早期气管内滴入以氨溴索为载体的布地奈德防治早产儿呼吸窘迫综合征的效果研究

Effect of Early Intratracheal Instillation of Budesonide Using Mucosolvan as A Vehicle to Prevent and Cure Neonatal Respiratory Distress Syndrome

目的探讨出生后早期气管内滴入以氨溴索为载体的布地奈德对早产儿呼吸窘迫综合征(NRDS)的防治效果。方法采用前瞻性临床对照研究方法,选取我院2010年1月—2012年5月胎龄≤32周或出生体质量<1500 g的早产儿87例,采用随机数字表法分为2组,对照组41例和观察组46例。对照组出生后早期气管内滴入肺表面活性物质和布地奈德混合剂,观察组气管内滴入大剂量氨溴索和布地奈德混合剂,均予经鼻持续气道正压通气(nCPAP),比较两组早产儿NRDS的发生情况、NRDS治愈率、有创机械通气率和纠正胎龄36周时的病死率。结果治疗前,对照组早产儿发生NRDS 32例,未发生NRDS 9例;观察组早产儿发生NRDS 28例,未发生NRDS 18例。两组NRDS发生率比较,差异无统计学意义(χ2=2.9892,P=0.0838)。治疗后两组均无NRDS新发病例,对照组NRDS治愈率为97%(31/32),观察组NRDS治愈率为96%(27/28),两组比较差异无统计学意义(χ2=0.0002,P=0.9900)。对照组有创机械通气率为31%(10/32),观察组有创机械通气率为32%(9/28),两组比较差异无统计学意义(χ2=0.0029,P=0.9574)。出院后纠正胎龄36周时随访,对照组失访1例,观察组失访2例。对照组死亡2例(5%),观察组死亡3例(7%),两组病死率比较差异无统计学意义(χ2=0.1099,P=0.7402)。结论早产儿出生后早期气管内滴入大剂量以氨溴索为载体的布地奈德,配合nCPAP,能有效防治NRDS,取得以肺表面活性物质为载体的布地奈德相同的疗效。其药源广、价廉、疗效确实,值得临床推广应用。

Objective To analyze the effects of early intratracheal instillation with budesonide using mucosolvan as a vehicle on neonatal respiratory distress syndrome （NRDS） in the preterm infants. Methods The study adopted prospective con- trolled clinical trial. 87 preterm infants （gestational ages ≤32 weeks or birth weights 〈 1 500 g） admitted to our hospital from January 2010 to May 2012 were randomly divided into control group （41 cases, intratracheal instillation of a mixture of pul- momary surfactant and budesonide at early stage after birth） and observation group （46 cases, intratracheal instillation of a mix- ture of high - dose mucosolvan and budesonide at early stage after birth）. The infants of both groups were given nasal continuous positive pressure （nCPAP）. The prevalence, cure rate, invasive mechanical ventilation rate and the survival rate at 36 weeks＇ post - conceptional age （PCA） of the two groups were analyzed. Results Before treatment, in the control group, 32 cases had NRDS and 9 cases had no NRDS; In observation group, 28 cases had NRDS and 18 cases had no NRDS. The prevalence of NRDS between the two groups showed no statistically significant difference （ χ2 = 2. 9892, P = 0. 0838 ）. After treatment, no new case was found in the two groups. The cure rate in the control group and observation group was 97% （31/32） and 96% （ 27/28 ） respectively, and the difference was not statistically significant （ χ2 = 0. 0002, P = 0. 9900）. The invasive mechanical ventilation rate in the control group and observation group was 31% （10/32） and 32% （9/28） respectively, and the difference was not statistically significant （χ2 =0. 0029, P = 0. 9574）. The two groups were followed up at 36 weeks＇ post -conceptional age, 1 case in the control group and 2 cases in the obsetvation were lost to following up. 2 cases （5%） in the control group and 3 cases （7%） in the observation group were died, and the difference was not statistically significant （ χ2 = 0. 1099, P = 0. 7402 ）. Conclusion Early intratracheal instillation of high - dose mucosolvan and budesonide together with nCPAP could pre- vent and cure NRDS as effectively as intratracheal instillation of pulmomary surfactant and budesonide, increasing the survival rate of preterm infants. Therefore, it could be promoted in clinic as an effective, cheap and easy - extended method.