全军ADR监测中心2011–2016年273例风险病例报告分析  

The analysis of 273 cases of risk case reports by ADR monitoring center during 2011-2016

作　　者：赵靓[1] 郭代红[1] 陈超[1] 赵博宇[2] 田小燕[2] 赵粟裕 赵鹏芝[1] ZHAO Liang;GUO Dai-hong;CHEN Chao;ZHAO Bo-yu;TIAN Xiao-Yan;ZHAO Su-yu;ZHAO Peng-zhi(PLA ADR Monitoring Center, Beijing 100853, China;College of Pharmacy, Chongqing Medical University, Chongqing 401331, China)

机构地区：[1]解放军总医院全军ADR监测中心,北京100853 [2]重庆医科大学药学院,重庆401331

出　　处：《中国药物应用与监测》2017年第2期102-106,共5页Chinese Journal of Drug Application and Monitoring

基　　金：2014全军后勤科研重点项目(BWS14R039)

摘　　要：目的:系统总结解放军ADR监测中心风险信号筛选、反馈、利用工作,分析风险病例报告的临床特点、规律和相关因素。方法:采用回顾性分析方法,对2011–2016年期间发布的60期《严重ADR报告月度分析简报》273例风险病例相关特征因素进行统计分析。结果:273例病例中,新发严重ADR 186例,集中趋势41例,加关注35例,死亡11例;男女比例为1.44:1,平均年龄(52.98±18.10)岁,构成比最大的年龄群为60~74岁;静脉给药为主要给药途径(65.20%),ADR多发生于用药后1 d以内(61.17%),涉及可疑药品以中药或中成药与抗感染药物构成比最高(21.25%,12.82%),所有风险病例以免疫疾病及感染、肝胆疾病构成比最高(28.29%,12.83%);不合理用药19例(6.96%)。结论:实施月度简报制度是筛选风险警示信息的有效手段,能够提供值得进一步验证的风险信号;新发严重病例为风险信号主要来源,临床用药时应重点关注;临床应提高ADR警戒意识,注意规避不合理用药导致的风险。Objective:To summarize the screening,feedback and utilization of the risk signals of the PLA ADR monitoring center,and to analyze the clinical characteristics,rules and relevant factors of case reports.Methods:A retrospective analysis was conducted to analyze the risk factors associated with the60monthly serious ADR monthly reports published from2011to2016.Results:Among the273risk cases,186were new cases,41were concentrated,35were concerned and11were dead.The ratio of male to female was1.44:1,the average age was(52.98±18.10)years,the age group with the highest proportion was60–74yearsold;intravenous administration was the main route of administration(65.20%),61.17%cases occurred within1day after treatment,most of the suspected drug was traditional Chinese medicine or anti-infective drugs(21.25%,12.82%,respectively).Among all therisk cases,the highest proportion(28.29%,12.83%respectively)was immune diseases and infection,and19cases(6.96%)were irrational uses of drugs.Conclusion:The implementation of the monthly bulletin system is an effective means to screen the riskwarning information.The new cases should be the main source of the risk signals,and the clinical medication should be paid more attentions.

关 键 词：药品不良反应 风险信号 合理用药 

分 类 号：R82[医药卫生—临床医学]