肺表面活性剂（珂立苏）治疗新生儿呼吸窘迫综合征多中心临床试验  

A multi-center randomized controlled clinical trial of surfactant （Calsurf） therapy for neonatal respiratory distress syndrome

作　　者：董声焕[1] 孙眉月[2] 寇同欣[3] 李克华[4] 徐英美[5] 郭静[6] 张宇鸣[7] 刘翠青[8] 陈克正[9] 李贵云 

机构地区：[1]首都儿科研究所,北京100020 [2]浙江大学医学院附属儿童医院,杭州310003 [3]北京双鹤药业股份有限公司,100102 [4]首都医科大学附属北京儿童医院,100045 [5]南京医科大学附属南京儿童医院,210008 [6]天津市儿童医院,300074 [7]200040上海市儿童医院 [8]河北省儿童医院,石家庄050031 [9]广州市儿童医院,510120 [10]河北省盐山县医院,061300

出　　处：《中国小儿急救医学》2009年第2期120-124,共5页Chinese Pediatric Emergency Medicine

基　　金：北京市科委资助课题（853670200）

摘　　要：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〈2500g，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70mg／kg；对照组以同样方法注入空气。结果给药后3d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24h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2d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8h和24h，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。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 nun 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 （ ≥ 1 500 g or 〈 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 othe

关 键 词：肺表面活性剂 新生儿呼吸窘迫综合征 多中心临床试验 

分 类 号：R722.1[医药卫生—儿科]