早期预防性低剂量重组人促红细胞生成素对极早产儿早产儿视网膜病变的影响。
Effect of early prophylactic low-dose recombinant human erythropoietin on retinopathy of prematurity in very preterm infants.
作者信息
Sun Huiqing, Song Juan, Kang Wenqing, Wang Yong, Sun Xiantao, Zhou Chongchen, Xiong Hong, Xu Falin, Li Mingchao, Zhang Xiaoli, Yu Zengyuan, Peng Xirui, Li Bingbing, Xu Yiran, Xing Shan, Wang Xiaoyang, Zhu Changlian
机构信息
Department of Neonatology, Children's Hospital Affiliated to Zhengzhou University, Henan Children's Hospital, Zhengzhou Children's Hospital, Zhengzhou, China.
Henan Key Laboratory of Child Brain Injury, Institute of Neuroscience and Third Affiliated Hospital, Zhengzhou University, Zhengzhou, 450052, China.
出版信息
J Transl Med. 2020 Oct 19;18(1):397. doi: 10.1186/s12967-020-02562-y.
BACKGROUND
Very preterm infants are at risk of developing retinopathy of prematurity (ROP). Recombinant human erythropoietin (rhEPO) is routinely used to prevent anemia in preterm infants; however, the effect of rhEPO on ROP development is still controversial. The purpose of this study was to evaluate the effect of early prophylactic low-dose rhEPO administration on ROP development in very preterm infants.
METHODS
A total of 1898 preterm infants born before 32 weeks of gestation were included. Preterm infants received rhEPO (n = 950; 500 U/kg, rhEPO group) or saline (n = 948, control group) intravenously within 72 h of birth and then once every other day for 2 weeks.
RESULTS
The total incidence of ROP was not significantly different between the two groups (10.2% vs. 13.2%, p = 0.055). Further analysis showed that rhEPO group had lower rates of type 2 ROP than the control group (2.2% vs. 4.1%, RR 0.98; 95% CI 0.96-1.00; p = 0.021). Subgroup analysis found that rhEPO treatment significantly decreased the incidence of type 2 ROP in infant boys (1.8% vs. 4.3%, p = 0.021) and in those with a gestational age of 28-29 weeks (1.1% vs. 4.9%, p = 0.002) and birth weight of 1000-1499 g (1.2% vs. 4.2%, p = 0.002). There was a small increasing tendency for the incidence of ROP in infants with a gestational age of < 28 weeks after rhEPO treatment.
CONCLUSIONS
Repeated low-dose rhEPO administration has no significant influence on the development of ROP; however, it may be effective for type 2 ROP in infant boys or in infants with gestational age > 28 weeks and birth weight > 1500 g. Trial registration The data of this study were retrieved from two clinical studies registered ClinicalTrials.gov (NCT02036073) on January 14, 2014, https://clinicaltrials.gov/ct2/show/NCT02036073 ; and (NCT03919500) on April 18, 2019. https://clinicaltrials.gov/ct2/show/NCT03919500 .
背景
极早产儿有发生早产儿视网膜病变（ROP）的风险。重组人促红细胞生成素（rhEPO）常用于预防早产儿贫血；然而，rhEPO对ROP发生发展的影响仍存在争议。本研究的目的是评估早期预防性低剂量rhEPO给药对极早产儿ROP发生发展的影响。
方法
共纳入1898例孕32周前出生的早产儿。早产儿在出生后72小时内静脉注射rhEPO（n = 950；500 U/kg，rhEPO组）或生理盐水（n = 948，对照组），然后每隔一天注射一次，共2周。
结果
两组ROP的总发生率无显著差异（10.2%对13.2%，p = 0.055）。进一步分析显示，rhEPO组2型ROP的发生率低于对照组（2.2%对4.1%，RR 0.98；95%CI 0.96 - 1.00；p = 0.021）。亚组分析发现，rhEPO治疗显著降低了男婴（1.8%对4.3%，p = 0.021）、孕周为28 - 29周（1.1%对4.9%，p = 0.002）和出生体重为1000 - 1499 g（1.2%对4.2%，p = 0.002）的婴儿2型ROP的发生率。rhEPO治疗后，孕周<28周的婴儿ROP发生率有小幅上升趋势。
结论
重复低剂量rhEPO给药对ROP的发生发展无显著影响；然而，它可能对男婴或孕周>28周且出生体重>1500 g的婴儿的2型ROP有效。试验注册 本研究的数据于2014年1月14日从两项注册于ClinicalTrials.gov（NCT02036073）的临床研究中检索，https://clinicaltrials.gov/ct2/show/NCT02036073 ；以及于2019年4月18日从（NCT03919500）中检索，https://clinicaltrials.gov/ct2/show/NCT03919500 。
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