Department of Medical Microbiology, Medical Centre Haaglanden (MCH), The Hague, The Netherlands.
Centre for Anti-infective Agents, Vienna, Austria.
Clin Microbiol Infect. 2015 Oct;21(10):881-5. doi: 10.1016/j.cmi.2015.06.007. Epub 2015 Jun 17.
Because of the increase in bacterial resistance to commonly used antibacterial drugs, old antibiotics are being 'revived' and, once again, are attracting interest. Many of these old antibiotics were approved long ago, in an era when there was no clear process for development, and requirements for efficacy to be demonstrated in rigorous clinical trials did not exist. At the time of these approvals, pharmacokinetic and pharmacodynamic principles were largely unknown, and did not inform the dose-finding process or recommendations for optimal usage. Indeed, the task of generating basic vital information for these old antibiotics remains to be performed. In this review, we provide a brief overview of the most essential data needed for dose justification and optimization. An overview of the shortage of data for selected old antibiotics illustrates the scope of the problem. In order to prevent harming patients with clinical decisions based on inadequate evidence, a redevelopment procedure for old antibiotics is urgently needed, including a regulatory framework.
由于细菌对常用抗菌药物的耐药性不断增加,旧的抗生素正在被“重新启用”,并再次引起人们的关注。这些旧抗生素中有许多是很久以前批准的,当时没有明确的开发流程,也没有要求在严格的临床试验中证明疗效。在这些批准的时候,药代动力学和药效学原理还知之甚少,也没有为剂量确定过程或最佳使用建议提供信息。实际上,为这些旧抗生素生成基本生命信息的任务仍有待完成。在这篇综述中,我们简要概述了剂量合理化和优化所需的最基本数据。对选定旧抗生素的数据短缺情况的概述说明了问题的范围。为了防止因临床决策证据不足而损害患者,迫切需要为旧抗生素重新开发程序,包括监管框架。