Singh Vijay K, Garcia Melissa, Seed Thomas M
a Division of Radioprotection, Department of Pharmacology and Molecular Therapeutics , F. Edward Hébert School of Medicine, Uniformed Services University of the Health Sciences , Bethesda , MD , USA.
b Armed Forces Radiobiology Research Institute , Uniformed Services University of the Health Sciences , Bethesda , MD , USA.
Int J Radiat Biol. 2017 Sep;93(9):870-884. doi: 10.1080/09553002.2017.1338782. Epub 2017 Jun 28.
The threat of a radiological/nuclear event is a critical concern for all government agencies involved in national security and public health preparedness. Countermeasures that are safe, easily administered, and effective at diminishing or eliminating adverse health effects to individuals and the overall public health impact of radiation exposure are urgently needed. Radiation countermeasures included in this three-part series have been classified under various subheadings based specifically on their developmental stages for United States Food and Drug Administration (FDA) approval. We have included FDA-approved agents for acute radiation syndrome (ARS) in part I. This is part II in which we have reviewed FDA-approved agents for limited indications, internalized radionuclides, emesis, late effects, radiomitigators available in the strategic national stockpile (SNS), agents with FDA investigational new drug (IND) status, and those with NHP efficacy data without FDA IND. Agents discussed in part III are those agents that have been peer reviewed, published, and have demonstrated significant survival benefits in animal models of ARS. Agents investigated in in vitro models only or studied in animal models without peer-reviewed publications have not been included.
The dearth of FDA-approved radiation countermeasures has prompted intensified research for a new generation of radiation countermeasures. A number of promising radiation countermeasures are currently moving forward with continued support and effort by both governmental agencies and by publicly and privately held pharmaceutical companies. There is a limited number of countermeasures which are progressing well following the Animal Rule and may get approved in the near future, thus serving to close the gap of this critically important, unmet radiobiomedical need.
对于所有参与国家安全和公共卫生应急准备的政府机构而言，放射性/核事件的威胁都是至关重要的关切事项。迫切需要安全、易于施用且能有效减轻或消除对个人的不良健康影响以及辐射暴露对公众健康总体影响的应对措施。这个分为三部分的系列中所包含的辐射应对措施，已根据其在美国食品药品监督管理局（FDA）批准的具体研发阶段，归类在不同的副标题之下。在第一部分中，我们纳入了FDA批准用于急性放射综合征（ARS）的药物。这是第二部分，我们在此回顾了FDA批准用于有限适应症、内化放射性核素、呕吐、晚期效应、战略国家储备（SNS）中可用的辐射缓解剂、具有FDA研究性新药（IND）状态的药物以及那些具有非人类灵长类动物（NHP）疗效数据但无FDA IND的药物。在第三部分中讨论的药物是那些已经经过同行评审、发表且在ARS动物模型中显示出显著生存益处的药物。仅在体外模型中研究或在没有经过同行评审发表的动物模型中研究的药物未被纳入。
FDA批准的辐射应对措施的匮乏促使人们加紧对新一代辐射应对措施的研究。目前，在政府机构以及公立和私营制药公司的持续支持与努力下，一些有前景的辐射应对措施正在推进。按照动物法则进展良好且可能在不久的将来获得批准的应对措施数量有限，这有助于填补这一至关重要的、未满足的放射生物医学需求的缺口。
