布地奈德联合肺表面活性物质气管内给药预防支气管肺发育不良的前瞻性随机对照研究

Efficacy and safety of intratracheal administration of budesonide combined with pulmonary surfactant in preventing bronchopulmonary dysplasia: a prospective randomized controlled trial

摘要:

目的 探讨布地奈德联合肺表面活性物质（pulmonary surfactant，PS）气管内给药预防支气管肺发育不良（bronchopulmonary dysplasia，BPD）的疗效及安全性。 方法 前瞻性选取2021年1~7月郑州大学第三附属医院新生儿重症监护室收治的BPD高危患儿122例为研究对象，随机分为常规组（单纯应用PS，首剂200 mg/kg，根据病情再次给予PS剂量为每次100 mg/kg）62例和观察组（PS应用同常规组，每次应用PS时加入布地奈德0.25 mg/kg混匀气管内滴注）60例，比较分析两组早产儿PS应用次数、不同时间点呼吸机参数、用氧情况、BPD发生率及严重程度、并发症发生率和纠正胎龄40周潮气呼吸肺功能。 结果 观察组PS应用2次或3次比例低于常规组（Ρ<0.05）。观察组给药后24 h、48 h、3 d、7 d及21 d的吸入氧浓度低于常规组，有创通气时间、无创通气时间、呼吸机使用时间、氧疗总时间短于常规组，BPD发生率及严重程度比例低于常规组（Ρ<0.05），两组间糖皮质激素相关并发症发生率比较差异无统计学意义（Ρ>0.05）。 结论 与单纯使用PS相比，布地奈德联合PS方案治疗BPD高危早产儿可以减少PS的重复使用次数，降低呼吸机参数，缩短呼吸支持时间，降低BPD发生率及严重程度，但未增加糖皮质激素相关并发症的发生率，临床上可考虑推广使用。

Abstract:

Objective To study the efficacy and safety of early intratracheal administration of budesonide combined with pulmonary surfactant (PS) in preventing bronchopulmonary dysplasia (BPD). Methods A prospective randomized controlled trial was designed. A total of 122 infants with a high risk of BPD who were admitted to the neonatal intensive care unit of the Third Affiliated Hospital of Zhengzhou University from January to July 2021 were enrolled. The infants were randomly divided into a conventional treatment group with 62 infants (treated with PS alone at an initial dose of 200 mg/kg, followed by a dose of 100 mg/kg according to the condition of the infant) and an observation group with 60 infants (treated with PS at the same dose as the conventional treatment group, with the addition of budesonide 0.25 mg/kg for intratracheal instillation at each time of PS application). The two groups were compared in terms of the times of PS use, ventilator parameters at different time points, oxygen inhalation, incidence rate and severity of BPD, incidence rate of complications, and tidal breathing pulmonary function at the corrected gestational age of 40 weeks. Results Compared with the conventional treatment group, the observation group had a significantly lower proportion of infants using PS for two or three times (P<0.05). Compared with the conventional treatment group, the observation group had a significantly lower fraction of inspired oxygen at 24 and 48 hours and 3, 7, and 21 days after administration, significantly shorter durations of invasive ventilation, noninvasive ventilation, ventilator application, and oxygen therapy, a significantly lower incidence rate of BPD, and a significantly lower severity of BPD (P<0.05). There was no significant difference in the incidence rate of glucocorticoid-related complications between the two groups (P>0.05). Conclusions Compared with PS use alone in preterm infants with a high risk of BPD, budesonide combined with PS can reduce repeated use of PS, lower ventilator parameters, shorten the duration of respiratory support, and reduce the incidence rate and severity of BPD, without increasing the incidence rate of glucocorticoid-related complications.