中国药物警戒 ›› 2026, Vol. 23 ›› Issue (7): 809-813.
DOI: 10.19803/j.1672-8629.20250226

• 安全与合理用药 • 上一篇    下一篇

982例儿童皮肤药品不良反应分析

吴光华1, 邢亚兵1, 张胜男1, 王菊平1, 陈晓博2, 夏旭东2,*   

  1. 1郑州大学附属儿童医院药学部,河南 郑州 450013;
    2河南省药品评价中心,河南 郑州 450004
  • 收稿日期:2025-04-12 出版日期:2026-07-15 发布日期:2026-07-16
  • 通讯作者: *夏旭东,男,硕士,高级工程师,药品安全性监测与评价。E-mail: hnadrxxd@163.com
  • 作者简介:吴光华,女,硕士,副主任药师,儿科临床药学。
  • 基金资助:
    国家药监局药品监管科学体系建设重点项目（RS2024G001）

982 cases of cutaneous adverse drug reaction in children

Wu Guanghua1, Xing Yabing1, Zhang Shengnan1, Wang Juping1, Chen Xiaobo2, Xia Xudong2,*   

  1. 1Department of Pharmacy, Children’s Hospital Affiliated to Zhengzhou University, Zhengzhou Henan 450013, China;
    2Henan Drug Reevaluation Center, Zhengzhou Henan 450004, China
  • Received:2025-04-12 Online:2026-07-15 Published:2026-07-16

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摘要： 目的 分析皮肤药品不良反应（Cutaneous Adverse Drug Reaction,CADR）的特点及临床表现,为儿童安全用药提供参考。方法 回顾性分析2018年1月1日至2024年12月31日郑州大学附属儿童医院发生CADR患儿的临床资料,包括性别、年龄、致敏药物、临床表现、累及系统-器官、潜伏期、治疗以及转归等。结果 纳入982例CADR报告,其中男性患儿586例、女性患儿396例,发病年龄主要集中在2~11岁。轻症CADR 956例,临床表现以发疹型药疹为主（698例次）;重症CADR 26例,临床表现为药物超敏反应综合征（9例次）、Stevens-Johnson综合征（9例次）、中毒性表皮坏死松解症（8例次）。排名前3位的致敏药物类别为抗感染药物、呼吸系统药物和抗癫痫药物。712例患者给予对症治疗,主要选用抗组胺药、外用或系统用糖皮质激素、炉甘石洗剂。971例患儿预后良好,另有11例转归不详。结论 儿童CADR临床表现以轻症为主,部分可进展为重症,临床在用药期间应加强用药

关键词: 皮肤药品不良反应, 儿童, 抗感染药物, 抗癫痫药物, 抗组胺药物, 发疹型药疹

Abstract: Objective To investigate the prevalence and clinical characteristics of cutaneous adverse drug reactions (CADRs) in pediatric patients, and to give evidence-based recommendations for safe medication and rational drug use. Methods A retrospective analysis was conducted of 982 cases of CADRs reported by the Children’s Hospital Affiliated to Zhengzhou University between January 2018 and December 2024. The data collected included demographics (age and gender), clinical manifestations, culprit medications, latency periods, systemic organ involvement, therapeutic interventions, and clinical outcomes. Results Among the 982 cases of CADRs, 586 involved males, and the majority were observed in the group aged 2-11. Exanthematous drug eruptions were the dominating mild manifestations, and severe reactions included drug hypersensitivity syndrome, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Anti-infective drugs, respiratory medications, and antiepileptic drugs were identified as the predominant causative agents. Among these cases, 712 underwent symptomatic treatment with antihistamines, topical/systemic steroids, and glycerite lotion. Most of the patients achieved favorable outcomes, Most of the patients achieved favorable outcomes, while the prognosis remained unknown in 11 cases. Conclusion CADRs are usually mild in children, but some cases may progress to severe CARDs. Clinicians should give pharmaceutical care during treatment to ensure the safety of drug use.

Key words: Cutaneous Adverse Drug Reaction, Children, Anti-Infective Drugs, Antiepileptic Drugs, Antihistamines Drugs, Exanthematous Drug Eruptions

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