贺州市医疗机构2014-2024年儿童药品不良反应调查分析  

Investigation and Analysis on Adverse Drug Reactions in Children in Medical Institutions of Hezhou from 2014 to 2024

作　　者：于丽华 赖经纶 蔡凌云 Yu Lihua;Lai Jinglun;Cai Lingyun(Hezhou Hospital of Traditional Chinese Medicine,Guangxi Hezhou 542899,China;Hezhou Market Supervision and Administration Bureau,Guangxi Hezhou 542899,China)

机构地区：[1]贺州市中医医院,广西贺州542899 [2]贺州市市场监督管理局,广西贺州542899

出　　处：《儿科药学杂志》2025年第4期18-24,共7页Journal of Pediatric Pharmacy

摘　　要：目的:回顾性分析2014年1月至2024年6月贺州市医疗机构上报的18岁以下儿童药品不良反应(ADR)报告,探讨儿童ADR的发生情况、特点及主要诱因,为儿童ADR监测与合理用药提供参考。方法:采用回顾性分析方法,对收集的ADR报告进行统计分析,包括ADR类型、临床表现、发生时间、涉及药物种类、给药途径、患儿年龄及性别分布等。结果:收集的3 531例ADR报告中已知一般ADR 2 586例(73.23%),新的一般ADR 688例(19.48%),已知严重ADR 217例(6.15%),新的严重ADR 40例(1.13%)。发生ADR的患儿年龄主要为≥28 d~7岁。发生ADR给药途径以静脉用药为主,其中静脉滴注2 973例(84.20%)、静脉注射95例(2.69%)、泵内注射29例(0.82%),其次是口服给药258例(7.31%)。引发ADR的前3位药品种类分别为抗菌药物1 518例(42.99%)、中成药845例(23.93%)、抗病毒药物346例(9.80%)。ADR最高的前10种药品分别为注射用双黄连冻干粉、清开灵注射液、注射用头孢曲松钠、注射用炎琥宁、注射用头孢哌酮钠/舒巴坦钠、注射用头孢呋辛钠、注射用头孢他啶、注射用哌拉西林钠/舒巴坦钠、注射用阿奇霉素、痰热清注射液。ADR累及系统/器官最多的是皮肤及其附件损害(2 453例,69.47%),其次是消化系统损害(361例,10.22%)和全身性损害(193例,5.47%)。结论:贺州市医疗机构上报的ADR发生情况、特点与国内报道相似,应强化医务工作者在静脉给药、联合用药、抗菌药物及中药注射剂的监管,加强专科临床药师对ADR的监测,减少儿童ADR的发生,保障儿童用药安全。Objective:To retrospectively analyze the adverse drug reactions(ADR)reports of children under 18 years reported by medical institutions in Hezhou from Jan.2014 to Jun.2024,and to explore the occurrence,characteristics and main causes of ADR in children,so as to provide reference for monitoring and rational drug use of ADR in children.Methods:Retrospective analysis was used to statistically analyze the types of ADR reports,clinical manifestations,timing of occurrence,drug categories,administration routes,and age and gender distributions of affected children.Results:Among the 3,531 ADR reports collected,2,586 cases(73.23%)were general ADR,688 cases were new general ADR(19.48%),217 cases were severe ADR(6.15%)and 40 cases were new severe ADR(1.13%).The age of children with ADR mainly ranged from⩾28 d to 7 years.The main administration routes of ADR were intravenous infusion in 2,973 cases(84.20%),intravenous injection in 95 cases(2.69%),and intra-pump injection in 29 cases(0.82%),followed by oral administration in 258 cases(7.31%).The top 3 drug categories of ADR were respectively antibacterial drugs in 1,518 cases(42.99%),Chinese patent medicine in 845 cases(23.93%)and antiviral drugs in 346 cases(9.80%).The top 10 drugs with the highest ADR were respectively Shuanghuanglian injection(lyophilized),Qingkailing injection,ceftriaxone sodium for injection,potassium sodium dehydroandrographolide succinate for injection,cefoperazone sodium for injection,cefuroxime sodium for injection,ceftazidime for injection,piperacillin sodium and sulbactam sodium for injection,azithromycin for injection,and Tanreqing injection.The most common system/organ involvements caused by ADR were damage of skin and its appendages(2,453 cases,69.47%),followed by the digestive system damage(361 cases,10.22%)and systemic damage(193 cases,5.47%).Conclusion:The situation and characteristics of ADR in medical institutions in Hezhou are similar to those reported in China.The supervision of medical staff in intravenous drug administration,drug combi

关 键 词：儿童 药品不良反应 用药安全 

分 类 号：R969.3[医药卫生—药理学]