重组人红细胞生成素-α治疗恶性实体瘤相关贫血的临床研究

Recombinant human erythropoietin-α in the treatment of malignant solid cancer-related anemia:a multicenter clinical trial

目的：研究大剂量、短程使用重组人红细胞生成素-α（erythropoietin-α,EPO-α）治疗恶性实体肿瘤患者贫血的有效性、安全性和对生活质量的影响。方法：病理确诊的恶性肿瘤相关贫血患者121例,接受EPO-α20ku第1～2天、10ku第3～10天皮下注射治疗,观察治疗前后患者贫血状况的变化和治疗的安全性,应用癌症治疗性贫血功能评价（functional assessment of cancer therapy anemia,FACT-An）量表对贫血患者进行治疗前后的生活质量测评。结果：EPO-α皮下注射20ku第1～2天、10ku第3～10天治疗能显著提高恶性实体肿瘤相关贫血患者的血红蛋白水平、改善患者生活质量。EPO-α治疗耐受性好,在研究过程中未出现不能耐受的不良反应。结论：大剂量、短程使用EPO-α能够有效提高恶性肿瘤相关贫血患者的血红蛋白水平,改善患者生活质量。

Objective：To investigate the efficacy and safety of short-course treatment with recombinant human erythropoietin-α （EPO-α） at high dose for malignant solid cancer-related anemia and its influence on the life quality of cancer patients with anemia. Methods：This prospective, multicenter clinical trial enrolled 121 patients with malignant cancer-related anemia. All the patients were administered EPO-α subcutaneously at 20 ku on d 1 and 2 and 10 ku from d 3 to d 10. Anemia status of patients and safety of therapeutical regimen were observed before and after EPO-α therapy. FACT-An Table was used to evaluate the quality of life of anemia patients before and after EPO-α therapy. Results： Subcutaneous administration of EPO-α at 20 ku on d 1 and 2 and 10 ku from d 3 to d 10 increased the plasma Hb level and improved the life qualities of anemia patients. EPO-α was well tolerated and no intolerable adverse event was observed during the clinical trial. Conclusion： Short-course treatment with EPO-α at high dose effectively can increase plasma Hb levels and improved life qualities of patients with cancer-related anemia.