Kurz Ch, Marth Ch, Windbichler G, Lahousen M, Medl M, Vavra N, Sevelda P
Department of Gynecologic Endocrinology, University of Vienna, Austria.
Gynecol Oncol. 1997 Jun;65(3):461-6. doi: 10.1006/gyno.1997.4675.
In order to examine the influence of erythropoietin (rHuEPO) on serum hemoglobin levels, transfusion requirements, and quality of life in patients with gynecologic malignancies under polychemotherapy and chronic tumor anemia (hemoglobin <11 g/dl), we performed a prospective, randomized, double-blinded placebo-controlled clinical trial. Between October 1992 and October 1993, 35 patients from 5 gynecologic departments were entered into this trial. Inclusion criteria were hemoglobin level <11 g/dl, ferritin level >29 ng/ml, stool negative for occult blood, and life expectancy for more than 3 months. Patients received either 150 U/kg body wt rHuEPO (Erypo by Cilag-Janssen) sc three times a week for 12 weeks (n = 23) or a placebo (n = 12). If the hemoglobin levels of the 4th, 8th, or 12th week were >2 g/dl above the baseline value and/or >12 g/dl, the patient was classified as a responder. Patients who required blood transfusions (hemoglobin <8 g/dl, erythrocytes <3 x 10(6)/ml, or clinical symptoms of anemia) were classified as nonresponders. A nonvalidated quality of life questionnaire was completed by the patient at the beginning of the treatment and then every fourth week before receiving chemotherapy. In the rHuEPO group 56.6% of the patients responded to the treatment (chi2 = 10.79, P = 0.001) and only 5 patients (21.7%) required blood transfusions, whereas 8 of 12 patients in the placebo group (66.6%) had to be transfused (chi2 = 6.81, P = 0.009). Quality of life did not differ significantly between the rHuEPO group and the placebo group of patients. Within the rHuEPO group those patients that responded showed a significant increase in physical activity after response in comparison to the preresponsive phase (P = 0.02, paired t test). We therefore concluded that rHuEPO significantly increases serum hemoglobin levels and decreases transfusions requirements while maintaining quality of life in patients with gynecological malignancies who are undergoing polychemotherapy.
为研究促红细胞生成素（rHuEPO）对接受多药化疗且患有慢性肿瘤性贫血（血红蛋白<11 g/dl）的妇科恶性肿瘤患者血清血红蛋白水平、输血需求及生活质量的影响，我们进行了一项前瞻性、随机、双盲、安慰剂对照的临床试验。1992年10月至1993年10月期间，来自5个妇科科室的35例患者进入该试验。纳入标准为血红蛋白水平<11 g/dl、铁蛋白水平>29 ng/ml、大便潜血阴性且预期寿命超过3个月。患者接受以下两种治疗之一：150 U/kg体重的rHuEPO（Cilag-Janssen公司的Erypo）皮下注射，每周3次，共12周（n = 23）；或安慰剂（n = 12）。如果第4周、第8周或第12周的血红蛋白水平比基线值高>2 g/dl和/或>12 g/dl，则该患者被归类为反应者。需要输血（血红蛋白<8 g/dl、红细胞<3×10⁶/ml或有贫血临床症状）的患者被归类为无反应者。在治疗开始时以及每次化疗前的第4周，患者完成一份未经验证的生活质量问卷。在rHuEPO组中，56.6%的患者对治疗有反应（χ² = 10.79，P = 0.001），只有5例患者（21.7%）需要输血，而安慰剂组12例患者中有8例（66.6%）必须输血（χ² = 6.81，P = 0.009）。rHuEPO组和安慰剂组患者的生活质量没有显著差异。在rHuEPO组中，有反应的患者在出现反应后与反应前相比，身体活动有显著增加（P = 0.02，配对t检验）。因此，我们得出结论，rHuEPO可显著提高妇科恶性肿瘤多药化疗患者的血清血红蛋白水平，减少输血需求，同时维持生活质量。
