Javier Manchón G, Natal Pujol A, Coroleu Lletget W, Zuasnábar Cotro A, Badía Barnusell J, Juncá Piera J, Bel Comós J, Sábado Alvarez C, Prats Viñas J
Servicio de Pediatría, Hospital Universitari Germans Trias i Pujol de Badalona.
An Esp Pediatr. 1997 Jun;46(6):587-92.
The purpose of this study was to test the therapeutic effect of human recombinant erythropoietin (rH-EPO) on anemia of prematurity.
Fifty-eight preterm infants less than 34 weeks of gestational age from three different hospitals were studied. Transfusional policies were similar in all three centers. Infants with ABO or Rh incompatibility were excluded. At 28 days after birth, 28 infants (48.3%) had hemoglobin levels under 10.5 g/dL and were randomized to receive rH-EPO or standard care. Those infants ascribed to the treatment group received 200 U/kg of body weight of rH-EPO subcutaneously once a day, three days a week for 4 weeks together with oral supplements of ferrous sulfate at a dosage of 4 mg/kg/day. Both groups received daily doses of 50 micrograms of folic acid and 5U of vitamin E per os. Erythropoietin and ferritin were determined at randomization and at 60 days of age. Hemoglobin, reticulocytes, leucocytes, granulocytes and platelets were measured once a week, from the beginning of the treatment until 60 days of age.
At randomization into treatments, there were no significant differences between the groups with respect to weight, gestational age, hemoglobin (9.42 +/- 0.73 vs 9.26 +/- 0.68 g/dL), reticulocytes (61.7 +/- 32.2 vs 68.0 +/- 61.0 x 10(9)/L), ferritin, EPO1 leucocytes or platelets. At 60 days of age, the treatment group showed higher hemoglobin values (10.5 +/- 1.73 vs 9.1 +/- 1.0 g/dL, p < 0.05). There were no significant differences between reticulocyte counts (176.4 +/- 91.1 vs 112.6 +/- 85.0 x 10(9)/L), granulocytes (2,351 +/- 868 vs 2,075 +/- 856 x 10(9)/L), platelets (400 +/- 138 vs 316 +/- 164 x 10(9)/L) or ferritin (209 +/- 177 vs 393 +/- 328 micrograms/mL). Of the infants in the nontreated group, 13.3% received blood transfusions between 30 and 60 days of age, while only 6.7% of the treatment group did (p = 0.31).
We have been able to find 11 controlled studies in the medical literature which deal with the clinical usage of rH-EPO in newborns. Six use the hormone in an early phase and 5 in a posterior one. Our study should be included in the later and, as happens in most of them, demonstrates the efficacy of rH-EPO in the treatment of late anemia of the preterm newborn as shown by an increment in the hemoglobin levels and a trend towards the diminution in the use of blood transfusions. We have not observed substantial adverse effects.
本研究旨在测试重组人促红细胞生成素（rH-EPO）对早产儿贫血的治疗效果。
研究了来自三家不同医院的58名胎龄小于34周的早产儿。三个中心的输血政策相似。排除ABO或Rh血型不合的婴儿。出生后28天，28名婴儿（48.3%）血红蛋白水平低于10.5 g/dL，被随机分为接受rH-EPO治疗组或标准治疗组。治疗组婴儿每天皮下注射200 U/kg体重的rH-EPO，每周三次，共4周，同时口服硫酸亚铁，剂量为4 mg/kg/天。两组均每日口服50微克叶酸和5 U维生素E。在随机分组时和60日龄时测定促红细胞生成素和铁蛋白。从治疗开始至60日龄，每周测量一次血红蛋白、网织红细胞、白细胞、粒细胞和血小板。
随机分组接受治疗时，两组在体重、胎龄、血红蛋白（9.42±0.73 vs 9.26±0.68 g/dL）、网织红细胞（61.7±32.2 vs 68.0±61.0×10⁹/L）、铁蛋白、促红细胞生成素1、白细胞或血小板方面无显著差异。在60日龄时，治疗组的血红蛋白值较高（10.5±1.73 vs 9.1±1.0 g/dL，p<0.05）。网织红细胞计数（176.4±91.1 vs 112.6±85.0×10⁹/L）、粒细胞（2351±868 vs 2075±856×10⁹/L）、血小板（400±138 vs 316±164×10⁹/L）或铁蛋白（209±177 vs 393±328微克/毫升）方面无显著差异。在未治疗组的婴儿中，13.3%在30至60日龄之间接受了输血，而治疗组只有6.7%接受了输血（p = 0.31）。
我们在医学文献中找到了11项关于rH-EPO在新生儿临床应用的对照研究。6项在早期使用该激素，5项在后期使用。我们的研究应归入后期研究，并且正如大多数研究一样，证明了rH-EPO在治疗早产儿晚期贫血方面的疗效，表现为血红蛋白水平升高以及输血使用量有减少趋势。我们未观察到明显的不良反应。
