猪肺磷脂注射液治疗晚期早产儿和足月儿呼吸窘迫综合征的多中心临床研究  

A multicenter study on the surfactant treatment in late-preterm or term infants with respiratory distress syndrome

机构地区：[1]晚期早产儿/足月儿呼吸窘迫综合征临床研究协作组

出　　处：《中华儿科杂志》2014年第10期724-728,共5页Chinese Journal of Pediatrics

基　　金：国家科技部“十二五”支撑项目（2012BAI04B04）;浙江省重点科技创新团队项目（2010R50045）

摘　　要：目的 多中心前瞻性观察表面活性物质对晚期早产儿（LPI）和足月儿呼吸窘迫综合征（RDS）的临床疗效,并对其有效剂量和安全性进行评价.方法 共8家三级医院新生儿重症监护室（NICU）参加研究,以2011年3月至2012年4月生后72 h内入住NICU的需要机械通气且吸入氧浓度（FiO2）≥0.4才能维持动脉氧分压（PaO2） ≥50 mmHg（1 mmHg =0.133 kPa）或氧饱和度（SpO2）＞90％的出生胎龄≥34周的LPI或足月RDS患儿为研究对象,给予猪肺磷脂注射液首剂量80～150 mg/kg,记录患儿的人口学信息、给药信息,给药前及给药后不同时间点的血气分析结果、呼吸机参数,观察气胸、肺出血、感染等临床并发症,记录临床转归、治疗费用、药物不良事件等,并根据呼吸机参数、血气指标的动态变化对疗效进行评价.组间比较采用t检验或单因素方差分析或x2检验.结果 共96例患儿纳入研究,男69例（71.9％）,女27例（28.1％）,平均出生胎龄（36.5±2.1）周;57例（59.4％）为LPI.经阴道分娩12例（12.5％）,宫缩发动后剖宫产24例（25.0％）,无宫缩的选择性剖宫产60例（62.5％）.首剂猪肺磷脂注射液给药时间为出生后13.3（5.1～26.5）h,首剂给药剂量为（109±20） mg/kg,10例（10.4％）患儿接受第2剂.给药后0.5h,PaO2、SpO2明显上升,PaCO2、FiO2明显下降,随着时间延长至6.0h,FiO2进一步下降,平均气道压也较前下降.给药后0.5h,PaO2/FiO2、氧合指数、肺泡-动脉氧分压差（A-aDO2）、PaO2/PAO2等指标均较给药前明显改善,且给药后6.Oh持续改善.共27例（28.1％）患儿出现各种并发症,平均住院时间为（19 ±9）d,平均住院费用为（39 000 ±36 000）元人民币,73例（76.0％）患儿治愈出院.大剂量组（≥100 mg/kg）给药后6.0h时PaO2/FiO2、氧合指数、A-aDO2、PaO2/PAO2的改善显著优于小剂量组,机械通气时间缩短,但不能缩短住院时间,不增加住院费用和并发症�Objective To investigate the efficacy and safety of surfactant when it was used to treat late-preterm or term infants with respiratory distress syndrome （RDS）.Method Infants who were born at ≥34 weeks＇ gestational age and diagnosed with respiratory distress syndrome,required mechanical ventilation,admitted to 8 tertiary NICUs at 〈 72 hours of age were enrolled.Surfactant was given if the infant required FiO2 ≥0.4 to maintain PaO2 ≥50 mmHg（1 mmHg =0.133 kPa） or SpO2 〉 90%.Before and after surfactant treatment,the results of blood gas,ventilator settings,and the incidence of complications were recorded and analyzed.Comparison between continuous variables was made by t-test or one way analysis of variance （ANOVA）.Categorical data was analyzed by a 2-tailed Pearson x2 test.Result Totally 96 infants were enrolled in this prospective study.The mean gestational age was （36.5 ± 2.1）weeks.Of whom,71.9% （n=69）were male,59.4% （n =57） were late-preterm infants,62.5% （n =60） were delivered by elective cesarean section.The first dose of surfactant was given at the median age of 13.3 hours with the dosage of （109 ±20） mg/kg.The second dose was given to 10.4% （n =10） infants.Half an hour post surfactant,PaO2/FiO2,OI,A-aDO2,PaO2/PAO2 improved significantly,and lasted for 6 hours.The mean length of hospital stay was （19 ± 9） days,median medical cost was （39 000 ± 36 000） yuan.Totally 73 cases （76.0%） were discharged after the treatment completed.Compared to small dosage,the improvement of PaO2/FiO2,OI,A-aDO2,PaO2/PAO2 was more significant at 6 hours after relatively large dose （≥ 100 mg/kg） of surfactant,and the length of mechanical ventilation was shorter.But the length of hospital stay,medical costs,and the incidence of complications was not significantly different between these two dosage groups.Conclusion Surfactant significantly improved the oxygenation in latepreterm or term infants with respiratory distress syndrome.

关 键 词：呼吸窘迫综合征 新生儿 肺表面活性物质相关蛋白质类 多中心研究 

分 类 号：R722[医药卫生—儿科]