研究动态
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美国的监管批准核反应堆爆炸和与炭疽病毒相关的生物恐怖主义的药物治疗。

United States' regulatory approved pharmacotherapies for nuclear reactor explosions and anthrax-associated bioterrorism.

发表日期:2023 Aug 18
作者: Charles L Bennett, Peter Georgantopoulos, Robert Peter Gale, Kevin Knopf, William J Hrushesky, Chadi Nabhan, James O Armitage
来源: Food & Function

摘要:

核反应堆事故和生物恐怖袭击爆发都是令人担忧的公共卫生灾害。关于美国食品药品监督管理局(FDA)批准的能够减轻这些事件后果的药物,我们知之甚少。我们回顾了FDA数据,支撑这些药物的监管批准。我们回顾了用于治疗造血系统急性辐射综合征(H-ARS)和治疗或预防芽孢类炭疽病(炭疽病)暴露后的肺部感染的药物。有四种药物获得了H-ARS的批准:粒细胞-集落刺激因子(G-CSF),粒细胞/巨噬细胞集落刺激因子,聚乙二醇化G-CSF和罗米洛格胺。对于与生物恐怖主义相关的炭疽病,FDA批准了五种抗生素(氧氟沙星、青霉素G、左氧氟沙星、莫西沙星和环丙沙星),两种单克隆抗体(希沙让单抗和急性細菌性炭疽双抗素),一种多克隆抗毒素(炭疽免疫球蛋白静脉注射液)和两种疫苗(炭疽类疫苗吸附和带有佐剂的炭疽类疫苗吸附)。一个国家储备系统确保社区能够随时获取这些药物。我们的文献搜索基于包含在drugs@FDA(2001-2023)中的数据。两种潜在的大规模公共卫生灾难是炭疽气溶胶传播和放射事故。五种仅授权用于炭疽疫情的药物仅在这一适应症上获得了FDA的批准,五种抗生素作为常见感染的抗生素和芽孢类炭疽病的抗生素获得了FDA批准,四种药物获得了癌症和放射事故的支持性治疗的监管批准。
Nuclear reactor incidents and bioterrorism outbreaks are concerning public health disasters. Little is known about US Food and Drug Administration (FDA)-approved agents that can mitigate consequences of these events. We review FDA data supporting regulatory approvals of these agents.We reviewed pharmaceutical products approved to treat Hematopoietic Acute Radiation Syndrome (H-ARS) and to treat or prevent pulmonary infections following Bacillus anthracis (anthrax) exposure. Four drugs were approved for H-ARS: granulocyte-colony stimulating factor (G-CSF), granulocyte/macrophage colony stimulating factor, pegylated G-CSF, and romiplostim. For bioterrorism-associated anthrax, the FDA approved five antibiotics (doxycycline, penicillin-G, levofloxacin, moxifloxacin, and ciprofloxacin), two monoclonal antibodies (obiltoxaximab and raxibacumab), one polyclonal antitoxin (Anthrax Immune Globulin Intravenous) and two vaccines (Anthrax Vaccine Adsorbed and Anthrax Vaccine Adsorbed with an adjuvant). A national stockpile system ensures that communities have ready access to these agents. Our literature search was based on data included in drugs@FDA (2001-2023).Two potential mass public health disasters are aerosolized anthrax dissemination and radiological incidents. Five agents authorized for anthrax emergencies only have FDA approval for this indication, five antibiotics have FDA approvals as antibiotics for common infections and for bacillus anthrax, and four agents have regulatory approvals for supportive care for cancer and for radiological incidents.