Analysis of Clinical Characteristics and Influencing Factors of Adverse Drug Reactions of Different Severity Caused by Intravenous Azithromycin in a Children's Hospital
Objective:To analyze the clinical characteristics and influencing factors of children with adverse drug reactions(ADRs)of different severity caused by intravenous azithromycin in a hospital,and provide reference for safe and rational use of azithromycin in clinical practice.Methods:The reports of ADRs caused by intravenous azithromycin in 264 patients that were reported by Wuxi Children's Hospital Affiliated to Jiangnan University to the National Adverse Drug Reaction Monitoring System from December 2016 to December 2021 were selected as the research data,and the information such as child age,sex,body weight,examination indicators and severity of ADRs,as well as usage,dosage and combined use of azithromycin was collected,to analyze the clinical characteristics and influencing factors of children with ADRs of different severity caused by azithromycin.Results:According to the Common Terminology Criteria for Adverse Events(CTCAE)Version 5.0,among the ADR reports of 264 cases,120 cases were of severity grade Ⅰ(45.45%),91 cases were of severity grade Ⅱ(34.47%),51 cases were of severity grade Ⅲ(19.32%),and 2 cases were of severity grade Ⅳ(0.76%).Compared with patients with grade Ⅰ ADRs,those with grade Ⅱ and above ADRs were significantly younger and had smaller body weights(P<0.05),and their aspartate transaminase(AST)levels were significantly higher(P<0.05);in terms of medication,compared with patients with grade Ⅰ ADRs,those with grade Ⅱ and above ADRs had a higher proportion of azithromycin combined with ambroxol and number of combined drugs more than 3(P<0.05).The Logistic regression analysis results showed that age,body weight,AST level,azithromycin combined with ambroxol,and number of combined drugs more than 3 were the influencing factors for children with grade Ⅱ and above ADRs(P<0.05).Conclusion:Children with grade Ⅱ and above ADRs caused by intravenous azithromycin have younger age,lower body weights,higher AST levels,more combined use of azithromycin and ambroxol,and more number of combined drugs more than 3.These factors are important influencing factors for the occurrence of grade Ⅱ and above ADRs in children using intravenous azithromycin.Therefore,clinical monitoring and management of high-risk children should be strengthened to ensure the safe medication of children.
azithromycinchildrenadverse drug reactionsseverityclinical characteristicsrisk factors