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甲氧基聚乙二醇-促红细胞生成素β:值得等待还是已过新奇期?

Methoxy polyethylene glycol-epoetin beta: worth waiting for or a novelty worn off?

机构信息

West Virginia University School of Medicine, Medicine - Nephrology, Box 9165, One Medical Center Drive, Morgantown, West Virginia 26506, USA.

出版信息

Expert Opin Pharmacother. 2009 Jun;10(9):1509-14. doi: 10.1517/14656560902997982.

DOI:10.1517/14656560902997982
PMID:19505218
Abstract

BACKGROUND

Since their inception nearly two decades ago, erythropoietin-stimulating agents (ESAs) have revolutionized the care of patients with renal anemia. Until recently, treatment options included the epoetins and darbepoetin alfa. As the use of these agents for chronic kidney disease (CKD) became widespread, the introduction of ESAs--touted for their longer-acting properties--was excitedly anticipated.

OBJECTIVES

To review the option of methoxy polyethylene glycol-epoetin beta for ESA therapy in patients with renal anemia.

METHODS

Peer-reviewed scientific literature, published abstracts and renal business journals were reviewed in the writing of this opinion.

RESULTS/CONCLUSION: Methoxy polyethylene glycol-epoetin beta (CERA) is an effective long-acting ESA approved for treatment of renal anemia and available for use outside of the United States. CERA corrects and maintains hemoglobin (Hb) levels in patients with CKD and its efficacy mirrors that of the epoetins and darbepoetin alfa. CERA holds promise for its safety record, administration requirements, and the potential impact on social and pharmacoeconomic barriers to treatment for patients with renal anemia.

摘要

背景

自近二十年前问世以来,红细胞生成素刺激剂(ESAs)彻底改变了肾性贫血患者的治疗方式。直到最近,治疗方案还包括促红细胞生成素和达贝泊汀。随着这些药物在慢性肾脏病(CKD)中的广泛应用,具有长效特性的 ESAs 的引入备受期待。

目的

综述用于肾性贫血治疗的聚乙二醇-红细胞生成素-β(methoxy polyethylene glycol-epoetin beta)作为 ESA 的选择方案。

方法

在撰写本意见时,我们查阅了同行评议的科学文献、已发表的摘要和肾脏商业期刊。

结果/结论:聚乙二醇-红细胞生成素-β(CERA)是一种有效的长效 ESA,已获批用于治疗肾性贫血,且已在美国以外地区使用。CERA 可纠正和维持 CKD 患者的血红蛋白(Hb)水平,其疗效与促红细胞生成素和达贝泊汀相当。CERA 的安全性记录、给药要求以及对治疗肾性贫血患者的社会和药物经济学障碍的潜在影响,使其前景广阔。

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Methoxy polyethylene glycol-epoetin beta: worth waiting for or a novelty worn off?甲氧基聚乙二醇-促红细胞生成素β:值得等待还是已过新奇期?
Expert Opin Pharmacother. 2009 Jun;10(9):1509-14. doi: 10.1517/14656560902997982.
2
CERA: third-generation erythropoiesis-stimulating agent.CERA:第三代促红细胞生成素刺激剂。
Expert Opin Pharmacother. 2008 Apr;9(5):839-49. doi: 10.1517/14656566.9.5.839.
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Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis.促红细胞生成素用于治疗成人慢性肾脏病贫血:一项网状Meta分析
Cochrane Database Syst Rev. 2014 Dec 8;2014(12):CD010590. doi: 10.1002/14651858.CD010590.pub2.
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Issues Emerg Health Technol. 2008 Feb(113):1-6.
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[Methoxy polyethylene glycol-epoetin beta (Mircera) in the treatment of a patient with chronic kidney disease presenting late-onset hypersensitivity to other epoetins].[聚乙二醇甲醚化促红细胞生成素β(Mircera)治疗对其他促红细胞生成素出现迟发性超敏反应的慢性肾脏病患者]
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Once-monthly subcutaneous C.E.R.A. maintains stable hemoglobin control in patients with chronic kidney disease on dialysis and converted directly from epoetin one to three times weekly.对于接受透析且从每周注射一至三次促红细胞生成素直接转换过来的慢性肾病患者,每月一次皮下注射C.E.R.A.可维持血红蛋白水平的稳定控制。
Clin J Am Soc Nephrol. 2007 Jul;2(4):637-46. doi: 10.2215/CJN.03631006. Epub 2007 May 23.
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Anemia control in kidney transplant patients treated with methoxy polyethylene glycol-epoetin beta (mircera): the Anemiatrans Group.接受甲氧基聚乙二醇 - 促红细胞生成素β(Mircera)治疗的肾移植患者的贫血控制:Anemiatrans研究组
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CERA (Continuous Erythropoietin Receptor Activator): a new erythropoiesis-stimulating agent for the treatment of anemia.CERA(持续促红细胞生成素受体激活剂):一种用于治疗贫血的新型促红细胞生成刺激剂。
Curr Hematol Rep. 2005 Nov;4(6):436-40.
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Efficacy of intravenous methoxy polyethylene glycol-epoetin beta administered every 2 weeks compared with epoetin administered 3 times weekly in patients treated by hemodialysis or peritoneal dialysis: a randomized trial.与每周3次给予促红细胞生成素相比,每2周静脉注射甲氧基聚乙二醇-促红细胞生成素β在接受血液透析或腹膜透析治疗的患者中的疗效:一项随机试验。
Am J Kidney Dis. 2007 Dec;50(6):989-1000. doi: 10.1053/j.ajkd.2007.08.013.
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Recent advances in erythropoietic agents in renal anemia.肾性贫血中促红细胞生成药物的最新进展
Semin Nephrol. 2006 Jul;26(4):313-8. doi: 10.1016/j.semnephrol.2006.05.008.

引用本文的文献

1
Dose equivalence between continuous erythropoietin receptor activator (CERA), Darbepoetin and Epoetin in patients with advanced chronic kidney disease.晚期慢性肾病患者中持续促红细胞生成素受体激活剂(CERA)、达贝泊汀和促红细胞生成素之间的剂量等效性。
Hippokratia. 2014 Oct-Dec;18(4):315-8.
2
Methoxy polyethylene glycol-epoetin beta versus darbepoetin alfa for anemia in non-dialysis-dependent CKD: a systematic review.甲氧基聚乙二醇-促红细胞生成素β与阿法达贝泊汀治疗非透析依赖型慢性肾脏病贫血的系统评价
Int J Clin Pharm. 2014 Dec;36(6):1115-25. doi: 10.1007/s11096-014-0023-x. Epub 2014 Oct 7.
3
Cost-effectiveness of continuous erythropoietin receptor activator in anemia.
持续促红细胞生成素受体激活剂治疗贫血的成本效益
Clinicoecon Outcomes Res. 2014 Jul 3;6:319-30. doi: 10.2147/CEOR.S46930. eCollection 2014.