某院400例住院患者皮肤及其附件药品不良反应报告分析  

Analysis of Adverse Drug Reaction Reports of Skin and Its Appendages of 400 Inpatients in a Hospital

作　　者：胡晔 尹存林 吴慧[1,2] 张琳琳 王红霞 黄磊 HU Ye;YIN Cunlin;WU Hui;ZHANG Linlin;WANG Hongxia;HUANG Lei(Yancheng First Hospital,Affiliated Hospital of Nanjing University Medical School,Yancheng,Jiangsu,China 224000;The First People′s Hospital of Yancheng,Yancheng,Jiangsu,China 224000)

机构地区：[1]南京大学医学院附属盐城第一医院,江苏盐城224000 [2]江苏省盐城市第一人民医院,江苏盐城224000

出　　处：《中国药业》2024年第10期34-37,共4页China Pharmaceuticals

基　　金：江苏省研究型医院学会精益化用药-石药专项科研基金[JY202211]。

摘　　要：目的为临床安全用药提供参考。方法收集江苏省某三级甲等医院2019年4月至2022年12月上报国家药品不良反应监测系统的住院患者皮肤及其附件药品不良反应(ADR)报告400份,统计患者的基本信息、用药类型、给药途径、ADR类型等,采用单因素分析和二元Logistic回归分析评估皮肤严重ADR的危险因素。结果400份ADR报告涉及患者400例(432例次),其中男202例(50.50%),女198例(49.50%);年龄以0~17岁最多(142例,35.50%)。严重ADR 61例(15.25%)。临床症状以丘疹/斑丘疹最多(375例次,86.81%),主要由抗菌药物(144例次,33.33%)引起。涉及药物157种,其中化学药139种,中成药18种,多数(119种,75.80%)经静脉给药,ADR发生例次排名前10的药品均为注射剂,以碘克沙醇注射液最多(40例次,9.26%)。过敏史、肝肾疾病史、合并用药和年龄≥60岁是发生皮肤及其附件严重ADR的独立危险因素(P<0.05)。结论临床治疗时应关注有肝肾疾病史、过敏史和合并用药的老年(≥60岁)住院患者的皮肤情况,一旦发现皮肤及其附件ADR应立即对症处理,避免严重ADR的发生。Objective To provide a reference for safe drug use in clinical practice.Methods The data of 400 adverse drug reaction(ADR)reports related to skin and its appendages in inpatients reported to the National Adverse Drug Reaction Monitoring System in a grade-A tertiary hospital in Jiangsu from April 2019 to December 2022 were collected.The patients′basic information,medication type,route of administration and ADR type were collected.The univariate analysis and binary Logistic regression analysis were used to evaluate the risk factors for serious skin ADRs.Results A total of 400 patients(432 case times)were involved in 400 ADR reports,including 202 males(50.50%)and 198 females(49.50%),mostly aged 0 to 17 years(142 cases,35.50%).There were 61 cases of serious ADRs(15.25%).The most common clinical symptoms were papules/maculopapules(375 case times,86.81%),which mainly induced by antibacterial drugs(144 case times,33.33%).A total of 157 varieties of drugs were involved,including 139 chemical drugs and 18 Chinese patent medicines,and most of drugs(119 varieties,75.80%)were given intravenously;the top ten drugs inducing many case times of ADRs were all injections,among wich Iodixanol Injection was the top one(40 case times,9.26%).History of allergy,history of hepatorenal disease,concomitant medication and age≥60 years were the independent risk factors for the serious ADRs of skin and its appendages(P<0.05).Conclusion Clinical medical staff should pay attention to the skin condition of elderly inpatients(≥60 years)with a history of hepatorenal disease,history of allergy and concomitant medication.Once ADRs were detected on the skin and its appendages,targeted treatment should be taken immediately to avoid the occurrence of serious ADRs.

关 键 词：皮肤 皮肤附件 药品不良反应 严重药品不良反应 住院患者 危险因素 药事管理 

分 类 号：R917[医药卫生—药物分析学]