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辐射暴露及相关损伤的医学应对措施:药品特性、美国食品药品监督管理局批准状况及纳入国家战略储备情况

Medical Countermeasures for Radiation Exposure and Related Injuries: Characterization of Medicines, FDA-Approval Status and Inclusion into the Strategic National Stockpile.

作者信息

Singh Vijay K, Romaine Patricia L P, Seed Thomas M

机构信息

*Radiation Countermeasures Program, Armed Forces Radiobiology Research Institute, Bethesda, MD; †Department of Radiation Biology, F. Edward Hébert School of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD; ‡Tech Micro Services, Bethesda, MD.

出版信息

Health Phys. 2015 Jun;108(6):607-30. doi: 10.1097/HP.0000000000000279.

Abstract

World events over the past decade have highlighted the threat of nuclear terrorism as well as an urgent need to develop radiation countermeasures for acute radiation exposures and subsequent bodily injuries. An increased probability of radiological or nuclear incidents due to detonation of nuclear weapons by terrorists, sabotage of nuclear facilities, dispersal and exposure to radioactive materials, and accidents provides the basis for such enhanced radiation exposure risks for civilian populations. Although the search for suitable radiation countermeasures for radiation-associated injuries was initiated more than half a century ago, no safe and effective radiation countermeasure for the most severe of these injuries, namely acute radiation syndrome (ARS), has been approved by the United States Food and Drug Administration (FDA). The dearth of FDA-approved radiation countermeasures has prompted intensified research for a new generation of radiation countermeasures. In this communication, the authors have listed and reviewed the status of radiation countermeasures that are currently available for use, or those that might be used for exceptional nuclear/radiological contingencies, plus a limited few medicines that show early promise but still remain experimental in nature and unauthorized for human use by the FDA.

摘要

过去十年间的世界局势凸显了核恐怖主义的威胁,以及开发针对急性辐射暴露及后续身体损伤的辐射对策的迫切需求。恐怖分子引爆核武器、破坏核设施、散布和暴露于放射性物质以及发生事故,导致发生放射性或核事件的可能性增加,这为平民群体带来了更高的辐射暴露风险。尽管半个多世纪前就已开始寻找适用于辐射相关损伤的辐射对策,但美国食品药品监督管理局(FDA)尚未批准针对这些最严重损伤(即急性辐射综合征,ARS)的安全有效的辐射对策。FDA批准的辐射对策匮乏,促使人们加紧对新一代辐射对策的研究。在本通讯中,作者列出并综述了目前可使用的辐射对策的现状,或那些可能用于特殊核/辐射突发事件的对策,以及少数几种显示出早期前景但本质上仍属实验性且未经FDA批准用于人体的药物。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4066/4418776/d65cd00379c5/hp-108-607-g001.jpg

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