经鼻持续气道正压给氧多中心临床试验研究

A multi-center clinical trial of oxygen administration with nasal continuous positive airway pressure

目的评价经鼻持续气道正压（CPAP）给氧的效果。方法2003年1月至2007年12月首都儿科研究所（牵头）和北京市9家郊区县医院对107例因肺部疾患导致低氧血症新生儿和婴幼儿进行多中心临床试验，通过脉搏血氧仪并结合临床观察对国产的CPAP氧疗仪和普通给氧方法（面罩、头罩）在改善血氧饱和度的效果方面进行评价。结果CPAP治疗组46例，普通给氧组61例。应用CPAP后新生儿组在给氧后0．5h及2h血氧饱和度为（88．6±7．9）％及（94．4±5．0）％，普通给氧组为（82．4±5．7）％及（90．3±4．5）％，两组间差异有显著性（P〈0．05）。婴幼儿组在CPAP给氧后1h血氧饱和度为（95．7±2．6）％，普通给氧组为（87．3±15．8）％，两组间差异有显著性（P〈0．05）。给氧后紫绀和呼吸困难程度的改善，CPAP组优于普通给氧组。结论经鼻CPAP氧疗仪是适用于基层、安全、有效、效果优于普通给氧方法的给氧工具。

Objective To evaluate the effect of nasal continuous positive airway pressure （CPAP）. Methods A randomized controlled multi-center clinical trial was conducted during January 2003 to December 2007 in 107 newborns and infants with hypoxemia due to pulmonary diseases. These patients were hospitalized in Capital Institute of Pediatrics and 9 local hospitals. The changes of arterial oxygen saturation and clinical signs were studied after CPAP treatment and conventional oxygen therapy. Results CPAP group recruited 46 cases, conventional oxygen therapy group included 61 cases. After CPAP treatment, oxygen saturation values in newborns at 0.5 and 2 hour were （88.6 ± 7.9） % and （94.4 ± 5.0） %, and there was significant difference as compared with those in conventional oxygen therapy group [ （ 82.4 ± 5.7） % and （ 90.3 ± 4.5 ） % ]. Oxygen saturation value of infants with CPAP at 1 hour was （95.7 ± 2.6） %, and there was significant difference as compared with that in conventional oxygen therapy group[ （87.3 ± 15,8） % ]. Oxygen therapy alleviated the severity of cyanosis and dyspnea, and CPAP showed better outcome than conventional oxygen therapy. Conclusion Nasal CPAP apparatus is a safe, efficient instrument for oxygen administration and CPAP is better than conventional oxryen therapy. CPAP is suitable for primary hostal use.