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喜炎平注射液致儿童不良反应的临床特点分析

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目的:探讨喜炎平注射液致儿童药品不良反应(ADR)的发生规律与临床特点,为儿童安全合理用药提供参考.方法:收集山东省枣庄市 2012 年1月~2023 年12 月期间上报国家药品不良反应监测系统中使用喜炎平注射液致儿童ADR的报告,统计分析ADR报告类型、患儿性别、年龄、原患疾病、ADR严重程度、关联性评价、累及系统/器官、ADR发生与转归时间、处理措施、ADR报告来源等.结果:共纳入170 例ADR报告,严重ADR报告占4.12%,无死亡病例;男性114 例,女性 56 例,男女比例 2.0357∶1;156 例ADR报告发生在 0~6 岁儿童,发生时间以首次用药 30min内为主(61.76%);转归结果除 2 例不详外,168 例为好转或痊愈,131例ADR转归时间在发生ADR后1h内;ADR多为对药物过敏所致,以累及皮肤及其附件损害最多(77.35%),主要表现为皮疹、瘙痒和斑丘疹.7 例严重ADR报告均发生在 6 岁以下儿童中,且71.43%为 2 岁及以下患儿.结论:喜炎平注射液所致儿童ADR多为速发型,多数患儿预后良好.临床使用时应重点关注低龄儿童,尤其是 2 岁以下儿童,严格遵循药品说明书用药并加强药学监护,以减少ADR的发生.
Analysis of Clinical Characteristics of Adverse Reactions Induced by Xiyanping Injection in Children
Objective:To investigate the occurrence patterns and clinical characteristics of adverse drug reaction(ADR)induced by Xiyanping injection in children,so as to provide reference for safe and rational medication in children.Methods:The ADR reports induced by Xiyanping injection in children reported to the National Adverse Drug Reaction Monitoring System from January 2012 to December 2023 in Zaozhuang,Shandong Province were collected.The types of ADR reports,gender,age,primary disease,severity of ADR,assessment of causality,involved system/organ,onset and outcome time of ADR,management measures and sources of ADR reports were statistically analyzed.Results:Among a total of 170 ADR reports included,the proportion of serious ADR was 4.12%,and no death was observed.There were 114 males and 56 females,with a male to female ratio of 2.0357:1.A total of 156 ADR were reported in children aged 0~6 years,mainly occurring within 30 minutes after the first dose(61.76%).The outcomes of 168 cases were recovering/recovered,except for 2 cases with unknown outcomes.The outcome time of 131 ADR were within 1 hour after the onset of ADR.Most ADR were due to drug allergy,primarily involving the skin and its appendages(77.35%),with symptoms mainly manifesting as rash,pruritus and rash maculopapular.All 7 serious ADR occurred in children under 6 years of age,with 71.43%of children being under 2 years of age.Conclusion:Most ADR induced by Xiyanping injection in children are immediate,and most children have a good prognosis.In clinical use,special attention should be given to young children,particularly those under 2 years of age.It is essential to strictly follow the package insert and strengthen pharmaceutical supervision to reduce the occurrence of ADR.

Xiyanping injectionchildrenadverse drug reactionsafe medicationretrospective analysis

海彦娟、韩英

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北京中医药大学东方医院枣庄医院/山东省枣庄市中医医院药学部,枣庄 277000

喜炎平注射液 儿童 药品不良反应 安全用药 回顾性分析

山东中医药学会临床药学科研专项基金项目2023年度山东省中医药调研课题

SDACM202211ZYY2023025

2024

中国合理用药探索
中国执业药师协会

中国合理用药探索

影响因子:0.62
ISSN:2096-3327
年,卷(期):2024.21(9)