表面活性剂治疗和经鼻持续气道正压通气用于新生儿呼吸窘迫综合征。丹麦-瑞典多中心研究组。

Surfactant therapy and nasal continuous positive airway pressure for newborns with respiratory distress syndrome. Danish-Swedish Multicenter Study Group.

作者信息

Verder H, Robertson B, Greisen G, Ebbesen F, Albertsen P, Lundstrøm K, Jacobsen T

机构信息

Department of Pediatrics, Holbaek Central Hospital, Denmark.

出版信息

N Engl J Med. 1994 Oct 20;331(16):1051-5. doi: 10.1056/NEJM199410203311603.

DOI:10.1056/NEJM199410203311603

PMID:8090164

Abstract

BACKGROUND

In southern Scandinavia most babies with respiratory distress syndrome are initially treated with nasal continuous positive airway pressure. We performed a multicenter trial to investigate whether the addition of a single dose of porcine surfactant administered during a short intubation before the occurrence of serious deterioration could reduce the subsequent need for mechanical ventilation.

METHODS

We randomly assigned 35 infants with moderate-to-severe respiratory distress syndrome to surfactant therapy (Curosurf, 200 mg per kilogram of body weight) plus nasal continuous positive airway pressure and 33 infants to nasal continuous positive airway pressure alone. The study was not blinded. The indications for mechanical ventilation were a ratio of arterial to alveolar oxygen tension of less than 0.15, severe apneic attacks, or both.

RESULTS

Six hours after randomization, when the median age of the babies was 18 hours, the mean ratio of arterial to alveolar oxygen tension was 0.37 in the surfactant-treated babies, as compared with 0.25 in the controls (P < 0.001). The need for subsequent mechanical ventilation was reduced with surfactant therapy (to 43 percent of the surfactant-treated babies as compared with 85 percent of the controls; P = 0.003). When 17 infants with ratios of arterial-to-alveolar oxygen tension of less than 0.15 at randomization were excluded, the need for mechanical ventilation was still significantly reduced in the surfactant-treated group (to 33 percent [9 of 27 babies], as compared with 83 percent [20 of 24 babies] in the control group; (P < 0.001). After 28 days, two of the surfactant-treated babies had died, as compared with five of the control babies.

CONCLUSIONS

In babies with moderate-to-severe respiratory distress syndrome treated with nasal continuous positive airway pressure, a single dose of surfactant reduced the need for subsequent mechanical ventilation.

摘要

背景

在斯堪的纳维亚半岛南部，大多数患有呼吸窘迫综合征的婴儿最初接受鼻持续气道正压通气治疗。我们进行了一项多中心试验，以研究在严重病情恶化前进行短时间插管时添加单剂量猪肺表面活性物质是否能减少随后对机械通气的需求。

方法

我们将35例中度至重度呼吸窘迫综合征婴儿随机分为接受肺表面活性物质治疗（固尔苏，200毫克/千克体重）加鼻持续气道正压通气组和33例仅接受鼻持续气道正压通气组。该研究未设盲。机械通气的指征为动脉血氧分压与肺泡血氧分压之比小于0.15、严重呼吸暂停发作或两者兼具。

结果

随机分组6小时后，婴儿的中位年龄为18小时，接受肺表面活性物质治疗的婴儿动脉血氧分压与肺泡血氧分压的平均比值为0.37，而对照组为0.25（P<0.001）。肺表面活性物质治疗降低了随后对机械通气的需求（接受肺表面活性物质治疗的婴儿中为43%，而对照组为85%；P=0.003）。当排除随机分组时动脉血氧分压与肺泡血氧分压之比小于0.15的17例婴儿后，肺表面活性物质治疗组对机械通气的需求仍显著降低（降至33%[27例婴儿中的9例]，而对照组为83%[24例婴儿中的20例]；P<0.001）。28天后，接受肺表面活性物质治疗的婴儿中有2例死亡，而对照组有5例死亡。