Gold standards in pharmacovigilance: the use of definitive anecdotal reports of adverse drug reactions as pure gold and high-grade ore.
Gold standards in pharmacovigilance: the use of definitive anecdotal reports of adverse drug reactions as pure gold and high-grade ore.
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药物警戒的黄金标准：使用药物不良反应的明确轶事报告作为纯金和高品位矿石。
DOI：
10.2165/00002018-200629100-00086
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发表时间：
2007
期刊：
影响因子：
4.2
通讯作者：
J. Aronson
中科院分区：
文献类型：
--
作者：
M. Hauben;J. Aronson
关于药物不良反应的轶事报告通常被认为证据质量差。这对于上市后药品安全监测尤其重要，因为这在很大程度上依赖于自发的轶事报告。自发报告的众多局限性怎么强调都不过分，但故事还有另一面：这些数据集也包含可以被认为描述明确不良反应的轶事报告，无需进一步的正式验证。我们之前定义了四类此类不良反应：(i)药物或代谢物的细胞外或细胞内组织沉积；（ii）特定的解剖位置或损伤模式；（iii）生理功能障碍或直接组织损伤，可通过理化测试证明；以及（iv）感染，由于使用感染剂作为治疗物质或由于可证明的污染。在这篇文章中，我们讨论了这些明确的（“眼间”）不良反应对药物警戒的影响。
Anecdotal reports of adverse drug reactions are generally regarded as being of poor evidential quality. This is especially relevant for postmarketing drug safety surveillance, which relies heavily on spontaneous anecdotal reports. The numerous limitations of spontaneous reports cannot be overemphasised, but there is another side to the story: these datasets also contain anecdotal reports that can be considered to describe definitive adverse reactions, without the need for further formal verification. We have previously defined four categories of such adverse reactions: (i) extracellular or intracellular tissue deposition of the drug or a metabolite; (ii) a specific anatomical location or pattern of injury; (iii) physiological dysfunction or direct tissue damage demonstrable by physicochemical testing; and (iv) infection, as a result of the administration of an infective agent as the therapeutic substance or because of demonstrable contamination. In this article, we discuss the implications of these definitive ('between-the-eyes') adverse effects for pharmacovigilance.