Department of Nephrology, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, National Children's Regional Medical Center, Hangzhou, China.
Department of Surgical Oncology, National Clinical Research Center for Child Health, National Children's Regional Medical Center, The Children's Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Biomol Biomed. 2023 May 1;23(3):354-363. doi: 10.17305/bb.2022.8437.
Anemia is a common complication of chronic kidney disease (CKD), and its prevalence rises as the disease progresses. Intravenous or subcutaneous erythropoiesis-stimulating agents (ESAs) are advised to treat CKD-associated anemia, since shortage of erythropoietin (EPO) and iron are the main cause of anemia. However, ESA resistance and safety have spurred a lot of interest in the development of alternate anemia therapies. Roxadustat, an orally administered hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that increases erythropoiesis and may modulate iron metabolism, was recently licensed in China, Chile, South Korea, Japan and the European Union for the treatment of CKD-related anemia. Despite this, clinical trials have shown a number of adverse effects, including cardiovascular disease, hyperkalemia, and infections. In addition, of concern is roxadustat's possible effects on other organs and systems. In this review, based on clinical evidence, we discuss the potentially detrimental effects of roxadustat to the known biology on systems other than kidney, and the need for long-term follow-up in order for roxadustat to be approved in more countries in the future.
贫血是慢性肾脏病（CKD）的常见并发症，随着疾病的进展，其患病率逐渐升高。建议使用静脉内或皮下注射红细胞生成刺激剂（ESA）治疗 CKD 相关贫血，因为促红细胞生成素（EPO）和铁的缺乏是贫血的主要原因。然而，ESA 耐药性和安全性问题激发了人们对替代贫血治疗方法的研究兴趣。罗沙司他是一种口服给药的低氧诱导因子脯氨酰羟化酶抑制剂（HIF-PHI），可增加红细胞生成并可能调节铁代谢，最近在中国、智利、韩国、日本和欧盟获得批准，用于治疗 CKD 相关贫血。尽管如此，临床试验显示了许多不良反应，包括心血管疾病、高钾血症和感染。此外，人们还担心罗沙司他可能对其他器官和系统产生影响。在本综述中，我们根据临床证据，讨论了罗沙司他对肾脏以外的已知生物学系统的潜在有害影响，以及为了将来在更多国家获得批准，需要进行长期随访。
