中国药物警戒 ›› 2014, Vol. 11 ›› Issue (7): 407-412.

• 药械安全性研究 • 上一篇    下一篇

药品不良反应报告数据规整的实践与思考

王玲1, 周晶鑫2, 张学宁3, 蔺旭东4   

  1. 1国家药品不良反应监测中心,北京 100045;
    2哈尔滨市药品不良反应监测中心,黑龙江 哈尔滨 150016;
    3国家人口计生委计划生育药具不良反应监测中心,江苏 南京210036;
    4河北省药品不良反应监测中心,河北 石家庄 050090
  • 收稿日期:2016-02-03 修回日期:2016-02-03 出版日期:2014-07-08 发布日期:2016-03-02
  • 作者简介:王玲,女,硕士,高级工程师,药械安全性监测与评价。

Practice and Investigation on Data Normalization of Adverse Drug Reaction Reporting

WANG Ling1, ZHOU Jing-xin2, ZHANG Xue-ning3, LIN Xu-dong4   

  1. 1National Center for ADR Monitoring, Beijing 100045, China;
    2Harbin Center for ADR Monitoring, Heilongjiang Harbin 150016, China;
    3State Contraceptives Adverse Reaction Surveilience Center, Jiangsu Nanjing 210036, China;
    4Hebei Center for ADR Monitoring, Hebei Shijiazhuang 050090, China
  • Received:2016-02-03 Revised:2016-02-03 Online:2014-07-08 Published:2016-03-02

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摘要： 目的我国药品不良反应报告数据增长迅速,但数据存在不规范现象,降低了药品不良反应监测与评价效率,影响了数据的有效利用。通过探讨数据规整方法和应用,为提高我国药品不良反应报告质量提出建议和参考。方法通过开展药品不良反应报告数据规整工作实践,对监测系统内的数据进行研究,归纳报告不规范现象、对其原因进行分析,探讨报告规范化、改善报告质量的方式方法。结果建立了标准数据库、规整规则数据库,对病例报告能够自动执行标准化工作。结论数据规整是提升报告规范化的有效方法,在实际工作中具有重要作用。报告质量的提升是一项系统工程,需要各方共同努力。

关键词: 药品不良反应, 数据规整, 监测系统

Abstract: ObjectiveThe reporting data of adverse drug reaction has been increasing more and more rapidly. Whereas, the existing nonstandard data decreased the efficiency of adverse drug reaction monitoring and evaluation, and influenced the effective use of the data. By discussing the methods and applications of data normalization, to provide reference and suggestion for improving the quality of reports. MethodsOn the basis of our real working practices in data normalization, the case reports from the monitoring system were studied, non standard reports were summarized and the reasons were analyzed, the methods of data normalization and reporting quality improvement were discussed. ResultsThe standard databases and the rule databases were created, they were capable of automatic completion of the standardization work of the new cases. ConclusionThe data normalization is an effective method for improving the quality of the reports, it plays an important role in the actual work. Improving the quality of the reports is a systematic project , it needs the joint efforts of all the parties.

Key words: adverse drug reaction, data normalization, monitoring system

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