促红细胞生成素预防极早产儿坏死性小肠结肠炎：一项随机对照试验。
Erythropoietin prevents necrotizing enterocolitis in very preterm infants: a randomized controlled trial.
作者信息
Wang Yong, Song Juan, Sun Huiqing, Xu Falin, Li Kenan, Nie Chunxia, Zhang Xiaoli, Peng Xirui, Xia Lei, Shen Ziyun, Yuan Xiao, Zhang Shan, Ding Xue, Zhang Yaodong, Kang Wenqing, Qian Liling, Zhou Wenhao, Wang Xiaoyang, Cheng Xiuyong, Zhu Changlian
机构信息
Henan Key Laboratory of Child Brain Injury, Department of Neonatology, 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
J Transl Med. 2020 Aug 8;18(1):308. doi: 10.1186/s12967-020-02459-w.
BACKGROUND
Necrotizing enterocolitis (NEC) is one of the most severe complications in very preterm infants, but there are currently no accepted methods to prevent NEC. Studies have shown that erythropoietin (EPO) has the potential to prevent NEC or improve outcomes of preterm NEC. This study aimed to determine whether recombinant human EPO (rhEPO) could protect against NEC in very preterm infants.
METHODS
The study was a prospective randomized clinical trial performed among four NICU centers. A total of 1327 preterm infants with gestational age ≤ 32 weeks were admitted to the centers, and 42 infants were excluded leaving 1285 eligible infants to be randomized to the rhEPO or control group. Infants in the rhEPO group were given 500 IU/kg rhEPO intravenously every other day for 2 weeks, while the control group was given the same volume of saline. The primary outcome was the incidence of NEC in very preterm infants at 36 weeks of corrected gestational age.
RESULTS
A total of 1285 infants were analyzed at 36 weeks of corrected age for the incidence of NEC. rhEPO treatment significantly decreased the incidence of NEC (stage I, II and III) (12.0% vs. 17.1%, p = 0.010), especially confirmed NEC (stage II and III) (3.0% vs. 5.4%, p = 0.027). Meanwhile, rhEPO treatment significantly reduced the number of red blood cells transfusion in the confirmed NEC cases (1.2 ± 0.4 vs. 2.7 ± 1.0, p = 0.004). Subgroup analyses showed that rhEPO treatment significantly decreased the incidence of confirmed NEC at gestational age < 28 weeks (p = 0.019), and the incidence of all stages NEC in preterm infants with hemoglobin < 90 g/l (p = 0.000) and 5 min Apgar score > 5 (p = 0.028).
CONCLUSION
Repeated low-dose rhEPO treatment is beneficial against NEC in very preterm infants. Trial registration The protocol was registered retrospectively at ClinicalTrials.gov (NCT03919500) on April 18, 2019. https://clinicaltrials.gov/ct2/show/NCT03919500.
背景
坏死性小肠结肠炎（NEC）是极早产儿最严重的并发症之一，但目前尚无公认的预防NEC的方法。研究表明，促红细胞生成素（EPO）有可能预防NEC或改善早产儿坏死性小肠结肠炎的预后。本研究旨在确定重组人促红细胞生成素（rhEPO）是否能保护极早产儿免受NEC的侵害。
方法
该研究是在四个新生儿重症监护病房（NICU）中心进行的一项前瞻性随机临床试验。共有1327名孕周≤32周的早产儿被收治入这些中心，42名婴儿被排除，剩余1285名符合条件的婴儿被随机分为rhEPO组或对照组。rhEPO组婴儿每隔一天静脉注射500 IU/kg rhEPO，共2周，而对照组则给予相同体积的生理盐水。主要结局是校正胎龄36周时极早产儿中NEC的发生率。
结果
在校正年龄36周时，共对1285名婴儿进行了NEC发生率分析。rhEPO治疗显著降低了NEC（I、II和III期）的发生率（12.0%对17.1%，p = 0.010），尤其是确诊的NEC（II和III期）（3.0%对5.4%，p = 0.027）。同时，rhEPO治疗显著减少了确诊NEC病例的红细胞输注次数（1.2±0.4对2.7±1.0，p = 0.004）。亚组分析表明，rhEPO治疗显著降低了胎龄<28周时确诊NEC的发生率（p = 0.叭9），以及血红蛋白<90 g/l（p = 0.000）和5分钟阿氏评分>5（p = 0.028）的早产儿中所有阶段NEC的发生率。
结论
重复低剂量rhEPO治疗对极早产儿预防NEC有益。试验注册该方案于2019年4月18日在ClinicalTrials.gov（NCT03919500）进行了回顾性注册。https://clinicaltrials.gov/ct2/show/NCT03919500 。
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