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基于文献病例的托莫西汀儿童不良反应谱及风险特征分析
黄彦凯
(宁波市医疗中心李惠利医院,浙江宁波 315041)
摘要:
目的:探讨托莫西汀致儿童不良反应(ADR)的临床特点,为安全用药提供参考。方法:检索中国知网、万方、PubMed 和 EMBase 数据库截至2025 年12 月收录的托莫西汀致儿童ADR 案例报道和病例分析,对患儿一般资料、用药情况、ADR 发生时 间、临床表现、治疗及转归进行分析。结果:纳入文献38 篇,涉及患儿41 例,男女比例2. 73 ∶ 1,年龄(10. 76±3. 25)岁。ADR 发 生的中位时间21. 5(8. 0,46. 0)天,其中58. 54%发生在用药后1 个月内。ADR 共累及13 个系统器官,主要为精神病类、生殖系 统及乳腺疾病和肾脏及泌尿系统疾病。说明书未收录的ADR(38. 1%)主要为强迫症和激活综合征;严重ADR 集中在心血管系 统。结论:儿童用药需掌握各系统ADR 特点,根据其可能机制或流行病学信息,必要时采取治疗药物监测手段。
关键词:  托莫西汀  注意缺陷多动障碍  儿童  不良反应  文献分析 [中图分类号]R749. 94  R969. 3      [文献标识码]A
DOI:doi:10.13407/j.cnki.jpp.1672-108X.2026.11.014
基金项目:
Analysis of Adverse Drug Reaction Spectrum and Risk Characteristics of Atomoxetine in Children Based onLiterature Cases
Huang Yankai
(Ningbo Medical Center Lihuili Hospital, Zhejiang Ningbo 315041, China)
Abstract:
Objective: To explore the clinical characteristics of adverse drug reactions (ADR) induced by atomoxetine in children, and to provide reference for safe medication. Methods: CNKI, Wanfang, PubMed, and EMBase databases were retrieved to collect case reports and case series analysis of ADR induced by atomoxetine in children up to Dec. 2025. Information on patient demographics, medication, time of ADR occurrence, clinical manifestations, treatment, and outcomes were analyzed. Results: A total of 38 articles including 41 patients were enrolled. The male-to-female ratio was 2. 73 ∶ 1, with a mean patient age of (10. 76 ± 3. 25) years. The median time to ADR occurrence was 21. 5 (8. 0, 46. 0) d, with 58. 54% of ADR occurring within one month of drug initiation. ADR affected a total of 13 systems and organs, mainly including mental disorders, reproductive system and breast diseases, and renal and urinary system diseases. Unlabeled ADR (38. 1%) were primarily psychiatric, manifesting as obsessive-compulsive disorder and activation syndrome. Severe ADR were concentrated in cardiovascular system. Conclusion: Clinicians should be aware of the characteristics of ADR across various systems in children with atomoxetine. Based on potential mechanism or epidemiological information, therapeutic drug monitoring can be implemented when necessary to promptly address risks associated with medication.
Key words:  atomoxetine  attention deficit hyperactivity disorder  children  adverse drug reactions  literature analysis

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