当前位置: X-MOL 学术CNS Drugs › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Erythropoietin Improves Poor Outcomes in Preterm Infants with Intraventricular Hemorrhage
CNS Drugs ( IF 6 ) Pub Date : 2021-05-06 , DOI: 10.1007/s40263-021-00817-w
Juan Song 1 , Yong Wang 1 , Falin Xu 1 , Huiqing Sun 2 , Xiaoli Zhang 1 , Lei Xia 1 , Shan Zhang 1 , Kenan Li 1 , Xirui Peng 1 , Bingbing Li 1 , Yaodong Zhang 2 , Wenqing Kang 2 , Xiaoyang Wang 1, 3 , Changlian Zhu 1, 4, 5
Affiliation  

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).



中文翻译:

促红细胞生成素可改善脑室内出血早产儿的不良预后

背景

脑室内出血(IVH)是早产儿常见的并发症,预后不佳,尤其是在严重的情况下,目前尚无广泛接受的有效治疗方法。已证明促红细胞生成素在新生儿脑损伤中具有神经保护作用。

客观的

本研究的目的是评估重复低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。出生后 72 小时内被诊断为 IVH 的胎龄≤ 32 周的早产儿被随机分配接受 rhEPO 500 IU/kg 或安慰剂(等量生理盐水)每隔一天服用 2 周。主要结局是在矫正年龄 18 个月时评估的死亡或神经功能障碍。

结果

共有 316 名符合条件的婴儿被纳入研究,其中 157 名在 rhEPO 组,159 名在安慰剂组。尽管 rhEPO 组和安慰剂组在 18 个月矫正年龄时的死亡率( p  = 0.176)或神经功能障碍的发生率(p = 0.055)没有显着差异,但在rhEPO 组:14.9 对 26.4%;优势比 (OR) 0.398;95% 置信区间 (CI) 0.199–0.796;p  = 0.009。此外,rhEPO 组的心理发展指数评分 < 70 的发生率低于安慰剂组:7.2% vs. 15.3%;或 0.326;95% CI 0.122–0.875;p  = 0.026。

结论

反复低剂量 rhEPO 治疗可改善早产儿 IVH 的预后。

试用注册

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

更新日期:2021-05-06
down
wechat
bug