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促红细胞生成素改善伴有脑室内出血的早产儿不良结局。

Erythropoietin Improves Poor Outcomes in Preterm Infants with Intraventricular Hemorrhage.

机构信息

Henan Key Laboratory of Child Brain Injury and Henan Pediatric Clinical Research Center, Institute of Neuroscience and Third Affiliated Hospital of Zhengzhou University, Zhengzhou, 450052, China.

Department of Neonatology, Children's Hospital of Zhengzhou University, Zhengzhou, 450018, China.

出版信息

CNS Drugs. 2021 Jun;35(6):681-690. doi: 10.1007/s40263-021-00817-w. Epub 2021 May 6.

Abstract

BACKGROUND

Intraventricular hemorrhage (IVH) is a common complication in preterm infants that has poor outcomes, especially in severe cases, and there are currently no widely accepted effective treatments. Erythropoietin has been shown to be neuroprotective in neonatal brain injury.

OBJECTIVE

The objective of this study was to evaluate the protective effect of repeated low-dose recombinant human erythropoietin (rhEPO) in preterm infants with IVH.

METHODS

This was a single-blinded prospective randomized controlled trial. Preterm infants ≤ 32 weeks gestational age who were diagnosed with IVH within 72 h after birth were randomized to receive rhEPO 500 IU/kg or placebo (equivalent volume of saline) every other day for 2 weeks. The primary outcome was death or neurological disability assessed at 18 months of corrected age.

RESULTS

A total of 316 eligible infants were included in the study, with 157 in the rhEPO group and 159 in the placebo group. Although no significant differences in mortality (p = 0.176) or incidence of neurological disability (p = 0.055) separately at 18 months of corrected age were seen between the rhEPO and placebo groups, significantly fewer infants had poor outcomes (death and neurological disability) in the rhEPO group: 14.9 vs. 26.4%; odds ratio (OR) 0.398; 95% confidence interval (CI) 0.199-0.796; p = 0.009. In addition, the incidence of Mental Development Index scores of < 70 was lower in the rhEPO group than in the placebo group: 7.2 vs. 15.3%; OR 0.326; 95% CI 0.122-0.875; p = 0.026.

CONCLUSIONS

Treatment with repeated low-dose rhEPO improved outcomes in preterm infants with IVH.

TRIAL REGISTRATION

The study was retrospectively registered on ClinicalTrials.gov on 16 April 2019 (NCT03914690).

摘要

背景

脑室内出血(IVH)是早产儿的常见并发症,预后较差,尤其是在重症病例中,目前尚无广泛接受的有效治疗方法。促红细胞生成素已被证明对新生儿脑损伤具有神经保护作用。

目的

本研究旨在评估重复给予小剂量重组人促红细胞生成素(rhEPO)对 IVH 早产儿的保护作用。

方法

这是一项单盲前瞻性随机对照试验。胎龄≤32 周的早产儿,出生后 72 小时内诊断为 IVH,随机接受 rhEPO 500 IU/kg 或安慰剂(等体积生理盐水),每 2 天 1 次,共 2 周。主要结局为校正后 18 个月时死亡或神经发育障碍。

结果

共有 316 名符合条件的婴儿纳入研究,rhEPO 组 157 名,安慰剂组 159 名。虽然 rhEPO 组和安慰剂组在 18 个月校正年龄时的死亡率(p=0.176)或神经发育障碍发生率(p=0.055)均无显著差异,但 rhEPO 组的不良结局(死亡和神经发育障碍)发生率显著较低:14.9%比 26.4%;比值比(OR)0.398;95%置信区间(CI)0.199-0.796;p=0.009。此外,rhEPO 组的精神发育指数评分<70 的发生率低于安慰剂组:7.2%比 15.3%;OR 0.326;95%CI 0.122-0.875;p=0.026。

结论

重复给予小剂量 rhEPO 可改善 IVH 早产儿的结局。

试验注册

该研究于 2019 年 4 月 16 日在 ClinicalTrials.gov 上进行了回顾性注册(NCT03914690)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/85b8/8219571/22908f820292/40263_2021_817_Fig1_HTML.jpg

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