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目的探讨预防性应用牛肺表面活性物质对胎龄<32周早产儿病死率和主要并发症发生率的影响。方法 2012年10月至2013年9月在国内9家医院进行多中心临床对照研究,研究对象为胎龄<32周的早产儿,分为预防组(生后30分钟内给药)和早期治疗组(出生后2小时内给药),均气管插管内滴入国产牛肺表面活性剂(70mg/kg)。比较两组患儿的呼吸窘迫综合征(respiratory distress syndrome,RDS)发生率、病死率和主要并发症发生率等指标。结果共纳入有效病例预防组116例,早期治疗组91例。预防组RDS的发生率略高于早期治疗组,但差异无显著性(P>0.05),重度RDS的发生率明显低于早期治疗组,差异具有显著性(P<0.05)。预防组患儿中至重度支气管肺发育不良(bronchopulmonary dysplasia,BPD)和动脉导管未闭(patent ductus arteriosus,PDA)的发生率明显低于早期治疗组,差异具有显著性(P均<0.05),重度脑室内出血(intraventricular hemorrhage,IVH)、中至重度坏死性小肠结肠炎(necrotizing enterocolitis,NEC)、气漏、肺出血及败血症的发生率预防组和早期治疗组比较差异均无显著性(P均>0.05)。结论对于胎龄<32周的早产儿,预防性应用肺表面活性物质可以降低重度RDS、中至重度BPD和PDA的发生风险。
Objective To investigate the effect of prophylactic application of bovine pulmonary surfactant on mortality and major complications of gestational age <32 weeks in preterm infants. Methods From October 2012 to September 2013, a multicenter clinical trial was conducted in 9 hospitals in China. The study was conducted on preterm infants of gestational age <32 weeks and divided into prevention group (given within 30 minutes after birth) and early treatment Group (administered within 2 hours after birth) were intragastrically intratracheal instillation of domestic bovine surfactant (70mg / kg). The incidences of respiratory distress syndrome (RDS), mortality and major complication rates were compared between the two groups. Results A total of 116 cases were included in the effective case prevention group and 91 cases in the early treatment group. The incidence of RDS in prevention group was slightly higher than that of early treatment group, but the difference was not significant (P> 0.05). The incidence of severe RDS was significantly lower than that of early treatment group (P <0.05). The incidence of moderate to severe bronchopulmonary dysplasia (BPD) and patent ductus arteriosus (PDA) in the prevention group was significantly lower than that in the early treatment group (P <0.05) Severe intraventricular hemorrhage (IVH), moderate to severe necrotizing enterocolitis (NEC), the incidence of air leaks, pulmonary hemorrhage and sepsis in the prevention group and the early treatment group showed no significant difference (P > 0.05). Conclusions Preventive use of pulmonary surfactant in preterm infants <32 weeks gestational age may reduce the risk of developing severe RDS, moderate to severe BPD, and PDA.