银杏注射制剂疑似药品不良反应监测数据分析  

Analysis of Suspected ADR Monitoring Data of Ginkgo Injection Preparations

作　　者：张雨[1] 李雨蔓 夏旭东 ZHANG Yu;LI Yu-man;XIA Xu-dong(Department of Pharmacy,Zhengzhou Railway Vocational and Technical College,Henan Zhengzhou 450052,China;Henan Drug Reevaluation Center,Henan Zhengzhou 450004,China)

机构地区：[1]郑州铁路职业技术学院药学系,河南郑州450052 [2]河南省药品评价中心,河南郑州450004

出　　处：《中国药物评价》2023年第5期439-444,共6页Chinese Journal of Drug Evaluation

摘　　要：目的:比较来自于河南省药品不良反应监测自发报告系统的银杏注射制剂(舒血宁注射液、银杏达莫注射液、银杏提取物注射液、银杏内酯注射液、杏芎氯化钠注射液、银杏二萜内酯葡胺注射液)的不良反应发生情况,为临床合理用药及药品风险评估提供参考依据。方法:对2014—2021年河南省药品不良反应自发报告系统收集的疑似银杏注射制剂不良反应监测数据进行对比分析。结果和结论:银杏注射制剂不良反应报告主要来自于医疗机构;人群性别分布总体较均匀;患者年龄集中分布在60岁以上;不良反应表现以一般不良反应为主,表现为瘙痒、皮疹、恶心、潮红、发热等;新的药品不良反应有呼吸困难、心悸、静脉炎、失眠等。对于新的药品不良反应,建议药品上市许可持有人加强监测,积极开展信号监测及风险评估工作。To compare the occurrence of ADR of ginkgo injection preparations(Shuxuening injection,ginkgo Damo injection,ginkgo extract injection,ginkgolide injection,xingxiong sodium chloride injection and ginkgolide glucosamine injection)in Henan Province ADR monitoring system.so as to provide reference basis for clinical rational drug use and drug risk assessment.Methods:The adverse drug reaction information of suspected ginkgo injection collected by the spontaneous adverse drug reaction reporting system of Henan Province from 2014 to 2021 was compared and analyzed.Results&Conclusion:Reports of adverse reactions of ginkgo injection were mainly from medical institutions.The gender distribution of the population is generally uniform.The patients were more than 60 years old.The main ADR were general adverse reactions,including pruritus,rash,nausea,flushing,fever,etc.The new ADR include dyspnea,palpitation,phlebitis,insomnia and so on.For new ADR.It is recommended that drug marketing authorization holders strengthen monitoring and actively carry out signal monitoring and risk assessment.

关 键 词：银杏注射制剂 药品不良反应 信号检测 数据分析 

分 类 号：R994.11[医药卫生—毒理学]