肺表面活性物质联合布地奈德气管注入治疗早产儿呼吸窘迫综合征的随机对照研究

Pulmonary surfactant in combination with intratracheal budesonide instillation for treatment of respiratory distress syndrome in preterm infants:a randomized controlled trial

目的比较肺表面活性物质(pulmonary surfactants,PS)联合布地奈德与单用PS治疗早产儿呼吸窘迫综合征(respiratory distress syndrome,RDS)和预防支气管肺发育不良(bronchopulmonary dysplasia,BPD)的临床疗效及安全性。方法选择2016年10月至2019年10月徐州市中心医院新生儿重症监护病房收治的胎龄<33周RDS早产儿进行前瞻性研究,随机分为PS组和PS+布地奈德组,根据分组给予相应治疗。比较两组气管注入给药后1 h、12 h、24 h的氧合指数(oxygenation index,OI)、血气分析、吸入氧浓度(fraction of inspiration O2,FiO2)、PS再次使用、静脉使用地塞米松、通气模式、连续呼吸支持天数、糖皮质激素相关并发症、住院天数等短期治疗及预后情况。结果共纳入RDS早产儿198例,PS组101例,PS+布地奈德组97例。PS+布地奈德组给药后24 h OI[(3.3±1.3)比(4.1±2.0)]、连续呼吸支持天数[8(5,11)d比10(5,15)d]均明显小于PS组,差异有统计学意义(P<0.05)。两组患儿给药后1 h、12 h的OI,给药后1 h、12 h、24 h的PaCO2、FiO2,以及PS再次使用率、地塞米松静脉使用率、通气模式、糖皮质激素相关并发症发生率、BPD发生率、住院天数等比较差异均无统计学意义(P>0.05)。PS+布地奈德组胎龄<28周患儿“BPD+出生36 h后死亡或自动出院”率略低于PS组(29.4%比38.9%,P=0.555)。结论与单用PS相比,PS联合布地奈德气管注入治疗早产儿RDS可以改善注入后24 h的OI、缩短连续呼吸支持天数,但未降低BPD发生率,也未增加糖皮质激素相关并发症发生率。

Objective To compare the clinical efficacy and safety of intratracheal instillation of pulmonary surfactant(PS)combined with budesonide and PS alone in the treatment of respiratory distress syndrome(RDS)and prevention of bronchopulmonary dysplasia(BPD)in preterm infants.Method Preterm infants of gestational age<33 weeks with RDS admitted to the neonatal intensive care unit of Xuzhou Central Hospital from October 2016 to October 2019 were randomly assigned into PS group and PS+budesonide group,and given the corresponding treatment according to the group.The oxygenation index(OI),blood gas analysis,fraction of inspiration O2(FiO2)at 1,12 and 24 hours after intratracheal instillation,whether to use PS again,intravenous dexamethasone,ventilation mode,days of continuous respiratory support,glucocorticoid-related complications,length of stay and prognosis were compared between the two groups.Result A total of 198 preterm infants with RDS were enrolled in the study,including 101 in the PS group and 97 in the PS+budesonide group.The OI at 24 hours after intratracheal instillation[(3.3±1.3)vs.(4.1±2.0)]and the days of continuous respiratory support[8(5,11)d vs.10(5,15)d]in the PS+budesonide group were significantly less than those in the PS group(P<0.05).There were no significant difference in OI at 1 and 12 hours after instillation,PaCO2 and FiO2 at 1,12 and 24 hours after instillation,the rate of second dose of PS,intravenous dexamethasone,ventilation mode,length of stay,incidence of glucocorticoid-related complications and BPD between the two groups(P>0.05).The rate of"BPD,death or abandoning treatment after 36 hours of birth"in the preterm infants with gestational age<28 weeks in the PS+budesonide group was slightly lower than that in the PS group(29.4%vs.38.9%,P=0.555).Conclusion Comparing with the treatment of PS alone,PS combined with budesonide intratracheal instillation in treating RDS in preterm infants can improve OI at 24 hours after instillation and shorten the days of continuous respiratory support without reducing the incidence of BPD or increasing the incidence of glucocorticoid-related complications.