Department of Nephrology and Dialysis, Ospedale A. Manzoni, Via dell'Eremo 9, 23900 Lecco, Italy.
Expert Opin Drug Saf. 2012 Nov;11(6):923-31. doi: 10.1517/14740338.2012.712680. Epub 2012 Aug 23.
Erythropoiesis-stimulating agents (ESAs) have been the main therapy for anemia in CKD patients since the late eighties. Since then, treatment indications have progressively changed, together with a progressive increase in therapeutic targets, in terms of hemoglobin levels.
This paper discusses possible concerns about ESA use and increased cardiovascular risk (in particular stroke), hypertension, cancer progression and the development of pure red cell aplasia. A literature search was done on PubMed to obtain studies about the adverse effects of ESA in the CKD population.
The publication of the TREAT study has largely contributed to the concerns about ESA use, indicating that complete anemia correction may not be safe in the CKD population. This may be particularly true in high-risk patients, especially if hyporesponsive to ESA treatment. However, there is a gray area of no evidence either way for intermediate levels (11.5 - 13 g/dl), in comparison with higher or lower levels. New recommendations about ESA use in the CKD population by the Food and Drug Administration seem to move toward treatment individualization.
自 80 年代末以来，促红细胞生成素刺激剂（ESA）一直是治疗 CKD 患者贫血的主要方法。从那时起，治疗指征逐渐发生变化，治疗目标也逐渐提高，体现在血红蛋白水平上。
本文讨论了 ESA 使用和心血管风险（特别是中风）增加、高血压、癌症进展和纯红细胞再生障碍的可能问题。在 PubMed 上进行了文献检索，以获得关于 ESA 在 CKD 人群中不良反应的研究。
TREAT 研究的发表在很大程度上引发了对 ESA 使用的担忧，表明完全纠正贫血在 CKD 人群中可能不安全。对于高危患者来说，尤其是对 ESA 治疗反应不佳的患者，这种情况可能更为明显。然而，对于中间水平（11.5-13g/dl），与较高或较低水平相比，尚无证据表明这是正确的。美国食品和药物管理局（FDA）对 CKD 患者 ESA 使用的新建议似乎倾向于个体化治疗。
