Amar M, Cendoroglo Neto M, Canziani M E, Nadaletto M A, Ajzen H, Draibe S A
Disciplina de Nefrologia da Escola Paulista de Medicina, São Paulo.
Rev Assoc Med Bras (1992). 1994 Apr-Jun;40(2):101-7.
The recombinant human erythropoietin (rHuEPO) by subcutaneous route has been considered the drug of choice for the correction of the anemia of chronic renal patients. PURPOSE--To evaluate the efficacy of a new preparation of rHuEPO in the correction of the anemia of chronic renal patients maintained by haemodialysis, exclusively administered by subcutaneous route, studying the adverse effects and searching for predictive factors for the response to this medication. METHODS--Twelve patients in regular haemodialysis were treated with freeze-dried rHuEPO by subcutaneous route during 18 months with initial doses of 20U/kg/dialysis. They were submitted to a careful clinical and laboratory monitoring for all this study. RESULTS--Eleven patients ended the study reaching the target hematocrit (Htc) of 30% and keeping it during the whole period of the study. The mean correction and maintenance doses of rHuEPO were 65U/kg/dialysis and 51U/kg/dialysis respectively. At the 12th week of the study a significative increase of Htc (18.4 +/- 3.5% vs. 25.4% +/- 3.8%, p < 0.05) was demonstrated. An increase of the erythrocytes and hemoglobin was concomitantly observed. Leucocytes and platelets increased significantly from the 24th week and kept steadily until the end of study. Just potassium increased in the biochemistry analysis of the patients at the 4th and the 12th week of the study returning to the basal values at the 24th week. The evolution of the iron metabolism parameters demonstrated an intermitent and statistically significant decrease of transferrin saturation at the 1st, 12th and 24th week, returning to the basal levels at the end of study. The serum ferritin did not change (582.7 +/- 700, 9ng/mL vs. 700.0 +/- 651, 6ng/nL). The weight and the blood pressure did not change either, although 2 normotensive patients became hypertensive and 2 others with controlled hypertension needed drug rearrange for blood pressure control (36%). A patient had a seizure episode with a full recovery. CONCLUSION--The rHuEPO has proved to be a safe and an efficient drug with easily controlled adverse effect.
皮下注射重组人促红细胞生成素（rHuEPO）被认为是纠正慢性肾病患者贫血的首选药物。目的——评估一种新型rHuEPO制剂在纠正维持性血液透析慢性肾病患者贫血方面的疗效，该制剂仅通过皮下途径给药，研究其不良反应并寻找对该药物反应的预测因素。方法——12例规律血液透析患者接受皮下注射冻干rHuEPO治疗18个月，初始剂量为20U/kg/透析。在整个研究过程中对他们进行仔细的临床和实验室监测。结果——11例患者完成研究，达到目标血细胞比容（Htc）30%，并在研究全过程保持。rHuEPO的平均纠正剂量和维持剂量分别为65U/kg/透析和51U/kg/透析。在研究第12周时，Htc有显著升高（18.4±3.5%对25.4%±3.8%，p<0.05）。同时观察到红细胞和血红蛋白增加。白细胞和血小板从第24周开始显著增加并持续稳定至研究结束。仅在研究第4周和第12周患者生化分析中钾升高，在第24周恢复至基础值。铁代谢参数的变化显示在第1、12和24周转铁蛋白饱和度有间歇性且具有统计学意义的下降，在研究结束时恢复至基础水平。血清铁蛋白未改变（582.7±700.9ng/mL对700.0±651.6ng/nL）。体重和血压也未改变，尽管2例血压正常患者变为高血压，另外2例血压得到控制的高血压患者需要调整药物以控制血压（36%）。1例患者发生癫痫发作，已完全康复。结论——rHuEPO已被证明是一种安全有效的药物，不良反应易于控制。
