重组人促红素注射液治疗肿瘤相关性贫血68例

Treatment of cancer-related anemia with recombinant human erythropoietin injection in 68 patients

目的:评价重组人促红素注射液(商品名:济脉欣)治疗肿瘤相关性贫血的有效性及安全性。方法:采用随机、单盲、阳性药平行对照、多中心非劣效性临床试验设计。将137例肿瘤相关性贫血患者随机分为试验组(68例)和对照组(69例)。试验组采用济脉欣,每次150 IU·kg^(-1),每周3次皮下注射,连续用药8周;对照组采用重组人促红素注射液(商品名:益比奥),每次150 IU·kg^(-1),每周3次,皮下注射,连续用药8周。评价其疗效和安全性。结果:用药8周后,两组间血红蛋白、红细胞压积以及网织红细胞差异无统计学意义(P>0.05);试验组和对照组的有效率分别为70.59%和71.01%,组间差异无统计学意义(P>0.05);Karnofsky评分组间差异无统计学意义(P>0.05)。整个试验过程中,不良事件发生率组间差异无统计学意义(P>0.05)。结论:济脉欣用于肿瘤相关性贫血,可以改善临床贫血症状,提高患者生活质量,且不良反应发生率低。济脉欣治疗肿瘤相关性贫血与对照药益比奥的有效性和安全性相当。

Objective： To evaluate the efficacy and safety of Jimaixin（ recombinant human erythropoietin injection） in the treatment of cancer-related anemia. Methods： This study was a randomized,single-blind,positive agent parallel controlled,multicenter,and non-inferiority clinical trial. Cancer-related anemia in 137 patients wererandomly divided into two groups： Jimaixin（ n = 68） and Yibiao（ control,n = 69） groups. They treated either with subcutaneous injection of Jimaixin（ 150 IU·kg-1,3 times a week,for 8 weeks） or Yibiao（ 150 IU·kg-1,3 times a week,for 8 weeks）. The efficacy and safety of Jimaixin in the treatment of cancer-related anemia were evaluated,and compared with Yibiao. Results： At 8 weeks after treatment,no significant difference was found in hemoglobin,hematocrit and reticulocyte count between the two groups（ P 〉0. 05）. The effective rates were70. 59% and 71. 01% in Jimaixin and Yibiao groups,respectively; there was no significant difference between the two groups（ P 〉0. 05）. There was no significant difference in the Karnofsky scores between the two groups（ P 〉0. 05）. During the study,adverse events were compared,and the differences between the two groups had no statistical significance（ P 〉0. 05）. Conclusion： Jimaixin can improve the clinical symptoms of anemia and the quality of life in patients with cancer-related anemia,and incidence of its adverse reactions is low. Compared with the control Yibiao,the curative effect and safety of Jimaixin does not show any difference in patients with cancer-related anemia.