Normalization of hemoglobin level in patients with chronic kidney disease and anemia

Normalization of hemoglobin level in patients with chronic kidney disease and anemia
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DOI:
10.1056/nejmoa062276
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发表时间:
2006-11-16
影响因子:
158.5
通讯作者:
Scherhag, Armin
Scherhag, Armin
中科院分区:
医学1区
文献类型:
--
作者:
Drueke, Tilman B.;Locatelli, Francesco;Scherhag, Armin

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背景:3期或4期慢性肾脏病患者的贫血纠正是否能改善心血管结局尚未确定。研究方法:我们将603名肾小球滤过率(GFR)估计值为15.0 - 35.0 ml/min/1.73 m2体表面积和轻度至中度贫血的患者随机分组,(血红蛋白水平,11.0至12.5 g/dl)至正常范围内的目标血红蛋白值(13.0 - 15.0 g/dl,组1)或低于正常范围(10.5 - 11.5 g/dl,组2)。皮下促红细胞生成素(促红细胞生成素β)在随机分组时开始(第1组)或仅在血红蛋白水平降至10.5 g/dl以下后开始(第2组)。主要终点是8个心血管事件的复合终点;次要终点包括左心室质量指数、生活质量评分和慢性肾脏疾病的进展。结果如下:在3年研究期间,贫血的完全纠正不影响首次心血管事件的可能性(第1组58起事件vs.第2组47起事件;风险比,0.78; 95%置信区间,0.53 - 1.14; P = 0.20)。两组的左心室质量指数保持稳定。基线时,第1组的平均估计GFR为24.9 ml/min,第2组为24.2 ml/min,每年分别下降3.6 ml/min和3.1 ml/min(P = 0.40)。第1组中需要透析的患者多于第2组(127 vs. 111,P = 0.03)。总体健康状况和身体功能显著改善(P = 0.003和P
Background: Whether correction of anemia in patients with stage 3 or 4 chronic kidney disease improves cardiovascular outcomes is not established. Methods: We randomly assigned 603 patients with an estimated glomerular filtration rate (GFR) of 15.0 to 35.0 ml per minute per 1.73 m(sup 2) of body-surface area and mild-to-moderate anemia (hemoglobin level, 11.0 to 12.5 g per deciliter) to a target hemoglobin value in the normal range (13.0 to 15.0 g per deciliter, group 1) or the subnormal range (10.5 to 11.5 g per deciliter, group 2). Subcutaneous erythropoietin (epoetin beta) was initiated at randomization (group 1) or only after the hemoglobin level fell below 10.5 g per deciliter (group 2). The primary end point was a composite of eight cardiovascular events; secondary end points included left ventricular mass index, quality-of-life scores, and the progression of chronic kidney disease. Results: During the 3-year study, complete correction of anemia did not affect the likelihood of a first cardiovascular event (58 events in group 1 vs. 47 events in group 2; hazard ratio, 0.78; 95% confidence interval, 0.53 to 1.14; P=0.20). Left ventricular mass index remained stable in both groups. The mean estimated GFR was 24.9 ml per minute in group 1 and 24.2 ml per minute in group 2 at baseline and decreased by 3.6 and 3.1 ml per minute per year, respectively (P=0.40). Dialysis was required in more patients in group 1 than in group 2 (127 vs. 111, P=0.03). General health and physical function improved significantly (P=0.003 and P