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比较两种天然表面活性剂制剂治疗呼吸窘迫综合征的随机临床试验。

Randomized clinical trial comparing two natural surfactant preparations to treat respiratory distress syndrome.

作者信息

Hammoud M, Al-Kazmi N, Alshemmiri M, Thalib L, Ranjani V T, Devarajan L V, Elsori H

机构信息

Department of Pediatrics, Faculty of Medicine, Kuwait University, Safat, Kuwait.

出版信息

J Matern Fetal Neonatal Med. 2004 Mar;15(3):167-75. doi: 10.1080/14767050410001668266.

Abstract

OBJECTIVES

Natural surfactant preparations have been shown to reduce the severity and mortality of respiratory distress syndrome (RDS) in preterm infants. The objective of this study was to compare the efficacy of two natural surfactants, namely SF-RI 1 (Alveofact) and barectant (Survanta), on the incidence of chronic lung disease (CLD) and other associated complications of RDS in preterm infants.

METHODS

Preterm infants with RDS requiring artificial ventilation were randomly selected to receive an initial dose of either Alveofact or Survanta. The two treatment groups were tested for variation in gas exchange, ventilatory settings and neonatal complications such as CLD and mortality.

RESULTS

After 5 days the Survanta-treated infants had a lower fraction of inspired oxygen (FiO2) compared with the Alveofact-treated infants. There were no differences in the ventilatory settings. More infants in the Survanta group were extubated at 3 days and fewer required the use of postnatal steroids. Less CLD and duration of oxygenation were experienced by the Survanta-treated group.

CONCLUSIONS

Improved oxygenation and reduced ventilatory requirements were greater with Survanta compared to Alveofact, which in turn was associated with a trend towards a lower incidence of serious pulmonary complications.

摘要

目的

天然表面活性剂制剂已被证明可降低早产儿呼吸窘迫综合征(RDS)的严重程度和死亡率。本研究的目的是比较两种天然表面活性剂,即SF-RI 1(肺泡表面活性物质)和牛肺表面活性剂(固尔苏)对早产儿慢性肺病(CLD)的发生率及RDS其他相关并发症的疗效。

方法

随机选择需要人工通气的RDS早产儿,给予初始剂量的肺泡表面活性物质或固尔苏。对两个治疗组进行气体交换、通气设置及新生儿并发症(如CLD和死亡率)方面的差异检测。

结果

5天后,与接受肺泡表面活性物质治疗的婴儿相比,接受固尔苏治疗的婴儿吸入氧分数(FiO2)更低。通气设置方面无差异。固尔苏组更多婴儿在3天时拔管,且较少需要使用产后类固醇。接受固尔苏治疗的组发生CLD及氧疗时间更短。

结论

与肺泡表面活性物质相比,固尔苏改善氧合及降低通气需求的效果更佳,这反过来与严重肺部并发症发生率降低的趋势相关。

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