619例严重药品不良反应报告回顾性分析  

Retrospective analysis of 619 cases of serious adverse drug reactions

作　　者：王平 WANG Ping(Huainan Food and Drug Inspection Detachment Complaint and Reporting Center,Huainan,Anhui 232007,China)

机构地区：[1]淮南市食品药品稽查支队投诉举报中心,安徽淮南232007

出　　处：《安徽医药》2020年第8期1693-1696,共4页Anhui Medical and Pharmaceutical Journal

摘　　要：目的对严重药品不良反应(SADR)发生的特点、规律和影响因素进行统计分析,为指导临床安全合理用药提供依据。方法利用EXCEL数据透视表等功能,对淮南市2015-2019年通过"国家药品不良反应监测系统"上报的SADR监测数据进行统计分析。结果 2015-2019年累计收集上报SADR报告619例(1.8%)。其中女性350例(56.5%),男性268例(43.3%);SADR高发年龄段为61~70岁,为166例(26.8%);涉及药物剂型24种,其中注射剂SADR为460例,构成比最高(74.3%);静脉滴注给药SADR为408例,构成比最高(65.9%);涉及283个品种规格,抗肿瘤药物SADR为159例,构成比最高(25.7%),其中,注射用盐酸吉西他滨的SADR报告最多,为40例(6.5%)。结论 SADR累及系统-器官范围广,对病人健康和生命安全危害大,是提示影响公众用药安全的最重要信息。SADR的发生与病人年龄、药物剂型、给药途径和用药品种等多种因素有关。合理用药是减少SADR发生的关键因素之一。医疗机构应加强抗肿瘤药物、抗菌药物和静脉给药SADR监测,注重实施风险预警。Objective To analyze the characteristics,regularity and influencing factors of serious adverse drug reactions(SADR),and to provide a basis for guiding clinical safe and rational drug use.Methods Using EXCEL data pivot table and other functions,statistical analysis of SADR monitoring data reported by Huainan City from 2015 to 2019 through the "National Adverse Drug Reaction Monitoring System".Results From 2015 to 2019,619 cases(1.8%)of SADR reports were collected and reported.Among them,350 cases were female(56.5%)and 268 were male(43.3%);the high incidence of SADR was 61 to 70 years old,and had166 cases(26.8%);24 drug dosage forms were involved,of which 460 were SADR injections,the highest composition ratio was74.3%;408 cases of SADR administered by intravenous infusion,the highest composition ratiowas 65.9%;283 varieties of specificationswere involved,the antitumor drug SADR was 159 cases,the highest composition ratio was 25.7%,of which,the SADR of gemcitabine hydrochloride for injection was the most reported,with 40 cases(6.5%).Conclusions SADR involves a wide range of organs and organs,and poses a great harm to human health and life safety.It is the most important information that prompts the impact of public drug safety.The occurrence of SADR is related to a variety of factors such as the patient’s age,drug dosage form,administration route and medication variety.Reasonable medication is one of the key factors to reduce the occurrence of SADR.Medical institutions should strictly follow the four principles of safety,effectiveness,economy,and appropriateness,so that it can be taken orally without intramuscular injection,intramuscular injection without infusion.Anti-tumor drugs,anti-infective drugs and intravenous SADR monitoring should be strengthened,focusing on collecting drug safety risk information such as SADR with pharmacovigilance significance,ADR monitoring technical institutions at all levels should strengthen mission training and risk warning,prompting the public to use drugs safely,and minimizing th

关 键 词：药物毒性 药物副反应报告系统 处方不当 合理用药 

分 类 号：R95[医药卫生—药学]