Effect of exogenous surfactant (Calfactant) in pediatric acute lung injury - A randomized controlled trial
Effect of exogenous surfactant (Calfactant) in pediatric acute lung injury - A randomized controlled trial
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DOI：
10.1001/jama.293.4.470
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发表时间：
2005-01-26
影响因子：
120.7
通讯作者：
Egan, EA
中科院分区：
文献类型：
--
作者：
Willson, DF;Thomas, NJ;Egan, EA
背景尽管有证据表明急性肺损伤(ALI)患者存在肺表面活性物质功能障碍，但几种表面活性物质制剂治疗成人ALI的试验尚未成功。对ALI儿童的初步研究表明，注入一种含有高水平表面活性物质特异性蛋白B的天然肺表面活性物质(钙活性物质)可能是有益的。目的确定在婴儿、儿童和青少年ALI患者中气管内滴注钙活性物质是否会缩短呼吸衰竭的病程。设计、设置和患者2000年7月至2003年7月对153例ALI呼吸衰竭的婴儿、儿童和青少年进行了一项多中心、随机、盲法试验。21个三级护理儿科重症监护室参加。入选标准包括年龄1周至21岁，气管插管后48小时内入选，双侧肺部疾病的放射学证据，以及氧合指数高于7。排除早产儿和既有肺、心脏或中枢神经系统疾病的儿童。介入治疗采用气管内滴注2剂80毫升/米(2)钙活化剂或同等体积的空气安慰剂，间隔12小时。主要结果是无呼吸机天数和死亡率；结果与安慰剂组的氧合指数(SD)从20.5(14.7)降至15.1(9.0)相比，卡维他汀组12小时后的氧合指数(SD)从20(12.9)降至13.9(9.6)(P=.01)。安慰剂组的死亡率显著高于钙化剂组(27/75vs15/77；优势比，2.32；95%可信区间，1.15-4.85)，尽管无呼吸机天数没有差异。安慰剂组中有更多的患者对常规机械通气没有反应。两组的远期并发症无差异。结论Calfacant可显著改善婴幼儿、儿童和青少年ALI患者的氧合状态，显著降低病死率，但以呼吸机治疗时间、重症监护病房或住院天数衡量的呼吸衰竭病程并未观察到明显减少。
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/m(2) 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. There were no differences in long-term complications.Conclusions Calfactant acutely improved oxygenation and significantly decreased mortality in infants, children, and adolescents with ALI although no significant decrease in the course of respiratory failure measured by duration of ventilator therapy, intensive care unit, or hospital stay was observed.