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Aerosolized lucinactant: a potential alternative to intratracheal surfactant replacement therapy.

机译:气雾剂-气管内表面活性剂替代疗法的潜在替代品。

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BACKGROUND: Surfactant replacement therapy (SRT) has been demonstrated to be both safe and highly effective in the treatment of preterm infants with respiratory distress syndrome (RDS). However, administration of the various available suspensions has required endotracheal intubation and its inherent risks. Delivery of aerosolized SRT would be a laudable goal. OBJECTIVE: To review the chemistry, pharmacodynamics, clinical efficacy and safety of aerosolized lucinactant for the prevention/treatment of RDS in the preterm infant. METHODS: Laboratory and clinical experience with aerosolized lucinactant are reviewed. RESULTS/CONCLUSIONS: Laboratory studies confirm the ability of lucinactant to withstand the aerosolization process and to maintain its biological activity. A small clinical pilot trial demonstrated safety and feasibility and provided a signal to suggest proof of concept and the justification for a larger Phase III trial.
机译:背景:表面活性剂替代疗法(SRT)已被证明在治疗呼吸窘迫综合征(RDS)的早产儿中既安全又高效。然而,施用各种可用的悬浮液需要气管内插管及其固有的风险。雾化SRT的交付将是一个值得称赞的目标。目的:探讨气雾剂型表面活性剂预防/治疗早产儿RDS的化学,药效学,临床疗效和安全性。方法:回顾了雾化发光剂的实验室和临床经验。结果/结论:实验室研究证实了光敏剂具有承受雾化过程并保持其生物学活性的能力。一项小型临床试验性试验证明了安全性和可行性,并提供了信号,为更大的III期试验提供了概念验证和理由。

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