Shah Rashmi R
, 8 Birchdale, Gerrards Cross, Bucks, UK.
Drug Saf Case Rep. 2017 Sep 20;4(1):11. doi: 10.1007/s40800-017-0053-0.
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.
本文鼓励医生发表药品不良反应（ADR）的病例报告，回顾了有充分记录的已发表病例报告在促进公众安全与健康以及推动基础药理学发展方面所发挥的作用。许多监管指南的起源最终都可追溯到此类报告引发的安全担忧。文章阐述了ADR病例报告与药物药代动力学同步监测相结合时，如何引发进一步研究，从而在药理学领域取得重大进展，尤其是在药物遗传学、药物相互作用机制以及炎症合并症期间药物代谢调节方面。已发表的病例报告与自发病例报告有显著差异，因为前者经过符合质量要求的同行评审，在读者中能立即获得更广泛的关注，促使其他人报告类似病例，并最终根据风险导致对该药物实施处方限制或从市场上撤药。因此，报告者不应因以下情况而气馁：（a）反应的异常或奇特性质；（b）从开始用药到疑似反应发生的间隔时间，无论间隔多长；（c）药物的知名度或其上市时间长短；（d）任何不发表的压力。病例报告应发表在可通过如PubMed等数据库检索的知名期刊上。
