发表药物不良反应病例报告的重要性:促进公共卫生和推进药理学和治疗学。

Rashmi R Shah
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引用次数: 9

摘要

这篇文章鼓励医生发表药物不良反应(adr)的病例报告,回顾了文献完备的发表病例报告如何促进公共安全和健康,从而促进了基础药理学的发展。许多监管准则的起源最终可以追溯到此类报告引发的安全问题。它说明了不良反应的病例报告与药物药代动力学的同时监测如何导致进一步的研究,从而在药理学,特别是药物遗传学,药物-药物相互作用机制和炎症合并症期间药物代谢的调节方面取得重大进展。已发表的病例报告与自发的病例报告有很大不同,因为它们享有符合质量要求的同行评审,并且在读者中立即具有更广泛的知名度,从而引发其他人报告类似病例,并最终导致根据风险限制处方或从市场上撤回药物。因此,记者不应该气馁,因为(1)反应的不寻常或奇异的性质;(b)从开始给药到出现疑似反应的时间间隔,无论时间长短;(c)该药物的知名度或上市时间;(d)任何不发表的压力。病例报告应发表在可通过PubMed等数据库搜索的知名期刊上。
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Importance of Publishing Adverse Drug Reaction Case Reports: Promoting Public Health and Advancing Pharmacology and Therapeutics.

This article, which encourages physicians to publish case reports of adverse drug reactions (ADRs), is a review of how well-documented published case reports have contributed to promoting public safety and health and thus served to advance basic pharmacology. The origin of a number of regulatory guidelines can ultimately be traced to safety concerns triggered by such reports. It illustrates how case reports of ADRs, when coupled with simultaneous monitoring of drug pharmacokinetics, have also led to further investigations resulting in major advances in pharmacology, especially pharmacogenetics, mechanisms of drug-drug interactions and modulation of drug metabolism during inflammatory co-morbidities. Published case reports differ significantly from spontaneous case reports since they enjoy quality-compliant peer review and an immediate wider visibility among the readership, triggering others to report similar cases, and ultimately leading to prescribing restrictions on or withdrawals of the drug from the market depending on the risk. Therefore, the reporter should not be discouraged by (a) the unusual or bizarre nature of the reaction; (b) the interval, however long, from commencing drug administration to the onset of the suspected reaction; (c) however well-known the drug or the period for which it has been on the market; and (d) any pressure not to publish. Case reports should be published in reputable journals that are searchable through databases such as PubMed.

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