重组人促红素注射液治疗肿瘤相关性贫血68例
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摘要
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.
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.
引文
[1]中国临床肿瘤学会肿瘤相关性贫血专家委员会.肿瘤相关性贫血临床实践指南(2015-2016版)[J].中国实用内科杂志,2015,35(11):922-923.
[2]GATES GA,HAUGHEY BH.Effect of blood transfusion on recurrence of head and neck carcinoma.Retrospective review and meta-analysis[J].Ann Otol Rhinol Laryngol,1992,101(9):724-730.
[3]黄耘祥,董亮.等容稀释性自体输血对妇科恶性肿瘤患者围手术期免疫功能的影响[J].临床血液学杂志:输血与检验,2011,24(3):329-331.
[4]陈健,王伟,李兴慧,等.异体输血对食管癌患者术后免疫功能的影响[J].现代肿瘤医学,2015,23(19):2766-2768.
[5]张霞,曾泗宇,石卫民.重组人促红素治疗恶性肿瘤伴贫血的药效观察[J].河北医学,2015,21(9):1468-1470.
[6]BOHLIUS J,LANGENSIEPEN S,SCHWARZER G,et al.Recombinant human erythropoietin and overall survival in cancer patients:results of a comprehensive meta-analysis[J].J Natl Cancer Inst,2005,97(7):489-498.
[7]BOHLIUS J,WILSON J,SEIDENFELD J,et al.Erythropoietin or darbepoetin for patients with cancer[J].Cochrane Database Syst Rev,2006,3:CD003407.
[8]TANG XW,LEI JH,LI JH.Clinical efficacy of erythropoietin in the treatment of patients with cancer-related anemia[J].Chinese J General Practice,2017,15(10):1722-1724.
[9]ANEMIA CR.Clinical practice guidelines on cancer-related anemia(2012-2013 Edition)[J].Chin Clin Oncol,2012,1(2):18-38.
[10]朱国旺.促红素治疗更符合肿瘤贫血患者生理状况——专家解读《肿瘤相关性贫血临床实践指南》[N].中国医药报,2012-07-19(006).
[2]GATES GA,HAUGHEY BH.Effect of blood transfusion on recurrence of head and neck carcinoma.Retrospective review and meta-analysis[J].Ann Otol Rhinol Laryngol,1992,101(9):724-730.
[3]黄耘祥,董亮.等容稀释性自体输血对妇科恶性肿瘤患者围手术期免疫功能的影响[J].临床血液学杂志:输血与检验,2011,24(3):329-331.
[4]陈健,王伟,李兴慧,等.异体输血对食管癌患者术后免疫功能的影响[J].现代肿瘤医学,2015,23(19):2766-2768.
[5]张霞,曾泗宇,石卫民.重组人促红素治疗恶性肿瘤伴贫血的药效观察[J].河北医学,2015,21(9):1468-1470.
[6]BOHLIUS J,LANGENSIEPEN S,SCHWARZER G,et al.Recombinant human erythropoietin and overall survival in cancer patients:results of a comprehensive meta-analysis[J].J Natl Cancer Inst,2005,97(7):489-498.
[7]BOHLIUS J,WILSON J,SEIDENFELD J,et al.Erythropoietin or darbepoetin for patients with cancer[J].Cochrane Database Syst Rev,2006,3:CD003407.
[8]TANG XW,LEI JH,LI JH.Clinical efficacy of erythropoietin in the treatment of patients with cancer-related anemia[J].Chinese J General Practice,2017,15(10):1722-1724.
[9]ANEMIA CR.Clinical practice guidelines on cancer-related anemia(2012-2013 Edition)[J].Chin Clin Oncol,2012,1(2):18-38.
[10]朱国旺.促红素治疗更符合肿瘤贫血患者生理状况——专家解读《肿瘤相关性贫血临床实践指南》[N].中国医药报,2012-07-19(006).