Cascinu S, Fedeli A, Del Ferro E, Luzi Fedeli S, Catalano G
Servizio di Oncologia, Ospedali Riuniti, Pesaro, Italy.
J Clin Oncol. 1994 May;12(5):1058-62. doi: 10.1200/JCO.1994.12.5.1058.
To evaluate the effect of exogenous recombinant human erythropoietin (rHuEPO) on the increase of hemoglobin levels and on the transfusion requirements in patients with cisplatin (CDDP)-induced anemia, we performed a double-blind randomized trial with placebo.
One hundred patients with CDDP-associated anemia (hemoglobin level < 90 g/L) were randomized to receive either placebo (saline solution) or rHuEPO (100 U/kg body weight subcutaneously) three times per week. The end points of this study were the increase in hemoglobin levels to greater than 100 g/L after 3, 6, and 9 weeks and the effect on transfusion requirements.
Ninety-nine of 100 patients were assessable for response and toxicity. In the rHuEPO arm, mean hemoglobin levels were statistically significantly increased after the third, sixth, and ninth weeks of therapy (101.1 +/- 9.0, 102.4 +/- 6.6, and 105.1 +/- 9.4 g/L, respectively) compared with the mean baseline value (86.3 +/- 6.2 g/L). In the placebo arm, there were no increases in mean hemoglobin levels at the third, sixth, and ninth weeks (81.0 +/- 5.2, 81.3 +/- 9.2, and 81.2 +/- 11 g/L, respectively) compared with the mean baseline value (87.3 +/- 5.2 g/L). Furthermore only 20% of patients required blood transfusions in the rHuEPO arm versus 56% of patients in the placebo arm (P = .01), with a mean units of blood transfused per patient of 0.30 in the rHuEPO arm and 1.8 in the placebo arm (P = .01). Treatment was well tolerated, with no significant side effects.
CDDP-induced anemia is corrected by rHuEPO, which results in reduced blood transfusion requirements.
为评估外源性重组人促红细胞生成素（rHuEPO）对顺铂（CDDP）所致贫血患者血红蛋白水平升高及输血需求的影响，我们进行了一项使用安慰剂的双盲随机试验。
100例CDDP相关性贫血（血红蛋白水平<90 g/L）患者被随机分为两组，分别接受安慰剂（生理盐水溶液）或rHuEPO（100 U/kg体重皮下注射），每周3次。本研究的终点为3周、6周和9周后血红蛋白水平升高至大于100 g/L以及对输血需求的影响。
100例患者中有99例可评估反应和毒性。在rHuEPO组，与平均基线值（86.3±6.2 g/L）相比，治疗第3周、第6周和第9周后平均血红蛋白水平有统计学显著升高（分别为101.1±9.0、102.4±6.6和105.1±9.4 g/L）。在安慰剂组，与平均基线值（87.3±5.2 g/L）相比，第3周、第6周和第9周平均血红蛋白水平无升高（分别为81.0±5.2、81.3±9.2和81.2±11 g/L）。此外，rHuEPO组仅20%的患者需要输血，而安慰剂组为56%（P = .01），rHuEPO组患者人均输血量为0.30单位，安慰剂组为1.8单位（P = .01）。治疗耐受性良好，无明显副作用。
rHuEPO可纠正CDDP所致贫血，从而减少输血需求。
