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

机译:慢性肾脏疾病和贫血患者的血红蛋白水平正常化。

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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 m2 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<0.001, respectively, in group 1, as compared with group 2). There was no significant difference in the combined incidence of adverse events between the two groups, but hypertensive episodes and headaches were more prevalent in group 1. CONCLUSIONS: In patients with chronic kidney disease, early complete correction of anemia does not reduce the risk of cardiovascular events. (ClinicalTrials.gov number, NCT00321919 [ClinicalTrials.gov].).
机译:背景:尚无纠正3期或4期慢性肾脏病患者贫血的纠正措施能否改善心血管疾病的预后。方法:我们随机分配603例肾小球滤过率(GFR)为每分钟1.73平方米每分钟15.0至35.0毫升和轻度至中度贫血(血红蛋白水平为每分升11.0至12.5克)的患者,分别为目标血红蛋白值在正常范围内(每分升13.0至15.0 g,第1组)或在非正常范围内(每分升10.5至11.5 g,第2组)。皮下促红细胞生成素(epoetin beta)在随机分组(组1)或仅在血红蛋白水平降至每分升10.5 g以下(组2)后开始。主要终点是八项心血管事件的综合结果。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:在为期3年的研究中,贫血的完全纠正并不影响首次发生心血管事件的可能性(第1组58例,第2组47例;危险比0.78; 95%置信区间0.53至1.14 ; P = 0.20)。两组左心室质量指数均保持稳定。在基线时,第1组的平均估计GFR为24.9 ml /分钟,第2组的平均估计GFR为24.2 ml /分钟,每年分别降低3.6和3.1 ml / min(P = 0.40)。与第2组相比,第1组中需要更多透析的患者(127比111,P = 0.03)。总体健康和身体机能显着改善(与第2组相比,第1组分别为P = 0.003和P <0.001)。两组不良事件的总发生率之间无显着差异,但在第1组中高血压发作和头痛更为普遍。结论:在慢性肾脏病患者中,尽早完全纠正贫血并不能降低心血管疾病的风险事件。 (ClinicalTrials.gov号,NCT00321919 [ClinicalTrials.gov]。)。

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