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OA
Clinical trial on endotracheal administration of poractant alfa injection combined with budesonide suspension in preterm infants with respiratory distress syndrome
目的 观察猪肺磷脂注射液与布地奈德混悬液联合应用对早产儿呼吸窘迫综合征(RDS)的临床疗效和安全性.方法 将RDS患儿按治疗方法分为对照组和试验组.对照组给予200 mg·kg-1猪肺磷脂注射液气管内给药,12 h后追加100 mg·kg-1.试验组在此基础上联合吸入用布地奈德混悬液0.25 mg·kg-1,每日2次.2组均持续治疗3 d.比较2组患儿的临床症状、呼吸支持指标、血气分析指标、血清炎症与应激指标和临床疗效,并进行安全性评价.结果 共纳入136例,试验组和对照组各纳入59例和65例.治疗后,试验组和对照组的治疗总有效率分别为89.83％(53例/59例)和78.46％(49例/65例),气促消失时间分别为(36.85±5.62)和(39.52±7.15)h,三凹征消失时间分别为(40.58±7.93)和(43.88±8.61)h,肺部啰音消失时间分别为(49.34±7.96)和(54.18±9.63)h,机械通气时间分别为(4.15±0.78)和(4.45±0.87)d,总氧疗时间分别为(7.56±1.32)和(8.12±1.13)d,新生儿重症监护室(NICU)住院时间分别为(17.42±2.55)和(18.66±3.28)d,氧分压(PaO2)分别为(65.24±9.24)和(61.58±9.85)mmHg,二氧化碳分压(PaCO2)分别为(41.85±6.61)和(44.92±7.13)mmHg,氧合指数(OI)分别为8.44±0.95和 8.92±1.16,白细胞介素-6(IL-6)水平分别为(45.78±5.42)和(48.74±7.25)pg·mL-1,C 反应蛋白(CRP)水平分别为(11.63±1.56)和(12.65±3.04)mg.L-1,皮质醇(Cor)水平分别为(296.54±36.87)和(315.16±45.32)nmol·L-1,促肾上腺皮质激素(ACTH)水平分别为(61.23±7.65)和(65.20±9.48)pg·mL-1,试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P＜0.05).治疗期间,试验组主要药物不良反应包括气漏综合征、肺出血、血氧饱和度下降、高血糖和心动过缓;对照组包括肺出血、血氧饱和度下降、高血糖和心动过缓.试验组和对照组的并发症及药物不良反应总发生率分别为13.56％(8例/59例)和13.85％(9例/65例),在统计学上差异无统计学意义(P＞0.05).结论 猪肺磷脂注射液联合布地奈德混悬液可以提高早产儿RDS治疗总有效率,加快症状缓解,抑制炎症反应和氧化应激,且不增加额外的药物不良反应.
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.
何思思;周金君;李玉峰;金霞;张小华
南通大学附属南通妇幼保健院儿科,江苏南通 226400南通大学附属南通妇幼保健院儿科,江苏南通 226400南通大学附属南通妇幼保健院儿科,江苏南通 226400南通大学附属南通妇幼保健院儿科,江苏南通 226400南通大学附属南通妇幼保健院儿科,江苏南通 226400
医药卫生
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
poractant alfa injectionbudesonide suspensionpreterm infantrespiratory distress syndromeinflammation
《中国临床药理学杂志》 2026 (7)
934-939,6
南通市卫生健康委员会科研基金资助项目(QN2025041)
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