Tsai J C, Lai Y H, Tsai Z Y, Chien L J, Tsai J H
Department of Internal Medicine, Kaoshiung Medical College, Taiwan, Republic of China.
Gaoxiong Yi Xue Ke Xue Za Zhi. 1991 Mar;7(3):126-35.
To evaluate the clinical efficacy of recombinant human erythropoietin (EPO) and its influencing factors in the treatment of anemia in hemodialysis (HD) patients, 17 chronic stable HD patients (10 males, 7 females; mean age: 46.0 +/- 2.6 years) with severe anemia were enrolled in this study. The study period (ranging from 5 to 11 months) was divided into the initial 12 weeks of correction phase and the subsequent maintenance phase. EPO, 1500 U initially, was administered intravenously twice weekly (BIW group, n = 10) or thrice weekly (TIW group, n = 7) at the end of each HD. Dose was doubled every 4 weeks until up to a maximum dose of 6000 U if increment of hematocrit (Hct) was less than 3%. At the end of correction phase, anemia was markedly improved. Hct and hemoglobin (Hb) increased from 19.3 +/- 0.8 to 28.7 +/- 1.1% and from 6.5 +/- 0.3 to 9.6 +/- 0.4 g/dl, respectively. Fifteen patients (88%) reached to the target Hct of 30% at 13.7 +/- 1.2 weeks. At the end of study, Hct and Hb was maintained at 29.1 +/- 0.7% and 9.6 +/- 0.3 g/dl, respectively. Requirement of EPO dose to reach the target and maintain the stable Hct (greater than or equal to 28%) was 99 +/- 14 and 62 +/- 11 U/kg/week, respectively. Laboratory parameters showed that serum iron, transferrin saturation, sugar and triglyceride decreased significantly and uric acid and aluminum (Al) increased significantly. There was no significant change in predialysis blood pressure, body weight, cardiac ratio, and ECG. Quality of life was markedly improved with the better subjective feelings, physical activity and Karnorfsky index. Common adverse effects included exacerbated hypertension (23%), hyperphosphatemia (18%), hyperkalemia (18%), and flu-like syndrome (12%). All of them could be managed by medical and dialysis treatment. Investigation of influencing factors on response to EPO suggests that 1) TIW group had a better response than BIW group 2) Response was better in patients with more adequate iron status and less severe Al burden. 3) Time to target Hct correlated approximately with basal serum Al levels but did not correlate with basal serum parathyroid hormone levels. In conclusion, low dose of EPO therapy corrects anemia effectively with minimal adverse effects in HD patients. Dosing regimen, iron status, and serum Al will influence the response to EPO.
为评估重组人促红细胞生成素（EPO）治疗血液透析（HD）患者贫血的临床疗效及其影响因素，本研究纳入了17例重度贫血的慢性稳定HD患者（男10例，女7例；平均年龄：46.0±2.6岁）。研究期（5至11个月）分为初始12周的纠正期和随后的维持期。初始剂量为1500 U的EPO，在每次HD结束时每周静脉注射两次（BIW组，n = 10）或每周三次（TIW组，n = 7）。如果血细胞比容（Hct）增幅小于3%，则每4周剂量加倍，直至最大剂量6000 U。在纠正期结束时，贫血明显改善。Hct和血红蛋白（Hb）分别从19.3±0.8%增至28.7±1.1%，以及从6.5±0.3 g/dl增至9.6±0.4 g/dl。15例患者（88%）在13.7±1.2周时达到目标Hct 30%。在研究结束时，Hct和Hb分别维持在29.1±0.7%和9.6±0.3 g/dl。达到目标并维持稳定Hct（大于或等于28%）所需的EPO剂量分别为99±14和62±11 U/kg/周。实验室参数显示，血清铁、转铁蛋白饱和度、血糖和甘油三酯显著降低，尿酸和铝（Al）显著升高。透析前血压、体重、心脏比率和心电图无显著变化。生活质量显著改善，主观感受、身体活动和卡诺夫斯基指数均更佳。常见不良反应包括高血压加重（23%）、高磷血症（18%）、高钾血症（18%）和类流感综合征（12%）。所有这些不良反应均可通过药物和透析治疗进行处理。对EPO反应的影响因素研究表明：1）TIW组的反应优于BIW组；2）铁状态更充足且Al负荷较轻的患者反应更佳；3）达到目标Hct的时间与基础血清Al水平大致相关，但与基础血清甲状旁腺激素水平无关。总之，低剂量EPO疗法可有效纠正HD患者的贫血，且不良反应最小。给药方案、铁状态和血清Al会影响对EPO的反应。
