A controlled trial of synthetic surfactant in infants weighing 1250 g or more with respiratory distress syndrome. The American Exosurf Neonatal Study Group I, and the Canadian Exosurf Neonatal Study Group.

A controlled trial of synthetic surfactant in infants weighing 1250 g or more with respiratory distress syndrome. The American Exosurf Neonatal Study Group I, and the Canadian Exosurf Neonatal Study Group.
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对体重 1250 克或以上患有呼吸窘迫综合征的婴儿进行合成表面活性剂的对照试验。

DOI:
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发表时间:
1991
期刊:
影响因子:
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通讯作者:
V. Chernick
V. Chernick
中科院分区:
--
文献类型:
--
作者:
W. Long;A. Corbet;R. Cotton;S. Courtney;G. McGuiness;D. Walter;J. Watts;J. Smyth;H. Bard;V. Chernick

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背景表面活性物质替代疗法现在被认为是小早产儿的一种挽救生命和安全的干预措施,但关于其在较大早产儿中的风险和益处的证据很少。方法:我们在美国23家医院和加拿大13家医院的1237名呼吸窘迫婴儿中进行了一项安慰剂对照的盲法试验。在入院时,所有婴儿体重至少为1250 g,接受机械通气,动脉与肺泡氧分压的比值低于0.22。合成表面活性剂(Exosurf,每公斤体重5毫升)或空气(安慰剂)的初始剂量在出生后24小时内给药,12小时后给予第二剂。共有614名婴儿被分配接受表面活性剂,623名接受安慰剂。结果:与安慰剂组相比,表面活性剂组在28天内死亡或在28天内存活的支气管肺发育不良婴儿较少(7%对12%,P = 0.002)。在出生后的前28天,表面活性剂组因呼吸窘迫综合征而死亡的人数较少(1% vs. 3%,P = 0.043),新生儿总死亡率较低(4% vs. 7%,P = 0.04),支气管肺发育不良的发生率较低(3% vs. 6%,P = 0.008)。表面活性剂组的肺漏气、脑室内出血、动脉导管未闭、癫痫发作、低血压和肺动脉高压的发生率也显着较低。使用表面活性剂治疗的婴儿比使用安慰剂的婴儿更快地脱离氧气和机械通气,并且他们很少需要高频通气或体外膜氧合。在接受表面活性剂治疗的婴儿中观察到的主要副作用更常见的是肺出血(6名婴儿vs. 1名婴儿,P = 0.055)。结论:出生时体重至少1250 g的呼吸窘迫综合征婴儿,使用两种剂量的合成表面活性剂治疗可提高存活率并降低围产期发病率。
Background Surfactant-replacement therapy is now recognized as a life-saving and safe intervention in small premature infants, but there is little evidence concerning its risks and benefits in larger premature infants. Methods We conducted a placebo-controlled, blinded trial in 1237 infants with respiratory distress who were enrolled at 23 hospitals in the United States and 13 hospitals in Canada. At entry all the infants weighed at least 1250 g, were receiving mechanical ventilation, and had a ratio of arterial to alveolar oxygen tension below 0.22. The initial dose of either the synthetic surfactant (Exosurf, 5 ml per kilogram of body weight) or air (the placebo) was administered less than 24 hours after birth, with a second dose given 12 hours later. A total of 614 infants were assigned to receive surfactant, and 623 to receive placebo. Results Fewer infants in the surfactant group than in the placebo group died before 28 days of age or survived at 28 days with bronchopulmonary dysplasia (7 percent vs. 12 percent, P = 0.002). In the first 28 days of life, there were fewer deaths due to respiratory distress syndrome in the surfactant group (1 percent vs. 3 percent, P = 0.043), lower overall neonatal mortality (4 percent vs. 7 percent, P = 0.04), and a lower incidence of bronchopulmonary dysplasia (3 percent vs. 6 percent, P = 0.008). There was also a significantly lower incidence of pulmonary air leaks, intraventricular hemorrhage, patent ductus arteriosus, seizures, hypotension, and pulmonary hypertension in the surfactant group. The infants treated with surfactant were weaned from oxygen and mechanical ventilation significantly sooner than those given placebo, and they less often required high-frequency ventilation or extracorporeal membrane oxygenation. The primary side effect observed more frequently among the infants who received surfactant treatment was pulmonary hemorrhage (six infants vs. one infant, P = 0.055). Conclusions In infants weighing at least 1250 g at birth who have respiratory distress syndrome, treatment with two doses of synthetic surfactant improves survival and reduces perinatal morbidity.
EXOSURF(一种无蛋白合成表面活性剂)用于预防和早期治疗透明膜疾病的初步临床试验。
DOI: --
发表时间: 1991
期刊: Pediatrics
影响因子: 8
作者:
Phibbs,RH;Ballard,RA;Clements,JA;Heilbron,DC;Phibbs,CS;Schlueter,MA;Sniderman,SH;Tooley,WH;Wakeley,A
通讯作者: Wakeley,A
用合成表面活性剂处理的早产兔子的肺功能。
DOI: 10.1164/ajrccm/136.3.651
发表时间: 1987
期刊: The American review of respiratory disease
影响因子: --
作者:
Tooley,WH;Clements,JA;Muramatsu,K;Brown,CL;Schlueter,MA
通讯作者: Schlueter,MA