DECREASED MORTALITY-RATE AMONG SMALL PREMATURE-INFANTS TREATED AT BIRTH WITH A SINGLE DOSE OF SYNTHETIC SURFACTANT - A MULTICENTER CONTROLLED TRIAL
DECREASED MORTALITY-RATE AMONG SMALL PREMATURE-INFANTS TREATED AT BIRTH WITH A SINGLE DOSE OF SYNTHETIC SURFACTANT - A MULTICENTER CONTROLLED TRIAL
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DOI：
10.1016/s0022-3476(05)80502-5
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发表时间：
1991-02-01
影响因子：
5.1
通讯作者：
LONG, W
中科院分区：
文献类型：
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作者：
CORBET, A;BUCCIARELLI, R;LONG, W
为了确定单次预防剂量的合成表面活性剂是否会降低死亡率和发病率，我们在美国的19家医院对新生儿进行了一项随机对照试验。体重700 ~ 1100 gm的早产儿在机械通气时，出生后尽快将Exosurf制剂（5 ml/kg）灌注气管内。对照婴儿用空气（5 ml/kg）治疗。给药是由临床医生秘密进行的，他们在2年内没有透露他们所灌输的东西。222名婴儿接受空气治疗，224名接受合成表面活性剂治疗；36例患有先天性肺炎或畸形的婴儿被排除在初步疗效分析之外。28日龄时，空气组死亡44只，表面活性剂组死亡27只（p = 0.022）。到足月1岁时，空气组死亡61例，表面活性剂组死亡35例（p = 0.002）。虽然呼吸窘迫综合征的发病率没有减少，但因呼吸窘迫综合征而死亡的人数却显著减少，对氧气的需求和平均气道压力的显著降低表明，接受exosurf治疗的婴儿肺部疾病的严重程度较轻。支气管肺发育不良、脑室内出血、动脉导管未闭、坏死性小肠结肠炎、感染等并发症的发生率差异无统计学意义。结果表明，在出生后不久接受治疗的高危早产儿中，单次预防性剂量的Exosurf可减少呼吸窘迫综合征的死亡人数和总体死亡率。
To determine whether a single prophylactic dose of synthetic surfactant would reduce mortality and morbidity rates, we performed a randomized, controlled trial of Exosurf Neonatal at 19 hospitals in the United States. The Exosurf preparation (5 ml/kg) was instilled into the endotracheal tube of premature infants weighing 700 to 1100 gm during mechanical ventilation, as soon as practical after birth. Control infants were treated with air (5 ml/kg). Dose administration was performed in secrecy by clinicians who did not reveal for 2 years what they had instilled. A total of 222 infants received air and 224 received the synthetic surfactant; 36 infants with congenital pneumonia or malformations were excluded from the primary efficacy analysis. By the age of 28 days, there were 44 deaths in the air group and 27 deaths in the surfactant group (p = 0.022). By the age of 1 year after term there were 61 deaths in the air group and 35 deaths in the surfactant group (p = 0.002). Although there was no reduction in the incidence of respiratory distress syndrome, a significant reduction in the number of deaths attributed to respiratory distress syndrome, a significant reduction in the requirements for oxygen and mean airway pressure indicated that lung disease was less severe in the Exosurf-treated infants. There were no significant differences in the incidence of complications such as bronchopulmonary dysplasia, intraventricular hemorrhage, patent ductus arteriosus, necrotizing enterocolitis, and infection. The results indicate that a single prophylactic dose of Exosurf, in high-risk premature infants treated soon after birth, reduces the number of deaths from respiratory distress syndrome and the overall mortality rate.