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促红细胞生成素对早产儿无神经保护作用
作者:小柯机器人 发布时间:2020/1/16 14:15:21

近日,美国华盛顿大学Sandra E. Juul及其团队进行了促红细胞生成素对早产儿神经保护的随机试验。2020年1月16日,国际知名学术期刊《新英格兰医学杂志》发表了这一成果。

在新生儿脑损伤的临床前模型中,高剂量促红细胞生成素具有神经保护作用,临床2期试验已表明潜在疗效。然而,这种疗法对极早产婴儿的益处和安全性尚未清楚。

在这项多中心、随机、双盲的高剂量促红细胞生成素试验中,研究组招募了941名孕24周至27周6天分娩的婴儿,在出生后24小时内分别接受促红细胞生成素或安慰剂治疗,均持续治疗至胎龄32周。

共有741名婴儿被纳入疗效分析,其中376名接受促红细胞生成素治疗,365名接受安慰剂治疗。促红细胞生成素组早产儿在2岁时死亡或严重神经发育障碍的发生率为26%,安慰剂组亦为26%,差异不显著。

两组中早产儿视网膜病变、颅内出血、败血症、坏死性小肠结肠炎、支气管肺发育不良、死亡或严重不良事件的发生率均无显著差异。

总之,从出生后24小时至胎龄32周,对极早产儿进行大剂量促红细胞生成素治疗,并不能降低其2岁时严重神经发育障碍或死亡的风险。

附:英文原文

Title: A Randomized Trial of Erythropoietin for Neuroprotection in Preterm Infants

Author: Sandra E. Juul, M.D., Ph.D.,, Bryan A. Comstock, M.S.,, Rajan Wadhawan, M.D.,, Dennis E. Mayock, M.D.,, Sherry E. Courtney, M.D.,, Tonya Robinson, M.D.,, Kaashif A. Ahmad, M.D.,, Ellen Bendel-Stenzel, M.D.,, Mariana Baserga, M.D.,, Edmund F. LaGamma, M.D.,, L. Corbin Downey, M.D.,, Raghavendra Rao, M.D.,, Nancy Fahim, M.D.,, Andrea Lampland, M.D.,, Ivan D. Frantz III, M.D.,, Janine Y. Khan, M.D.,, Michael Weiss, M.D.,, Maureen M. Gilmore, M.D.,, Robin K. Ohls, M.D.,, Nishant Srinivasan, M.D.,, Jorge E. Perez, M.D.,, Victor McKay, M.D.,, Phuong T. Vu, Ph.D.,, Jean Lowe, Ph.D.,, Karl Kuban, M.D.,, T. Michael O’Shea, M.D., M.P.H.,, Adam L. Hartman, M.D.,, and Patrick J. Heagerty, Ph.D.

Issue&Volume: 2020-01-15

Abstract:

Background

High-dose erythropoietin has been shown to have a neuroprotective effect in preclinical models of neonatal brain injury, and phase 2 trials have suggested possible efficacy; however, the benefits and safety of this therapy in extremely preterm infants have not been established.

Methods

In this multicenter, randomized, double-blind trial of high-dose erythropoietin, we assigned 941 infants who were born at 24 weeks 0 days to 27 weeks 6 days of gestation to receive erythropoietin or placebo within 24 hours after birth. Erythropoietin was administered intravenously at a dose of 1000 U per kilogram of body weight every 48 hours for a total of six doses, followed by a maintenance dose of 400 U per kilogram three times per week by subcutaneous injection through 32 completed weeks of postmenstrual age. Placebo was administered as intravenous saline followed by sham injections. The primary outcome was death or severe neurodevelopmental impairment at 22 to 26 months of postmenstrual age. Severe neurodevelopmental impairment was defined as severe cerebral palsy or a composite motor or composite cognitive score of less than 70 (which corresponds to 2 SD below the mean, with higher scores indicating better performance) on the Bayley Scales of Infant and Toddler Development, third edition.

Results

A total of 741 infants were included in the per-protocol efficacy analysis: 376 received erythropoietin and 365 received placebo. There was no significant difference between the erythropoietin group and the placebo group in the incidence of death or severe neurodevelopmental impairment at 2 years of age (97 children [26%] vs. 94 children [26%]; relative risk, 1.03; 95% confidence interval, 0.81 to 1.32; P=0.80). There were no significant differences between the groups in the rates of retinopathy of prematurity, intracranial hemorrhage, sepsis, necrotizing enterocolitis, bronchopulmonary dysplasia, or death or in the frequency of serious adverse events.

Conclusions
High-dose erythropoietin treatment administered to extremely preterm infants from 24 hours after birth through 32 weeks of postmenstrual age did not result in a lower risk of severe neurodevelopmental impairment or death at 2 years of age.

DOI: 10.1056/NEJMoa1907423

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1907423

 

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home