基因重组人红细胞生成素注射液治疗肾性贫血的多中心临床研究  

Treatment of Renal Anemia with Recombinant Human Erythropoietin： a Multicentre Clinical Study

作　　者：苏颖[1] 李学旺[1] 余学清[2] 王质刚[2] 冯学亮 刘先蓉 

机构地区：[1]中国医学科学院 中国协和医科大学 协和医院肾内科,北京100730 [2]中国医学科学院中国协和医科大学协和医院肾内科,北京100730

出　　处：《中国医学科学院学报》2001年第3期232-236,共5页Acta Academiae Medicinae Sinicae

摘　　要：目的 观察基因重组人红细胞生成素治疗肾性贫血的疗效及安全性。方法 采用非盲非对照方法进行多中心临床研究。初始给药剂量：血透和腹透患者每周 150 U/kg,非透析者每周 100 U/kg，每周分 2～ 3次皮下或静脉注射。根据血红蛋白和红细胞压积升高的情况调整剂量，疗程为 12周。 结果 共 358例患者进入试验，中途退出 8例， 350例计入统计。完成 12周治疗者 182例，显效 57.1％（ 104/182），有效 30.2％（ 55/182），总有效率 87.3％，无效 12.7％（ 23/182）。不良反应主要是高血压（ 14.6％），偶有头痛、注射部位疼痛等。结论 基因重组人红细胞生成素治疗肾性贫血安全有效。Objective To investigate the safety and efficacy of recombinant human erythropoietin in the treatment of renal anemia. Methods The study was a non- control multicentre trial. Hemodialysis and peritoneal dialysis patients were given 150 U/kg and non- dialysis patients 100 U/kg everyweek intravenously or subcutaneously for 12 weeks. Results There were 358 patients taking part in the study and 8 had withdrawn.Finally, 350 cases were analyzed. At the end of the trial, 104 among 182 patients（ 57.1％） were found with excellent effect,55（ 30.2％） good effect， totally effective rate was 87.3％ and 23（ 12.7％） with no effect. The main side effect was hypertension with an incidence of 14.6％ . Others included local pain, headache etc. All of the side effects were mild and the treatment could continue. Conclusion Recombinant human erythropoietin is effective in correction of renal anemia with mild side effects.

关 键 词：慢性肾功能衰竭 贫血 重组人红细胞生成素 治疗 肾性贫血 多中心临床研究 

分 类 号：R556.9[医药卫生—血液循环系统疾病] R973.3[医药卫生—内科学]