不同起始量肺表面活性物质治疗新生儿呼吸窘迫综合征的多中心临床疗效比较

Difference of multi-center controlled clinical efficacy in treatment of neonatal respiratory distress syndrome with different initial doses of pulmonary surfactant

目的探讨不同起始量的肺表面活性物质(pulmonary surfactant,PS)治疗新生儿呼吸窘迫综合征(neonatal respiratory distress syndrome,NRDS)的疗效及差异。方法采用前瞻性、多中心对照临床研究方法,按多阶段分层随机抽样的方法,收集三家医院新生儿病房收治的143例新生儿呼吸窘迫综合征的患儿,且使用肺表面活性物质(商品名:珂立苏)治疗,采用完全随机设计的方法分成对照组和实验组,分别使用起始剂量为70 mg/kg和100 mg/kg的PS进行治疗,检测并记录使用PS前后不同时间血气分析结果、胸片结果、重复使用PS的次数、并发症的发生、机械通气时间、用氧时间及住院天数等指标。结果 1两组用药后需氧浓度、PaO_2、PaCO_2、胸片结果均较用药前有好转(P<0.05);2 PS100组应用PS后12、24、36 h较PS70组对氧的需求更低(P<0.05),PO_2及PCO_2改善更明显(P<0.05);3 PS100组应用PS后24 h,胸片情况较PS70组明显好转(P<0.05);4PS100组在机械通气时间、用氧时间方面均低于PS70组(P<0.05)。结论应用肺表面活性物质治疗NRDS起始剂量为100 mg/kg的疗效优于70 mg/kg。

Objective To investigate the difference of clinical efficacy in treatment of neonatal respiratory distress syndrome （NRDS） with different initial doses of pulmonary surfactant （PS）. Methods Prospective multi-center controlled clinical trials and multi-stage stratified random sampling were employed, and 143 cases of NRDS treated with PS from 3 NICUs were enrolled in the trails. The neonates were randomly divided into 2 groups, which were treated with initial dose of PS at 70 mg/kg （ PS70 ） and at 100 mg/kg （ PS100 ） , respectively. Blood gas analysis, chest X-ray results, repeated use of PS, complication occurrence, duration of mechanical ventilation, oxygen therapy and hospitalization were analyzed. Results The data demonstrated that PaO2 , PaCO2 and chest X-ray results were improved in both groups after PS treatment （ P 〈 0. 05 ）. PS100 group had lower oxygen demand （P 〈 0.05 ） at 12, 24 h and 36 h after PS administration compared with PS7o group, and PO2 and PCO2 were improved more significantly in PS100 group （ P 〈 0. 05 ）. PS100 group showed significantly improved chest X-ray results at 24 h after PS administration compared with PSTo group （ P 〈 0. 05 ）. Duration of mechanical ventilation and oxygen therapy were reduced more in PS100 group than in PS70 group （P 〈 0. 05 ）. Conclusion PS exerts better clinical efficacy in NRDS at the initial dose of 100 mg/kg than at 70 mg/kg.