新型冠状病毒肺炎免疫调节治疗性蛋白：当前临床开发及临床药理学考量。
Immunomodulatory Therapeutic Proteins in COVID-19: Current Clinical Development and Clinical Pharmacology Considerations.
机构信息
Division of Inflammation and Immune Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Division of Rheumatology and Transplant Medicine, Office of Immunology and Inflammation, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
出版信息
J Clin Pharmacol. 2020 Oct;60(10):1275-1293. doi: 10.1002/jcph.1729. Epub 2020 Sep 8.
The coronavirus disease 2019 (COVID-19) pandemic caused by infection with SARS-CoV-2 has led to more than 600 000 deaths worldwide. Patients with severe disease often experience acute respiratory distress characterized by upregulation of multiple cytokines. Immunomodulatory biological therapies are being evaluated in clinical trials for the management of the systemic inflammatory response and pulmonary complications in patients with advanced stages of COVID-19. In this review, we summarize the clinical pharmacology considerations in the development of immunomodulatory therapeutic proteins for mitigating the heightened inflammatory response identified in COVID-19.
由严重急性呼吸综合征冠状病毒 2 型（SARS-CoV-2）感染引起的 2019 冠状病毒病（COVID-19）大流行，已在全球导致超过 60 万人死亡。重症患者常出现以多种细胞因子上调为特征的急性呼吸窘迫。免疫调节生物疗法正在临床试验中评估，以管理 COVID-19 晚期患者的全身炎症反应和肺部并发症。在这篇综述中，我们总结了免疫调节治疗性蛋白在开发中的临床药理学考虑因素，以减轻 COVID-19 中确定的高度炎症反应。
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