目的 分析儿童使用丙戊酸相关药品不良反应报告及其发生特点，为临床合理用药提供参考。方法 收集2016年1月1日—2026年3月31日北京地区药品不良反应监测数据库中儿童使用丙戊酸相关报告，使用国际医学用语词典（MedDRA）的系统器官分类（SOC）与首选术语（PT）对不良反应进行分类整理，对病例基本特征、不良反应发生情况、处置与转归情况进行描述性分析。结果 共收集儿童使用丙戊酸相关报告203例，男女比为1.04∶1，平均年龄为（13.2±7.5）岁。报告共涉及17个SOC与275个PT，主要涉及的器官系统分类为各类神经系统疾病、各类检查和皮肤及皮下组织类疾病等，PT词排名前3位依次为皮疹、体质量增加、高氨血症。结论 儿童使用丙戊酸相关不良反应可累及多个系统，应密切监测用药期间可能出现的各类不良反应，警惕高氨血症等可能造成严重后果的事件，以保障儿童用药安全与临床合理用药。

Objective This study aimed to analyze the adverse drug reaction reports related to valproic acid in children and to characterize their occurrence patterns, thereby providing a reference for clinical rational use. Methods Reports related to valproic acid use in children were collected from the Beijing Adverse Drug Reaction Monitoring Center from January 1, 2016 to March 31, 2026. Adverse drug reactions were classified and organized using the SOC and PT of the MedDRA. Descriptive analyses were conducted on basic case characteristics, adverse drug reaction occurrence, as well as management and outcomes. Results A total of 203 reports related to valproic acid were collected, with a male-to-female ratio of 1.04:1, and a mean age of (13.2 ± 7.5) years. The reports involved 17 SOCs and 275 PTs. The main involved system organ classes were nervous system disorders, investigations, and skin and subcutaneous tissue disorders. The top 3 PTs in terms of frequency were rash, weight gain, and hyperammonemia. Conclusion Adverse drug reactions related to valproic acid use in children can involve multiple systems. Close monitoring of various adverse reactions during treatment is warranted, with particular vigilance for events that may lead to serious consequences, such as hyperammonemia, to ensure the safety of pediatric medication and promote rational clinical drug use.

R971

国家自然科学基金资助项目（72404198）；药品监管科学全国重点实验室课题（2024SKLDRS0232）