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基于“中国医院药物警戒系统”ADR主动监测模块的研究与应用 被引量:13

Research and application of adverse drug reaction active monitoring module based on the China Hospital Pharmacovigilance System
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摘要 目的依托国家药品不良反应监测中心开发的“中国医院药物警戒系统”中药品不良反应(ADR)主动监测模块,统计分析2018年1月至7月本院ADR主动监测上报情况,探讨其目前应用效果及不足,为哨点医院的工作开展提供技术参考。方法从“中国医院药物警戒系统”数据库中导出ADR报告,对ADR报告数量、报告类型、涉及药品、累及器官/系统等进行归纳整理,并进一步探讨提高ADR检出率的措施。结果227例ADR报告中,新的严重的ADR报告(3例,1%),严重的ADR报告(32例,14%),新的一般的ADR报告(22例,10%),一般的ADR报告(170例,75%)。抗感染药物所致的不良反应(66例,29.07%)所占比例最高,其次为抗肿瘤药(39例,17.18%),以消化系统症状99例(35.48%)最为常见。结论“中国医院药物警戒系统”可以优化ADR的上报过程,缩短上报时间,提升医院ADR监测管理水平,对加强医院药物警戒工作有着重要意义。 Objective To discuss the application and possible improvement and provide technical reference for pharmacovigilance working in Sentinel hospitals through the China Hospital Pharmacovigilance System adverse drug reaction(ADR)active monitoring module developed by The National Center for Monitoring Adverse Drug Reactions.Methods The ADR reports were retrieved from the uploaded database of China Hospital Pharmacovigilance System.The quantity,type,drugs involved,and organ/systems involved in ADR were summarized and sorted out,and the measures to improve the ADR detection rate were suggested.Results Among the 227 ADR reports,3 were new and severe ADR reports(1%),32 severe ADR reports(14%),22 new and normal ADR reports(10%)and 170 general ADR reports(75%).The most frequent ADRs resulted from anti-infection drugs(66 cases,29.07%),followed by antineoplastic drugs(39 cases,17.18%).Among ADRs involving organs and/or systems,digestive system was most commonly damaged(99 cases,35.48%).Conclusion The system may optimize the reporting process of ADRs and shorten the reporting time,which can improve the monitoring and management level of ADRs and strengthen the pharmaovigilance in hospitals.
作者 吴菲 沈爱宗 李民 WU Fei;SHEN Ai-zong;LI Min(Department of Pharmacy,The First Affiliated Hospital of USTC,Division of Life Sciences and Medicine,University of Science and Technology of China,Hefei 230001)
出处 《中南药学》 CAS 2020年第1期154-157,共4页 Central South Pharmacy
关键词 中国医院药物警戒系统 主动监测 药品不良反应 China Hospital Pharmacovigilance System active monitoring adverse drug reaction
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