CORRECTION OF THE ANEMIA OF END-STAGE RENAL-DISEASE WITH RECOMBINANT-HUMAN-ERYTHROPOIETIN - RESULTS OF A COMBINED PHASE-I AND PHASE-II CLINICAL-TRIAL
CORRECTION OF THE ANEMIA OF END-STAGE RENAL-DISEASE WITH RECOMBINANT-HUMAN-ERYTHROPOIETIN - RESULTS OF A COMBINED PHASE-I AND PHASE-II CLINICAL-TRIAL
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DOI：
10.1056/nejm198701083160203
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发表时间：
1987-01-08
影响因子：
158.5
通讯作者：
ADAMSON, JW
中科院分区：
文献类型：
--
作者：
ESCHBACH, JW;EGRIE, JC;ADAMSON, JW
我们给25名正在接受血液透析的终末期肾病贫血患者使用重组人促红细胞生成素。透析后每周三次静脉注射重组人促红细胞生成素，并监测输血需求、红细胞压积、铁动力学和网织红细胞反应。在15至500单位/千克体重的剂量范围内，观察到有效红细胞生成呈剂量依赖性增加。在每公斤500单位时，在三周内观察到红细胞压积的变化高达10个百分点，并且观察到铁动力学增加了三到四倍的基础值，如通过铁蛋白转铁蛋白摄取所测量的。在接受有效剂量重组人促红细胞生成素的18名患者中，12名需要输血的患者不再需要输血，11名患者的红细胞压积增加到35%或更多。沿着红细胞压积升高，4例患者血压升高，大多数患者血清肌酐和钾水平升高。未观察到器官功能障碍或其他毒性作用，也未形成重组激素抗体。这些结果表明，重组人促红细胞生成素是有效的，可以消除需要输血的免疫致敏，感染和铁过载的风险，并可以恢复红细胞压积正常的许多患者的贫血的终末期肾病。
We administered recombinant human erythropoietin to 25 anemic patients with end-stage renal disease who were undergoing hemodialysis. The recombinant human erythropoietin was given intravenously three times weekly after dialysis, and transfusion requirements, hematocrit, ferrokinetics, and reticulocyte responses were monitored. Over a range of doses between 15 and 500 units per kilogram of body weight, dose-dependent increases in effective erythropoiesis were noted. At 500 units per kilogram, changes in the hematocrit of as much as 10 percentage points were seen within three weeks, and increases in ferrokinetics of three to four times basal values, as measured by erythron transferrin uptake, were observed. Of 18 patients receiving effective doses of recombinant human erythropoietin, 12 who had required transfusions no longer needed them, and in 11 the hematocrit increased to 35 percent or more. Along with the rise in hematocrit, four patients had an increase in blood pressure, and a majority had increases in serum creatinine and potassium levels. No organ dysfunction or other toxic effects were observed, and no antibodies to the recombinant hormone were formed. These results demonstrate that recombinant human erythropoietin is effective, can eliminate the need for transfusions with their risks of immunologic sensitization, infection, and iron overload, and can restore the hematocrit to normal in many patients with the anemia of end-stage renal disease.