长短效红细胞生成素在维持性血液透析患者中应用的临床观察

The clinical applications of long-acting and short-acting erythropoietin in hemodialysis patients

目的观察长效红细胞生成素(美信罗)与短效红细胞生成素β(罗可曼)在治疗维持性血液透析患者中贫血的疗效,同期评估和比较两者的安全性和耐受性。方法入选2008年02月到2010年5月在广东省人民医院血液净化中心行维持性血液透析且符合入选标准的患者,随机分成2组,长效红细胞生成素组给药方法为美信罗注射液,起始剂量0.4μg/kg,静脉注射,每2周1次;短效红细胞生成素组给药方法为罗可曼注射液,40IU/kg,静脉注射,每周3次。研究时间共55周,其中筛选期2周,纠正期16周,评估期8周,延长期28周,在第53周时做最后1次随访,第24周评估期2组血红蛋白变化的差异性,同期评估Hb的反应率及较基线值的变化,记录并评估不良事件,在第53周时评估2组的安全性和耐受性。结果共22例患者入选,每组11例,第24周时2组的反应率均为82%(9/11),24周内2组血红蛋白的变化无统计学意义,第53周最后评估2组的反应率,2组总血红蛋白的反应率81%(19/22),其中长效组72%(8/11),短效组100%(11/11)。重复测量的方差分析结果显示2组血红蛋白的变化值无统计学意义,疗效相当。2组不良事件的发生率亦无差异。结论长效红细胞生成素与短效红细胞生成素疗效相当,各组血红蛋白稳步上升,安全及耐受性好,临床可个体化选择不同的剂型。

Objective To observe the efficacy of the long-acting erythropoietin （Maxim Luo） and the short-acting erythropoietin β （LUO Man） in the treatment of anemia in maintenance hemodialysis patients,and to evaluate and compare the safety and tolerability between the two preparations.Method We recruited the hemodialysis patients who met the inclusion criteria and were treated in the Blood Purification Center of Guangdong General Hospital during the period from February 2008 to May 2010.They were randomly divided into two groups,the long-acting group,in which patients were intravenously administrated with Maxim Lo beginning from 0.4 μg/kg and once every two weeks,and the short acting group,in which patients were intravenously administrated with LUO Man 40 IU/kg three times a week.The study lasted for 55 weeks,including screening period for 2 weeks,correction period for 16 weeks,evaluation period for 8 weeks,and extension period for 28 weeks.The last follow-up was conducted at the 53th week.Hemoglobin concentration difference,hemoglobin response rate,and hemoglobin concentration change against basal value were evaluated at the 24th week,and safety and tolerability were compared between the 2 groups at the 53th week.Results Twenty-two patients （11 cases in each group） were enrolled in this study.The response rate to the treatment was 82％ （9/11） in both groups.Hemoglobin change at the 24th week was statistically insignificant between the two groups.Hemoglobin response rate at the 53th week was 81％ （19/22） in the 22 patients,with the rate of 72％ （8/11） in long acting group and 100％ （11/11） in short acting group.Analysis of variance to the repeated measurements showed that hemoglobin concentration change and adverse events were statistically insignificant between the two groups.Conclusion The therapeutic effect was similar between long-acting erythropoietin and short-acting erythropoietin β.Both preparations are well tolerated and effective for erythropoiesis.Either long-acting or short-acting erythropoietin can be used clinically according to patient＇s situation.