国产与进口肺表面活性物质治疗早产儿呼吸窘迫综合征临床比较

Comparison of homemade and imported pulmonary surfactant replacement therapy in premature infants with respiratory distress syndrome

目的比较国产和进口肺表面活性物质(Pulmonary surfactant,PS)治疗早产儿呼吸窘迫综合征(Respirory distress syndrome,RDS)的临床疗效及安全性。方法将2009年5月-2010年10月出生的RPD早产儿107例分为3组。A组(42例)患儿应用国产PS和机械通气治疗,B组(37例)患儿应用进口PS和机械通气治疗,C组(28例)患儿单纯应用机械通气治疗。结果①应用国产或进口PS均可迅速改善RDS患儿临床症状(P<0.05)。②三组患儿血气值比较差异无统计学意义(P>0.05)。③用药后1～24 h,A、B组机械通气参数PIP值明显低于C组(P<0.05)。④用药后2～6 h,A组机械通气参数FiO2明显低于C组。⑤应用PS后2～6 h,A、B组胸片显示,肺部病变明显好转。⑥三组机械通气时间、住院时间、并发症和结局等比较,差异无统计学意义(P>0.05)。⑦A、B组重复用药情况差异无统计学意义(P>0.05)。结论国产与进口肺表面活性物质治疗早产儿RDS同样安全有效,操作时应用进口PS更加方便快捷。

Objective To compare the clinical efficacy and safety between homemade and imported pulmonary surfactant（PS）replacement therapy in premature infants with respiratory distress syndrome（RDS）.Methods 107 premature infants with RDS from May 2009 to October 2010 were divide into 3 groups.Group A（n=42）was given homemade PS and and assisted ventilation;Group B（n=37）was given imported PS and assisted ventilation;Group C（n=28） was only used assisted ventilation.Results ①The symptoms and signs of RDS were improved obviously and quickly after PS treatment（P0.05）.②There was no significant difference in blood gas indexes between the 3 groups（P0.05）.③The ventilator parameters of PIP in group A/B were lower than those in group C（P0.05）during 1-24 h after PS treatment.④The ventilator parameters of FiO2 in group A were lower than those in group C（P0.05）during 2-6 h after PS treatment（P0.05）.⑤Thoracic X-ray showed that the lung diseases in group A/B was improved significantly during 2-6 h after PS treatment（P0.05）.⑥There was no significant difference between the 3 groups in duration of assisted ventilation,time of hospital stay and complications,etc（P0.05）.⑦There was no significant difference in repeated PS use between group A and group B（P0.05）.Conclusion Homemade and imported PS have the same efficacy and safety for RDS in premature infants,and imported PS is more convenient.