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屎肠球菌 SF68 作为药物益生菌功效和安全性评价的模型。

Enterococcus faecium SF68 as a model for efficacy and safety evaluation of pharmaceutical probiotics.

机构信息

1 Handong Global University, 3 Namsong-ri Heunghae Buk-gu, Pohang Gyungbuk, 791-708, Republic of Korea.

2 Cerbios-Pharma SA, Via Figino 6, 6917 Barbengo/Lugano, Switzerland.

出版信息

Benef Microbes. 2018 Apr 25;9(3):375-388. doi: 10.3920/BM2017.0148. Epub 2018 Apr 10.

DOI:10.3920/BM2017.0148
PMID:29633645
Abstract

As normal inhabitants of diverse ecosystems, including the human gastrointestinal tract, the enterococci, and especially the two species Enterococcus faecalis and Enterococcus faecium, can be considered ubiquitous with regard to our natural environment. E. faecium has gained special importance thanks to beneficial strains marketed as probiotics, and because of its beneficial role in traditional fermented foods such as artisanal cheeses in some Southern European countries. Yet, following reports on the increasing association of some enterococcal strains with nosocomial infections such as endocarditis and bacteraemia, it became evident that strains from clinical origin are frequently highly resistant to 'last-defence-line' antibiotics such as the glycopeptide derivatives. For this reason enterococci have been classified in risk group 2 in the European Directive 93/88. With this paper it is intended to clarify the uncertain situation around the safety of the species E. faecium, also with referring to intra-species heterogeneity. In fact, well established scientific and surveillance data support the safety of some probiotic E. faecium strains for both human and animal applications. As a model, summarising yet extensive information is provided on the efficacy and safety of E. faecium SF68®, a pharmaceutical probiotic with a long history of safe use. We propose the approach presented in this review as a model for the evaluation of safety of probiotic strains of this species.

摘要

作为多样化生态系统的正常居民,包括人类胃肠道中的肠球菌,特别是粪肠球菌和屎肠球菌,就我们的自然环境而言,可以被认为是无处不在的。由于作为益生菌销售的有益菌株,以及由于其在传统发酵食品(如一些南欧国家的手工奶酪)中的有益作用,屎肠球菌获得了特殊的重要性。然而,由于一些肠球菌菌株与医院感染(如心内膜炎和菌血症)的关联性越来越大的报道,从临床来源的菌株经常对'最后防线'抗生素(如糖肽衍生物)高度耐药的情况变得明显。出于这个原因,肠球菌被欧洲指令 93/88 分类为风险组 2。本文旨在澄清有关屎肠球菌物种安全性的不确定情况,同时也涉及种内异质性。事实上,已确立的科学和监测数据支持某些益生菌屎肠球菌菌株用于人类和动物应用的安全性。作为一个模型,提供了关于 SF68® 屎肠球菌的功效和安全性的广泛信息,SF68® 屎肠球菌是一种具有长期安全使用历史的制药益生菌。我们提出了本综述中提出的方法,作为评估该物种益生菌菌株安全性的模型。

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