Shannon K M, Keith J F, Mentzer W C, Ehrenkranz R A, Brown M S, Widness J A, Gleason C A, Bifano E M, Millard D D, Davis C B
Department of Pediatrics, University of California, San Francisco 94143-0724, USA.
Pediatrics. 1995 Jan;95(1):1-8.
We hypothesized that treatment with recombinant human erythropoietin (r-HuEPO) would stimulate erythropoiesis and would thereby reduce the need for erythrocyte transfusions in preterm infants. We treated 157 preterm infants born at 26.9 +/- 1.6 weeks of gestation who weighed 924 +/- 183 g at birth with either subcutaneous r-HuEPO (100 U/kg/d, 5 days per week) or placebo for 6 weeks in a randomized, double-blind, controlled clinical trial. All patients received oral iron and were managed according to uniform conservative transfusion guidelines.
Treatment with r-HuEPO was associated with fewer erythrocyte transfusions (1.1 +/- 1.5 per infant in the r-HuEPO group versus 1.6 +/- 1.7 per infant in the placebo group; P = .046) and with a reduction in the volume of packed erythrocytes transfused (16.5 +/- 23.0 mL versus 23.9 +/- 25.7 mL per infant; P = .023). Overall, 43% of the infants in the r-HuEPO group and 31% of placebo-treated infants were transfusion-free during the study (P = .18). The volume of blood removed for laboratory tests and the need for respiratory support at the start of treatment had major effects on transfusion requirements independent of r-HuEPO. Reticulocyte counts were higher during treatment in the r-HuEPO group (P = .0001), and r-HuEPO-treated infants had higher hematocrit values at the end of the study (32% versus 27.3% in the placebo group; P = .0001). We found no differences in the incidence of major complications of prematurity between the treatment groups.
We conclude that treatment with r-HuEPO at a weekly dose of 500 U/kg stimulates erythropoiesis, moderates the course of anemia, is associated with a reduction in erythrocyte transfusions, and appears safe in very low birth weight preterm infants who are receiving iron supplements. Conservative transfusion criteria, minimization of phlebotomy losses, and treatment with r-HuEPO are complementary strategies to reduce erythrocyte transfusions in these infants.
我们假设,用重组人促红细胞生成素(r-HuEPO)进行治疗会刺激红细胞生成,从而减少早产儿对红细胞输血的需求。在一项随机、双盲、对照临床试验中,我们对157名妊娠26.9±1.6周、出生体重924±183克的早产儿进行了治疗,这些婴儿被随机分为皮下注射r-HuEPO(100 U/kg/天,每周5天)组或安慰剂组,治疗6周。所有患者均接受口服铁剂治疗,并按照统一的保守输血指南进行管理。
r-HuEPO治疗组的红细胞输血次数较少(r-HuEPO组每名婴儿1.1±1.5次,安慰剂组每名婴儿1.6±1.7次;P = 0.046),且输注的浓缩红细胞体积减少(每名婴儿分别为16.5±23.0 mL和23.9±25.7 mL;P = 0.023)。总体而言,r-HuEPO组43%的婴儿和安慰剂治疗组31%的婴儿在研究期间未接受输血(P = 0.18)。治疗开始时用于实验室检查的抽血量和呼吸支持需求对输血需求有重大影响,与r-HuEPO无关。r-HuEPO组治疗期间的网织红细胞计数较高(P = 0.