2010年至2017年北京地区246例多索茶碱药物不良反应报告分析  

Analysis of 246 cases of adverse drug reactions induced by doxofylline in Beijing area from 2010 to 2017

作　　者：石秀锦[1] 梁颖[1] 张晓[2] 方振威[1] 魏娟娟[1] 林阳[1] SHI Xiu-jin;LIANG Ying;ZHANG Xiao;FANG Zhen-wei;WEI Juan-juan;LIN Yang(Department of Pharmacy,Beijing Anzhen Hospital,Capital Medical University,Beijing 100029,China;Beijing Center for Adverse Drug Reaction Monitoring,Beijing 100054,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,北京100054

出　　处：《中国临床药理学杂志》2020年第10期1369-1373,共5页The Chinese Journal of Clinical Pharmacology

基　　金：北京市医院管理中心临床医学发展专项经费基金资助项目(ZYLX201805)。

摘　　要：目的统计分析多索茶碱药物不良反应(ADR)的发生特点,为临床多索茶碱合理用药提供参考。方法收集整理2010年至2017年北京市药品不良反应监测中心数据库怀疑药品为多索茶碱的ADR报告,提取患者一般情况、用药情况、ADR发生情况及转归等信息,按照MedDRA系统将ADR分类,进行统计分析。结果246例ADR报告中,男84例,年龄(64.8±15.6)岁,50岁以上者占86.9%;女162例,年龄(69.5±14.2)岁,50岁以上者占90.1%。原患疾病以呼吸系统疾病、循环系统疾病及神经疾病位列前3位。静脉滴注(95.6%)为主要给药途径,超过一半(53.3%)的ADR发生在用药第1天。ADR导致神经系统疾病(19.0%)、心脏器官疾病(17.0%)、皮肤及皮下组织类疾病(16.4%)列为前3位,临床表现多见心悸、头晕、恶心、皮疹、过敏样反应、憋气等;严重ADR报告4例,表现为晕厥(1例)、抽搐(1例)、心脏不适(1例)和肝细胞损害(1例)。结论临床应重视多索茶碱的合理使用,加强ADR监测以防范或规避相关用药风险。Objective To analyze the characteristics of adverse drug reaction(ADR)induced by doxofylline,and provide references for the clinical rational use.Methods The ADR reports of doxofylline were collected from 2010 to 2017 in the database of Beijing Center for ADR Monitoring and systematically classified according to MedDRA system.The information of patients’general condition,medication condition,adverse reactions and outcome were extracted and statistically analyzed.Results Among the 246 ADR cases,84 were males,with an average age of(64.8±15.6)years,86.9%were over 50 years old;162 were females,with an average age of(69.5±14.2)years,90.1%were over 50 years old.Respiratory diseases,circulatory diseases and neurological diseases were the top three among primary diseases.Intravenous drip(95.6%)was the main route of administration.More than half(53.3%)of ADRs occurred on the first day of treatment.ADRs mainly involved the nervous system diseases(19.0%),heart organ diseases(17.0%),skin and subcutaneous tissue diseases(16.4%).Main manifestations of ADRs were palpitation,dizziness,nausea,rash,allergic reaction,breathing,etc.Serious ADR was reported in 4 cases,including syncope(1 case),convulsion(1 case),heart discomfort(1 case)and liver cell damage(1 case).Conclusion The rational use of doxofylline needs attention.ADR monitoring should be strengthened in order to prevent or avoid medication-related risks.

关 键 词：多索茶碱 药物不良反应 合理用药 

分 类 号：R97[医药卫生—药品]