某儿童医院静脉用阿奇霉素所致不同严重程度药物不良反应的临床特点与影响因素分析

Analysis of Clinical Characteristics and Influencing Factors of Adverse Drug Reactions of Different Severity Caused by Intravenous Azithromycin in a Children's Hospital

目的:分析医院静脉用阿奇霉素所致不同严重程度药物不良反应(adverse drug reactions,ADRs)患儿的临床特点与影响因素,为临床阿奇霉素的安全合理使用提供参考。方法:选取2016年12月—2021年12月江南大学附属无锡市儿童医院上报国家药品不良反应监测系统的264例静脉用阿奇霉素所致ADRs报告作为研究资料,采集患儿的年龄、性别、体质量、检查指标和ADRs严重程度,以及阿奇霉素的用法用量和联合用药等情况,分析阿奇霉素所致不同严重程度ADRs患儿的临床特点与影响因素。结果:根据《常见不良反应术语评定标准(CTCAE)5.0版》,264例ADRs报告中,严重程度Ⅰ级的有120例(占45.45%),Ⅱ级的有91例(占34.47%),Ⅲ级的有51例(占19.32%),Ⅳ级的有2例(占0.76%);与Ⅰ级ADRs患者相比,Ⅱ级及以上ADRs患者的年龄和体质量均明显更小(P<0.05),而其天冬氨酸转氨酶(aspartate transaminase,AST)水平则明显更高(P<0.05);而在用药方面,相较于Ⅰ级ADRs患者,Ⅱ级及以上ADRs患者阿奇霉素与氨溴索联用、联合用药数>3种的占比更高(P<0.05);Logistic回归分析结果显示,年龄、体质量、AST水平、阿奇霉素与氨溴索联用、联合用药数>3种是患儿发生Ⅱ级以上ADRs的影响因素(P<0.05)。结论:静脉用阿奇霉素所致的Ⅱ级及以上ADRs患儿存在低年龄、低体质量、高AST水平、更多的阿奇霉素与氨溴索联用、更多的联合用药数>3种的情况,而这些因素也是使用静脉用阿奇霉素患儿发生Ⅱ级及以上ADRs的重要影响因素,临床对于高风险患儿应当加强监护和管理,以确保患儿的用药安全。

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.