预防及治疗用噬菌体质量标准专家共识

Consensus on Standards of Phage Quality for Prophylactic and Therapeutic Use

日益严重的细菌耐药性给全球公共卫生带来了重大挑战,噬菌体疗法作为细菌感染治疗的替补疗法,近年来重新得到医生、研究者和产业界的重视。噬菌体是特异性感染细菌的一类病毒。噬菌体疗法可以精准靶向并清除病原菌而不破坏自然环境微生态及人体正常菌群。由于噬菌体的活病毒属性、杀菌特异性等特征,使得噬菌体的药学、非临床和临床研究有别于传统药物。目前,国内外尚缺乏相关规范和指南,限制了噬菌体的转化应用和推广。为此,基于国内外前期噬菌体治疗临床研究的经验,并参考噬菌体治疗相关文献报道,组织噬菌体基础研究、临床、药学等领域专家,起草了本共识。对入库噬菌体的来源、噬菌体宿主、入库噬菌体的生物学特性以及入库噬菌体的包装与标识提出要求,旨在规范应用型噬菌体的标准,并满足噬菌体库的共享需求,加速推动噬菌体的研究、转化及应用。

The emergence of drug resistant pathogens has posed a major challenge to global public health.Phage therapy,as an alternative therapy for the treatment of bacterial infections,has received renewed attention from clinicians,researchers and industrialists in recent years.Phages are a kind of viruses that specifically infect bacteria.Phage therapy can precisely target and eliminate pathogens without harming the natural environment or human microbiota.Due to the characteristics of phages such as live virus property and bactericidal specificity,the pharmacological,non-clinical and clinical studies of phages are different from those of traditional drugs.Currently,there is still a lack of relevant standards and guidelines worldwide,which has severely limited the translational application of phages and their products.To this end,based on the experience of clinical studies on phage therapy in the early stage,and referring to the literature reports on phage therapy,we organized experts including researchers,clinicians,and pharmacologists to draft this consensus.Requirements for phage source,phage host,biological properties of phages,and packaging and labelling of phages are proposed.The aim is to standardize the standards for phage applications and to meet the needs of phage library sharing,so as to accelerate the research,translation and application of phages.