57份乳块消类药品不良反应报告临床特征分析  

Analysis of clinical characteristics of 57 cases of adverse drug reaction reports of Rukuaixiao

作　　者：李学堂 谢彦军[2] 邱健珉 陈亚飞 鞠永静 李霞 LI Xuetang;XIE Yanjun;QIU Jianmin;CHEN Yafei;JU Yongjing;LI Xia(Department of Pharmacy,Linyi Central Hospital of Shandong Province,Linyi,Shandong 276400,China;Shandong Adverse Drug Reaction Monitoring Center,Jinan,Shandong 250014,China;Pharmacovigilance Center of Linyi City,Linyi,Shandong 276000,China)

机构地区：[1]山东省临沂市中心医院药学部,山东临沂276400 [2]山东省药品不良反应监测中心,山东济南250014 [3]山东省临沂市药物警戒中心,山东临沂276000

出　　处：《医药前沿》2023年第32期1-3,共3页Journal of Frontiers of Medicine

基　　金：山东省药品不良反应专业评价(临沂平台)项目课题(2022SDADRKY20)。

摘　　要：目的:分析57份乳块消类药品不良反应报告的临床特征,为临床合理用药提供参考。方法:选取2004年1月—2023年5月山东省药品不良反应监测系统中涉及乳块消类药品不良反应的报告为研究对象,按照国家药品不良反应监测中心报告质量评估标准对报告进行整理,分析药品剂型、患者性别及年龄、合并用药、药品不良反应累及器官/系统、临床表现、转归等情况。结果:根据国家药品不良反应监测中心报告质量评估标准,共纳入57份涉及乳块消类药品不良反应报告,其中一般报告56份(98.25%)、严重报告1份(1.75%),且均按说明书用法用量使用,无超剂量应用情况。57份乳块消类药品不良反应报告中,片剂占比最高,达64.92%;女性患者55例,男性2例;年龄分布以41~50岁年龄段占比最高,达43.86%;单独用药54份、合并用药3份;药品不良反应主要发生于用药后1~7 d,占比达68.42%;累及消化系统占比最高,达54.17%,1例患者出现肝损伤,且可造成肝功能异常的风险在说明书中未提及,为新发严重不良反应;患者痊愈35例(61.40%)、好转22例(38.60%)。结论:乳块消类药品不良反应以片剂为主,41~50岁年龄段患者为不良反应高发人群,且主要发生于用药后1~7 d,多累及消化系统,临床应予以重点关注。Objective To analyze the clinical characteristics of 57 reports of adverse drug reactions of Rukuaixiao,and to provide reference for clinical rational drug use.Methods From January 2004 to May 2023,the reports of adverse drug reactions involving Rukuaixiao in the adverse drug reaction monitoring system of Shandong Province were selected as the research objects.The reports were sorted out according to the report quality evaluation criteria of the National Center for Adverse Drug Reaction Monitoring,and the drug dosage form,patient gender and age,combined medication,adverse drug reactions involving organs/systems,clinical manifestations,and outcomes were analyzed.Results According to the report quality evaluation criteria of the National Center for Adverse Drug Reaction Monitoring,a total of 57 adverse drug reaction reports involving Rukuaixiao were included,including 56 cases(98.25%)of general reports and 1 case(1.75%)of serious reports.All of them were used according to the usage and dosage of the instructions,and there was no overdose application.Among the 57 reports of adverse drug reactions,tablets accounted for the highest proportion,reaching 64.92%.There were 55 female patients and 2 male patients,the age distribution is the highest in the 41-50 age group,reaching 43.86%.54 cases of single drug use,3 cases of combined drug use;Adverse drug reactions mainly occurred in 1-7 days after medication,accounting for 68.42%;The proportion of digestive system involvement was the highest,reaching 54.17%,and 1 patient had liver injury,and abnormal liver function was not mentioned in the instructions,which was a new serious adverse reaction.35 cases(61.40%)were cured and 22 cases(38.60%)were improved.Conclusions The adverse reactions of Rukuaixiao were mainly tablets.The patients aged 41-50 years-old were the high-risk group of adverse reactions,which mainly occurred 1-7 days after medication.The digestive system was mostly involved,which should be paid more attention in clinical practice.

关 键 词：不良反应 乳块消 药品剂型 临床表现 

分 类 号：R97[医药卫生—药品]