Heras P, Kritikos K, Hatzopoulos A, Mitsibounas D
Department of Internal Medicine, General Hospital of Kos, Kos, Greece.
Eur J Cancer Care (Engl). 2008 Nov;17(6):619-23. doi: 10.1111/j.1365-2354.2007.00892.x. Epub 2008 Aug 13.
Anaemia is common in patients receiving chemotherapy, causing symptoms that have a major impact on quality of life (QoL). Epoetin beta rapidly increases haemoglobin (Hb) levels and improves QoL in anaemic patients with a variety of tumours. This was a randomized, double-blind, parallel-group, dose-finding study assessing the efficacy and safety of once-weekly epoetin beta in patients with solid tumours receiving chemotherapy. Adult patients with anaemia (Hb < 11 g/dL) were randomized to receive epoetin beta 30,000 IU or 20,000 IU once weekly for 12 weeks. All patients received oral iron supplementation. Haemoglobin levels, transfusion need and QoL [Functional Assessment of Cancer Therapy-fatigue (FACT-F) subscale score] were assessed at regular intervals. Fifty patients were randomized; 30 patients received epoetin beta 30,000 IU once weekly and 20 received 20,000 IU once weekly. Mean (+/- SD) increase in Hb from baseline to week 12 was 1.75 +/- 2.15 g/dL in the 30,000 IU group (P = 0.008 vs. baseline) and 1.04 +/- 1.75 g/dL in the 20,000 IU group (non-significant). Haemoglobin response (increase in Hb >or=2 g/dL from baseline) was observed in 78.3% of patients receiving epoetin beta 30,000 IU and 66.7% receiving epoetin beta 20,000 IU. Improvements in FACT-F subscale score were significantly (P < 0.001) correlated with increases in Hb level. Transfusion use was low during the study in both groups. Both epoetin beta regiments were well tolerated and there were no dose-dependent adverse events. Epoetin beta 30,000 IU once weekly is an effective and well-tolerated treatment of anaemia in patients with solid tumours.
贫血在接受化疗的患者中很常见，其引发的症状会对生活质量（QoL）产生重大影响。促红细胞生成素β能迅速提高血红蛋白（Hb）水平，并改善患有各种肿瘤的贫血患者的生活质量。这是一项随机、双盲、平行组、剂量探索性研究，旨在评估每周一次的促红细胞生成素β对接受化疗的实体瘤患者的疗效和安全性。成年贫血患者（Hb < 11 g/dL）被随机分为两组，分别每周一次接受30,000 IU或20,000 IU的促红细胞生成素β，持续12周。所有患者均接受口服铁剂补充。定期评估血红蛋白水平、输血需求和生活质量[癌症治疗功能评估-疲劳（FACT-F）子量表评分]。50名患者被随机分组；30名患者每周一次接受30,000 IU促红细胞生成素β，20名患者每周一次接受20,000 IU促红细胞生成素β。30,000 IU组从基线到第12周Hb的平均（±标准差）升高为1.75 ± 2.15 g/dL（与基线相比，P = 0.008），20,000 IU组为1.04 ± 1.75 g/dL（无统计学意义）。接受30,000 IU促红细胞生成素β的患者中，78.3%出现血红蛋白反应（Hb较基线升高≥2 g/dL）；接受20,000 IU促红细胞生成素β的患者中，这一比例为66.7%。FACT-F子量表评分的改善与Hb水平的升高显著相关（P < 0.001）。两组在研究期间的输血使用率都很低。两种促红细胞生成素β治疗方案的耐受性都很好，且没有剂量依赖性不良事件。每周一次30,000 IU促红细胞生成素β是实体瘤患者贫血的一种有效且耐受性良好的治疗方法。
