Albertazzi A, Di Liberato L, Daniele F, Battistel V, Colombi L
Department of Nephrology and Dialysis, University G. D'Annunzio, Chieti, Italy.
Int J Artif Organs. 1998 Jan;21(1):12-8.
Chronic renal failure is characterized by a normochromic normocytic anemia, the severity of which generally increases during progression toward uremia. The purpose of the study was to evaluate the efficacy and safety of recombinant human erythropoietin (rHu-EPO) given subcutaneously (s.c.), the dose required to reach and maintain Hb levels within 10 and 11 g% and its effects, if any, on the progression of chronic renal failure. Eighty-four pre-dialysis patients (46 F, 38M, age 61.7+/-13.9 years) with Hb levels between 6 and 9 g% and serum creatinine ranging from 3 to 9 mg/dl were treated with s.c. rHu-EPO (2000 U/twice weekly). After 6 weeks, if Hb increase was below 1 g%, 1000 U of s.c. rHu-EPO were added at each administration (3000 U twice weekly). Once the Hb target was reached (10-11 g%), the rHu-EPO weekly dose was halved and administration reduced to once weekly. The patients showed a significant rise in mean Hb values (p<0.001) after 3 months. Mean Hb values were as follows: 8.00+/-0.77 g% (pretreatment), 9.35+/-1.0 (3rd month), 10.06+/-1.04 (6th month), 10.25+/-0.62 g% (12th month). The mean rHu-EPO doses were 4000 U/w (start of the study), 3592+/-1685 U/w (6th month), 2840-/+1178 U/w (12th month). Renal function was evaluated by plotting the reciprocal of serum creatinine values vs time with a two period comparison: period A (retrospective-8 mo); period B (prospective-12 mo). The residual renal function was not impaired by rHu-EPO therapy. Meanwhile, no relevant modifications were observed in mean blood pressure values. Low doses of s.c. rHu-EPO were well tolerated, safe and effective; this therapeutic approach should therefore be considered for the improvement of anemia in pre-dialysis patients. A slow and gradual correction of anemia induces an improved sense of well being and a more active of life style.
慢性肾衰竭的特征是正细胞正色素性贫血，其严重程度通常在向尿毒症进展过程中加重。本研究的目的是评估皮下注射重组人促红细胞生成素（rHu-EPO）的疗效和安全性、达到并维持血红蛋白（Hb）水平在10至11g%所需的剂量及其对慢性肾衰竭进展的影响（若有）。84例透析前患者（46例女性，38例男性，年龄61.7±13.9岁），Hb水平在6至9g%之间，血清肌酐范围为3至9mg/dl，接受皮下注射rHu-EPO（2000U/每周两次）治疗。6周后，若Hb升高低于1g%，每次给药时添加1000U皮下注射rHu-EPO（每周两次，每次3000U）。一旦达到Hb目标（10 - 11g%），rHu-EPO每周剂量减半，给药减至每周一次。3个月后患者平均Hb值显著升高（p<0.001）。平均Hb值如下：8.00±0.77g%（治疗前），9.35±1.0（第3个月），10.06±1.04（第6个月），10.25±0.62g%（第12个月）。rHu-EPO平均剂量分别为4000U/周（研究开始时），3592±1685U/周（第6个月），2840±1178U/周（第12个月）。通过绘制血清肌酐值的倒数与时间的关系图进行两阶段比较来评估肾功能：A阶段（回顾性 - 8个月）；B阶段（前瞻性 - 12个月）。rHu-EPO治疗未损害残余肾功能。同时，平均血压值未观察到相关变化。低剂量皮下注射rHu-EPO耐受性良好、安全且有效；因此，这种治疗方法应被考虑用于改善透析前患者的贫血。缓慢而逐渐地纠正贫血可改善幸福感并使生活方式更积极。
