Watson A J, Gimenez L F, Cotton S, Walser M, Spivak J L
Division of Nephrology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Am J Med. 1990 Oct;89(4):432-5. doi: 10.1016/0002-9343(90)90371-j.
The purpose of this study was to determine the efficacy of recombinant human erythropoietin (rHuEPO) given subcutaneously three times/week in patients with chronic renal failure and anemia (predialysis).
Eleven patients with predialysis chronic renal failure participated in a double-blind, placebo-controlled study of subcutaneously administered erythropoietin. For 12 weeks, patients received either rHuEPO 100 mu/kg body weight three times/week subcutananeously or a placebo. After 12 weeks of placebo, patients now also received rHuEPO in a dose up to 150 mu/kg three times/week until target hematocrit was achieved. Throughout the study, blood pressure was monitored closely and blood work was obtained regularly for hemoglobin, hematocrit, reticulocyte count, and iron profile determinations.
At 12 weeks, the hematocrit of the treated group had risen from 29% +/- 2% to 35% +/- 2% (p less than 0.001). The placebo group baseline hematocrit was 28% +/- 2% and at 12 weeks 26% +/- 2% After 12 weeks of rHuEPO therapy, the hematocrit of the prior placebo group was 32% +/- 2% (p less than 0.001 versus baseline). No significant change in biochemical parameters was noted. Mean blood pressure values were comparable before and after treatment. All protein ultimately required iron supplementation. In two patients, the rate of progression of renal failure appeared to increase as their hematocrit rose and rHuEPO was discontinued.
It is concluded that rHuEPO given subcutaneously is an effective and safe therapy for patients with chronic renal failure who are anemic and who are not receiving dialysis.
本研究旨在确定每周三次皮下注射重组人促红细胞生成素（rHuEPO）对慢性肾衰竭合并贫血（透析前）患者的疗效。
11例透析前慢性肾衰竭患者参与了一项皮下注射促红细胞生成素的双盲、安慰剂对照研究。在12周内，患者每周三次皮下注射100μ/kg体重的rHuEPO或安慰剂。12周安慰剂治疗后，患者现在也接受每周三次剂量高达150μ/kg的rHuEPO，直至达到目标血细胞比容。在整个研究过程中，密切监测血压，并定期进行血液检查，以测定血红蛋白、血细胞比容、网织红细胞计数和铁代谢指标。
12周时，治疗组的血细胞比容从29%±2%升至35%±2%（p<0.001）。安慰剂组基线血细胞比容为28%±2%，12周时为26%±2%。rHuEPO治疗12周后，先前安慰剂组的血细胞比容为32%±2%（与基线相比p<0.001）。未观察到生化参数有显著变化。治疗前后平均血压值相当。所有患者最终均需要补充铁剂。在两名患者中，随着血细胞比容升高且停用rHuEPO，肾衰竭进展速率似乎加快。
得出结论，皮下注射rHuEPO对未接受透析的慢性肾衰竭贫血患者是一种有效且安全的治疗方法。
