国产外源性肺表面活性物质治疗新生儿重症感染性肺炎多中心前瞻性临床研究

目的 研究国产外源性肺表面活性物质（珂立苏）对新生儿重症感染性肺炎的治疗效果。方法 研究对象为来自中国5家医院的208例重症感染性肺炎新生儿，在入院时根据家长意愿给予常规治疗（对照组，81例）和珂立苏治疗+常规治疗（珂立苏组，127例），比较两组患儿入院时对氧的依赖程度、治疗前后动脉血气分析结果及肺脏超声表现的变化、机械通气时间、住院时间、住院费用、并发症及预后等。结果 入院时珂立苏组吸入氧浓度明显高于对照组，动脉血氧分压明显低于对照组，二氧化碳分压明显高于对照组，氧合指数明显低于对照组（P < 0.01）。治疗1 h后，两组患儿动脉血气和氧合状态均得到改善，且珂立苏组改善状况显著优于对照组（P < 0.05）。补充珂立苏后4~6 h，患儿肺部实变程度显著减轻。与对照组比较，珂立苏组机械通气时间、住院时间均明显缩短，而两组患儿并发症发生率差异无统计学意义，预后均良好。结论 珂立苏治疗能显著改善新生儿重症感染性肺炎患儿的氧合状态，减轻肺实变程度，缩短患儿机械通气时间和住院时间，值得临床推广应用。

Clinical effect of exogenous pulmonary surfactant in the treatment of severe neonatal infectious pneumonia: a multicenter prospective clinical trial

Objective To study the clinical effect of calsurf, a domestic exogenous pulmonary surfactant, in the treatment of severe neonatal infectious pneumonia. Methods A total of 208 neonates with severe infectious pneumonia who hospitalized in 5 hospitals of China were enrolled. According to their parents' wishes on admission, these neonates were administered with conventional treatment (control group; n=81) and calsurf treatment + conventional treatment (calsurf treatment group, n=127). The two groups were compared in terms of the degree of oxygen dependence on admission, blood gas parameters before and after treatment, lung ultrasound results, duration of mechanical ventilation, length of hospital stay, hospital costs, complications and prognosis. Results Compared with the control group on admission, the calsurf treatment group had significantly higher inhaled oxygen concentration and partial pressure of carbon dioxide and significantly lower arterial partial pressure of oxygen and oxygenation index (P < 0.01). After 1 hour of treatment, both groups had significant improvements in the above indices (P < 0.05), and the improvements were more significant in the calsurf treatment group (P < 0.05). After 4-6 hours of calsurf administration, there was a significant reduction in the degree of pulmonary consolidation. The calsurf treatment group had significantly shorter duration of mechanical ventilation and length of hospital stay than the control group, while there was no significant difference in the incidence rate of complications between the two groups. The neonates of both groups had a good prognosis. Conclusions In neonates with severe infectious pneumonia, calsurf treatment can significantly improve oxygenation, reduce the degree of pulmonary consolidation, and shorten the duration of mechanical ventilation and length of hospital stay. Therefore, it should be considered in neonates with severe infectious pneumonia.