某院2014-2019年296例中药注射剂不良反应/事件报告分析  

An analysis of reports of 296 TCM injection adverse reactions or events in a hospital from 2014 to 2019

作　　者：邓志清[1] 罗忠勇[1] 贺少仕 禹琦[1] DENG Zhiqing;LUO Zhongyong;HE Shaoshi;YU Qi(Pharmacy Department,Loudi Central Hospital of Hu'nan Province,Hu'nan,Loudi 417000,China)

机构地区：[1]湖南省娄底市中心医院药剂科,湖南娄底417000

出　　处：《中国医药科学》2021年第24期137-141,共5页China Medicine And Pharmacy

基　　金：湖南省娄底市中心医院科研项目(Y2020-16)。

摘　　要：目的分析娄底市中心医院中药注射剂不良反应/事件(ADR/ADE)发生的特点,为临床合理用药提供参考。方法对我院2014年1月至2019年12月上报的296例中药注射剂ADR/ADE报告进行统计分析,包括患者性别与年龄,引发ADR/ADE的药品分布,ADR/ADE累及器官/系统的主要临床表现,严重ADR/ADE的转归情况等。结果在296例ADR/ADE报告中,共涉及药物品种22种,出现例次排名前3位的为注射用血塞通、注射用血栓通、参麦注射液;ADR/ADE主要累及的器官/系统为皮肤及其附件损害(184例次,占39.57%);严重的ADR/ADE有18例(6.08%),17例痊愈,1例好转,主要临床表现为高热、寒战、血压降低、呼吸困难等全身性损害。结论中药注射剂因成分复杂和临床不合理使用易发生ADR/ADE,临床上应采取辨证论治、处方前置审核、输液安全监测等措施减少ADR/ADE的重复发生。Objective To analyze the characteristics of the incidence of traditional Chinese medicine(TCM)injection adverse reactions or events(ADRs/ADEs)in Loudi Central Hospital,and to provide reference for rational use of medicine in clinical practice.Methods A total of 296 TCM injection ADR/ADE reported in our hospital from January 2014 to December 2019 were statistically analyzed,covering the patients'gender and age,the distribution of medicines that incur ADR/ADE,main clinical manifestations of ADR/ADE involving organs or systems,the prognosis of severe ADR/ADE,etc.Results Among the 296 ADR/ADE reports,22 medicine varieties were involved,and the top three were Sanqi Panax Notoginseng for Injection,hrombus scavenger injection and Shenmai injection.The main ADR/ADE involving organs or systems were skin and its accessories that had been injured(184 cases which accounted for 39.57%).There were 18 cases(6.08%)of severe ADR/ADE,among which 17 cases were cured and 1 case was ameliorated,with the clinical manifestations being mainly systemic damage such as high fever,chills,decreased blood pressure,dyspnea,etc.Conclusion TCM injections are prone to ADR/ADE due to complex components and irrational clinical use,and measures such as treatment based on syndrome differentiation,pre-prescription review,infusion safety monitoring,etc.should be taken in clinical practice to reduce the recurrence of ADR/ADE.

关 键 词：药品不良反应 药品不良事件 合理用药 回顾性分析 

分 类 号：R285.6[医药卫生—中药学]