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

作　　者：王志菡 张红霞 王英 骆志国[3] 项颖[4] 李毅刚[5] 肖志华[6] 张伟华[7] 陈锦飞[8] 吴昌平[9] 刘安文[10] 吴学勇[11] 冯刚[12] 彭杰文[13] WANG Zhi-han;ZHANG Hong-xia;WANG Ying;LUO Zhi-guo;XIANG Ying;LI Yi-gang;XIAO Zhi-hua;ZHANG Wei-hua;CHEN Jin-fei;WU Chang-ping;LIU An-wen;WU Xue-yong;FENG Gang;PENG Jie-wen(West China Hospital,Sichuan University,Chengdu 610041,China;NCPC Jintan Biological Technology Co.,Ltd.,Shijiazhuang 050035,China;Taihe Hospital,Shiyan 442099,China;Chongqing Cancer Hospital,Chongqing 400030,China;Yue Bei People＇s Hospital,Shaoguan 512025,China;Hubei Cancer Hospital,Wuhan 430079,China;First Hospital of Shanxi Medical University,Taiyuan 030001,China;The Affiliated Nanjing Hospital of Nanjing Medical University,Nanjing 210006,China;The First People＇s Hospital of Changzhou,Changzhou 213003,China;The Second Affiliated Hospital of Nanchang University,Nanchang 330006,China;Shanghai Jing＇an District Central Hospital,Shanghai 200040,China;Wuhan Puai Hospital,Wuhan 430033,China;People＇s Hospital of Zhongshan,Zhongshan 528403,China)

机构地区：[1]四川大学华西医院,成都610041 [2]华北制药金坦生物技术股份有限公司,石家庄050035 [3]十堰太和医院,十堰442099 [4]重庆市肿瘤医院,重庆400030 [5]粤北人民医院,韶关512025 [6]湖北省肿瘤医院,武汉430079 [7]山西医科大学第一医院,太原030001 [8]南京医科大学附属南京医院,南京210006 [9]常州市第一人民医院,常州213003 [10]南昌大学附属第二医院,南昌330006 [11]上海市静安区中心医院,上海200040 [12]武汉市普爱医院,武汉430033 [13]中山市人民医院,中山528403

出　　处：《中国新药杂志》2018年第17期2042-2046,共5页Chinese Journal of New Drugs

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.

关 键 词：重组人促红素 济脉欣 肿瘤相关性贫血 

分 类 号：R969.4[医药卫生—药理学] R979.1[医药卫生—药学]