应用重组人红细胞生成素注射液(宁红欣)治疗肾性贫血的多中心临床试验报告

目的 为进一步验证重组人红细胞生成素注射液(宁红欣)对肾性贫血的疗效,并观察可能出现的不良反应。方法 我们组织69家医院对1115例慢性肾衰肾性贫血患者进行了多中心临床研究,采用自身对照,应用皮下及静脉方式给药进行治疗。结果 完成试验疗程者共1079例,其中显效734例(68％);有效303例(28.1％);无效42例(3.89％);总有效率为96.1％。36例患者中途退出试验。宁红欣主要不良反应有血压升高、头痛等,多数不需停药即可好转。未发现严重不良反应。非透析治疗病例用药期间未见肾功能明显变化。结论 宁红欣治疗肾性贫血安全、有效,与Ⅱ期临床试验结果相似。

Multi-center clinical trial on treatment of renal anemia with reconbinant human erythro-poietin

Objective This multi - center clinical trial was carried out to verify the availability and observe probable side effects of lecombinant human erythiopoietin (ning hong - xin). Methods 1115 renal anemic patients with chronic renal failme were given with EPO at dosages of 100 unites/kg/week to 150 units/kg/week by i. v and subcutaneous injection.Results 1079 patients completed the studv.A-mong these cases 734(68%)had good effects,303(28. 1%)had effects,and 42(3.89%)had no effect. The total effective tate was 96.1% .36 patients were withdrawn from the srudy. The main side effects were hypertension and headache, and were unproved vithout withdrawing EPO. No severe side effects were found over study period. Condusions Ning hong - xin was safe and effective in treating renal anemia.