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Drug Safety:检测来自新加坡自发性不良事件报告系统不成比例的报告信号

2017-08-29 MedSci MedSci原创

近日,国际杂志 《Drug Safety》上在线发表一项关于连续概率比测试在检测来自新加坡自发性不良事件报告系统不成比例的报告信号的应用研究。

近日,国际杂志 《Drug Safety》上在线发表一项关于连续概率比测试在检测来自新加坡自发性不良事件报告系统不成比例的报告信号的应用研究。

在公共卫生方面,从及时有效的自发性药物不良反应报告中检测出安全性问题的能力仍然很重要。该研究探讨了连续概率比测试(SPRT)的行为和在新加坡检测不相称报告(SDR)信号的能力。

研究人员使用SPRT24.1的两个假设相对风险(hRR)的组合来检测小型数据库中常见和罕见不良事件的信号。研究人员比较了SPRT与其他方法在检测到的信号数量以及是否检测到标记的不良药物反应或反应术语被认为是严重的情况。使用的其他方法包括报告优势比(ROR),Bayesian Confidence Propagation Neural Network (BCPNN) Gamma Poisson Shrinker (GPS)

SPRT与所有方法共同生成2187个信号,268个唯一信号,以及70个与至少一种其他方法相同的信号,并且在其他两种方法检测到的178种情况中没有产生信号,并且检测到403个唯一信号。在灵敏度方面,ROR表现优于其他方法,但SPRT方法发现更多的新信号。方法的性能与阴性预测值和特异性相似。

研究认为将SPRhRR组合用于监管机构可能是有用的筛选工具,因该对系统的医疗效用进行更详细的调查。

原始出处:

Cheng Leng Chan, Sowmya Rudrappa, Pei San Ang et al. Detecting Signals of Disproportionate Reporting from Singapore’s Spontaneous Adverse Event Reporting System: An Application of the Sequential Probability Ratio Test

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    2018-03-13 爆笑小医
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    2018-05-07 quxin068
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    2017-08-31 sodoo
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    2017-08-30 130****4638

    学习了谢谢分享

    0

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    2017-08-30 明月清辉

    谢谢分享.学习了

    0

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    2017-08-30 changjiu

    学习一下谢谢

    0

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    2017-08-30 1dd8c52fm63(暂无匿称)

    了解了解.继续关注

    0

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    2017-08-30 飛歌

    学习了很有用

    0

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