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聚焦特定损伤药物及监管审批状态的辐射防护对策综述:第三部分。处于研发早期阶段的防护对策以及无需监管审批即可使用的“标准护理”药物和程序。

A review of radiation countermeasures focusing on injury-specific medicinals and regulatory approval status: part III. Countermeasures under early stages of development along with 'standard of care' medicinal and procedures not requiring regulatory approval for use.

作者信息

Singh Vijay K, Hanlon Briana K, Santiago Paola T, Seed Thomas M

机构信息

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 , U.S.A.

b Armed Forces Radiobiology Research Institute , Uniformed Services University of the Health Sciences , Bethesda , MD , U.S.A.

出版信息

Int J Radiat Biol. 2017 Sep;93(9):885-906. doi: 10.1080/09553002.2017.1332440. Epub 2017 Jun 28.

DOI:10.1080/09553002.2017.1332440
PMID:28657400
Abstract

PURPOSE

Terrorist attacks, with their intent to maximize psychological and economic damage as well as inflicting sickness and death on given targeted populations, are an ever-growing worldwide concern in government and public sectors as they become more frequent, violent, and sensational. If given the chance, it is likely that terrorists will use radiological or nuclear weapons. To thwart these sinister efforts, both physical and medical countermeasures against these weapons are currently being researched and developed so that they can be utilized by the first responders, military, and medical providers alike. This is the third article of a three-part series in which we have reviewed additional radiation countermeasures that are currently under early preclinical phases of development using largely animal models and have listed and discussed clinical support measures, including agents used for radiation-induced emesis, as well as countermeasures not requiring Food and Drug Administration approval.

CONCLUSIONS

Despite the significant progress that has been made in this area during the last several years, additional effort is needed in order to push promising new agents, currently under development, through the regulatory pipeline. This pipeline for new promising drugs appears to be unreasonably slow and cumbersome; possible reasons for this inefficiency are briefly discussed. Significant and continued effort needs to be afforded to this research and development area, as to date, there is no approved radioprotector that can be administered prior to high dose radiation exposure. This represents a very significant, unmet medical need and a significant security issue. A large number of agents with potential to interact with different biological targets are under development. In the next few years, several additional radiation countermeasures will likely receive Food and Drug Administration approval, increasing treatment options for victims exposed to unwanted ionizing irradiation.

摘要

目的

恐怖袭击旨在造成最大程度的心理和经济破坏,并对特定目标人群造成疾病和死亡,随着其变得更加频繁、暴力和耸人听闻,在政府和公共部门中已成为全球日益关注的问题。如果有机会,恐怖分子很可能会使用放射性或核武器。为了挫败这些险恶企图,目前正在研究和开发针对这些武器的物理和医学对策,以便急救人员、军队和医疗人员都能使用。这是一个系列文章的第三篇,在该系列中,我们回顾了目前处于临床前早期开发阶段的其他辐射对策,这些研究主要使用动物模型,并列出并讨论了临床支持措施,包括用于治疗辐射引起的呕吐的药物,以及无需美国食品药品监督管理局批准的对策。

结论

尽管在过去几年中该领域取得了重大进展,但仍需要做出更多努力,以便推动目前正在开发的有前景的新药物通过监管流程。这条新的有前景药物的流程似乎异常缓慢且繁琐;本文简要讨论了造成这种低效率的可能原因。需要对该研发领域给予重大且持续的努力,因为迄今为止,尚无经批准的辐射防护剂可在高剂量辐射暴露前使用。这代表了一个非常重大的、未满足的医疗需求以及一个重大的安全问题。大量有可能与不同生物靶点相互作用的药物正在研发中。在未来几年,可能会有几种额外的辐射对策获得美国食品药品监督管理局的批准,从而增加对遭受不必要电离辐射的受害者的治疗选择。

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