红细胞生成素大剂量冲击维持疗法治疗血液肿瘤贫血的临床研究

Clinical Study of Induction high dose therapy followed by Main- tenance with EPO in Anemic Hematological Malignancy Patients

目的研究红细胞生成素(EPO)大剂量冲击维持疗法治疗血液肿瘤贫血患者的临床疗效和安全性。方法采用开放性非随机的临床研究方法,恶性血液肿瘤患者在化疗同时,于第1周采用EPO120,000U冲击用药(40,000U皮下d1、d3、d5),随后EPO每周40,000U皮下(d8、d15、d22)维持用药,共4周。比较治疗前后每周的血红蛋白(Hb)和红细胞压积(Hct)水平,并评价EPO治疗的不良反应。结果2003年10月～2005年12月共入组42例同期化疗的血液肿瘤贫血患者。所有患者给予EPO治疗后Hb水平呈持续上升趋势,在治疗后第2、4周Hb比治疗前上升≥2.0g/dl的患者分别占26.8%和52.6%。在治疗后第2、4周Hb的平均值分别为85.6g/dl和92.8g/dl,与治疗前相比均具有显著性差异(P<0.05)。治疗前后平均Hct值亦有显著性差异(P<0.05)。所有使用EPO大剂量冲击维持疗法治疗的患者均耐受良好。结论血液肿瘤贫血患者使用EPO大剂量冲击维持疗法,可有效改善患者的贫血状况,且使用安全,耐受良好。

Objective Anemia is a common complication of hematological malignancy. And the use of EPO has been proved to improve the complaints of patients with cancer-related anemia. This study is to determine whether induction high dose EPO followed by weekly maintenance usage could improve hemoglobin （Hb） levels in anemic hematological malignancy patients receiving chemotherapy. Methods The open-label, nonrandomized clinical study evaluated the response rate of induction EPO 120,000 U （40,000 U SC d1, d3, d5） followed by maintenance dose of 40,000 U SC once weekly for 3 weeks （d8, d15, d22）. Mean Hemoglobin and Hct were measured pretreatment and weekly during the treatment. Results From Oct. 2003 to Dec. 2005, 42 cancerrelated anemic hematological malignancy patients receiving concurrent chemotherapy were accrued. Mean hemoglobin and Hct kept increasing during the treatment, and the percentage that hemoglobin ≥2.0g/dl increase compared with pretreatment （69. 5g/dl） in week 2（n-41） and week 4 （n=38）are26.8%and52.6% respectively. Mean hemoglobin at week 2 and week 4 are 85.6g/dl and 92.8 g/dl respectively, and significantly higher than pretreatment （P〈0 05）. All patients accepting this treatment were well tolerant. Conclusion Induction high dose therapy followed by maintenance with EPO can improve hemoglobin and Hct in cancer-related anemic hematological malignancy patients undergoing chemotherapy with limited adverse effects.