Ohls R K, Harcum J, Schibler K R, Christensen R D
Division of Neonatology, the University of New Mexico, Albuquerque 87131-5311, USA.
J Pediatr. 1997 Nov;131(5):661-5. doi: 10.1016/s0022-3476(97)70089-1.
Clinical trials of erythropoietin (EPO) administration to preterm infants have not focused on infants weighing 750 gm or less, the population most likely to receive multiple transfusions because of large phlebotomy losses. It is unknown whether preterm infants weighing 750 gm or less will respond to EPO by accelerating erythropoiesis, or whether EPO administered to this population will decrease blood transfusions.
We randomly assigned 28 extremely low birth weight preterm infants (mean +/- SEM: 24.7 +/- 0.3 weeks' gestation, 662 +/- 14 gm birth weight), in the first 72 hours of life, to receive either EPO (200 U/kg/day) or placebo for 14 days and administered transfusions only according to protocol over a 21-day study period. All infants received 1 mg/kg/day iron dextran in their total parenteral nutrition solution during the 14-day treatment period.
During the 21-day study period, a lower number and volume of transfusions were received by the EPO recipients (4.7 +/- 0.7 transfusions per patient and 70 +/- 11 ml/kg per patient) than by the placebo recipients (7.5 +/- 1.1 transfusions per patient and 112 +/- 17 ml/kg per patient; p < 0.05, EPO vs placebo), whereas hematocrits remained similar in the two groups. Reticulocyte counts were similar in both groups on day 1 but were greater in the EPO recipients on day 14 (EPO day 1, 351 +/- 53; EPO day 14, 359 +/- 40 x 10(3)/microl; placebo day 1, 334 +/- 64; placebo day 14, 120 +/- 10 x 10(3)/microl; p < 0.01, EPO vs placebo). Serum ferritin concentrations were similar in both groups at the beginning of the study but were greater in the placebo recipients by day 14 (EPO, 262 +/- 44 microg/L; placebo, 593 +/- 92 microg/L; p < 0.01). No adverse effects of EPO or iron were noted.
The combination of EPO and parenteral iron stimulates erythropoiesis in preterm infants weighing 750 gm or less and results in fewer transfusions during their first 3 weeks of life.
对早产儿使用促红细胞生成素（EPO）的临床试验尚未聚焦于体重750克及以下的婴儿，这一群体因大量采血损失而最有可能接受多次输血。尚不清楚体重750克及以下的早产儿是否会因EPO而加速红细胞生成，或者对该群体使用EPO是否会减少输血次数。
我们将28名极低出生体重的早产儿（平均±标准误：胎龄24.7±0.3周，出生体重662±14克）在出生后的头72小时内随机分配，一组接受EPO（200 U/kg/天），另一组接受安慰剂，为期14天，并在21天的研究期内仅按方案进行输血。在为期14天的治疗期间，所有婴儿在其全胃肠外营养溶液中接受1毫克/千克/天的右旋糖酐铁。
在21天的研究期内，接受EPO治疗的婴儿（每位患者4.7±0.7次输血，每位患者70±11毫升/千克）比接受安慰剂的婴儿（每位患者7.5±1.1次输血，每位患者112±17毫升/千克；EPO组与安慰剂组相比，p<0.05）接受的输血次数和输血量更少，而两组的血细胞比容保持相似。两组在第1天的网织红细胞计数相似，但在第14天接受EPO治疗的婴儿更高（EPO组第1天，351±53；EPO组第14天，359±40×10³/微升；安慰剂组第1天，334±64；安慰剂组第14天，120±10×10³/微升；EPO组与安慰剂组相比，p<0.01）。研究开始时两组的血清铁蛋白浓度相似，但到第14天时安慰剂组更高（EPO组，262±44微克/升；安慰剂组，593±92微克/升；p<0.01）。未观察到EPO或铁的不良反应。
EPO与胃肠外铁联合使用可刺激体重750克及以下早产儿的红细胞生成，并使其在出生后的前3周内输血次数减少。
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