Meyer M P, Meyer J H, Commerford A, Hann F M, Sive A A, Moller G, Jacobs P, Malan A F
Department of Paediatrics and Child Health, University of Cape Town, South Africa.
Pediatrics. 1994 Jun;93(6 Pt 1):918-23.
To assess the efficacy of recombinant human erythropoietin (rHuEpo) in the treatment of the anemia of prematurity.
A double-blind, placebo-controlled study was conducted on 80 preterm infants (< or = 32 weeks; postnatal age, 2 to 8 weeks; central hematocrit < or = 35%). Patients were randomly assigned to receive subcutaneous rHuEpo (Eprex, 600 U/kg per week) or an equivalent volume of placebo, for up to 6 weeks. All patients received supplements of vitamin E (25 IU) and iron (3 mg/kg per day). The iron supplement was increased if declining serum ferritin measurements were noted.
Treatment and placebo groups did not differ significantly with respect to mean gestational age, birth weight, hematocrit, or reticulocyte count at study entry. Fewer transfusions were administered to those receiving erythropoietin (7 compared with 21; P = .002). Compared with the placebo group, the infants receiving rHuEpo had a higher mean hematocrit (32.3 +/- 4% vs 29.3 +/- 6.2%; P = .014) and absolute reticulocyte count (223 +/- 73 vs 124.9 +/- 73 x 10(9)/L; P < .001) at the end of the study. The mean neutrophil count was not significantly reduced at study exit (P = .8), nor at any other period during the trial in the rHuEpo group. Intercurrent events (mostly infections) were not increased in the treatment group, although there was one case of sudden infant death syndrome at age 4 months.
Using a dose of rHuEpo of 600 U/kg per week, this study has shown a clear reduction in the requirement for blood transfusion in preterm infants.
评估重组人促红细胞生成素（rHuEpo）治疗早产儿贫血的疗效。
对80例早产儿（孕周≤32周；出生后年龄2至8周；中心血细胞比容≤35%）进行了一项双盲、安慰剂对照研究。患者被随机分配接受皮下注射rHuEpo（益比奥，每周600 U/kg）或等量安慰剂，治疗长达6周。所有患者均补充维生素E（25 IU）和铁（每天3 mg/kg）。如果血清铁蛋白测量值下降，则增加铁补充量。
治疗组和安慰剂组在研究开始时的平均孕周、出生体重、血细胞比容或网织红细胞计数方面无显著差异。接受促红细胞生成素治疗的患者输血次数较少（7次与21次相比；P = 0.002）。与安慰剂组相比，接受rHuEpo治疗的婴儿在研究结束时平均血细胞比容更高（32.3±4%对29.3±6.2%；P = 0.014），绝对网织红细胞计数更高（223±73对124.9±73×10⁹/L；P < 0.001）。研究结束时，rHuEpo组的平均中性粒细胞计数没有显著降低（P = 0.8），在试验的任何其他时期也没有降低。治疗组的并发事件（主要是感染）没有增加，尽管有1例4个月大的婴儿猝死综合征。
本研究表明，使用每周600 U/kg的rHuEpo剂量可明显减少早产儿的输血需求。
