吸入布地奈德治疗近足月新生儿呼吸窘迫综合征:一项随机、安慰剂对照试验

Inhaled Budesonide in Neonatal Respiratory Distress Syndrome of Near-Term Neonates: A Randomized, Placebo-Controlled Trial.

作者信息

Elfarargy Mohamed S, Al-Ashmawy Ghada M, Abu-Risha Sally M, Khattab Haidy A

机构信息

Department of Pediatrics (MSE), Faculty of Medicine, Tanta University, City, Country.

Department of Biochemistry (GMA-A), Faculty of Pharmacy, Tanta University, City, Country.

出版信息

J Pediatr Pharmacol Ther. 2022;27(1):38-44. doi: 10.5863/1551-6776-27.1.38. Epub 2021 Dec 22.

Abstract

OBJECTIVE

This study evaluates the value of inhaled budesonide (BUD) administration in neonatal respiratory distress syndrome (RDS) cases especially for near-term neonates.

METHODS

A randomized controlled trial involving 120 neonates with respiratory distress, which was diagnosed as RDS, was conducted from July 2016 to March 2018. The neonates studied were divided into 2 groups: group 1 (the inhaled BUD group), consisting of 60 neonates who received BUD (2 mL, 0.25-mg/mL suspension) inhalation, twice daily for 5 days; and group 2 (the placebo group), consisting of 60 neonates with RDS who received humidified distilled sterile water inhalation (2 mL). Downes score, RDS grades, and interleukin 8 (IL-8) levels were monitored and measured on the first and fifth days of incubation.

RESULTS

Statistically significant differences (SSDs) in RDS grades, Downes score, and IL-8 levels on the fifth day of admission were observed between groups 1 and 2 (p = 0.001) and between the first and fifth days of incubation in group 1 (p = 0.001). The SSDs in the duration of hospitalization (p = 0.001) and the number of neonates receiving mechanical ventilation (p = 0.032) were found between both groups.

CONCLUSIONS

Budesonide inhalation is associated with improvements in clinical and laboratory parameters in neonates with RDS.

摘要

目的

本研究评估吸入布地奈德(BUD)对新生儿呼吸窘迫综合征(RDS)尤其是近足月新生儿的治疗价值。

方法

2016年7月至2018年3月,对120例诊断为RDS的呼吸窘迫新生儿进行了一项随机对照试验。研究对象分为2组:第1组(吸入布地奈德组),60例新生儿,接受布地奈德(2 mL,0.25 mg/mL混悬液)吸入治疗,每日2次,共5天;第2组(安慰剂组),60例RDS新生儿,接受无菌蒸馏水湿化吸入(2 mL)。在孵育的第1天和第5天监测并测量唐斯评分、RDS分级和白细胞介素8(IL-8)水平。

结果

第1组和第2组之间以及第1组孵育第1天和第5天之间,入院第5天的RDS分级、唐斯评分和IL-8水平存在统计学显著差异(p = 0.001)。两组之间在住院时间(p = 0.001)和接受机械通气的新生儿数量(p = 0.032)方面存在统计学显著差异。

结论

吸入布地奈德可改善RDS新生儿的临床和实验室参数。

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