Spiriti M A Aloe, Latagliata R, Niscola P, Cortelezzi A, Francesconi M, Ferrari D, Volpe E, Clavio M, Grossi A, Reyes M Tambone, Musto P, Mitra M E, Azzarà A, Pagnini D, D'Arena G, Spadano A, Balleari E, Pecorari P, Capochiani E, De Biasi E, Perego D, Monarca B, Pisani F, Scaramella G, Petti M C
II Facoltà di Medicina e Chirurgia, Università di Roma La Sapienza-Azienda Ospedaliera Sant'Andrea, Rome, Italy.
Ann Hematol. 2005 Mar;84(3):167-76. doi: 10.1007/s00277-004-0961-9. Epub 2004 Nov 30.
This study evaluated the impact of a new epoetin alfa dosing regimen on quality of life (QOL), transfusion requirements, and hemoglobin (Hb) levels in 133 patients with low-risk myelodysplastic syndrome (MDS) and Hb < or =10 g/dl. Epoetin alfa 40,000 IU was given subcutaneously twice weekly; after 4 weeks, the dose could be reduced to 40,000 IU weekly in patients achieving erythroid response. QOL was assessed using the functional assessment of cancer therapy-anemia (FACT-An) questionnaire. FACT-An scores increased on average by 7.5 after 4 weeks and by 8.8 after 8 weeks compared with baseline. FACT-An scores were positively associated with Hb values (r=0.53, P<0.01). The mean FACT-An score increase at week 8 was 10.2 in responders and 5.6 in nonresponders. The overall erythroid response rate at week 8 was 68%: 74% in transfusion-independent patients and 59% in transfusion-dependent patients. Of all responders at week 8, response was maintained in 86% at week 12, 71% at week 16, 65% at week 20, and 54% at week 24. Treatment was generally well tolerated. Our data provide new and encouraging results regarding the benefits of 40,000 IU biweekly induction doses followed by 40,000 IU weekly in improving QOL, correcting anemia, and reducing transfusion requirements in low-risk MDS patients.
本研究评估了一种新的促红细胞生成素α给药方案对133例低危骨髓增生异常综合征(MDS)且血红蛋白(Hb)≤10 g/dl患者的生活质量(QOL)、输血需求及Hb水平的影响。促红细胞生成素α 40,000 IU每周皮下注射两次;4周后,对于出现红系反应的患者,剂量可减至每周40,000 IU。使用癌症治疗贫血功能评估(FACT - An)问卷评估QOL。与基线相比,4周后FACT - An评分平均增加7.5,8周后增加8.8。FACT - An评分与Hb值呈正相关(r = 0.53,P < 0.01)。第8周时,有反应者的FACT - An评分平均增加10.2,无反应者增加5.6。第8周时总的红系反应率为68%:非输血依赖患者为74%,输血依赖患者为59%。在第8周所有有反应者中,第12周时86%维持反应,第16周时71%,第20周时65%,第24周时54%。治疗总体耐受性良好。我们的数据为每两周诱导剂量40,000 IU随后每周40,000 IU在改善低危MDS患者的QOL、纠正贫血及减少输血需求方面的益处提供了新的、令人鼓舞的结果。