Cianciaruso Bruno, Ravani Pietro, Barrett Brendan J, Levin Adeera
Division of Nephrology, Faculty of Medicine, University "Federico II" of Naples, Naples - Italy.
J Nephrol. 2008 Nov-Dec;21(6):861-70.
This study is part of a 3-country study testing whether normal levels of hemoglobin (Hgb) delay the progression of left ventricular (LV) growth in chronic kidney disease (CKD) patients not on dialysis.
This was an open-label, randomized, multicenter, controlled trial conducted in 27 tertiary-care hospitals in Italy. Treated subjects (n=46) received epoetin-alpha (EPO-alpha) to maintain Hgb levels in the range 12-14 g/dL. Control subjects (n=49) were not treated unless their Hgb decreased to 9.0 g/dL. Primary outcome was LV mass index (MI) change after 24 months. Subcutaneous EPO-alpha was withdrawn in Europe and the study prematurely terminated; therefore, a 12-month analysis was carried out.
Mean age was 57 years (38% were women, 18% with diabetes, 76% taking ACEI or ARB and 22% statins). EPO-alpha median final dose was 2,000 IU/week. Hgb significantly increased (12.4 -/+ 1.1 g/L) for the treatment group and decreased for controls (11.3 -/+ 1.3 g/L; p<0.001). The intention-to-treat analysis was conducted in 78 patients. Mean baseline LVMI for treated patients and controls was 109.5 -/+ 23 g/m2 and 108.7 -/+ 29 g/m2, respectively. LVMI did not change among controls, whereas it decreased slightly, though not significantly, among treated patients.
The current Italian trial was negative, maybe due to its limitations: lack of power, 1-year follow-up and normal LVMI in some patients at start; however, it was consistent with other published studies. Thus, it is unlikely that targeting hemoglobin in the normal range for CKD patients is of benefit.
本研究是一项三国研究的一部分，旨在测试正常血红蛋白（Hgb）水平是否会延缓未接受透析的慢性肾脏病（CKD）患者左心室（LV）生长的进程。
这是一项在意大利27家三级医疗中心进行的开放标签、随机、多中心对照试验。治疗组受试者（n = 46）接受促红细胞生成素-α（EPO-α）治疗，以维持Hgb水平在12 - 14 g/dL范围内。对照组受试者（n = 49）除非Hgb降至9.0 g/dL，否则不接受治疗。主要结局是24个月后左心室质量指数（MI）的变化。欧洲已停止皮下注射EPO-α，该研究提前终止；因此，进行了为期12个月的分析。
平均年龄为57岁（38%为女性，18%患有糖尿病，76%服用ACEI或ARB，22%服用他汀类药物）。EPO-α的最终中位剂量为2000 IU/周。治疗组Hgb显著升高（12.4 ± 1.1 g/L），而对照组Hgb下降（11.3 ± 1.3 g/L；p<0.001）。对78例患者进行了意向性治疗分析。治疗组和对照组患者的平均基线左心室质量指数分别为109.5 ± 23 g/m²和108.7 ± 29 g/m²。对照组的左心室质量指数没有变化，而治疗组患者的左心室质量指数虽略有下降，但不显著。
当前的意大利试验结果为阴性，可能是由于其局限性：样本量不足、1年随访以及部分患者起始时左心室质量指数正常；然而，该结果与其他已发表的研究一致。因此，将CKD患者的血红蛋白水平控制在正常范围内不太可能有益。
