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[摘要]
慢性肾脏病(CKD)会导致肾性贫血,严重的肾性贫血会增加患者的死亡率。2017年10月18日FibroGen公司宣布国家食品药品监督管理总局(CFDA)已受理其提交的口服新药罗沙司他(Roxadustat,FG-4592)的上市申请,如获批准,将成为全球第一个低氧诱导因子(HIF)脯氨酰羟化酶(PH)抑制剂类的首创新药,中国将成为最先批准的国家。罗沙司他是一种新型HIF-PH酶抑制剂,通过稳定HIF,抑制其降解,从而激活相关基因的转录,产生相应的生理反应,发挥抗肾性贫血的作用,而且疗效显著,不良反应少,给药方便,可减少或规避铁剂的使用。介绍罗沙司他的作用机制、药动学、临床研究、不良反应等研究进展,为临床应用提供参考。
[Key word]
[Abstract]
Chronic kidney disease (CKD) leads to renal anemia, and severe renal anemia increases mortality in patients with CKD. On October 18, 2017, FibroGen Inc. announces that CFDA has accepted the company's New Drug Application submitted recently for registration of Roxadustat which administered by oral. If approved, Roxadustat will be the first inhibitors of hypoxia-inducible factor (HIF) -prolyl hydroxylase (PH) enzyme available worldwide, China will be the first approval country for this first-in-class drug. Roxadustat is a new type of HIF-PH enzyme inhibitors, which can activate the transcription of related genes and produce a corresponding physiological response to treat renal anemia by stabilizing HIF to inhibit its degradation. Roxadustat has obvious efficacy, with low adverse reactions and convenient administration, which can reduce or avoid the use of iron. In this paper we introduce it's the mechanism, pharmacokinetics, clinical study, adverse reactions, potential application value of Roxadustat with view to promoting new drug information spreading and providing reference for clinical application.
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