国产重组人促红细胞生成素临床疗效观察

Recombinant human erythropoietin made in China in anemic patients with chronic renal failure: results of a clinic trial

摘要: 采用随机对照的方法,观察了25例(对照)和24例(开放)国产重组人促红细胞生成素(EPO)对慢性肾功能衰竭肾性贫血患者的疗效和副作用。结果表明,采用皮下和静脉给药的方法,用国产EPO治疗慢性肾功能不全肾性贫血患者总有效率为93.9%,显效率为67.3%,有效率为26.5%,无效率为6.1%,与进口EPO疗效相当。国产EPO不良反应:透析器凝血发生率为4.0%,内瘘堵塞发生率为8.5%,与进口EPO相比无明显差异。

Abstract: A randomized controlled clinical trial of recombinant human erythropoietin （rHuEPO） made in China was evaluated in 25 pairs and 24 open cases of anemia resulted from chronic renal failure. The rHuEPO of EPOGEN and RECORMON were served as standard control drugs. The results showed that the total 93.9% effective rate of rHuEPO was achived in treatment of anemia due to chronic renal failure, and there were no significant diffrences between the rHuEPO made in China and EPOGEN and RECORMON. The side effects of rHuEPO were the clotting of dialysers（4.0%） and thrombosis of arteriovenous fistulae（8.5%）,but there was no significant difference compared with the control group. There were no hepatic or orther toxic effects found.