外源性肺泡表面活性剂(Calfactant)对小儿急性肺损伤的疗效:随机对照试验

作     者：Willson D. F. Thomas N. J. Markovitz B. P. 李开 

作者机构：Univ. Virginia Children’s Med.Ctr. PO Box 800-386 Charlottesville VA 22908 United States 

出 版 物：《世界核心医学期刊文摘（儿科学分册）》 (Dkgest of the World Latest Medical Information)

年 卷 期：2005年第1卷第6期

页      面：1-2页

学科分类：1002[医学-临床医学] 100202[医学-儿科学] 10[医学] 

主　　题：急性肺损伤 Calfactant 随机对照试验 常规机械通气 气管内滴注 氧合指数 呼吸衰竭 出生后 三级医疗 安慰剂 

摘      要：Context: Despite evidence that patients with acute lung injury (ALI) have pulmonary surfactant dysfunction, trials of several surfactant preparations to treat adults with ALI have not been successful. Preliminary studies in children with ALI have shown that instillation of a natural lung surfactant (calfactant) containing high levels of surfactant-specific protein B may be beneficial. Objective: To determine if endotracheal instillation of calfactant in infants, children, and adolescents with ALI would shorten the course of respiratory failure. Design, Setting, and Patients: A multicenter, randomized, blinded trial of calfactant compared with placebo in 153 infants, children, and adolescents with respiratory failure from ALI conducted from July 2000 to July 2003. Twenty-one tertiary care pediatric intensive care units participated. Entry criteria included age 1 week to 21 years, enrollment within 48 hours of endotracheal intubation, radiological evidence of bilateral lung disease, and an oxygenation index higher than 7. Premature infants and children with preexisting lung, cardiac, or central nervous system disease were excluded. Intervention: Treatment with intratracheal instillation of 2 doses of 80 mL/m2 calfactant or an equal volume of air placebo administered 12 hours apart. Main Outcome Measures: Ventilator-free days and mortality; secondary outcome measures were hospital course, adverse events, and failure of conventional mechanical ventilation. Results: The calfactant group experienced an acute mean (SD) decrease in oxygenation index from 20 (12.9) to 13.9 (9.6) after 12 hours compared with the placebo group’s decrease from 20.5 (14.7) to 15.1 (9.0) (P=.01). Mortality was significantly greater in the placebo group compared with the calfactant group (27/75 vs 15/77; odds ratio, 2.32; 95%confidence interval, 1.15-4.85), although ventilator-free days were not different. More patients in the placebo group did not respond to conventional mechanical ventilation. T