噬菌体抗菌治疗安全性评估体系的建立

Establishment of safety assessment system of phage therapy

摘要:

人类已经进入后抗生素时代，噬菌体治疗近年来重新备受重视，噬菌体制剂不同于传统抗菌药物，已有对传统抗菌药物的安全性评估体系不适合用于对噬菌体治疗制剂的评估，需要建立对噬菌体治疗安全性评估的体系。本文就噬菌体治疗所涉及的安全性问题进行系统分析研究，通过噬菌体本身的选择、噬菌体制剂制备、制剂形式、制剂给予途径、剂量和频次等，以及噬菌体治疗细菌感染性疾病患者选择等所涉及的安全性和噬菌体治疗对周围微环境的影响等进行全面分析。建立噬菌体治疗安全性评估体系，为噬菌体治疗尽早进入临床奠定基础。

关键词:噬菌体治疗;抗菌;安全性;评估体系

Abstract:

We have entered into post-antibiotic era, phage therapy has been refocused recently, bacteriophages are different from the normal antibiotics. It is unsuitable to use the established safety assessment system for classical antimicrobial agents to evaluate the safety of bacteriophages for therapy. So, it is necessary to establish the safety assessment system of phage therapy involved in the whole procedures of choosing bacteriophages, including phage production, the choice of bacteriophage products, phage's administration routes, and the bacterial infection patients that enrolled for phage therapy. In this study, we systematically analyzed the safety problem involved in phage therapy and established the safety assessment system of phage therapy. It can provide basis for phages to enter into clinical therapy in the future.

Key words:phage therapy;antibacterial;safety;assessment system