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Richard C. Zink, 黄钦, 张陆勇, 包文俊. 运用统计和图形相结合方法对药物警戒中的自发报告不良反应事件进行比例失衡分析[J]. 中国天然药物, 2013, 11(3): 314-320.
引用本文: Richard C. Zink, 黄钦, 张陆勇, 包文俊. 运用统计和图形相结合方法对药物警戒中的自发报告不良反应事件进行比例失衡分析[J]. 中国天然药物, 2013, 11(3): 314-320.
Richard C. Zink, HUANG Qin, ZHANG Lu-Yong, BAO Wen-Jun. Statistical and graphical approaches for disproportionality analysis of spontaneously-reported adverse events in pharmacovigilance[J]. Chinese Journal of Natural Medicines, 2013, 11(3): 314-320.
Citation: Richard C. Zink, HUANG Qin, ZHANG Lu-Yong, BAO Wen-Jun. Statistical and graphical approaches for disproportionality analysis of spontaneously-reported adverse events in pharmacovigilance[J]. Chinese Journal of Natural Medicines, 2013, 11(3): 314-320.

运用统计和图形相结合方法对药物警戒中的自发报告不良反应事件进行比例失衡分析

Statistical and graphical approaches for disproportionality analysis of spontaneously-reported adverse events in pharmacovigilance

  • 摘要: 目的:将比例失衡分析和动态互动的可视图相结合来对药物警戒中的不良反应事件的自发报告进行研究。方法:我们描述了用于计算失衡比例的方法包括报告比值比(Reporting Odds Ratio)、报告率比例(Proportional Reporting Ratio)、多项伽玛泊松分布缩减(Multi-Item Gamma Poisson Shrinker)以及贝叶斯可信传播神经网络(Bayesian Confidence Propagation Neural Network)的四种统计方法,并用树图和其他图形技术来展示其失衡比例的计算结果。结果:药品上市后,为了监测其安全性,监管部门、制药公司和医疗机械生产商会从医生、患者或医学文献中收集药品的自发报告不良反应事件(SRAEs)。为了识别潜在的安全信号,我们采用了多种比例失衡分析法在某一不良反应事件发生的数据库中将其与特定药品使用的共存发生率和其在未用药情况的该不良反应事件发生率进行比较。我们利用树图来互动性地展示某一药物的不良反应事件,以及多个药物的不良反应事件。结论:用互动性图形来展示失衡比例使得分析者迅速地辨识出安全信号,以便开展更多的随访分析。将动态交互式图形和统计方法相结合可为传统分析提供更深入的数据了解。

     

    Abstract: AIM:Combine disproportionality analysis with dynamically interactive graphics to understand spontaneously-reported adverse events in pharmacovigilance.METHODS:Four statistical methods,including Reporting Odds Ratio,Proportional Reporting Ratio,Multi-Item Gamma Poisson Shrinker and Bayesian Confidence Propagation Neural Network that are used for computing disproportionality are described.Tree maps and other graphical techniques are used to display the disproportionality results.RESULTS:Spontaneously-reported adverse events in pharmacovigilance are collected from physicians,patients,or the medical literature by regulatory agencies,pharmaceutical companies and device manufacturers to monitor the safety of a product once it reaches the market.In order to identify potential safety-signals,disproportionality analysis methods compare the rate at which a particular event of interest co-occurs with a given drug with the rate this event occurs without the drug in the event database.Tree maps are employed to interactively display the adverse events for particular drugs and compare the adverse events among the drugs.CONCLUSIONS:Interactive graphical displays of disproportionality allow the analyst to quickly identify safety signals and perform additional follow-up analyses.Combining statistical methods with dynamically interactive graphics affords insights into the data inaccessible by traditional analysis methods.

     

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