FDA, The United States Food and Drug Administration

FDA,美国食品和药物管理局
  • 文章类型: Journal Article
    自2019年12月以来,严重急性呼吸道综合症冠状病毒2(SARS-CoV-2)已成为一种新兴的人类病毒,世界人口易患2019年冠状病毒病(COVID-19)。SARS-CoV-2比以前的冠状病毒具有更高的传播能力,由核糖核酸(RNA)病毒性质相关的高突变率,导致SARS-CoV-2变体在全球传播时出现。中和抗体被鉴定为针对COVID-19的即时和直接作用治疗剂。单结构域抗体(sdAb),作为具有非复杂结构和内在稳定性的小生物分子,可以获得与常规抗体相当的抗原结合能力,作为一种有吸引力的中和溶液。SARS-CoV-2刺突蛋白附着于肺上皮细胞上的人血管紧张素转换酶2(ACE2)受体以引发病毒感染,作为潜在的治疗靶点。sdAb已经显示出广泛的中和对SARS-CoV-2的各种突变,有效阻止和预防感染,同时有效阻止突变逃逸。此外,sdAb可以发展成为针对COVID-19的多价抗体或吸入性生物治疗剂。
    With severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as an emergent human virus since December 2019, the world population is susceptible to coronavirus disease 2019 (COVID-19). SARS-CoV-2 has higher transmissibility than the previous coronaviruses, associated by the ribonucleic acid (RNA) virus nature with high mutation rate, caused SARS-CoV-2 variants to arise while circulating worldwide. Neutralizing antibodies are identified as immediate and direct-acting therapeutic against COVID-19. Single-domain antibodies (sdAbs), as small biomolecules with non-complex structure and intrinsic stability, can acquire antigen-binding capabilities comparable to conventional antibodies, which serve as an attractive neutralizing solution. SARS-CoV-2 spike protein attaches to human angiotensin-converting enzyme 2 (ACE2) receptor on lung epithelial cells to initiate viral infection, serves as potential therapeutic target. sdAbs have shown broad neutralization towards SARS-CoV-2 with various mutations, effectively stop and prevent infection while efficiently block mutational escape. In addition, sdAbs can be developed into multivalent antibodies or inhaled biotherapeutics against COVID-19.
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  • 文章类型: Case Reports
    在接种COVID-19疫苗后,临床和放射学报道了疫苗接种部位同侧的腋窝淋巴结病。这可能是一个重要的诊断困境,特别是在正在分期或重新分期的癌症患者中,因为这个良性实体可能模仿转移,导致不必要的活检和治疗改变。在这里,我们介绍了一名乳腺癌患者和一名头颈部鳞状细胞癌患者,他们之前已经接受了前两剂mRNA型COVID-19疫苗,现在在第3次加强剂量后,在FDGPET/CT上出现新的高代谢反应性淋巴结病。
    Axillary lymphadenopathy ipsilateral to the vaccination site has been clinically and radiologically reported after administration of COVID-19 vaccines. This can be an important diagnostic dilemma, particularly in cancer patients who are being staged or re-staged, as this benign entity may mimic metastasis, cause unnecessary biopsies and changes in therapy. Here we present a breast cancer patient and a patient with squamous cell carcinoma of the head and neck, who had already received the first two doses of mRNA type COVID-19 vaccines before, now presenting with new hypermetabolic reactive lymphadenopathy on FDG PET/CT after the third booster dose.
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