CAJ | 학술논문

目的评价肺表面活性剂(珂立苏)治疗新生儿呼吸窘迫综合征(RDS)的效果和安全性.方法在全国七大城市儿童医院进行随机的、有对照的、多中心临床试验.研究对象主要入选标准:临床诊断新生儿RDS,出生体质量＜2 500 g,a/APO2＜0.22.入选合格病例107例,其中给药组57例,对照组50例.北京双鹤药业生产的珂立苏以混悬液形式从气管插管滴入,剂量70 mg/kg;对照组以同样方法注入空气.结果给药后3 d内RDS患儿氧合及通气功能(PaO2、a/APO2、FiO2、PaCO2)明显改善,a/APO2在给药2、8及24 h明显高于对照组,差异有非常显著性(P＜0.01).呼吸机重要参数(PIP)、MAP、PEEP)给药后2 d内在各时间点均显著低于对照组(P＜0.05).根据首剂给药后a/APO2的改变判断疗效,有良好反应者占84.2%.X线胸片改变提示,给药后8 h和24 h,肺含气情况有显著改善.除1/3病例在给药时有短暂气道阻塞表现外,无其他不良反应.给药组与对照组并发症发生率差异无显著性(P＞0.05).结论珂立苏治疗RDS有效、安全.
목적 평개폐표면활성제(가립소)치료신생인호흡군박종합정(RDS)적효과화안전성.방법 재전국칠대성시인동의원진행수궤적、유대조적、다중심림상시험.연구대상주요입선표준:림상진단신생인RDS,출생체질량＜2 500 g,a/APO2＜0.22.입선합격병례107례,기중급약조57례,대조조50례.북경쌍학약업생산적가립소이혼현액형식종기관삽관적입,제량70 mg/kg;대조조이동양방법주입공기.결과 급약후3 d내RDS환인양합급통기공능(PaO2、a/APO2、FiO2、PaCO2)명현개선,a/APO2재급약2、8급24 h명현고우대조조,차이유비상현저성(P＜0.01).호흡궤중요삼수(PIP)、MAP、PEEP)급약후2 d내재각시간점균현저저우대조조(P＜0.05).근거수제급약후a/APO2적개변판단료효,유량호반응자점84.2%.X선흉편개변제시,급약후8 h화24 h,폐함기정황유현저개선.제1/3병례재급약시유단잠기도조새표현외,무기타불량반응.급약조여대조조병발증발생솔차이무현저성(P＞0.05).결론 가립소치료RDS유효、안전.
Objective To study the relative efficacy and safety of Calsurf (surfactant extracted from calf lung lavage,Beijing Double Crane Pharmaceutical Co. Ltd. ) in treatment of neonatal respiratory distress syndrome (RDS). Methods Multi-center randomized controlled clinical trial was organized in 7 children's hospitals nation wide. Criteria for enrollment were clinical diagnosis of RDS, birth weight ＜ 2 500 g, FiO2 ＞0. 5 for maintaining PaO2＞50 mm Hg, a/APO2＜0. 22 and less than 36 h post partum. Patients were randomized to either surfactant treatment or control group. Randomization were stratified by birth weight (≥ 1500 gor ＜ 1 500 g) for each hospital. All patients were intubated and received mechanical ventilation. In surfactant treatment group 70 mg/kg Calsurf suspension was instilled into endotracheal tube. 12-24 h after first dose a second dose can be given if the need arises. For the control group an equal amount of air was instilled. Changes of oxygenation and ventilation were measured by comparing pre-treatment and post-treatment values at 2 h,8 h,24 h,48 h,3 days and 5 days. PaO2 and PaCO2 were measured,a/APO2 were calculated,ventilator settings (FiO2 ,PIP,MAP,PEEP) were recorded. Chest X-ray was finished 0. 5 h before treatment,8 h and 24 h after treatment. Results Surfactant treatment group received Calsurf at 14 h of mean age. Four patients received a second dose. In 3 days after treatment oxygenation and ventilation improved, a/APO2 values were higher and showed significant improvement at 2 h,8 h ,24 h after treatment compared with control group. After treatment ventilator parameters (FiO2 ,PIP,MAP,PEEP) improved within 2 days in all time points. According to changes of a/APO2 after initial dose of surfactant totally 84.2% of patients had good response. Chest X-ray results showed,after treatment 8 h and 24 h there were significant improvement in lung aeration. Temporary partial airway obstruction was found in 1/3 patients when received surfactant. No other side effects were found after Calsurf instillation. There were no significant differences in the incidence of complications in surfactant treatment and control group. Conclusion Calsurf is effective and safe for treatment of neonatal RDS.