2017年江苏省1452例热毒宁注射液不良反应报告分析  

Analysis of 1 452 Cases of Adverse Drug Reactions of Reduning Injection in Jiangsu Province

作　　者：余舒乐 王梦雷 丁跃辉[1,2] 叶露 陈红斗 Yu Shule;Wang Menglei;Ding Yuehui;Ye Lu;Chen Hongdou(Department of Pharmacy,Affiliated Suqian Hospital of Xuzhou Medical University,Suqian 223800,Jiangsu,China;Suqian People's Hospital of Nanjing Drum-Tower Hospital Group)

机构地区：[1]徐州医科大学附属宿迁医院药学部,江苏宿迁223800 [2]南京鼓楼医院集团宿迁市人民医院药学部

出　　处：《药物流行病学杂志》2019年第12期800-804,共5页Chinese Journal of Pharmacoepidemiology

基　　金：2018年度宿迁市科技计划项目(编号:Z2018074)

摘　　要：目的:了解热毒宁注射液发生药品不良反应(ADR)的特点及相关因素,探讨其安全性,为临床用药提供参考。方法:提取2017年江苏省药品不良反应监测系统中符合纳入标准的热毒宁注射液ADR报告共1452例,统计患者的性别、年龄、原患疾病,用药剂量、给药途径、溶媒、联合用药情况,以及ADR发生时间、累及器官系统与临床表现、处置与转归情况等,按相关定义划分为一般的、新的、严重的ADR,对照说明书,从适应证、用药剂量、给药途径、溶媒、疗程等方面评价热毒宁注射液用药合理性。结果:1452例热毒宁注射液ADR报告中,一般的ADR 1390例,新的ADR 233例,严重的ADR 62例,新的严重的ADR 26例。发生较多的是<10岁的儿童,有837例(57.64%);1112例(76.58%)ADR发生在用药前30 min;联合用药596例(41.05%);不合理用药所致ADR中,无适应证41例(2.89%),剂量不合理286例(19.70%),给药途径不合理25例(1.72%),超疗程37例(2.55%),溶媒不合理18例(1.24%);ADR累及系统/器官1665例次,主要为皮肤系统995例次(59.76%)。结论:热毒宁注射液ADR例数较多,但严重的ADR例数较少,最常见的是过敏反应,且存在一些不合理使用情况,临床应加强合理用药,确保用药安全。Objective:To analyze the characteristics and related factors of adverse drug reactions(ADR)in reduning injection,and to discuss its safety,so as to provide reference for clinical medication.Methods:113721 reports collected from the 2017 adverse reactions database of Jiangsu province,and 1452 reports of reduning injection were extracted for retrospective analysis.The patient’s gender,age,primary disease,dosage,administration route,solvent,combination medication,occurrence time,the organ systems involved,and clinical manifestation,treatment and outcome were collected and the rationality was evaluated according to the instruction.Results:Among the 1452 cases,1390 were normal,233 were new,62 were severe,and 26 were new and severe.837 cases(57.64%)were children<10 years old and 1112 cases(76.58%)occurred within 30 min during the medication.There were 41 cases(2.89%)of unindicated drugs,286 cases(19.70%)of unreasonable doses,25 cases(1.72%)of improper routes of administration,37 cases(2.55%)of over-course of drugs,18 cases(1.24%)of unreasonable solvents,and 596 cases(40.05%)of combined drugs.ADR involved 1665 cases of system/organ mainly 995 cases of skin system(59.76%).Conclusion:Although there are many cases of adverse reactions to reduning,there are few cases of severe adverse reactions,the most common is allergic reaction,and there are some unreasonable uses in practice.Therefore,rational drug use should be strengthened in clinical practice to ensure drug safety.

关 键 词：热毒宁注射液 药品不良反应 报告 合理用药 安全用药 

分 类 号：R286[医药卫生—中药学]