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重组人促红细胞生成素β:每周给药对儿科癌症患者贫血、生活质量及长期预后的影响

Recombinant human erythropoietin β: the effect of weekly dosing on anemia, quality of life, and long-term outcomes in pediatric cancer patients.

作者信息

Durmaz Oguzhan, Demirkaya Metin, Sevinir Betül

机构信息

Division of Pediatric Nephrology, Department of Pediatrics, Faculty of Medicine, Uludag University, Bursa, Turkey.

出版信息

Pediatr Hematol Oncol. 2011 Sep;28(6):461-8. doi: 10.3109/08880018.2011.570857. Epub 2011 Jun 27.

DOI:10.3109/08880018.2011.570857
PMID:21707225
Abstract

Anemia, which is a common problem in cancer patients, has a negative effect on survival by decreasing the efficacy of chemotherapy and particularly of radiotherapy, as well as impairing the quality of life (QoL) of patients. Recombinant human erythropoietin (rHuEPO) decreases a patient's need for transfusions and increases their QoL. The aim of this study was to evaluate the effect of weekly single-dose EPO treatment on transfusion rates, QoL, and hemoglobin (Hb) levels. In addition, patients were followed up for a long period to assess the impact of EPO treatment on survival. The study was conducted from December 2001 to December 2002 in patients with newly diagnosed lymphoma or solid tumors using a prospective and controlled design. EPO-β was given as a single dose of 450 U/kg once a week for 12 weeks. The study and control groups included 16 patients each. Hb levels measured in the study group at the 4th, 8th, and 12th weeks were significantly higher than the values recorded before the start of chemotherapy. In the control group, Hb levels post chemotherapy were significantly lower than values recorded prior to treatment. The increased Hb levels in the study group were significant at the 8th and 12th weeks of treatment compared to levels measured prior to treatment. In the control group, Hb levels at the 4th and 8th weeks were significantly lower than pretreatment levels. When the percent increase of Hb levels of the study and control groups with respect to treatment week was compared, the difference was statistically significant at the 4th, 8th, and 12th weeks. Although the increase on the performance scale within each group during treatment was significant in both the study and control groups, the increase was more marked in the study group. The percent increase on the performance scale with respect to week of treatment was higher in the study group than in the control group. In EPO treatment group, side effects were seen in 38% of patients, with 19% being local pain in the injection area, 13% local hyperemia, and 6% headache. The mean follow-up period of the study and control group was 7.03 ± 0.41 (6.0-7.41) and 7.46 ± 0.45 (6.58-7.83) years, respectively; no statistically significant difference existed between these figures. Overall survival at the end of 7 years of follow-up was 68.8% and 81.3% for the study and control groups, respectively. The use of EPO-β in lymphoma and solid tumor patients on a once-weekly regimen (450 U/kg) was determined to be effective in increasing Hb levels, decreasing transfusion rates, and improving QoL. This regimen was safe, did not cause serious side effects, and can be recommended because of its high patient compliance and tolerability. An effect of EPO on prognosis was not evident. We could not have an explanation on the effect of EPO treatment on prognosis, as there were low number of patients and advanced-staged patients died earlier. Therefore, a larger number of patients are needed to clarify the effect of EPO treatment on prognosis.

摘要

贫血是癌症患者的常见问题,它会降低化疗尤其是放疗的疗效,进而对患者生存产生负面影响,还会损害患者的生活质量(QoL)。重组人促红细胞生成素(rHuEPO)可减少患者的输血需求并提高其生活质量。本研究的目的是评估每周单剂量EPO治疗对输血率、生活质量和血红蛋白(Hb)水平的影响。此外,对患者进行长期随访以评估EPO治疗对生存的影响。该研究于2001年12月至2002年12月对新诊断的淋巴瘤或实体瘤患者采用前瞻性对照设计进行。EPO-β以450 U/kg的单剂量每周给药一次,共给药12周。研究组和对照组各有16例患者。研究组在第4周、第8周和第12周测得的Hb水平显著高于化疗开始前记录的值。在对照组中,化疗后的Hb水平显著低于治疗前记录的值。与治疗前测得的水平相比,研究组在治疗第8周和第12周时Hb水平升高显著。在对照组中,第4周和第8周的Hb水平显著低于治疗前水平。当比较研究组和对照组Hb水平相对于治疗周数的升高百分比时,在第4周、第8周和第12周差异具有统计学意义。尽管治疗期间每组的体能状态评分均有显著提高,但研究组的提高更为明显。研究组体能状态评分相对于治疗周数的升高百分比高于对照组。在EPO治疗组中,38%的患者出现副作用,其中19%为注射部位局部疼痛,13%为局部充血,6%为头痛。研究组和对照组的平均随访期分别为7.03±0.41(6.0 - 7.41)年和7.46±0.45(6.58 - 7.83)年;这些数字之间无统计学显著差异。随访7年后,研究组和对照组的总生存率分别为68.8%和81.3%。确定对淋巴瘤和实体瘤患者每周一次(450 U/kg)使用EPO-β可有效提高Hb水平、降低输血率并改善生活质量。该方案安全,未引起严重副作用,因其患者依从性和耐受性高而可被推荐。EPO对预后的影响不明显。由于患者数量少且晚期患者死亡较早,我们无法对EPO治疗对预后的影响作出解释。因此,需要更多患者来阐明EPO治疗对预后的影响。

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