多中心随机对照评价重组人红细胞生成素注射液2种给药方法治疗肿瘤化疗相关贫血的临床研究  

A multicenter randomly controlled clinical trial to evaluate the efficacy and safety of rhEPO(36000IU) in the treatment of cancer chemotherapy-related anemia

作　　者：王宏羽[1] 张湘茹[1] 孙燕[1] 

机构地区：[1]中国医学科学院中国协和医科大学肿瘤医院内科,北京100021

出　　处：《中国肿瘤临床与康复》2009年第3期222-226,共5页Chinese Journal of Clinical Oncology and Rehabilitation

摘　　要：目的通过与重组人红细胞生成素(rhEPO 10000 IU)给药进行对照比较,评价使用重组人红细胞生成素注射液(36000 IU/支)每周一次给药治疗肿瘤化疗相关贫血的疗效和安全性。方法多中心、随机开放、剂量平行对照,将206例非髓性恶性肿瘤化疗合并贫血的患者随机分为两组,试验组rhEPO 36 000 IU,每周给药1次。对照组rhEPO 10 000 IU,每周给药三次,疗程均为8周。结果共入组患者206例,其中对照组102例,试验组104例,8周内对照组和试验组血红蛋白上升的显效率分别为52.0%和51.9%。两组总有效率(显效+有效)分别为73.5%和67.3%,经CMH检验两组差异无显著性(P>0.05)。两组血红蛋白上升的最大值分别为112 g/L和113 g/L,最大值与基线的差值分别为22 g/L和23 g/L,两组比较差异均无显著性。两组血红蛋白较基线值上升≥10 g/L的中位天数分别为18 d和16 d(P>0.05);两组血红蛋白较基线值上升≥20 g/L的中位天数分别为31d和32 d(P>0.05)。两组治疗期间输血比例分别为2.9%和8.7%,两组间输血次数和输血总量差异均无显著性(P>0.05)。对照组全部不良事件发生率为21.6%,试验组18.3%。对照组不良反应发生率为2.9%,试验组为1.9%。对照组严重不良事件发生率为3.9%,试验组为1.0%。结论在治疗8周内,rhEPO(36 000 IU)每周一次给药纠正贫血的总有效率(显效+有效)与常规剂量(10 000IU)每周三次给药的作用相当,可明显减少给药的注射频率,减轻患者痛苦;不增加不良事件的发生率,不良反应轻微,持续时间短,多可自行缓解。Objective To study the efficacy and safety of rhEPO （36000IU） in the treatment of cancer chemotherapy-related anemia as compared with rhEPO（10000IU）. Methods A multicenter randomized and dose parallel-controlled clinical trial was carried out in 206 non-myelogenous malignant tumors patients with cancer chemotherapy-related anemia. The patients were enrolled and randomly assigned into 2 groups. The treatment group was given rhEPO（36000IU） once a week and the control group was given rhE- PO（10000IU） three times a week for 8 weeks. Results 206 patients were enrolled, 106 patients in the treatment group, and 102 patients in the control group. The obvious effective rates of increase in Hb were 52. 0% in the control group and 51.9% in the treatment group in 8 weeks. The overall response rates were 73.5% and 67. 3% respectively. CMH test showed that the difference between the two groups was not significant （P 〉0. 05）. The maximum values of increase in Hb from baseline were 112 g/L in the control group and 113 g/L in the treatment group. The differences of hemoglobin values between the maximum value and the baseline were 22 g/L and 23 g/L respectively,with no significant difference between the two groups. The median time of Hb increase /〉 10 g/L from the baseline was 18 days and 16 days respectively, P 〉 0. 05. The median time of Hb increase ≥20 g/L from the baseline was 31 days and 32 days respectively, P 〉 0.05. The percentages of red-cell transfusion were 2. 9% and 8.7% respectively in the two groups during the treatment, with no significant difference in the times of red-cell transfusion and the number of red-cell units transfused between the two groups （ P 〉 0. 05 ）. The total incidence rates of adverse events were 21.6% and 18. 3% respectively in the two groups, the incidence rates of drug associated adverse event were 2. 9% and 1.9% respectively, the rates of severe adverse events were 3.9% and 1.0% respectively. Conclusion Within eight weeks, the overall response rate of rhEPO

关 键 词：重组人红细胞生成素(36000IU/支)注射液 化学疗法 贫血 

分 类 号：R730.5[医药卫生—肿瘤]