目的 为初步评估在无创辅助通气基础上进行雾化肺表面活性物质(AS)治疗呼吸窘迫综合征(RDS)早产儿的安全性及效果,开展了此项临床研究。方法 2019年7月—2020年6月,经监护人知情同意,符合入选标准的RDS早产儿,入院后在经鼻间歇正压通气(NIPPV)基础上,通过振动筛网雾化器系统给予100 mg/kg注射用牛肺表面活性剂,雾化完毕继续无创辅助通气。详细观察及记录患儿在雾化初期的生命体征及血气分析结果,记录在雾化治疗期间不良反应发生情况以及患儿病情转归情况。结果 20例患儿参与研究,1例出生后26天死亡,其余均存活出院。5例在AS治疗后3天内无创辅助通气失败。和雾化前比较,AS治疗后1小时患儿血气分析主要指标均改善,血氧饱和度上升,心率下降(P＜0.05),但血压及呼吸机参数无明显变化(P＞0.05)。在雾化过程中,所有患儿无明显不良反应发生。结论 此项临床研究初步显示AS联合无创辅助通气治疗早产儿RDS是安全可行的,但尚需进一步临床研究评估其效果。

Objective To evaluate the safety and efficacy of non-invasive ventilation with aerosolized surfactant (AS) in the treatment of premature infants with respiratory distress syndrome (RDS). Methods From July 2019 to June 2020, in this unblinded Phase I study, the premature infants with RDS who met the criteria with the informed consent of their guardians were enrolled. They were treated with nasal intermittent positive pressure ventilation (NIPPV) and received one dose (100 mg/kg) of aerosolized surfactant by vibrating mesh system (Aeroneb Solo) after hospitalization. The vital signs, adverse reactions and blood gas during areosolizing were recorded and prognosis of them also recorded in detail. Results Twenty infants were enrolled, nineteen completed the study, one died in 26 days. Five infants still required endotracheal intubation and mechanical ventilation after AS treatment. One hour after AS treatment, infants' oxygen saturation and indicators of pulse oximetry improved (P＜0.05), and heart rate decreased (P＜0.05) , but blood pressure and parameters of ventilator had no change (P＞0.05). Infants all tolerated the aerosol treatment well. No other significant adverse events were identified. Conclusion We have demonstrated the feasibility and safety of AS treatment in preterm infants with RDS receiving non-invasive respiratory support. The treatment was well tolerated by infants and clinical caregivers , but still need further study.

目的 探讨湿化高流量鼻导管通气(HHFNC)联合枸橼酸咖啡因治疗早产儿呼吸暂停的临床疗效。方法 选取2016年1月—2017年12月我院收治的58例呼吸暂停的早产儿为研究对象,随机分为两组:HHFNC组和对照组,HHFNC组除采用枸橼酸咖啡因治疗方案外,联合HHFNC法进行治疗;对照组采取鼻导管吸氧联合枸橼酸咖啡因治疗。结果 HHFNC组较之对照组治疗早产儿呼吸暂停的总有效率更高,差异有统计学意义(P<0.05);HHFNC组较之对照组总用氧时间、无创辅助通气的时间减少,住院时间缩短,差异有统计学意义(P<0.05)。结论 湿化高流量鼻导管通气(HHFNC)联合枸橼酸咖啡因减少早产儿呼吸暂停的发生,改善早产儿呼吸状况。