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孕25至30周出生的早产儿早期常规与晚期选择性猪肺磷脂治疗:一项前瞻性随机多中心研究

Early regular versus late selective poractant treatment in preterm infants born between 25 and 30 gestational weeks: a prospective randomized multicenter study.

作者信息

Dilmen Uğur, Özdemir Ramazan, Tatar Aksoy Hatice, Uras Nurdan, Demirel Nihal, Kırimi Ercan, Erdeve Ömer, Özer Esra, Baş Ahmet Yağmur, Gürsoy Tuğba, Zenciroğlu Ayşegül, Ovalı Fahri, Oğuz Ş Suna

机构信息

Zekai Tahir Burak Maternity and Teaching Hospital, Neonatal Intensive Care Unit , Ankara , Turkey .

出版信息

J Matern Fetal Neonatal Med. 2014 Mar;27(4):411-5. doi: 10.3109/14767058.2013.818120. Epub 2013 Jul 30.

DOI:10.3109/14767058.2013.818120
PMID:23795582
Abstract

OBJECTIVE

Surfactant treatment in the early hours of life significantly decreases the rates of death and air leak, and increases survival without bronchopulmonary dysplasia (BPD) in preterm infants. We aimed to compare the impact of early surfactant (ES) administration to late selective (LS) treatment on neonatal outcomes in preterm infants.

METHODS

All preterm infants between 25 and 30 wks gestational age and who were not entubated in the delivery room and did not have any major congenital malformation or perinatal asphyxia were randomized to ES treatment (200 mg/kg Curosurf® administration in 1 hour after birth) or LS treatment (200 mg/kg Curosurf®administration in the first 6 h of life if needed). The patients were treated by nasal continuous positive airway pressure (nCPAP) treatment regardless of the surfactant requirement. Outcomes were the necessity of mechanical ventilation, nCPAP duration, the oxygen requirement duration, the rates of BPD, retinopathy of prematurity (ROP) and mortality, and the assessment of the following situations; (pneumothorax, patent ductus arteriosus (PDA), necrotizing enterocolitis (NEC), and intraventricular hemorrhage (IVH) ≥ grade III).

RESULTS

Among 159 infants enrolled in the study, 79 were randomized to ES and 80 to LS treatment groups. Thirty-five patients (44%) in the LS treatment group needed surfactant administration. Necessity of second dose surfactant administration was 8.9% in the ES treatment group. Although necessity of mechanical ventilation, nCPAP duration, oxygen need duration, rates of PDA, NEC, BPD, ROP stage >3 and mortality did not show a significant difference between groups, the ES treatment group had lower rates of pneumothorax and IVH ≥ grade III when compared to the LS treatment group.

CONCLUSIONS

ES treatment decreases IVH (≥ grade III) and pneumothorax rates but does not have any effect on BPD when compared to LS.

摘要

目的

在生命早期进行表面活性剂治疗可显著降低早产儿的死亡率和气漏发生率,并提高无支气管肺发育不良(BPD)的存活率。我们旨在比较早期给予表面活性剂(ES)与晚期选择性(LS)治疗对早产儿新生儿结局的影响。

方法

将所有孕龄在25至30周之间、在产房未插管且无任何重大先天性畸形或围产期窒息的早产儿随机分为ES治疗组(出生后1小时内给予200mg/kg珂立苏®)或LS治疗组(如有需要,在出生后6小时内给予200mg/kg珂立苏®)。无论是否需要表面活性剂治疗,患者均接受经鼻持续气道正压通气(nCPAP)治疗。观察指标包括机械通气的必要性、nCPAP持续时间、吸氧持续时间、BPD发生率、早产儿视网膜病变(ROP)发生率和死亡率,以及对以下情况的评估;(气胸、动脉导管未闭(PDA)、坏死性小肠结肠炎(NEC)和脑室内出血(IVH)≥III级)。

结果

在纳入研究的159例婴儿中,79例随机分配至ES治疗组,80例分配至LS治疗组。LS治疗组中有35例患者(44%)需要给予表面活性剂。ES治疗组中需要给予第二剂表面活性剂的比例为8.9%。尽管两组在机械通气的必要性、nCPAP持续时间、吸氧需求持续时间、PDA、NEC、BPD、ROP分期>3期和死亡率方面无显著差异,但与LS治疗组相比,ES治疗组的气胸和IVH≥III级发生率较低。

结论

与LS治疗相比,ES治疗可降低IVH(≥III级)和气胸发生率,但对BPD无影响。

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