基于山东省药品不良反应监测中心数据库的血塞通注射剂风险信号挖掘  

Risk signal mining of Xuesaitong injection(血塞通注射剂)based on the database of Shandong Province Adverse Drug Reaction Monitoring Center

作　　者：李宁 陈焕蕾[1] 王振华[1] Li Ning;Chen Huanlei;Wang Zhenhua(Department of Clinical Pharmacy,Weifang Hospital of Traditional Chinese Medicine,Shandong Province,Weifang 261041,China)

机构地区：[1]潍坊市中医院临床药学科,潍坊261041

出　　处：《药物不良反应杂志》2023年第5期271-275,共5页Adverse Drug Reactions Journal

基　　金：山东省中医药科技项目(Q⁃2022020);山东省药品化妆品哨点课题项目(2020SDADRKY04);潍坊市卫生健康委员会中医药科研项目计划(WFZYY2020⁃4⁃109,WFZYY2022⁃4⁃020)。

摘　　要：目的挖掘血塞通注射剂的不良反应风险信号,为该药的安全合理应用提供参考。方法采用报告比值比(ROR)、比例报告比值比(PRR)和英国药品和保健品管理局综合标准法(MHRA法)3种方法对山东省药品不良反应监测中心数据库2018至2020年血塞通注射剂相关不良反应/事件(AR/AE)的风险信号进行挖掘。结果共收集到以血塞通注射剂为首要可疑药物的AR/AE报告2606例,其中男性1209例(46.39%),女性1397例(53.61%);中位年龄63岁(10~100岁),>60岁者占55.72%(1452/2606);严重AR/AE占13.24%(345/2606)。AR/AE共涉及15个器官/系统4218例次首选名称(PN),其中涉及器官/系统出现频率在前3位的为皮肤及其附件[37.15%(1567/4218)]、全身性损害[18.21%(768/4218)]和中枢及外周神经系统[14.13%(596/4218)]。ROR、PRR和MHRA法均为阳性的风险信号共19个(PN),包括喷嚏、心悸加重、心区不适、咽干、头痛加重、头胀、呼吸急促、抽搐、寒战、高热、胸闷、心动过速、头晕加重、丘疹、皮肤发热、心慌、心悸、畏寒和红斑疹,其中严重病例占比在前5位的PN依次为呼吸急促、高热、抽搐、心动过速和胸闷。结论血塞通注射剂可导致严重过敏反应,累及器官/系统以皮肤及其附件、全身性损害和中枢及外周神经系统最为常见,严重病例常表现为呼吸急促、高热、抽搐、心动过速和胸闷,在使用过程中需重点监测。Objective:To explore the adverse reaction risk signals of Xuesaitong injection,and provide reference for the safe and reasonable application of the drug.Methods:The risk signals of adverse reactions/events(AR/AE)associated with Xuesaitong injection were mined using 3 methods,including reporting odds ratio(ROR),proportional reporting ratio(PRR),and the Comprehensive Standard Method of Medicines and Healthcare Products Regulatory Agency(MHRA)based on data in Shandong Province Adverse Drug Reaction Monitoring Center Database from 2018 to 2020.Results:A total of 2606 AR/AE reports with Xuesaitong injection as the primary suspect drug were collected,involving 1209 males(46.39%)and 1397 females(53.61%).The median age of these patients was 63 years,ranging from 10 to 100 years,and 55.72%(1452/2606)of them were over 60 years.Severe AR/AE accounted for 13.24%(345/2606).AR/AE involved a total of 15 organs/systems,and relevant preferred names(PN)appeared 4218 times.Among them,the organs/systems involved ranking top 3 in frequency were skin and accessories[37.15%(1567/4218)],systemic disorders[18.21%(768/4218)],and central and peripheral nervous system[14.13%(596/4218)].There were a total of 19 risk signals that were positive by the ROR,PRR,and MHRA method,including sneezing,worsening palmus,discomfort in the cardiac area,dry throat,worsening headache,distention in the head,shortness of breath,convulsions,chills,high fever,chest tightness,tachycardia,worsening dizziness,papules,skin warm,palpitation,palmus,feeling cold,and erythema.The top 5 PN with severe cases were shortness of breath,high fever,convulsions,tachycardia,and chest tightness.Conclusions:Xuesaitong injection can lead to severe anaphylaxis and the most common organs/systems involved are skin and accessories,systemic disorders,and central and peripheral nervous system.Severe cases often present with shortness of breath,high fever,convulsions,tachycardia,and chest tightness,which require intensive monitoring during use of the drug.

关 键 词：药物不良反应报告系统 信号处理 计算机辅助 药物警戒 血塞通注射剂 中药注射剂 

分 类 号：R288[医药卫生—中药学]