456例小金胶囊相关不良反应报告分析  

Analysis of 456 cases of adverse drug reactions associated with xiaojin capsules

作　　者：张琳[1] 付娜[2] 魏娟娟[1] 石秀锦[1] 林阳[1] ZHANG Lin;FU Na;WEI Juan-juan;SHI Xiu-jin;LIN Yang(Department of Pharmacy,Anzhen Hospital of Capital Medical University,Beijing 100029,China;Beijing Center for ADR Monitoring,Beijing 100035,China)

机构地区：[1]首都医科大学附属北京安贞医院药事部,北京100029 [2]北京市药品不良反应监测中心,北京100035

出　　处：《中国药物应用与监测》2020年第5期325-328,共4页Chinese Journal of Drug Application and Monitoring

基　　金：国家“十三五新药创制重大专项”(2017ZX09304017);临床医学发展专项“扬帆”计划课题(ZYLX201805)。

摘　　要：目的:分析小金胶囊相关的药品不良反应(ADR)的发生特点及因素,为规避临床用药风险提供参考。方法:调取北京市药品不良反应监测中心2009–2018年小金胶囊所致ADR报告,对数据进行整理、分析,总结其临床应用、ADR发生特点及相关因素等。结果:456例ADR报告中,女性(92%)ADR发生率远高于男性;ADR多发于40~59岁年龄段(61.8%);有60例(13.2%)患者存在药物或食物过敏史;主要原患疾病为乳腺增生(47.1%),其次为甲状腺结节(17.8%);有73例(16.0%)报告存在超说明书用药问题;多数ADR发生在用药的0~3 d内(82%);ADR主要累及系统/器官为皮肤及附件损害(89.5%),其次为全身性损害(7.5%)。结论:医疗机构需对小金胶囊所致ADR加强监测,并提高不良反应的识别能力。Objective:To analyze the characteristics and related factors of adverse drug reaction(ADR)induced by Xiaojin capsules,and provide references to avoid medication risk.Methods:Data of ADR induced by Xiaojin capsules from 2009 to 2018 collected from Beijing ADR monitoring center were analyzed in terms of clinical application,characteristics and relevant risk factors.Results:Among 456 ADRs enrolled in this study,female patients(92%)were far more than male patients.Patients aged from 40 to 59 years were accounted for the highest proportion(61.8%).There were 60 patients(13.2%)had history of drug or food allergy.The main primary disease of the patients was hyperplasia of mammary glands(47.1%)followed by thyroid nodule(17.8%).There were offlabel uses of drugs in 73 cases(16.0%).Most ADR(82%)occurred in 0–3 days after administration.The most common systems/organs involved in ADR induced by Xiaojin capsules were skin and accessories(89.5%),which were followed by the systemic damage(7.5%).Conclusion:ADR caused by Xiaojin capsules should be closely monitored and be more aware of by medical institutions.

关 键 词：小金胶囊 药品不良反应 用药分析 

分 类 号：R969.3[医药卫生—药理学]