布拉德福德希尔的应用标准来评估cisapride-induced心律失常的因果关系:一个模型来评估药物警戒的因果关联。

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Perrio M,沃斯,Shakir SA

布拉德福德希尔的应用标准来评估cisapride-induced心律失常的因果关系:一个模型来评估药物警戒的因果关联。

药物Saf。2007; 30 (4): 333 - 46。

PubMed ID

17408310 (在PubMed

]

文摘

简介:布拉德福德希尔的标准是一个广泛使用的,有用的工具评估生物医学的因果关系。我们已经检查了他们的应用程序使用的药物警戒间隔延长cisapride-induced高职院校学前教育专业/心律失常。方法:文献检索进行了利用MEDLINE、EMBASE,反应每周和监管网站确定的证据之间的关系cisapride间隔延长/心律失常和高职院校学前教育专业,发表在英语语言。二百零五年的出版物被确认为可能适用于研究。排除不相关的文章,对高危人群的研究和评论文章,70出版物使用。布拉德福德。希尔的标准进行评估。其中包括24个病例报告、案例系列或自发报告总结;八的流行病学研究;22个临床研究;和16个实验(体内和体外)出版物。结果:最引人注目的证据之间的关联cisapride间隔延长使用和高职院校学前教育专业/心律失常来自案例/自发报告和生物合理性。 Considering the rare incidence of serious cardiac events, these criteria formed the basis for the strength of the association. The number of reports from different populations showed consistency. Specificity was supported by clinical and cardiographic characterisation of the events. There were temporal relationships between the events and the initiation of cisapride treatment, increases in the dosage and the receipt of interacting medications. The relationships between the adverse events and the latter two factors exhibited biological gradients. Experimental evidence could be found from biological models, as well as reports of positive dechallenge and/or rechallenge found in individual patients. Cisapride was found to bind the human ether-a-go-go-related gene (HERG) potassium channel, which provides a plausible mechanism for QTc interval prolongation/arrhythmia. Other QTc interval-prolonging/arrhythmic drugs that also bind to HERG provided an analogy for cisapride causing QTc interval prolongation/arrhythmia via this mechanism. The evidence provided by clinical studies was inconsistent, and epidemiological studies failed to demonstrate an association. Nevertheless, this did not prevent the assessment of causation. DISCUSSION: This study showed how different types of evidence found in pharmacovigilance can be evaluated using the Bradford Hill criteria. Further work is required to examine how the criteria can be applied to different types of adverse events and how they may be applied to pharmacovigilance.

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药物靶点

药物	目标	类	生物	药理作用	行动
Cisapride	电压门控钾通道亚科2 H成员	蛋白质	人类	未知的	抑制剂	细节