十年间ADR自发报告中467例典型病例风险信号再评价  

Re-evaluation of the risk signals of 467 typical cases based on ADR spontaneous reports of ten years

作　　者：高奥 赵鹏芝[1,2] 郭代红 GAO Ao;ZHAO Peng-zhi;GUO Dai-hong(Department ofPharmacy,Medical Supplies Center of Chinese PLA General Hospital,Beijing 100853,China;PLA ADR Monitoring Center,Beijing 200853,China)

机构地区：[1]解放军总医院医疗保障中心药剂科,北京100853 [2]解放军药品不良反应监测中心,北京100853

出　　处：《中国药物应用与监测》2022年第6期385-390,共6页Chinese Journal of Drug Application and Monitoring

基　　金：2017年军事医学创新工程重点项目(17CXZ010)。

摘　　要：目的:分析我中心10年间上报的药品不良反应(ADR)中典型风险病例的临床特点、风险分布和防治措施。方法:采用回顾性研究方法,对2011–2021年发布的120期《严重ADR报告月度分析简报》进行整理归纳,共收集467例典型病例相关风险信息,对其进行统计分析。结果:在214463例ADR自发报告中,评级严重报告19209例,经风险信号筛选确定典型病例467例(2.43%);其中新发严重333例、加关注66例、集中趋势48例、死亡20例;患者男女比例为1.46∶1,平均年龄(54.26±19.43)岁;导致ADR的主要药物剂型为注射制剂(70.88%),主要给药途径为静脉注射(63.60%);主要药品类别为抗感染药物(14.13%);累及器官/系统主要为免疫异常及感染(28.88%);主要表现为过敏性休克。结论:月度简报制度强化了ADR自发报告的数据挖掘利用,提升了风险信号筛选质量,有助于开展进一步的风险信号验证;对于军队药物警戒系统的运转、各网点医院的安全合理用药、以及药品说明书的完善等均具有显著的促进作用。Objective:To analyze the clinical characteristics,risk distribution,prevention and treatment measures of typical risk cases of adverse drug reaction(ADR)reported by our center in the past decade.Methods:A retrospective analysis was conducted on 467 typical risk cases reports from 120 monthly analysis briefs of severe ADR reports published from 2011 to 2021.Results:A total of 467 typical cases(2.43%)were identified by risk signal screening from 214463 spontaneous ADR reports with 19209 severe ADRs,among which 333 cases were newly severe,66 cases were concerned,48 cases were central trend,and 20 cases were dead.The male to female ratio was 1.46∶1,and the average age was(54.26±19.43)years old.Injection(70.88%)was the main dosage form,and intravenous injection(63.60%)was the main route of administration.The main drugs involved were anti-infective drugs(14.13%).The main systems/organs involved were immune abnormalities and infection(28.88%).The main manifestation was anaphylactic shock.Conclusion:The monthly-brief-report system could improve the data mining and utilization of ADR spontaneous reports,the screening quality of risk signals,and help to carry out further verification of risk signals,which could also significantly promote the operation of military pharmacovigilance system,safe and rational drug use in hospitals in various branches,and the improvement of drug instruction.

关 键 词：药品不良反应 严重药品不良反应报告 风险信号 典型病例 

分 类 号：R969.3[医药卫生—药理学] R979.1[医药卫生—药学]