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三种天然表面活性剂(珂立苏、固尔苏和肺泡表面活性物质)治疗新生儿呼吸窘迫综合征疗效的比较:一项随机对照试验

Comparison of the Efficacy of Three Natural Surfactants (Curosurf, Survanta, and Alveofact) in the Treatment of Respiratory Distress Syndrome Among Neonates: A Randomized Controlled Trial.

作者信息

Mussavi Mirhadi, Mirnia Keyvan, Asadollahi Khairollah

机构信息

Department of Pediatrics, Faculty of Medicine, Pediatric Health Researches Center, University of Medical Sciences, Tabriz, IR Iran.

Department of Social Medicine, Faculty of Medicine, Ilam University of Medical Sciences, Ilam, IR Iran.

出版信息

Iran J Pediatr. 2016 Jul 25;26(5):e5743. doi: 10.5812/ijp.5743. eCollection 2016 Oct.

Abstract

BACKGROUND

Although several different types of natural surfactants are available, including Alveofact, Curosurf, and Survanta, the preferred type and the magnitude of their effects are unknown.

OBJECTIVES

This study was designed to compare the effects of these three surfactants on the gas exchange and clinical outcomes of neonates with respiratory distress syndrome (RDS).

METHODS

This triple-blind randomized clinical trial studied all preterm neonates ≤ 37 weeks with RDS who were admitted to the neonatal intensive care unit (NICU) of Taleghani hospital (Tabriz, Iran) between 2012 and 2013. The patients were divided into three groups, each of which received one of these surfactants. The incidences of ventilator dependency, patent ductus arteriosus (PDA), broncho-pulmonary dysplasia (BPD), retinopathy of prematurity (ROP), intraventricular hemorrhage (IVH), hospital-stay length, and continuous positive airway pressure (CPAP) failure, as well as blood gas levels, were recorded as endpoint measurements and compared.

RESULTS

In total, 165 neonates of gestational age ≤ 37 weeks with RDS were examined. Neonates were allocated to three different groups randomly, including a Survanta group (n = 49), a Curosurf group (n = 62), and an Alveofact group (n = 54). The mean gestational age of the neonates was 31.6 ± 3.7 weeks, and their mean weight was 1,840 ± 790 grams. The male/female ratio was 2:1 (67% male, 33% female); 104 (63%) neonates were ≤ 32 weeks gestational age, and 61 (37%) were >32 weeks. There were no significant differences for gender or demographic characteristics among the neonates in relation to the type of applied surfactant. According to the clinical parameters (BPD, IVH, ROP, hospital-stay length, and mechanical ventilation requirement), no significant differences were observed between the groups before and after surfactant administration, but the differences between the Survanta and Alveofact groups for the incidence rates of pneumothorax (P = 0.03) and pulmonary hemorrhage (P = 0.03) were statistically significant.

CONCLUSIONS

No significant differences were observed in most of the clinical variables between the three types of natural surfactant, but in neonates ≤ 32 weeks, the incidence of pneumothorax was significantly higher in the Alveofact group; in neonates > 32 weeks, the incidences of PDA, mean hospital-stay length, and mean mechanical ventilation time were also significantly higher in the same group. It thus appears that Curosurf and Survanta replacement therapies among premature neonates with RDS perform better than Alveofact replacement therapy.

摘要

背景

尽管有几种不同类型的天然表面活性剂可供使用,包括肺泡表面活性物质(Alveofact)、固尔苏(Curosurf)和珂立苏(Survanta),但其首选类型及其效果的程度尚不清楚。

目的

本研究旨在比较这三种表面活性剂对新生儿呼吸窘迫综合征(RDS)气体交换和临床结局的影响。

方法

这项三盲随机临床试验研究了2012年至2013年间入住伊朗大不里士市塔莱哈尼医院新生儿重症监护病房(NICU)的所有孕周≤37周的RDS早产儿。患者分为三组,每组接受其中一种表面活性剂。记录呼吸机依赖、动脉导管未闭(PDA)、支气管肺发育不良(BPD)、早产儿视网膜病变(ROP)、脑室内出血(IVH)、住院时间和持续气道正压通气(CPAP)失败的发生率以及血气水平作为终点测量指标并进行比较。

结果

总共检查了165例孕周≤37周的RDS新生儿。新生儿被随机分配到三个不同的组,包括一个珂立苏组(n = 49)、一个固尔苏组(n = 62)和一个肺泡表面活性物质组(n = 54)。新生儿的平均孕周为31.6±3.7周,平均体重为1840±790克。男女比例为2:1(男性67%,女性33%);104例(63%)新生儿孕周≤32周,61例(37%)孕周>32周。就所应用表面活性剂的类型而言,新生儿的性别或人口统计学特征之间无显著差异。根据临床参数(BPD、IVH、ROP、住院时间和机械通气需求),表面活性剂给药前后各组之间未观察到显著差异,但珂立苏组和肺泡表面活性物质组在气胸发生率(P = 0.03)和肺出血发生率(P = 0.03)方面的差异具有统计学意义。

结论

三种类型的天然表面活性剂在大多数临床变量上未观察到显著差异,但在孕周≤32周的新生儿中,肺泡表面活性物质组气胸发生率显著更高;在孕周>32周的新生儿中,同一组的PDA发生率、平均住院时间和平均机械通气时间也显著更高。因此,对于患有RDS的早产儿,固尔苏和珂立苏替代疗法似乎比肺泡表面活性物质替代疗法效果更好。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/48e9/5297380/e91c0ab51eff/ijp-26-05-5743-i001.jpg

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