中文摘要：

目的探讨国产牛肺表面活性物质（PS，珂立苏）防治新生儿呼吸窘迫综合征（NRDS）的疗效及安全性。方法采用前瞻性、多中心对照临床研究方法，收集7家医院新生儿病房176例防治性使用牛PS患儿作为观察组，以同时期住院、家长拒绝使用PS患儿80例为对照组。观察2组患儿治疗前后不同时问点呼吸、心率、血压、经皮氧饱和度（SpO2）及动脉血气分析，用药前后6h胸部x线摄片，用氧方式及经鼻持续呼吸道正压通气使用时间，NRDS及相关并发症，住院时间、费用及其转归。结果1．与对照组比较，观察组不同时间点呼吸频率明显降低（P均〈0．01）；1h和4h动脉血氧分压[Pa（O2）]明显提高（P〈0．01）；NRDS发生例数（26／176例比32／80例）、需接受辅助通气患儿例数（17／176例比18／80例）以及氧疗持续时间[（15．6±6．7）d比（12．5±4．6）d]均明显降低（P均〈0．01）。2．观察组继发感染、支气管肺发育不良、气胸、动脉导管未闭、早产儿视网膜病、脑损伤（颅内出血、HIE、脑室周围白质软化）等发生率与对照组比较差异均无统计学意义（P均〉0．05）；观察组死亡或放弃治疗例数较对照组明显降低（20／176例比25／80例）（P〈0．01）。3．观察组存活患儿住院时间[（35．8±17．4）d比（42．6±15．7）d]及住院费用[（46568±16533）元比（56858±16334）元]较对照组均明显减少（P〈0．01，0．05）。结论防治性使用国产牛Ps能显著降低小早产儿RDS的发生率及病死率，且无明显不良反应发生。

英文摘要：

Objective To investigate the efficacy and safety of calf pulmonary surfactant （made in China） in prevention and treatment for neonatal respiratory distress syndrome （NRDS）. Methods A prospective, multi-center controlled clinical study was conducted. A total of 256 patients who came from 7 NICUs were enrolled in this study,with 176 cases who were treated with calf pulmonary surfactant as the observation group and 80 cases refused calf pulmonary surfaetant as the control group. The clinical data were observed and compared in the 2 groups, including respiration rate, heart rate, blood pressure, transcutaneous oxygen saturation, arterial blood gas analysis, bedside X-ray of the chest at 0 h and 6 h, the use of oxygen, ventilation and nasal continuous positive airway pressure, the incidence of NRDS and complications, and the length of stay hospital and the costs. Results 1. Compared with the control group,in the obser- vation group receiving the calf pulmonary suffactant treatment, the respiratory rate decreased at different time course （all P 〈0.01 ） ;Pa（ O2 ） improved significantly at 1 h and 4 h（P 〈0.01 ） ;the incidence of NRDS（26/176 cases vs 32/80 cases） ,receiving the ventilation （17/176 cases vs 18/80 cases） and oxygen therapy lasting [ （15.6 ± 6.7 ） d vs （12.5 ±4.6） d] decreased significantly（all P 〈 0.01 ）. 2. The differences in the incidence of secondary infection, bronchopulmonary dysplasia, pneumothorax, patent ductus arteriosus closure, retinopathy of premature and brain damage （intracranial hemorrhage,hypoxic-ischemic encephalopathy,and periventricular leukomalacia） were not statistically sig- nificant between the both groups （ all P 〉 0.05 ）. 3. Compared with the control group, in the observation group, the cases of death or the with-drawals declined significantly（ 20/176 cases vs 25/80 cases）, P 〈 0.01 ; the duration of hospital stay[ （35.8 ± 17.4） d vs（42.6 ± 15.7） d] and the costs[ （46 568 ± 16 533） yuan vs（56 858 ± 16