Essential Topics for the Regulatory Consideration of Phages as Clinically Valuable Therapeutic Agents: A Perspective from Spain.
Essential Topics for the Regulatory Consideration of Phages as Clinically Valuable Therapeutic Agents: A Perspective from Spain.
复制标题
DOI：
10.3390/microorganisms10040717
复制
发表时间：
2022-03-26
期刊：
影响因子：
4.5
通讯作者：
中科院分区：
文献类型：
--
作者：
抗生素耐药性是人类在短期内将面临的主要挑战之一。噬菌体疗法是一种有价值的替代抗生素的治疗方法，尽管这一概念几乎与噬菌体的发现一样古老，但在西方，由于20世纪中叶抗生素的发现和发展，它的广泛应用受到了阻碍。然而，由于抗菌素耐药性问题，噬菌体治疗的研究目前正在经历复兴。一些国家已经采取了新的特别规定，以支持在临床实践中短期植入噬菌体疗法。在这方面，来自FAGOMA（西班牙噬菌体和转导元件网络）的噬菌体治疗工作组最近联系了西班牙药物和医疗器械管理局（AEMPS），以促进对西班牙噬菌体治疗的监管。因此，FAGOMA被要求就有关噬菌体治疗立法的关键问题提供一般性意见。此次审查是FAGOMA倡议的高潮，旨在适当地为噬菌体治疗的监管辩论提供信息。
Antibiotic resistance is one of the major challenges that humankind shall face in the short term. (Bacterio)phage therapy is a valuable therapeutic alternative to antibiotics and, although the concept is almost as old as the discovery of phages, its wide application was hindered in the West by the discovery and development of antibiotics in the mid-twentieth century. However, research on phage therapy is currently experiencing a renaissance due to the antimicrobial resistance problem. Some countries are already adopting new ad hoc regulations to favor the short-term implantation of phage therapy in clinical practice. In this regard, the Phage Therapy Work Group from FAGOMA (Spanish Network of Bacteriophages and Transducing Elements) recently contacted the Spanish Drugs and Medical Devices Agency (AEMPS) to promote the regulation of phage therapy in Spain. As a result, FAGOMA was asked to provide a general view on key issues regarding phage therapy legislation. This review comes as the culmination of the FAGOMA initiative and aims at appropriately informing the regulatory debate on phage therapy.
登录
查看更多内容
影响因子：
9.8
作者：
Attrill EL;Claydon R;Łapińska U;Recker M;Meaden S;Brown AT;Westra ER;Harding SV;Pagliara S
通讯作者：
Pagliara S
未经处理的污水含有多种病毒种群。
影响因子：
6.4
作者：
Cantalupo PG;Calgua B;Zhao G;Hundesa A;Wier AD;Katz JP;Grabe M;Hendrix RW;Girones R;Wang D;Pipas JM
通讯作者：
Pipas JM
影响因子：
4.6
作者：
Chen LK;Kuo SC;Chang KC;Cheng CC;Yu PY;Chang CH;Chen TY;Tseng CC
通讯作者：
Tseng CC
影响因子：
3.7
作者：
Adriaenssens EM;Lehman SM;Vandersteegen K;Vandenheuvel D;Philippe DL;Cornelissen A;Clokie MR;García AJ;De Proft M;Maes M;Lavigne R
通讯作者：
Lavigne R
影响因子：
8.4
作者：
Borysowski, Jan;Gorski, Andrzej
通讯作者：
Gorski, Andrzej