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一项关于重组人促红细胞生成素(阿法依泊汀)用于接受化疗的癌症患者贫血治疗的多中心研究。

A multicenter study of recombinant human erythropoietin (epoetin alpha) in the management of anemia in cancer patients receiving chemotherapy.

作者信息

Pawlicki M, Jassem J, Bösze P, Lotan C, Kurteva G P, Siddiqui M, Kosmidis P A, Rigatos G A, Kansu E, Durkovic P, Aziz Z, Al Idrissi H, Roth A, Cozma G

机构信息

Klinik Chemioterapii, National Institute of Oncology, Kraków, Poland.

出版信息

Anticancer Drugs. 1997 Nov;8(10):949-57. doi: 10.1097/00001813-199711000-00006.

Abstract

Current evidence suggests that epoetin alpha administration is well tolerated and effective in the management of anemia of cancer and cancer chemotherapy. An open-label, multinational, non-comparative study was conducted in 215 cancer patients with anemia secondary to chemotherapy with platinum- or non-platinum-based combinations. Epoetin alpha was administered s.c. (150 IU/kg three times/week) for a planned period of 16 weeks. The response rate of epoetin alpha, defined as an increase in hemoglobin level of 2 g/dl or more from baseline, was 67%. The rate of response was not related to the chemotherapy regimen administered (platinum or non-platinum based). The percentage of patients transfused and the transfusion rate during epoetin alpha treatment were reduced. Transfusional need was eliminated in 64 (75%) of the 85 patients transfused before the study start, after 1 month of therapy. Quality of life, assessed using a visual analog scale, improved markedly in patients who experienced a hematological response. These patients also experienced a statistically significant (p < 0.0001) improvement in mean WHO performance score. These findings indicate that epoetin alpha is a well tolerated and effective agent which increases hemoglobin concentration and reduces transfusion requirements in anemic cancer patients receiving chemotherapy.

摘要

目前的证据表明,给予α-促红细胞生成素耐受性良好,对癌症及癌症化疗所致贫血的治疗有效。一项开放标签、多国、非对照研究纳入了215例因铂类或非铂类联合化疗继发贫血的癌症患者。皮下注射α-促红细胞生成素(150 IU/kg,每周3次),计划治疗16周。α-促红细胞生成素的缓解率定义为血红蛋白水平较基线升高2 g/dl或更多,为67%。缓解率与所采用的化疗方案(铂类或非铂类)无关。α-促红细胞生成素治疗期间接受输血的患者百分比及输血率降低。在研究开始前接受输血的85例患者中,治疗1个月后,64例(75%)不再需要输血。使用视觉模拟量表评估,血液学缓解的患者生活质量显著改善。这些患者的世界卫生组织平均体能状态评分也有统计学意义的显著改善(p < 0.0001)。这些结果表明,α-促红细胞生成素耐受性良好且有效,可提高贫血癌症化疗患者的血红蛋白浓度并减少输血需求。

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