重组人红细胞生成素(大鹰药业)(Recombinant human erythropoietin(Daying Pharmaceutical)) - 药物靶点：EPO receptor_在研适应症：贫血_专利_临床

概要

基本信息

药物类型

集落刺激因子

别名

诺之素

靶点

EPO receptor

作用机制

EPO receptor激动剂(促红细胞生成素受体激动剂)、Erythropoiesis刺激剂(红细胞生成刺激剂)

治疗领域

血液及淋巴系统疾病

在研适应症

贫血

非在研适应症-

原研机构

Daying Pharmaceutical

在研机构

Daying Pharmaceutical

非在研机构-

最高研发阶段批准上市

首次获批日期

中国 (2002-05-09),

贫血

最高研发阶段(中国)批准上市

特殊审评-

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关联

3

项与重组人红细胞生成素(大鹰药业) 相关的临床试验

ChiCTR2000032845 / Suspended临床4期

Prospective, open-label, multicenter clinical study on the efficacy and safety of recombinant human erythropoietin combined with retinoic acid and testosterone undecanoate in the treatment of anemia in patients with low-risk myelodysplastic syndrome

开始日期2020-05-06

申办/合作机构

The First Affiliated Hospital, Zhejiang University School of Medicine

ChiCTR2000030594 / Suspended临床4期

Phase II / III clinical study on the efficacy and safety of recombinant human erythropoietin combined with retinoic acid and testosterone undecanoate in the treatment of anemia in patients with relatively low-risk myelodysplastic syndrome

开始日期2020-04-01

申办/合作机构

浙江大学医学院附属第二医院

IRCT2014122920471N1 / Completed临床2期IIT

Effects of Human Recombinant Erythropoietine on Functional Outcome of Traumatic Cervical Spine Cord Injury; A Randomized Placebo Controlled Study

开始日期2012-01-01

申办/合作机构

Shiraz University of Medical Sciences

100 项与重组人红细胞生成素(大鹰药业) 相关的临床结果

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100 项与重组人红细胞生成素(大鹰药业) 相关的转化医学

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100 项与重组人红细胞生成素(大鹰药业) 相关的专利（医药）

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36

项与重组人红细胞生成素(大鹰药业) 相关的文献（医药）

2020-04-01·Therapeutic Apheresis and Dialysis

Long‐Term Safety and Efficacy of JR‐131, a Biosimilar of Darbepoetin Alfa, in Japanese Patients With Renal Anemia Undergoing Hemodialysis: Phase 3 Prospective Study

Article

作者: Masakane, Ikuto ; Nakamoto, Hidetomo ; Nishi, Shinichi ; Yamada, Masayuki ; Tsuruya, Kazuhiko

AbstractThe objective of this study was to evaluate the safety and efficacy of JR‐131, a biosimilar of darbepoetin alfa, for long‐term treatment of renal anemia patients undergoing hemodialysis. In this multicenter, single‐arm, phase 3 study, 159 patients with renal anemia who had been receiving darbepoetin alfa or recombinant human erythropoietins were treated with intravenous JR‐131 for 52 weeks. In patients receiving darbepoetin alfa, JR‐131 was administered at the same dose, while in patients receiving recombinant human erythropoietin the dose was determined based on the 1:200 conversion ratio following the Japanese darbepoetin alfa package insert. No notable adverse drug reactions were reported, and no anti‐JR‐131 antibodies were detected. The hemoglobin levels were maintained in the range of 10.0–12.0 g/dL throughout the study. JR‐131 proved to be a useful and lower‐cost alternative to darbepoetin alfa in the management of renal anemia in patients undergoing hemodialysis.

2019-01-01·Clinical Laboratory4区 · 医学

The Role of Reticulocyte Hemoglobin Content for Diagnosis of Iron Deficiency and Iron Deficiency Anemia, and Monitoring of Iron Therapy: a Literature Review

4区 · 医学

Review

作者: Gelaw, Yemataw ; Melku, Mulugeta ; Woldu, Berhanu

BACKGROUNDThe diagnosis of iron deficiency anemia is still complicated and most of the tests have drawbacks. Bone marrow examination, the gold standard for the diagnosis of iron deficiency and iron deficiency anemia, is a painful, invasive, and costly procedure. Other methods are also used to diagnose iron deficiency and iron deficiency anemia; soluble transferrin receptor, serum iron, serum ferritin, and transferrin saturation are most common biomarkers of iron status that are frequently affected by inflammation, chronic diseases, and in the normal aging process (except soluble transferrin receptor). All are less available compared to complete blood count with reticulocyte hemoglobin content (CHr). Reticulocytes have a normal life span of one or two days in the circulation. CHr is a good indication of iron availability and an early marker of iron deficient erythropoiesis which can be obtained readily using automated blood cell analyzers. Therefore, the main objective of the current review is to assess the role of CHr for diagnosis of iron deficiency, iron deficiency anemia, and monitoring of iron therapy.METHODSStudies published in English were searched using the National Library of Medicine, PubMed, and Google scholar databases.RESULTSAccording to this review, CHr has a moderate sensitivity and specificity for diagnosing iron deficiency, and is less affected by inflammation than serum iron, transferrin saturation, and ferritin and is an early predictor of treatment response. It is used in screening of iron deficiency, diagnosis of iron deficiency anemia, and diagnosis of functional iron deficiency anemia in acute or chronic diseases or inflammation. CHr is also important in treatment monitoring. It is useful for early measurement of response to iron therapy, increasing within days of the initiation of iron therapy. It helps monitoring of intravenous iron supplementation, recombinant human erythropoie¬tin therapy, and oral iron therapy in hemodialysis and non-hemodialysis patients, and children.CONCLUSIONSIt is easy to analyze, less time consuming, and less expensive than bone iron examination and iron biochemical tests. However, there is no standardized cutoff point and different researchers use varying cutoff values which affects its accuracy in diagnosing iron deficiency and it should therefore be standardized. Moreover, since CHr can be affected with any conditions that cause iron restricted erythropoiesis, further analysis may be needed.

2016-02-01·Drug Testing and Analysis2区 · 医学

Identification of recombinant human EPO variants in greyhound plasma and urine by ELISA, LC‐MS/MS and western blotting: a comparative study

2区 · 医学

Article

作者: Vine, John ; Timms, Mark ; Steel, Rohan

The recombinant human erythropoietins epoetin alfa (Eprex®), darbepoetin (Aranesp®) and methoxy polyethylene glycol‐epoetin beta (Mircera®) were administered to greyhounds for 7, 10 and 14 days respectively. Blood and urine samples were collected and analysed for erythropoietin by ELISA, LC‐MS/MS and western blotting. Limits of confirmation in plasma for western blotting and LC‐MS/MS methods ranged from a low of 2.5mIU/mL, and closely matched the sensitivity of ELISA screening. Copyright © 2015 John Wiley & Sons, Ltd.

100 项与重组人红细胞生成素(大鹰药业) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	B03XA01	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
贫血	中国	Daying Pharmaceutical	2002-05-09

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASCO2005	N/A	多发性骨髓瘤	245	recombinant human erythropoietin (Non users)	(鬱窪鹹齋壓願鏇網顧網) = 壓夢網鹹鹹繭糧簾夢鑰積鏇鬱遞鏇積齋壓糧壓 (簾餘獵餘壓醖衊淵範夢 )	-	2005-06-01