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重组人促红细胞生成素治疗化疗所致贫血及预防实体瘤相关输血需求:一项随机对照研究。

Recombinant human erythropoietin in the treatment of chemotherapy-induced anemia and prevention of transfusion requirement associated with solid tumors: a randomized, controlled study.

作者信息

Oberhoff C, Neri B, Amadori D, Petry K U, Gamucci T, Rebmann U, Nowrousian M R, Voigtmann R, Monfardini S, Armand J P, Herrmann R, Netter-Pinon J, Tubiana-Mathieu N, Zwierzina H

机构信息

Center for Gynecology and Obstetrics, University Hospital, Essen, Germany.

出版信息

Ann Oncol. 1998 Mar;9(3):255-60. doi: 10.1023/a:1008296622469.

Abstract

BACKGROUND

Anemia is a common side effect of anticancer chemotherapy. Blood transfusion, previously the only available treatment for chemotherapy-induced anemia, may result in some clinical or subclinical adverse effects in the recipients. Recombinant human erythropoietin (rhEPO) provides a new treatment modality for chemotherapy-induced anemia.

PATIENTS AND METHODS

To evaluate the effect of rhEPO on the need for blood transfusions and on hemoglobin (Hb) concentrations, 227 patients with solid tumors and chemotherapy-induced anemia were enrolled in a randomized, controlled, clinical trial. Of 189 patients evaluable for efficacy, 101 received 5000 IU rhEPO daily s.c., while 88 patients received no treatment during the 12-week controlled phase of the study.

RESULTS

The results demonstrate a statistically significant reduction in the need for blood transfusions (28% vs. 42%, P = 0.028) and in the mean volume of packed red blood cells transfused (152 ml vs. 190 ml, P = 0.044) in patients treated with rhEPO compared to untreated controls. This effect was even more pronounced in patients receiving platinum-based chemotherapy (26% vs. 45%, P = 0.038). During the controlled treatment phase, the median Hb values increased in the rhEPO patients while remaining unchanged in the control group. The response was seen in all tumor types.

CONCLUSIONS

RhEPO administration at a dose of 5000 IU daily s.c. increases hemoglobin levels and reduces transfusion requirements in chemotherapy-induced anemia, especially during platinum-based chemotherapy.

摘要

背景

贫血是抗癌化疗常见的副作用。输血曾是化疗所致贫血唯一可用的治疗方法,但可能会在受血者身上产生一些临床或亚临床不良反应。重组人促红细胞生成素(rhEPO)为化疗所致贫血提供了一种新的治疗方式。

患者与方法

为评估rhEPO对输血需求及血红蛋白(Hb)浓度的影响,227例实体瘤且伴有化疗所致贫血的患者被纳入一项随机对照临床试验。在189例可评估疗效的患者中,101例患者每日皮下注射5000 IU rhEPO,而88例患者在研究的12周对照期内未接受治疗。

结果

结果显示,与未治疗的对照组相比,接受rhEPO治疗的患者输血需求(28% 对 42%,P = 0.028)及输注的红细胞压积平均体积(152 ml对190 ml,P = 0.044)在统计学上显著降低。这种效果在接受铂类化疗的患者中更为明显(26% 对 45%,P = 0.038)。在对照治疗期,rhEPO治疗组患者的Hb中位数升高,而对照组则保持不变。在所有肿瘤类型中均观察到了这种反应。

结论

每日皮下注射5000 IU的rhEPO可提高化疗所致贫血患者的血红蛋白水平并减少输血需求,尤其是在铂类化疗期间。

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