中国药物警戒 ›› 2026, Vol. 23 ›› Issue (3): 302-306.
DOI: 10.19803/j.1672-8629.20250550

• 安全与合理用药 • 上一篇    下一篇

某省未成年人群应用阿奇霉素安全性风险分析

秦博1, 李根1, 杜宇2, 高山2, 兰姗2, 彭丹2, 江永贤1,*   

  1. 1四川省妇幼保健院,四川省妇女儿童医院,成都医学院附属妇女儿童医院药学部,四川 成都 610041;
    2四川省食品药品审查评价及安全监测中心,四川 成都 610041
  • 收稿日期:2025-08-15 出版日期:2026-03-15 发布日期:2026-03-17
  • 通讯作者: *江永贤,女,硕士,副主任药师,药物警戒与药事管理。E-mail: 243609682@qq.com
  • 作者简介:秦博,女,硕士,主管药师,药物警戒与临床药学。
  • 基金资助:
    国家药监局综合司关于药品监管科学体系建设重点项目（RS2024G00 1）; 四川省妇幼保健院科技创新项目（CXPJ08-2020）; 成都医学院2024年第一批临床科学研究基金项目（24LHXX1-07）; 成都市卫生健康委员会医学科研课题项目（2022388）

Safety Risk of Azithromycin in Minors

QIN Bo1, LI Gen1, DU Yu2, GAO Shan2, LAN Shan2, PENG Dan2, JIANG Yongxian1,*   

  1. 1Department of Pharmacy, Sichuan Provincial Maternity and Child Health Care Hospital/Sichuan Provincial Hospital for Women and Children/Women and Children's Hospital Affiliated to Chengdu Medical College, Chengdu Sichuan 610041, China;
    2Sichuan Provincial Center for Food and Drug Evaluation and Safety Monitoring, Chengdu Sichuan 610041, China
  • Received:2025-08-15 Online:2026-03-15 Published:2026-03-17

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摘要： 目的 探讨18岁以下人群阿奇霉素不良反应（ADR）发生情况及特征,为未成年人群应用阿奇霉素安全性提供参考。方法 收集2010年1月1日至2024年3月31日四川省药品不良反应监测中心收到的怀疑药品为阿奇霉素的ADR报告,统计患者基本情况、用药情况、ADR发生及转归等信息,分析ADR发生特点。结果 共收到5 143例ADR报告,严重报告126例,其中新的严重报告38例;男女性别差异不明显,存在用药剂量不合理情况（19.07%）。ADR多发生于用药后3 d内（4 875例,94.79%）,ADR累及多个系统-器官,排名前3位的分别是胃肠系统疾病、皮肤及皮下组织类疾病和全身性疾病及给药部位各种反应。严重ADR主要表现为胃肠系统ADR。98.83%临床转归为痊愈或好转。结论 18岁以下人群应用阿奇霉素导致的ADR可累及多个系统-器官,大多能耐受。建议临床合理应用,严格控制用药剂量,关注个体差异,加强用药监护,防止药物蓄积。

关键词: 阿奇霉素, 胃肠系统, 皮肤及皮下组织, 药品不良反应, 合理用药, 安全性, 未成年人群

Abstract: Objective To investigate the incidence and characteristics of adverse drug reactions (ADR) of azithromycin (AZM) in minors in order to provide data on safety of medications. Methods Reports of ADR caused by AZM in Sichuan Province that were published between January 2010 and March 2024 were retrieved. Key information, including patient demographics, medication-specific details (such as dosage, administration routes, and courses of treatment), manifestations of ADR, clinical outcomes, and other related parameters, was analyzed to delineate the patterns of AZM-associated ADR. Results A total of 5,143 ADR cases were collected, with no significant gender difference observed. Inappropriate dosage was found in 981 cases (19.07%), with 126 serious reports (38 new serious reports). Most of the ADR occurred within 3 days of administration (4,875, 94.79%). These ADR involved multiple systems-organs, the top three of which were gastrointestinal system disorders, skin/subcutaneous tissue reactions, and general disorders/reactions at the sites of administration. Severe ADR mostly manifested themselves as gast-rointestinal symptoms. Favorable clinical outcomes were observed in 98.83% of these cases, with complete recovery or significant improvement. Conclusion ADR caused by azithromycin among minors often involve multiple systems, but are mostly tolerable. Rational dosing, individualized medications, and close monitoring for early detection/intervention are recommended.

Key words: Azithromycin, Gastrointestinal System, Skin/Subcutaneous Tissue, Adverse Drug Reaction (ADR), Rational Drug Use, Safety, Minor Population

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