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用重组人促红细胞生成素纠正终末期肾病贫血。一项I期和II期联合临床试验的结果。

Correction of the anemia of end-stage renal disease with recombinant human erythropoietin. Results of a combined phase I and II clinical trial.

作者信息

Eschbach J W, Egrie J C, Downing M R, Browne J K, Adamson J W

出版信息

N Engl J Med. 1987 Jan 8;316(2):73-8. doi: 10.1056/NEJM198701083160203.

DOI:10.1056/NEJM198701083160203
PMID:3537801
Abstract

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.

摘要

我们对25例正在接受血液透析的终末期肾病贫血患者给予重组人促红细胞生成素。重组人促红细胞生成素在透析后每周静脉注射3次,并监测输血需求、血细胞比容、铁动力学和网织红细胞反应。在每公斤体重15至500单位的剂量范围内,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,3周内血细胞比容变化高达10个百分点,通过红细胞转铁蛋白摄取量测量,铁动力学增加至基础值的三到四倍。在18例接受有效剂量重组人促红细胞生成素的患者中,12例曾需要输血的患者不再需要输血,11例患者的血细胞比容升至35%或更高。随着血细胞比容升高,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,也未形成针对重组激素的抗体。这些结果表明,重组人促红细胞生成素是有效的,可消除输血需求及其免疫致敏、感染和铁过载风险,并可使许多终末期肾病贫血患者的血细胞比容恢复正常。

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1
Correction of the anemia of end-stage renal disease with recombinant human erythropoietin. Results of a combined phase I and II clinical trial.用重组人促红细胞生成素纠正终末期肾病贫血。一项I期和II期联合临床试验的结果。
N Engl J Med. 1987 Jan 8;316(2):73-8. doi: 10.1056/NEJM198701083160203.
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Correction of anaemia in haemodialysis patients with recombinant human erythropoietin.用重组人促红细胞生成素纠正血液透析患者的贫血
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[Erythropoietin--the first hematologic hormone in clinical use].[促红细胞生成素——首个临床应用的血液学激素]
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Clinical efficacy of recombinant human erythropoietin in hemodialysis patients.重组人促红细胞生成素在血液透析患者中的临床疗效
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The intensity of hemodialysis and the response to erythropoietin in patients with end-stage renal disease.终末期肾病患者的血液透析强度及对促红细胞生成素的反应
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[The correction of anemia with a high requirement for transfusion in patients on maintenance hemodialysis by conventional and reduced doses of recombinant human erythropoietin].[采用常规剂量和减量的重组人促红细胞生成素纠正维持性血液透析患者中对输血有高需求的贫血]
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Int J Cell Cloning. 1988 May;6(3):179-91. doi: 10.1002/stem.5530060304.
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Treatment of the anemia of progressive renal failure with recombinant human erythropoietin.用重组人促红细胞生成素治疗进行性肾衰竭贫血。
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[Human recombinant erythropoietin (rH-EPO) in chronic hemodialysis patients].慢性血液透析患者中的重组人促红细胞生成素(rH-EPO)
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