Multicenter trial of erythropoietin in patients on peritoneal dialysis.
Multicenter trial of erythropoietin in patients on peritoneal dialysis.
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腹膜透析患者促红细胞生成素的多中心试验。
DOI：
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发表时间：
1995
期刊：
影响因子：
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通讯作者：
J. Stone
中科院分区：
文献类型：
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作者：
A. Nissenson;S. Korbet;M. Faber;J. Burkart;D. Gentile;R. Hamburger;W. Mattern;M. Schreiber;R. Swartz;J. Stone
采用随机、双盲、安慰剂对照、多中心临床试验，评价腹膜透析患者皮下注射重组促红细胞生成素（EPO）的安全性和有效性。在前12周，78名患者随机接受EPO治疗，74名患者接受安慰剂治疗。此后，红细胞压积低于32%的安慰剂组患者与初始EPO组患者一起沿着进入EPO维持期。EPO组的红细胞压积在6周后从23.8%显著上升至32%，并在12周时维持在33.7%。在安慰剂组中，研究前红细胞压积也为23.8%，12周内红细胞压积无显著变化。随着红细胞压积的升高，仅EPO组的输血需求下降。88%的接受EPO治疗的患者在研究的第12周时贫血得到改善。在维持阶段有广泛的剂量需求，范围从每周三次8,000 U到每隔一周4,000 U。EPO治疗后的不良事件与血液透析患者中观察到的类似，在治疗的最初12周内，55%的EPO患者发生高血压或高血压恶化。在接受EPO治疗前，高血压患者的血压更容易升高。EPO在腹膜透析患者中安全有效，与血液透析患者一样。除了血压升高，这是可控的抗高血压药和超滤透析，没有严重的副作用。最佳目标红细胞压积，改善贫血对生活质量的影响，以及改善贫血对该患者人群终末器官（心脏，脑）的影响需要进一步研究。
A randomized, double-blind, placebo-controlled, multicenter trial was performed to assess the safety and efficacy of subcutaneous recombinant erythropoietin (EPO) in peritoneal dialysis patients. Seventy-eight patients were randomized to receive EPO and 74 received placebo during the first 12 wk. After this, placebo patients with hematocrit less than 32% entered the EPO maintenance phase along with the initial EPO patients. Hematocrit rose significantly in the EPO group from 23.8 to 32% after 6 wk, and this was sustained at 33.7% at 12 wk. In the placebo group, the prestudy hematocrit was 23.8% as well, and no significant change in hematocrit occurred over 12 wk. Concomitant with the rise in hematocrit, transfusion requirements fell only in the EPO group. Eighty-eight percent of patients receiving EPO had their anemia ameliorated by Week 12 of the study. There was a wide range of dosage requirements during the maintenance phase, ranging from 8,000 U thrice weekly to 4,000 U every other week. Adverse events after EPO were similar to those seen in hemodialysis patients given this agent, with hypertension developing or worsening in 55% of EPO patients during the initial 12 wk of therapy. Blood pressure was more likely to rise in patients with hypertension before receiving EPO. EPO is safe and effective in peritoneal dialysis patients, as it is in hemodialysis patients. Other than a rise in blood pressure, which is manageable with antihypertensives and ultrafiltration with dialysis, no serious side effects are seen. The optimal target hematocrit, effects of anemia improvement on quality of life, and end-organ (heart, brain) effects of anemia improvement in this patient population require further study.