中国临床药理学杂志2026，Vol.42Issue(7)：934-939,6.DOI:10.13699/j.cnki.1001-6821.2026.07.006
猪肺磷脂注射液联合布地奈德混悬液在早产儿呼吸窘迫综合征中的临床研究
Clinical trial on endotracheal administration of poractant alfa injection combined with budesonide suspension in preterm infants with respiratory distress syndrome
摘要
Abstract
Objective To observe the clinical efficacy and safety of porcine pulmonary surfactant injection combined with budesonide suspension in premature infants with respiratory distress syndrome(RDS).Methods Infants with RDS were divided into control group and treatment group based on treatment methods.The control group received endotracheal administration of poractant alfa injection at 200 mg·kg-1,with a supplemental dose of 100 mg·kg-1 after 12 h.The treatment group additionally received inhaled budesonide suspension at 0.25 mg·kg-1,twice daily.Both groups continued treatment for 3 d.The clinical symptoms and respiratory support parameters,blood gas analysis parameters,serum inflammatory and stress markers,clinical efficacy and safety evaluation were compared between the two groups.Results A total of 136 were enrolled,with 59 cases in treatment group and 65 cases in control group.After treatment,the total efficacy rates in treatment group and control group were 89.83％(53 cases/59 cases)and 78.46％(49 cases/65 cases),respectively;time to disappearance of tachypnea were(36.85±5.62)and(39.52±7.15)h,respectively;time to disappearance of retractions were(40.58±7.93)and(43.88±8.61)h,respectively;time to disappearance of lung rales were(49.34±7.96)and(54.18±9.63)h,respectively;duration of mechanical ventilation were(4.15±0.78)and(4.45±0.87)d,respectively;total duration of oxygen therapy were(7.56±1.32)and(8.12±1.13)d,respectively;duration of neonatal intensive care unit(NICU)stay were(17.42±2.55)and(18.66±3.28)d,respectively;partial pressure of oxygen(PaO2)levels were(65.24±9.24)and(61.58±9.85)mmHg,respectively;partial pressure of carbon dioxide(PaCO2)levels were(41.85±6.61)and(44.92±7.13)mmHg,respectively;oxygenation indexes(O1)were 8.44±0.95 and 8.92±1.16,respectively;interleukin-6(IL-6)levels were(45.78±5.42)and(48.74±7.25)pg·mL-1,respectively;C-reactive protein(CRP)levels were(11.63±1.56)and(12.65±3.04)mg·L-1,respectively;cortisol(Cor)levels were(296.54±36.87)and(315.16±45.32)nmol·L-1,respectively;adrenocorticotropic hormone(ACTH)levels were(61.23±7.65)and(65.20±9.48)pg·mL-1,respectively.There were statistically significant differences in the above indexes between treatment group and control group(all P＜0.05).During treatment,the main adverse drug reactions in treatment group included air leak syndrome,pulmonary hemorrhage,decreased blood oxygen saturation,hyperglycemia and bradycardia;the control group included pulmonary hemorrhage,decreased oxygen saturation,hyperglycemia and bradycardia.The total incidence of adverse drug reactions in treatment group and control group were 13.56％(8 cases/59 cases)and 13.85％(9 cases/65 cases),respectively,with no statistically significant difference(P＞0.05).Conclusion Poractant alfa injection combined with budesonide suspension can improve the total effective rate of treatment for RDS in preterm infants,accelerate symptom relief,inhibit inflammatory response and oxidative stress,without increasing the risk of additional adverse drug reactions.关键词
猪肺磷脂注射液/布地奈德混悬液/早产儿/呼吸窘迫综合征/炎症Key words
poractant alfa injection/budesonide suspension/preterm infant/respiratory distress syndrome/inflammation分类
医药卫生引用本文复制引用
何思思,周金君,李玉峰,金霞,张小华..猪肺磷脂注射液联合布地奈德混悬液在早产儿呼吸窘迫综合征中的临床研究[J].中国临床药理学杂志,2026,42(7):934-939,6.基金项目
南通市卫生健康委员会科研基金资助项目(QN2025041) （QN2025041）
