348例银杏内酯注射液致过敏样反应分析

Case Report of 348 Patients with Allergic-like Reactions Caused by Ginkgolide Injection

目的:分析银杏内酯注射液致过敏样反应的发生情况,为预防发生药品不良反应(ADR)及保障患者用药安全提供参考。方法:收集福建省2004年1月~2023年2月期间上报国家药品不良反应监测系统中使用银杏内酯注射液引起过敏样反应患者的基本信息,包括性别、年龄、ADR发生时间、累及系统-器官损害、临床表现等,并进行统计分析。结果:共纳入348例ADR报告,其中男性130例,女性218例,男女比例为0.6∶1;患者年龄主要集中在60岁及以上(272例,78.16%);ADR发生时间主要集中在用药过程中(302例,86.78%);348例ADR报告共涉及临床表现622例次,累及血管及淋巴管类疾病(247例次,39.71%)、皮肤及皮下组织类疾病(209例次,33.60%)等,其中新的ADR主要表现为皮疹、瘙痒等(333例次,53.54%),已知ADR主要表现为潮红、眩晕、恶心等(289例次,46.46%);经停药或对症处理后,患者痊愈(112例,32.18%)或好转(236例,67.82%)。结论:临床应加强银杏内酯注射液的用药监测,用药过程中需重视其引起的ADR并及时处理,以保障患者用药安全。

Objective:To analyze the occurrence of allergic-like reactions caused by ginkgolide injection,and provide reference for preventing adverse drug reactions(ADR)and ensure patient's medication safety.Methods:Collect the basic information on patients with allergic-like reactions caused by the use of ginkgolide injection reported to the National Adverse Drug Reaction Monitoring System in Fujian province from January 2004 to February 2023.The information includes gender,age,ADR occurrence time,involvement of systemic organ damage,clinical manifestations,etc.Statistical analysis was conducted.Results:A total of 348 ADR reports were included,including 130 males and 218 females,resulting in a male to female ratio of 0.6:1.The majority of patients were aged 60 years and above(272 cases,78.16%).ADR mainly occurred during the medication process(302 cases,86.78%).348 ADR reports involved a total of 622 clinical manifestations,including vascular and lymphatic vessel diseases(247 cases,39.71%),skin and subcutaneous tissue diseases(209 cases,33.60%),etc.New ADRs mainly manifested as rash,itching,etc.(333 cases,53.54%),while known ADRs mainly manifested as flushing,dizziness,nausea,etc.(289 cases,46.46%).After discontinuation of medication or symptomatic treatment,112 patients recovered(32.18%)or 236 patients improved(67.82%).Conclusion:Enhanced clinical monitoring of ginkgolide injection usage is recommended,with particular attention to ADRs during the medication process.Timely treatment should be administrated to ensure the patient safety during medication.