Roth D, Smith R D, Schulman G, Steinman T I, Hatch F E, Rudnick M R, Sloand J A, Freedman B I, Williams W W, Shadur C A
Department of Medicine and Surgery, University of Miami School of Medicine, FL.
Am J Kidney Dis. 1994 Nov;24(5):777-84. doi: 10.1016/s0272-6386(12)80671-8.
A study was undertaken to ascertain the effects of recombinant human erythropoietin (r-HuEPO) on renal function in chronic renal failure predialysis patients. The effect of improvement of anemia by r-HuEPO on the rate of decline in renal function in predialysis patients has not been previously studied prospectively in a large number of patients using reliable measures of glomerular filtration rate (GFR). To investigate the efficacy, safety, and impact of r-HuEPO therapy in chronic renal insufficiency patients, a 48-week, randomized, open-label, multicenter study was initiated in 83 anemic, predialysis (serum creatinine 3 to 8 mg/dL) patients. Serial GFRs were measured using 125I-iothalamate clearance. Forty patients were randomized to the untreated arm and 43 patients to the treatment arm (50 U/kg r-HuEPO subcutaneously three times weekly). Baseline characteristics were comparable for the r-HuEPO-treated and untreated groups. During this 48-week study, GFR, mean arterial blood pressure, and daily protein intake were not significantly different between the two groups. There was a statistically significant increase in hematocrit for the r-HuEPO-treated group that was not associated with acceleration of deterioration in residual renal function. This was demonstrated by the lack of a significant (P = 0.376) between-group difference in mean change in GFR from baseline to last available value for the r-HuEPO-treated (-2.1 +/- 3.2 mL/min) and untreated (-2.8 +/- 3.5 mL/min) groups. This study concludes that r-HuEPO therapy improves anemia in predialysis patients and does not accelerate the rate of progression to end-stage renal disease.
开展了一项研究，以确定重组人促红细胞生成素（r-HuEPO）对慢性肾衰竭透析前患者肾功能的影响。此前尚未在大量患者中使用可靠的肾小球滤过率（GFR）测量方法对r-HuEPO改善贫血对透析前患者肾功能下降速率的影响进行前瞻性研究。为了研究r-HuEPO治疗对慢性肾功能不全患者的疗效、安全性和影响，对83例贫血的透析前（血清肌酐3至8mg/dL）患者启动了一项为期48周的随机、开放标签、多中心研究。使用125I-碘他拉酸盐清除率测量系列GFR。40例患者被随机分配到未治疗组，43例患者被分配到治疗组（每周皮下注射3次50U/kg r-HuEPO）。r-HuEPO治疗组和未治疗组的基线特征具有可比性。在这项为期48周的研究中，两组之间的GFR、平均动脉血压和每日蛋白质摄入量没有显著差异。r-HuEPO治疗组的血细胞比容有统计学意义的增加，且与残余肾功能恶化加速无关。这通过r-HuEPO治疗组（-2.1±3.2 mL/min）和未治疗组（-2.8±3.5 mL/min）从基线到最后可用值的GFR平均变化的组间差异不显著（P = 0.376）得到证明。本研究得出结论，r-HuEPO治疗可改善透析前患者的贫血，且不会加速进展至终末期肾病的速率。
