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早产儿表面活性剂制剂的疗效比较。

Comparative effectiveness of surfactant preparations in premature infants.

机构信息

Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland, OH.

出版信息

J Pediatr. 2013 Oct;163(4):955-60.e1. doi: 10.1016/j.jpeds.2013.04.053. Epub 2013 Jun 12.

Abstract

OBJECTIVE

To compare effectiveness of 3 surfactant preparations (beractant, calfactant, and poractant alfa) in premature infants for preventing 3 outcomes: (1) air leak syndromes; (2) death; and (3) bronchopulmonary dysplasia (BPD) or death (composite outcome).

STUDY DESIGN

We conducted a comparative effectiveness study of premature infants admitted to 322 neonatal intensive care units in the US from 2005-2010 who were treated with beractant, calfactant, or poractant alfa. We compared the incidence of air leak syndromes, death, and BPD or death, adjusting for gestational age (GA), antenatal steroids, discharge year, and small for GA status.

RESULTS

A total of 51282 infants received surfactant; 40% received beractant, 30% calfactant, and 30% poractant alfa. Median birth weight was 1435 g (IQR 966-2065); median GA was 30 weeks (27-33). On adjusted analysis, we observed a similar risk of air leak syndromes (calfactant vs beractant OR = 1.17 [95% CI: 0.95, 1.43]; calfactant vs poractant OR = 1.23 [0.98, 1.56]; beractant vs poractant OR = 1.06 [0.87, 1.29]), death (calfactant vs beractant OR = 1.14 [0.93, 1.39]; calfactant vs poractant OR = 0.98 [0.78, 1.23]; beractant vs poractant OR = 0.86 [0.72, 1.04]), and BPD or death (calfactant vs beractant OR = 1.08 [0.93, 1.26]; calfactant vs poractant OR = 1.19 [1.00, 1.41]; beractant vs poractant OR = 1.10 [0.96, 1.27]).

CONCLUSIONS

Beractant, calfactant, and poractant alfa demonstrated similar effectiveness in prevention of air leak syndromes, death, and BPD or death in premature infants when adjusted for site. Previously described differences in mortality between surfactants likely do not represent true differences in effectiveness but may relate to site variation in outcomes.

摘要

目的

比较三种表面活性剂制剂(牛肺表面活性剂、猪肺表面活性剂和脯氨酸表面活性剂)在早产儿中的有效性,以预防三种结局:(1)气漏综合征;(2)死亡;以及(3)支气管肺发育不良(BPD)或死亡(复合结局)。

研究设计

我们对 2005 年至 2010 年间在美国 322 个新生儿重症监护病房接受牛肺表面活性剂、猪肺表面活性剂或脯氨酸表面活性剂治疗的早产儿进行了一项比较有效性研究。我们比较了气漏综合征、死亡和 BPD 或死亡的发生率,调整了胎龄(GA)、产前类固醇、出院年份和 GA 较小的情况。

结果

共有 51282 名婴儿接受了表面活性剂治疗;40%接受了牛肺表面活性剂,30%接受了猪肺表面活性剂,30%接受了脯氨酸表面活性剂。中位出生体重为 1435 克(IQR 966-2065);中位 GA 为 30 周(27-33)。在调整分析中,我们观察到气漏综合征的风险相似(猪肺表面活性剂与牛肺表面活性剂的比值比(OR)=1.17[95%可信区间:0.95,1.43];猪肺表面活性剂与脯氨酸表面活性剂的比值比(OR)=1.23[0.98,1.56];牛肺表面活性剂与脯氨酸表面活性剂的比值比(OR)=1.06[0.87,1.29])、死亡(猪肺表面活性剂与牛肺表面活性剂的比值比(OR)=1.14[0.93,1.39];猪肺表面活性剂与脯氨酸表面活性剂的比值比(OR)=0.98[0.78,1.23];牛肺表面活性剂与脯氨酸表面活性剂的比值比(OR)=0.86[0.72,1.04])和 BPD 或死亡(猪肺表面活性剂与牛肺表面活性剂的比值比(OR)=1.08[0.93,1.26];猪肺表面活性剂与脯氨酸表面活性剂的比值比(OR)=1.19[1.00,1.41];牛肺表面活性剂与脯氨酸表面活性剂的比值比(OR)=1.10[0.96,1.27])。

结论

在调整了地点因素后,牛肺表面活性剂、猪肺表面活性剂和脯氨酸表面活性剂在预防早产儿气漏综合征、死亡和 BPD 或死亡方面表现出相似的效果。以前描述的表面活性剂之间的死亡率差异可能并不代表真正的效果差异,而可能与地点的结果差异有关。

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Comparative effectiveness of surfactant preparations in premature infants.早产儿表面活性剂制剂的疗效比较。
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