltamivir accounted for 53. 74% of the reported adverse events related to pediatric and adolescent psychiatric disorders induced by PS drug, with the occurrence time within 1 d. Conclusion: The risk of oseltamivir-related adverse events of psychiatric disorders in children and adolescents is relatively high. Clinical use should be assessed in advance to strengthen early monitoring. |
| Key words: oseltamivir children and adolescents psychiatric disorders adverse events the U. S. Food and Drug Administration Adverse Event Reporting System real-world study |
