Ohls Robin K, Ehrenkranz Richard A, Das Abhik, Dusick Anna M, Yolton Kimberly, Romano Elaine, Delaney-Black Virginia, Papile Lu-Ann, Simon Neal P, Steichen Jean J, Lee Kimberly G
Department of Pediatrics, University of New Mexico Health Sciences Center, Albuquerque, NM 87131, USA.
Pediatrics. 2004 Nov;114(5):1287-91. doi: 10.1542/peds.2003-1129-L.
Clinical trials evaluating the use of erythropoietin (Epo) have demonstrated a limited reduction in transfusions; however, long-term developmental follow-up data are scarce.
We compared anthropometric measurements, postdischarge events, need for transfusions, and developmental outcomes at 18 to 22 months' corrected age in extremely low birth weight (ELBW) infants treated with early Epo and supplemental iron therapy with that of placebo/control infants treated with supplemental iron alone.
The National Institute of Child Health and Human Development Neonatal Research Network completed a randomized, controlled trial of early Epo and iron therapy in preterm infants < or =1250 g. A total of 172 ELBW (< or =1000-g birth weight) infants were enrolled (87 Epo and 85 placebo/control). Of the 72 Epo-treated and 70 placebo/control ELBW infants surviving to discharge, follow-up data (growth, development, rehospitalization, transfusions) at 18 to 22 months' corrected age were collected on 51 of 72 Epo-treated infants (71%) and 51 of 70 placebo/controls (73%) by certified examiners masked to the treatment group. Statistical significance was determined using chi2 analysis.
There were no significant differences between treatment groups in weight or length or in the percentage of infants weighing <10th percentile either at the time of discharge or at follow-up, and no difference was found in the mean head circumference between groups. A similar percentage of infants in each group was rehospitalized (38% Epo and 35% placebo/control) for similar reasons. There were no differences between groups with respect to the percentage of infants with Bayley-II Mental Developmental Index <70 (34% Epo and 36% placebo/control), blindness (0% Epo and 2% placebo/control), deafness or hearing loss requiring amplification (2% Epo and 2% placebo/control), moderate to severe cerebral palsy (16% Epo and 18% placebo/control) or the percentage of infants with any of the above-described neurodevelopmental impairments (42% Epo and 44% placebo/control).
Treatment of ELBW infants with early Epo and iron does not significantly influence anthropometric measurements, need for rehospitalization, transfusions after discharge, or developmental outcome at 18 to 22 months' corrected age.
评估促红细胞生成素（Epo）使用情况的临床试验表明，输血减少程度有限；然而，长期发育随访数据匮乏。
我们比较了早期接受Epo和补充铁剂治疗的极低出生体重（ELBW）婴儿与仅接受补充铁剂治疗的安慰剂/对照组婴儿在18至22个月矫正年龄时的人体测量指标、出院后情况、输血需求及发育结局。
美国国立儿童健康与人类发展研究所新生儿研究网络完成了一项针对出生体重≤1250g的早产儿的早期Epo和铁剂治疗的随机对照试验。共纳入172例ELBW（出生体重≤1000g）婴儿（87例接受Epo治疗，85例接受安慰剂/对照治疗）。在72例接受Epo治疗和70例接受安慰剂/对照治疗且存活至出院的ELBW婴儿中，由对治疗组情况不知情的认证检查人员收集了51例接受Epo治疗的婴儿（71%）和51例接受安慰剂/对照治疗的婴儿（73%）在18至22个月矫正年龄时的随访数据（生长、发育、再次住院、输血情况）。采用卡方分析确定统计学显著性。
治疗组之间在出院时或随访时的体重、身长或体重低于第10百分位数的婴儿百分比方面无显著差异，两组间平均头围也无差异。每组因相似原因再次住院的婴儿百分比相似（接受Epo治疗组为38%，安慰剂/对照组为35%）。在贝利婴幼儿发展量表第二版心理发展指数<70的婴儿百分比（接受Epo治疗组为34%，安慰剂/对照组为36%）、失明（接受Epo治疗组为0%，安慰剂/对照组为2%）、耳聋或需要佩戴助听器的听力损失（接受Epo治疗组为2%，安慰剂/对照组为2%）、中重度脑瘫（接受Epo治疗组为16%，安慰剂/对照组为18%）或有上述任何一种神经发育障碍的婴儿百分比（接受Epo治疗组为42%，安慰剂/对照组为44%）方面，两组间均无差异。
对ELBW婴儿进行早期Epo和铁剂治疗，在18至22个月矫正年龄时，对人体测量指标、再次住院需求、出院后输血情况或发育结局无显著影响。
