Sorokulova Iryna
Institute of Microbiology and Virology, National Academy of Science, Kiev, Ukraine.
Clin Infect Dis. 2008 Feb 1;46 Suppl 2:S92-5; discussion S144-51. doi: 10.1086/523334.
Preclinical testing of the microbial strains is the first important step in the development of probiotics. Requirements for the set of tests can vary depending on the bacterial species and the expected mechanism of action in the organism. Common approaches to preclinical testing of probiotic strains include strain identification (i.e., determination of phenotypic and genotypic properties), safety evaluation (i.e., characterization of history of use [safety contact], assessment of resistance to antibiotics, and evaluation of pathogenic properties in vitro and in animal models), and efficacy testing (i.e., functional characterization). Future progress in probiotics requires more studies to determine the mechanisms of their action, as well as an understanding of the basis and mechanisms of pathogenicity for different probiotic strains. Special attention should be given to recombinant probiotics, particularly in the formulation of criteria for selection of the host strain, for assessment of environmental safety, and for tracing the fate of recombinant DNA in vitro and in vivo.
微生物菌株的临床前测试是益生菌开发的首要重要步骤。测试组合的要求可能因细菌种类和预期在生物体中的作用机制而异。益生菌菌株临床前测试的常见方法包括菌株鉴定（即表型和基因型特性的测定）、安全性评估（即使用历史[安全接触]的表征、抗生素抗性评估以及体外和动物模型中致病性特性的评估）和功效测试（即功能表征）。益生菌的未来进展需要更多研究来确定其作用机制，以及了解不同益生菌菌株致病性的基础和机制。应特别关注重组益生菌，尤其是在制定宿主菌株选择标准、评估环境安全性以及追踪重组DNA在体外和体内的命运方面。
