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人工合成与天然表面活性剂治疗早产儿呼吸窘迫综合征的对比试验:发展中国家的经验

Comparative trial of artificial and natural surfactants in the treatment of respiratory distress syndrome of prematurity: experiences in a developing country.

作者信息

da Costa D E, Pai M G, Al Khusaiby S M

机构信息

Division of Neonatology, Royal Hospital, Sultanate of Oman.

出版信息

Pediatr Pulmonol. 1999 May;27(5):312-7. doi: 10.1002/(sici)1099-0496(199905)27:5<312::aid-ppul3>3.0.co;2-n.

DOI:10.1002/(sici)1099-0496(199905)27:5<312::aid-ppul3>3.0.co;2-n
PMID:10344709
Abstract

We conducted a randomized clinical trial to compare the effects of a synthetic (Exosurf) and natural (Survanta) surfactant in infants with neonatal respiratory distress syndrome. Eighty-nine patients were randomly allocated to receive one of the two surfactants. Primary outcome variables were the acute and long-term effects of the surfactant preparations, i.e., ventilatory requirements at 24 h of age as judged by the oxygenation index (OI), and the combined incidence of chronic lung disease or death at 28 days. The OIs in the Exosurf and Survanta groups at 24 h were the same (10.1 and 7, respectively; P > 0.05). The magnitude and rapidity of response, however, were greater for Survanta than for Exosurf. When arterial/alveolar oxygen tension ratios (a/A) were compared, the Exosurf group had a significantly worse a/A ratio at 24 h than the Survanta group (0.21 Exosurf vs. 0.37 Survanta; P < 0.05). The long-term outcome as judged by the combined incidence of death or chronic lung disease was not different in the two groups (18.6% Exosurf vs. 15.2% Survanta; P > 0.05). When the complications of prematurity were compared, there were no statistically significant differences between the two groups. We conclude that both preparations are reasonable choices for the treatment of respiratory distress syndrome of prematurity.

摘要

我们进行了一项随机临床试验,以比较合成表面活性剂(Exosurf)和天然表面活性剂(Survanta)对新生儿呼吸窘迫综合征婴儿的疗效。89名患者被随机分配接受两种表面活性剂中的一种。主要结局变量是表面活性剂制剂的急性和长期效果,即根据氧合指数(OI)判断的24小时龄时的通气需求,以及28天时慢性肺病或死亡的合并发生率。Exosurf组和Survanta组24小时时的OI相同(分别为10.1和7;P>0.05)。然而,Survanta组的反应幅度和速度大于Exosurf组。比较动脉/肺泡氧分压比(a/A)时,Exosurf组24小时时的a/A比显著低于Survanta组(Exosurf为0.21,Survanta为0.37;P<0.05)。两组中以死亡或慢性肺病合并发生率判断的长期结局无差异(Exosurf组为18.6%,Survanta组为15.2%;P>0.05)。比较早产并发症时,两组之间无统计学显著差异。我们得出结论,两种制剂都是治疗早产呼吸窘迫综合征的合理选择。

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Animal derived surfactant extract versus protein free synthetic surfactant for the prevention and treatment of respiratory distress syndrome.动物源性表面活性剂提取物与无蛋白合成表面活性剂用于预防和治疗呼吸窘迫综合征的比较
Cochrane Database Syst Rev. 2015 Aug 24;8(8):CD000144. doi: 10.1002/14651858.CD000144.pub3.
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Animal-derived surfactants for the treatment and prevention of neonatal respiratory distress syndrome: summary of clinical trials.
动物来源的表面活性剂治疗和预防新生儿呼吸窘迫综合征:临床试验总结。
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