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.
关键词
喜炎平注射液/儿童/药品不良反应/安全用药/回顾性分析
Key words
Xiyanping injection/children/adverse drug reaction/safe medication/retrospective analysis
维普
万方数据