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首页> 外文期刊>Pediatrics: Official Publication of the American Academy of Pediatrics >An approach to using recombinant erythropoietin for neuroprotection in very preterm infants.
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An approach to using recombinant erythropoietin for neuroprotection in very preterm infants.

机译：一种使用重组促红细胞生成素对极早产儿进行神经保护的方法。

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OBJECTIVE: Erythropoietin has been shown to be protective against hypoxic-ischemic and inflammatory injuries in cell culture, animal models of brain injury, and clinical trials of adult humans. The rationale for our study was that early administration of high-dose recombinant human erythropoietin may reduce perinatal brain injury (intraventricular hemorrhage and periventricular leukomalacia) in very preterm infants and improve neurodevelopmental outcome. We investigated whether administration of high-dose recombinant human erythropoietin to very preterm infants shortly after birth and subsequently during the first 2 days is safe in terms of short-term outcome. METHODS: This was a randomized, double-masked, single-center trial with a 2:1 allocation in favor of recombinant human erythropoietin. Preterm infants (gestational age: 24 to 31 weeks) were given recombinant human erythropoietin or NaCl 0.9% intravenously 3, 12 to 18, and 36 to 42 hours after birth. RESULTS: The percentage of infants who survivedwithout brain injury or retinopathy was 53% in the recombinant human erythropoietin group and 60% in the placebo group. There were no relevant differences regarding short-term outcomes such as intraventricular hemorrhage, retinopathy, sepsis, necrotizing enterocolitis, and bronchopulmonary dysplasia. For 5 infants who were in the recombinant human erythropoietin group and had a gestational age of 26 weeks, withdrawal of intensive care was decided (3 of 5 with severe bilateral intraventricular hemorrhage, 2 of 5 with pulmonary insufficiency); no infant of the control group died. Recombinant human erythropoietin treatment did not result in significant differences in blood pressure, cerebral oxygenation, hemoglobin, leukocyte, and platelet count. CONCLUSIONS: No significant adverse effects of early high-dose recombinant human erythropoietin treatment in very preterm infants were identified. These results enable us to embark on a large multicenter trial with the aim of determining whether early high-dose administration of recombinant human erythropoietin to very preterm infants improves neurodevelopmental outcome at 24 months' and 5 years' corrected age.
机译：目的：促红细胞生成素在细胞培养，脑损伤动物模型和成人临床试验中均显示出对缺氧缺血性和炎性损伤的保护作用。我们研究的基本原理是，尽早使用大剂量重组人促红细胞生成素可以减少早产儿的围产期脑损伤（脑室内出血和脑室白细胞软化），并改善神经发育结局。我们研究了就短期结局而言，在出生后不久以及随后的前两天内，对早产儿使用大剂量重组人促红细胞生成素是否安全。方法：这是一项以2：1分配以支持重组人促红细胞生成素的随机，双掩蔽，单中心试验。早产儿（胎龄：24至31周）在出生后3、12至18和36至42小时静脉内接受重组人促红细胞生成素或0.9％的NaCl静脉注射。结果：重组人促红细胞生成素组中无脑损伤或视网膜病变存活的婴儿百分比为53％，安慰剂组为60％。对于短期结果，如脑室内出血，视网膜病变，败血症，坏死性小肠结肠炎和支气管肺发育不良，没有相关差异。对于重组人促红细胞生成素组中胎龄小于26周的5例婴儿，决定退出重症监护（5例中有3例患有严重的双侧脑室内出血，5例中有2例由于肺功能不全）;对照组无婴儿死亡。重组人促红细胞生成素治疗并未导致血压，脑氧合，血红蛋白，白细胞和血小板计数的显着差异。结论：在早产儿中未发现早期大剂量重组人促红细胞生成素治疗的重大不良反应。这些结果使我们能够着手进行一项大型的多中心试验，目的在于确定在早产儿中早期大剂量施用重组人促红细胞生成素是否能改善24个月和5岁矫正年龄的神经发育结果。

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