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一项关于 Aerosurf®联合 nCPAP 预防早产儿 RDS 的开放性标签、初步研究。

An open label, pilot study of Aerosurf® combined with nCPAP to prevent RDS in preterm neonates.

机构信息

Department of Pediatrics, University of California San Diego, San Diego, California 92103, USA.

出版信息

J Aerosol Med Pulm Drug Deliv. 2010 Oct;23(5):303-9. doi: 10.1089/jamp.2009.0758.

DOI:10.1089/jamp.2009.0758
PMID:20455772
Abstract

BACKGROUND

Nasal continuous positive airway pressure (nCPAP) is an accepted mode of respiratory support for preterm infants with respiratory insufficiency. To avoid potential sequelae of endotracheal (ET) intubation and mechanical ventilation, prophylactic aerosolization of surfactant delivered via nCPAP has been attempted with limited success.

METHODS

To determine the feasibility and safety of prophylactic aerosolization of a peptide-containing synthetic surfactant, Aerosurf® (lucinactant for inhalation) was delivered by nCPAP to preterm infants at risk for respiratory distress syndrome (RDS). Neonates were enrolled into treatment group 1 (Aerosurf retreatment separated by at least 3 h) or treatment group 2 (Aerosurf retreatment separated by at least 1 h). A vibrating membrane nebulizer Aeroneb Pro® was used to aerosolize 20 mg/mL Aerosurf. All neonates received the initial 3-h treatment, and three retreatments were permitted within 48 h based on clinical response.

RESULTS

Seventeen infants were enrolled. Aerosurf was well tolerated, with transient desaturations observed during dosing without bradycardia or hypotension. Variability in output rates of the Aeroneb Pro was observed leading to different average dispensed drug volumes per treatment per patient. All infants survived; 29.4% required subsequent ET surfactant replacement therapy, 23.5% were diagnosed with RDS at 24 h, and 11.8% with bronchopulmonary dysplasia (BPD) at 28 days of life. Mean FiO₂ was 0.4 at baseline, and 0.32 at 4 h posttreatment.

CONCLUSIONS

Aerosurf can be safely administered via nCPAP in preterm infants at risk for RDS and may provide an alternative to surfactant administration via an ET tube. Further studies are required to evaluate this delivery approach.

摘要

背景

鼻持续气道正压通气(nCPAP)是一种被接受的呼吸支持方式,用于患有呼吸功能不全的早产儿。为了避免气管内(ET)插管和机械通气的潜在后遗症,通过 nCPAP 预防性雾化表面活性剂的方法已被尝试,但收效有限。

方法

为了确定预防性雾化含有肽的合成表面活性剂 Aerosurf®(吸入用lucinactant)的可行性和安全性,将其通过 nCPAP 递送至有发生呼吸窘迫综合征(RDS)风险的早产儿。将新生儿纳入治疗组 1(Aerosurf 重复治疗至少间隔 3 小时)或治疗组 2(Aerosurf 重复治疗至少间隔 1 小时)。使用振动膜雾化器 Aeroneb Pro®将 20mg/mL 的 Aerosurf 雾化。所有新生儿均接受初始 3 小时的治疗,根据临床反应,在 48 小时内允许进行三次重复治疗。

结果

共纳入 17 名婴儿。Aerosurf 耐受良好,在给药过程中观察到短暂的脱氧,但无心动过缓和低血压。Aeroneb Pro 的输出率存在差异,导致每个患者每次治疗的平均分配药物量不同。所有婴儿均存活;29.4%需要后续 ET 表面活性剂替代治疗,23.5%在 24 小时时被诊断为 RDS,11.8%在 28 天时有支气管肺发育不良(BPD)。基线时的平均 FiO₂为 0.4,治疗后 4 小时为 0.32。

结论

Aerosurf 可安全地通过 nCPAP 递送至有发生 RDS 风险的早产儿,并且可能为通过 ET 管给予表面活性剂提供替代方法。需要进一步的研究来评估这种给药方法。

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