An update on romiplostim for treatment of acute radiation syndrome.

Vijay K. Singh, T. Seed
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引用次数: 9

Abstract

Detonation of an improvised nuclear weapon, or a radiological dispersal device by terrorists, or an unintended radiological/nuclear accident in populated areas would result in a mass casualty scenario with radiation exposures of different severities. Such incidences are perceived as national security threats of major consequences. Acute radiation syndrome (ARS) is triggered by an exposure to a high dose of penetrating ionizing radiation during a short time window. In humans, moderate exposure to 2 to 4 Gy of ionizing radiation results in clinically manageable hematopoietic ARS (H-ARS), characterized by severe depletion of vital blood cells and bone marrow progenitors. Since 2015, the United States Food and Drug Administration (U.S. FDA) has approved four radiation medical countermeasures for H-ARS following the Animal Rule; namely, Neupogen, Neulasta, Leukine and Nplate (romiplostim). Here, we briefly present the treatment modalities for H-ARS. We have discussed the latest FDA-approved agent, romiplostim, as a treatment modality for H-ARS. The nature of this agent and the preclinical and clinical work that preceded its FDA approval as a radiation medical countermeasure are discussed, as are the development and use of related thrombopoietic agents for the treatment of radiation-exposed victims.
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罗普司汀治疗急性放射综合征的最新进展。
恐怖分子引爆简易核武器或放射性扩散装置,或在人口稠密地区发生意外的放射性/核事故,都会造成大规模伤亡,辐射暴露程度不同。此类事件被视为对国家安全的重大威胁。急性辐射综合征(ARS)是由在短时间窗口内暴露于高剂量穿透性电离辐射引发的。在人类中,适度暴露于2-4 Gy的电离辐射会导致临床上可控制的造血ARS(H-ARS),其特征是重要血细胞和骨髓祖细胞的严重耗竭。自2015年以来,美国食品药品监督管理局(U.S.FDA)根据动物规则批准了四种针对H-ARS的辐射医疗对策;即Neupogen、Neulasta、Leukine和Nplate(romipostim)。在这里,我们简要介绍了H-ARS的治疗方式。我们已经讨论了美国食品药品监督管理局批准的最新药物romipostim,作为H-ARS的一种治疗方式。讨论了这种制剂的性质以及在美国食品药品监督管理局批准其作为辐射医疗对策之前的临床前和临床工作,以及用于治疗辐射暴露受害者的相关血小板生成素制剂的开发和使用。
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