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Daprodustat: First Approval.达普司他:首次批准。
Drugs. 2020 Sep;80(14):1491-1497. doi: 10.1007/s40265-020-01384-y.
2
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Drugs. 2020 Sep;80(13):1365-1371. doi: 10.1007/s40265-020-01383-z.
3
Oxygen homeostasis and cardiovascular disease: A role for HIF?氧平衡与心血管疾病:HIF 的作用?
Biomed Pharmacother. 2020 Aug;128:110338. doi: 10.1016/j.biopha.2020.110338. Epub 2020 Jun 8.
4
Phase 3, Randomized, Double-Blind, Active-Comparator (Darbepoetin Alfa) Study of Oral Roxadustat in CKD Patients with Anemia on Hemodialysis in Japan.日本血液透析慢性肾脏病贫血患者罗沙司他的 3 期、随机、双盲、阳性对照(达贝泊汀α)研究。
J Am Soc Nephrol. 2020 Jul;31(7):1628-1639. doi: 10.1681/ASN.2019060623. Epub 2020 Jun 3.
5
Hypoxia-inducible factor prolyl hydroxylase inhibitor in the treatment of anemia in chronic kidney disease.缺氧诱导因子脯氨酰羟化酶抑制剂治疗慢性肾脏病贫血。
Curr Opin Nephrol Hypertens. 2020 Jul;29(4):414-422. doi: 10.1097/MNH.0000000000000617.
6
Effects of oral iron and calcium supplement on the pharmacokinetics and pharmacodynamics of molidustat: an oral HIF-PH inhibitor for the treatment of renal anaemia.口服铁和钙补充剂对莫立司他(一种用于治疗肾性贫血的口服 HIF-PH 抑制剂)药代动力学和药效学的影响。
Eur J Clin Pharmacol. 2020 Feb;76(2):185-197. doi: 10.1007/s00228-019-02813-y. Epub 2020 Jan 10.
7
Oral roxadustat three times weekly in ESA-naïve and ESA-converted patients with anemia of chronic kidney disease on hemodialysis: Results from two phase 3 studies.罗沙司他每周口服 3 次治疗血液透析慢性肾脏病贫血患者:两项 3 期研究结果。
Ther Apher Dial. 2020 Dec;24(6):628-641. doi: 10.1111/1744-9987.13468. Epub 2020 Feb 5.
8
Carcinogenicity Assessment of Daprodustat (GSK1278863), a Hypoxia-Inducible Factor (HIF)-Prolyl Hydroxylase Inhibitor.达普司他(GSK1278863)致癌性评估,一种低氧诱导因子(HIF)脯氨酰羟化酶抑制剂。
Toxicol Pathol. 2020 Feb;48(2):362-378. doi: 10.1177/0192623319880445. Epub 2019 Oct 22.
9
A randomized, 29-day, dose-ranging, efficacy and safety study of daprodustat, administered three times weekly in patients with anemia on hemodialysis.一项随机、29 天、剂量范围、评估达普司他疗效和安全性的研究,在每周三次给药方案下,评估达普司他在血液透析患者中的应用。
BMC Nephrol. 2019 Oct 16;20(1):372. doi: 10.1186/s12882-019-1547-z.
10
Prolyl-hydroxylase inhibitors for the treatment of anemia in chronic kidney disease.脯氨酰羟化酶抑制剂治疗慢性肾脏病贫血。
Curr Opin Nephrol Hypertens. 2019 Nov;28(6):600-606. doi: 10.1097/MNH.0000000000000554.

亚太肾脏病学会(APSN)关于适当使用 HIF-PH 抑制剂的建议。

Recommendations by the Asian Pacific society of nephrology (APSN) on the appropriate use of HIF-PH inhibitors.

机构信息

Division of Nephrology, Department of Medicine, Queen Mary Hospital, The University of Hong Kong, Pok Fu Lam, Hong Kong.

Department of Renal and Obstetric Medicine, Eastern Health Clinical School, Monash University, Melbourne, Australia.

出版信息

Nephrology (Carlton). 2021 Feb;26(2):105-118. doi: 10.1111/nep.13835. Epub 2020 Dec 9.

DOI:10.1111/nep.13835
PMID:33222343
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7898910/
Abstract

Renal anaemia is a common and important complication in patients with chronic kidney disease (CKD). The current standard-of-care treatment for renal anaemia in CKD patients involves ensuring adequate iron stores and administration of erythropoietin stimulating agents (ESA). Hypoxia inducible factor (HIF) is a key transcription factor primarily involved in the cellular regulation and efficiency of oxygen delivery. Manipulation of the HIF pathway by the use of HIF-prolyl hydroxylase inhibitors (HIF-PHI) has emerged as a novel approach for renal anaemia management. Despite it being approved for clinical use in various Asia-Pacific countries, its novelty mandates the need for nephrologists and clinicians generally in the region to well understand potential benefits and harms when prescribing this class of drug. The Asian Pacific society of nephrology HIF-PHI Recommendation Committee, formed by a panel of 11 nephrologists from the Asia-Pacific region who have clinical experience or have been investigators in HIF-PHI studies, reviewed and deliberated on the clinical and preclinical data concerning HIF-PHI. This recommendation summarizes the consensus views of the committee regarding the use of HIF-PHI, taking into account both available data and expert opinion in areas where evidence remains scarce.

摘要

肾性贫血是慢性肾脏病(CKD)患者中常见且重要的并发症。目前,CKD 患者肾性贫血的标准治疗方法包括确保铁储备充足和使用促红细胞生成素刺激剂(ESA)。缺氧诱导因子(HIF)是一种主要参与细胞调节和氧输送效率的关键转录因子。通过使用 HIF 脯氨酰羟化酶抑制剂(HIF-PHI)来操纵 HIF 通路,已成为治疗肾性贫血的一种新方法。尽管它已在亚太地区的多个国家获得临床批准,但由于其新颖性,该地区的肾病学家和临床医生通常需要充分了解在开具此类药物时的潜在益处和危害。由来自亚太地区的 11 位具有 HIF-PHI 临床经验或研究经验的肾病学家组成的亚太肾脏病学会 HIF-PHI 推荐委员会,审查和审议了有关 HIF-PHI 的临床前和临床数据。本建议综合了委员会关于使用 HIF-PHI 的共识意见,同时考虑了现有数据和在证据仍然稀缺的领域的专家意见。