RECOMBINANT HUMAN ERYTHROPOIETIN IN ANEMIC PATIENTS WITH END-STAGE RENAL-DISEASE - RESULTS OF A PHASE-III MULTICENTER CLINICAL-TRIAL
RECOMBINANT HUMAN ERYTHROPOIETIN IN ANEMIC PATIENTS WITH END-STAGE RENAL-DISEASE - RESULTS OF A PHASE-III MULTICENTER CLINICAL-TRIAL
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DOI：
10.7326/0003-4819-111-12-992
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发表时间：
1989-12-15
影响因子：
39.2
通讯作者：
ADAMSON, JW
中科院分区：
文献类型：
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作者：
ESCHBACH, JW;ABDULHADI, MH;ADAMSON, JW
为确定重组人促红细胞生成素（rHuEpo）的有效性和安全性，对333例无并发症贫血（红细胞比容< 0.30）的血液透析患者进行了研究。所有患者均静脉滴注rHuEpo，每周3次，剂量为300或150 U/kg体重，随后降至75 U/kg，并调整至维持红细胞压积0.35 +-。0.03 (SD)。基线红细胞压积(0.223 +-。97.4%的患者在12周内增加到0.35，超过基线0.06。所有患者在治疗2个月内均消除了红细胞输注（rHuEpo治疗前6个月内1030例）。68例铁超载患者在治疗6个月后血清铁蛋白水平降低39%。rHuEpo的中位维持剂量为75 U/kg，每周3次（范围为12.5 ~ 525 U/kg）。无应答者有贫血的并发症：骨髓纤维化、纤维性骨炎、骨髓炎和急性或慢性失血。不良反应包括肌痛，5%；缺铁，43%；血压升高，35%；癫痫发作占5.4%。肌酐、钾和磷酸盐水平略有升高，但明显升高。血小板计数略有增加，但血管通路的凝血没有增加。rHuEpo可纠正血液透析患者的贫血，从而消除输血，减少铁负荷，提高生活质量。必须监测和治疗铁储备和血压，以维持生黄素的有效性，并尽量减少高血压脑病的威胁。
To determine the effectiveness and safety of recombinant human erythropoietin (rHuEpo), Hemodialysis patients (333) with uncomplicated anemia (hematocrit < 0.30) were studied. All received rHuEpo intravenously, three times per week at 300 or 150 U/kg body weight, which was then reduced to 75 U/kg and adjusted to maintain the hematocrit at 0.35 .+-. 0.03 (SD). The baseline hematocrit (0.223 .+-. 0.002) increased to 0.35, more than 0.06 over baseline within 12 weeks in 97.4% of patients. Erythrocyte transfusions (1030 within the 6 months before rHuEpo therapy) were eliminated in all patients within 2 months of therapy. Sixty-eight patients with iron overload had a 39% reduction in serum ferritin levels after 6 months of therapy. The median maintenance dose of rHuEpo was 75 U/kg, three times per week (range, 12.5 to 525 U/kg). Nonresponders had complicating causes for anemia: myelofibrosis, osteitis fibrosa, osteomyelitis, and acute or chronic blood loss. Adverse effects included myalgias, 5%; iron deficiency, 43%; increased blood pressure, 35%; and seizures, 5.4%. The creatinine, potassium, and phosphate levels increased slightly but significantly. The platelet count increased slightly but there was no increase in clotting of vascular accesses. The anemia of hemodialysis patients is corrected by rHuEpo resulting in the elimination of transfusions, reduction in iron overload, and improved quality of life. Iron stores and blood pressure must be monitored and treated to maintain the effectiveness of rHuEpo and to minimize the threat of hypertensive encephalopathy.