2010-2022年武汉市出血相关不良反应/事件分析  

Analysis of Hemorrhage Related Adverse Drug Reactions/Events in Wuhan Between 2010 and 2022

作　　者：江莹 漆建军 魏安华 王璐 李田 姚梦迪 曾露[2] JIANG Ying;QI Jianjun;WEI Anhua;WANG Lu;LI Tian;YAO Mengdi;ZENG Lu(Wuhan Center for ADR/ADE Monitoring,Wuhan Hubei 430000,China;Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan Hubei 430033,China)

机构地区：[1]武汉市药品不良反应监测中心,湖北武汉430000 [2]华中科技大学同济医学院附属同济医院,湖北武汉430033

出　　处：《药品评价》2023年第9期1045-1049,共5页Drug Evaluation

摘　　要：目的 探讨武汉市出血相关药物不良反应/事件(ADR/ADE)的发生规律和临床特点,为临床安全用药提供参考依据。方法 采用回顾性研究方法,收集2010年1月至2020年12月年武汉市ADR自发呈报系统数据库中出血相关ADR/ADE报告,对患者人口学特征、出血相关不良反应/事件类型及器官分布等进行汇总,并深入分析出血高风险药品。结果 共纳入2 005例报告,数量呈逐年上升趋势,主要集中在60岁以上年龄段,男女构成比为1.34∶1;严重报告占比33.87%;ADR/ADE报告共涉及17类、341种药物,高风险药物排名前三分别为抗栓药物(66.03%)、抗感染药物(11.32%)、中药(4.79%);出血ADR发生时间多为用药7 d内;发生例次前3的首选语(PT)为血尿、胃出血、便血,涉及系统器官分类(SOC)为肾脏及泌尿系统疾病、胃肠系统疾病、血管与淋巴管类疾病。结论 出血高风险药品主要为抗栓药,但抗感染药物和中药诱发的出血事件也值得关注,药师需加强药学监护,不仅要关注出血ADR发生的主要部位泌尿道和胃肠道,还需关注老年人以及颅内等重要器官。Objective To investigate the occurrence regularity and clinical characteristics of hemorrhage related adverse drug reactions/events(ADR/ADE)in Wuhan,and to provide reference for clinical safe drug use.Methods A retrospective study was conducted to collect hemorrhage related ADR/ADE reports from Wuhan ADR Spontaneous Reporting System database from January 2010 to December 2020.The demographic characteristics,bleeding types and organ distribution of patients were summarized,and the drugs with high bleeding risk were analyzed in depth.Results A total of 2005 cases were included,the number of which showed an increasing trend year by year,mainly in the age group above 60,and the ratio of male to female was 1.34∶1,the proportion of"serious"was 33.87%.ADR/ADE reports involved a total of 17 categories and 341 kinds of drugs,and the high-risk drugs were mainly antithrombotic drugs(66.03%),next were anti-infective drugs(11.32%),traditional Chinese medicine(4.79%).Most bleeding events occurred within 7 days.The first 3 preferred terms(PT)cases were hematuria,gastric hemorrhage,and hematochezia,and system organ classification(SOC)mainly involved kidney and urinary system diseases,gastrointestinal system diseases,vascular and lymphatic diseases.Conclusion The drugs with high risk of drug-induced hemorrhage are mainly anti-thrombotic drugs,but the hemorrhage events induced by anti-infective drugs and Chinese medicine are also worthy of attention.Pharmacists need to strengthen pharmaceutical care,paying attention not only to the urinary tract and gastrointestinal tract,but also to the elderly and important organs such as the intracranial.

关 键 词：药物相关性副作用和不良反应 药物不良反应/事件 出血 自发呈报系统 药物警戒 药物副反应报告系统 

分 类 号：R95[医药卫生—药学]