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2014年加罗德讲座:欧洲抗菌药物敏感性试验委员会——我们正朝着国际共识迈进吗?

The 2014 Garrod Lecture: EUCAST - are we heading towards international agreement?

作者信息

Kahlmeter Gunnar

机构信息

Clinical Microbiology, Central Hospital, 351 85 Växjö, Sweden

出版信息

J Antimicrob Chemother. 2015 Sep;70(9):2427-39. doi: 10.1093/jac/dkv145. Epub 2015 Jun 18.

Abstract

Antimicrobial susceptibility testing with phenotypic methods is based on the measurement of the MIC (mg/L) and breakpoints to categorize bacteria and fungi as susceptible, intermediate or resistant. Phenotypic antimicrobial susceptibility testing requires an agreement on breakpoints and a rigorous standardization of methods and materials. Requirements for defining breakpoints include a definition of doses and dose intervals, information on MIC distributions for the target organisms, definitions of the highest MIC for organisms devoid of phenotypically expressed resistance (the epidemiological cut-off) and information on resistance mechanisms, pharmacokinetics, pharmacodynamics and clinical outcome in trials. In 2001, the breakpoint committees of France, Germany, Norway, Sweden, the Netherlands and the UK were tasked with developing European breakpoints under the umbrella of EUCAST, organized by ESCMID and later also by ECDC. Breakpoints for previously established antibacterial and antifungal agents in Europe have now been harmonized. With the EMA, EUCAST has since 2006 determined breakpoints for new agents. All breakpoints are freely available on the EUCAST web site; these are used in semi-automated antimicrobial susceptibility testing devices and have been employed since 2010 in a EUCAST disc diffusion method. They have been or are now being implemented in most countries inside Europe and many countries outside it. Everything needed to perform and interpret antimicrobial susceptibility testing is freely available from the EUCAST web site, as are aggregated MIC distributions based on more than 26 000 distributions.

摘要

采用表型方法进行的抗菌药物敏感性试验基于对最低抑菌浓度(mg/L)的测定以及将细菌和真菌分类为敏感、中介或耐药的折点。表型抗菌药物敏感性试验需要就折点达成一致,并对方法和材料进行严格标准化。定义折点的要求包括剂量和给药间隔的定义、目标微生物最低抑菌浓度分布的信息、无表型耐药性微生物的最高最低抑菌浓度(流行病学临界值)的定义以及耐药机制、药代动力学、药效学和试验临床结果的信息。2001年,法国、德国、挪威、瑞典、荷兰和英国的折点委员会在由欧洲临床微生物学和感染病学会(ESCMID)组织、后来欧洲疾病预防控制中心(ECDC)也参与的欧洲抗菌药物敏感性试验委员会(EUCAST)的框架下,负责制定欧洲折点。欧洲此前已确立的抗菌和抗真菌药物的折点现已统一。自2006年起,EUCAST与欧洲药品管理局(EMA)共同确定新药物的折点值。所有折点均可在EUCAST网站上免费获取;这些折点值用于半自动抗菌药物敏感性试验设备,并自2010年起用于EUCAST纸片扩散法。它们已在欧洲大多数国家以及许多其他国家得到应用或正在被采用。进行和解释抗菌药物敏感性试验所需的一切信息均可从EUCAST网站免费获取,基于26000多个分布汇总的最低抑菌浓度分布情况也是如此。

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