Department of Medicine, University of Calgary, Calgary, Alberta, Canada.
Clin J Am Soc Nephrol. 2012 Feb;7(2):348-53. doi: 10.2215/CJN.09960911. Epub 2012 Jan 19.
Recent clinical trials comparing the use of erythropoiesis-stimulating agents targeting low (generally a hemoglobin of 90-115 g/L) and near-normal hemoglobin targets (generally a hemoglobin >130 g/L) in patients with chronic kidney disease have shown no improvements in clinical outcomes (aside from a small reduction in transfusion) and potential harm for erythropoiesis-stimulating agents use targeting near-normal hemoglobin targets. Based on these results, the US Food and Drug Administration recently released modified recommendations for more conservative dosing of erythropoiesis-stimulating agents in patients with CKD. These recommendations now stress individualizing therapy for each patient and using the lowest possible erythropoiesis-stimulating agents dose required to reduce the need for transfusions. The evolution in the management of anemia associated with chronic kidney disease over time and the recent evidence that has stimulated these labeling changes is discussed. Also, the US Food and Drug Administration labeling changes are discussed, and areas of controversy are highlighted. Although the US Food and Drug Administration labeling changes are based on the results of recent large randomized trials testing ESAs targeting near-normal hemoglobin levels, more specific guidance to clinicians would have been helpful.
最近的临床试验比较了针对慢性肾脏病患者使用低目标（一般为血红蛋白 90-115g/L）和接近正常目标（一般为血红蛋白>130g/L）的红细胞生成刺激剂，结果显示，除了输血减少外，针对接近正常血红蛋白目标的红细胞生成刺激剂治疗并没有改善临床结局，反而可能存在潜在危害。基于这些结果，美国食品和药物管理局最近对慢性肾脏病患者的红细胞生成刺激剂更保守的剂量推荐进行了修改。这些建议现在强调了个体化治疗，即使用最低可能的红细胞生成刺激剂剂量来减少输血的需求。讨论了随着时间的推移，慢性肾脏病相关贫血管理的演变以及激发这些标签变化的最新证据。还讨论了美国食品和药物管理局的标签变化，并强调了有争议的领域。尽管美国食品和药物管理局的标签变化是基于最近测试针对接近正常血红蛋白水平的 ESA 的大型随机试验的结果，但向临床医生提供更具体的指导将是有帮助的。
