| 美国食品与药物管理局药品不良反应信号的定量评价方法概述及启示 |
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| 引用本文： | 毕玉侠,吴春福,杨静玉.美国食品与药物管理局药品不良反应信号的定量评价方法概述及启示[J].中国药房,2010(18):1640-1642. |
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| 作者姓名： | 毕玉侠 吴春福 杨静玉 |
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| 作者单位： | 沈阳药科大学社会药学研究中心; |
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| 摘 要： | 目的:分析美国食品与药物管理局(FDA)药品不良反应(ADR)信号的定量评价方法,为我国ADR评价工作提供参考。方法:采用文献研究、对比分析、数据归纳等方法,探讨美国FDA药品评价与研究中心对ADR信号的评价方法。结果与结论:美国FDA药品评价与研究中心通过采用多项伽玛泊松缩减法对ADR信号进行定量评价,可早期发现ADR信号,有效提升ADR信息的风险预警能力。我国有必要借鉴其ADR信号评价方法,运用各种数据分析手段,建立高质量的ADR评价数据库;同时,注重药物流行病学及统计学在ADR评价中的应用,将ADR评价方法由定性评价逐步向定量评价转变。
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| 关 键 词： | 药品不良反应 风险信号 数据挖掘 监测 定量评价 |
Quantitative Evaluation on Adverse Drug Reaction Signal in FDA and Its Illumination |
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| BI Yu-xia,WU Chun-fu,YANG Jing-yu.Quantitative Evaluation on Adverse Drug Reaction Signal in FDA and Its Illumination[J].China Pharmacy,2010(18):1640-1642. |
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| Authors: | BI Yu-xia WU Chun-fu YANG Jing-yu |
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| Institution: | BI Yu-xia,WU Chun-fu,YANG Jing-yu(Research Center of Social Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China) |
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| Abstract: | OBJECTIVE: To analyze and evaluate the quantitative evaluation of ADR signals in FDA and to provide a reference for ADR evaluation in China. METHODS: By means of literature review,contrasting analysis and data reduction,ADR signal evaluation in FDA was investigated. RESULTS&CONCLUSION: In USA MGPS method is used for the quantitative evaluation of ADR signal, which can earlier obtain ADR signal and effectively promote the risk warning ability of ADR information. This is practical in our country and we should... |
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| Keywords: | ADR Risk signal Date mining Monitoring Quantitative evaluation |
| 本文献已被 CNKI 维普 等数据库收录！ |
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