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2017-2023年四川省儿童患者药品不良事件分析OA

Analysis of Adverse Drug Events in Pediatrics in Sichuan Province During 2017-2023

中文摘要英文摘要

目的 分析四川省儿童患者药品不良事件发生的特点,为保障儿童临床用药的安全提供参考.方法 调取2017-2023 年四川省上报全国药品不良反应监测网络中57 098例患儿药品不良事件(ADE)数据,采用EXCEL 软件对人口学特征、用药信息、临床表现、对原患疾病的影响及转归信息进行回顾性分析.结果 报告数量最多的年龄层为 3~6 岁(14 142例,24.77%);怀疑药品总例次报告数量前3 依次为抗微生物药物(31 469例,50.80%)、中药注射剂(7 287例,1.76%)、呼吸系统药物(5 496例,8.87%),严重例次报告数量前 3 位依次为抗微生物药(2 749例,39.51%)、抗肿瘤药物(1 887 例,27.12%)和治疗精神障碍药物(356 例,5.12%).在患儿 ADE 中,中药注射剂的总例次构成比较高,但严重例次构成比较低;抗肿瘤药物的总例次构成比不高,但严重例次构成比较高.合并用药中电解质、酸碱平衡及营养药总例次报告数量居首位(14 001/24 001,58.34%),主要为溶媒氯化钠注射液和葡萄糖注射液.患儿 ADE 的临床表现分析显示,血液及淋巴系统疾病在严重报告中的占比较高.多数病例转归良好(痊愈42.37%,好转54.93%);严重 ADE 痊愈为23.81%,好转为65.60%.结论 临床应重视各年龄分层儿童的安全用药风险,重点关注抗微生物药和抗肿瘤药的使用,加强儿童用药监测工作.

Objective To analyze the characteristics of adverse drug events(ADEs)in pediatrics in Sichuan Prov-ince,and to provide evidence for the safety of clinical medication use in pediatrics.Methods The 57 098 adverse drug events of pediatric patients reported to the National Adverse Drug Reaction Monitoring Network by the institutions in Sichuan Province from 2017 to 2023 were retrieved,and EXCEL was used for retrospective analysis of demographic characteristics,medication in-formation,clinical manifestations,the impact on the original disease and prognosis.Results The age group with the highest number of reports was 3-6 years(14 142 cases,24.77%).The top 3 suspected drugs by total reported cases were antimicrobial agents(31 469 cases,50.80%),traditional Chinese medicine injections(7 287 cases,1.76%)and respiratory system drugs(5 496 cases,8.87%).For serious cases,the top 3 were antimicrobial agents(2 749 cases,39.51%),antineoplastic drugs(1 887 cases,27.12%),and psychotropic drugs(356 cases,5.12%).In pediatric ADEs,traditional Chinese medicine injec-tions account for a relatively high proportion of total cases but a low proportion of serious cases,whereas antineoplastic drugs show a low proportion of total cases but a relatively high proportion of serious cases.Among combination therapies,electrolytes,acid-base balance agents,and nutritional drugs ranked first(14 001/24 001,58.34%),primarily consisting of normal saline and glucose injections.Analysis of clinical manifestations showed that blood and lymphatic system disorders were more prevalent in se-rious reports than in total reports.Most cases had favorable outcomes(recovery rate:42.37%;improvement rate:54.93%),while severe ADEs had a recovery rate of 23.81%and an improvement rate of 65.60%.Conclusions Attention should be paid to medication safety risks across different pediatric age groups,with a particular focus on the use of antimicrobial and antineoplas-tic drugs.Enhanced monitoring of pediatric medication is recommended.

蔡凤群;王胡霖;康凤娇;王银;武刘芸;边原

四川省医学科学院•四川省人民医院(电子科技大学附属医院)药学部•个体化药物治疗四川省重点实验室,成都 610072||电子科技大学医学院,成都 610054电子科技大学医学院,成都 610054电子科技大学医学院,成都 610054电子科技大学医学院,成都 610054电子科技大学医学院,成都 610054四川省医学科学院•四川省人民医院(电子科技大学附属医院)药学部•个体化药物治疗四川省重点实验室,成都 610072||电子科技大学医学院,成都 610054

医药卫生

儿童药品不良事件用药安全回顾性分析

Adverse drug event/PediatricsMedication safetyRetrospective analysis

《医药导报》 2026 (4)

718-724,7

四川省药品监督管理局科技计划项目(2024012).

10.3870/j.issn.1004-0781.2026.04.023

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