Topf Joel Michels
St. John Hospital and Medical Center, Chronic Kidney Disease Clinics, 22201 Moross Road, Suite 150, Detroit, Michigan 48236, USA.
Expert Opin Pharmacother. 2008 Apr;9(5):839-49. doi: 10.1517/14656566.9.5.839.
For 20 years, anemia has been treated with erythropoietin-stimulating agents (ESA). Until recently there have been only two ESA: recombinant erythropoietin and darbepoetin. In 2007 a third agent was approved for clinical use, CERA.
This review covers all of the peer-reviewed literature regarding ESA. The review also covers unique aspects of the regulatory publications with the FDA and European Agency for the Evaluation of Medicinal Products.
CERA is effective at correcting renal anemia. Compared to previous ESA, CERA has a dramatically lengthened half-life, making it the only ESA licensed for once-a-month dosing. However, like the previous ESA, CERA has not been shown to reduce morbidity or mortality and has only been shown to correct anemia and improve quality of life.
二十年来,促红细胞生成素刺激剂(ESA)一直用于治疗贫血。直到最近,仅有两种ESA:重组促红细胞生成素和达贝泊汀。2007年,第三种药物CERA被批准用于临床。
本综述涵盖了所有关于ESA的同行评审文献。该综述还涵盖了美国食品药品监督管理局(FDA)和欧洲药品评估局的监管出版物的独特方面。
CERA在纠正肾性贫血方面有效。与先前的ESA相比,CERA的半衰期显著延长,使其成为唯一获准每月给药一次的ESA。然而,与先前的ESA一样,CERA尚未被证明能降低发病率或死亡率,仅被证明能纠正贫血并改善生活质量。