Möller Jens Christian, Schaible Thomas, Roll Claudia, Schiffmann Jan-Holger, Bindl Lutz, Schrod Lothar, Reiss Irwin, Kohl Martina, Demirakca Subha, Hentschel Roland, Paul Thomas, Vierzig Anne, Groneck Peter, von Seefeld Heide, Schumacher Helmut, Gortner Ludwig
Department of Pediatrics, Winterberg 1, 66119 Saarbrücken, Germany.
Intensive Care Med. 2003 Mar;29(3):437-46. doi: 10.1007/s00134-003-1650-1. Epub 2003 Feb 15.
To determine whether bovine surfactant given in cases of severe pediatric acute respiratory distress syndrome (ARDS) improves oxygenation.
Single-center study with 19 patients, followed by a multicenter randomized comparison of surfactant with a standardized treatment algorithm. Primary endpoint PaO(2)/FIO(2) at 48 h, secondary endpoints: PaO(2)/FIO(2) at 2, 4, 12, and 24 h, survival, survival without rescue, days on ventilator, subgroups analyzed by analysis of variance to identify patients who might benefit from surfactant.
Multicenter study in 19 reference centers for ARDS.
Children after the 44th postconceptional week and under 14 years old, admitted for at least 4 h, ventilated for 12-120 h, and without heart failure or chronic lung disease. In the multicenter study 35 patients were recruited; 20 were randomized to the surfactant group and 15 to the nonsurfactant group. Decreasing recruitment of patients led to a preliminary end of this study.
Administration of 100 mg/kg bovine surfactant intratracheally under continuous ventilation and PEEP, as soon as the PaO(2)/FIO(2) ratio dropped to less than 100 for 2 h (in the pilot study increments of 50 mg/kg as long as the PaO(2)/FIO(2) did not increase by 20%). A second equivalent dose within 48 h was permitted.
In the pilot study the PaO(2)/FIO(2) increased by a mean of 100 at 48 h (n=19). A higher PaO(2)/FIO(2) ratio was observed in the surfactant group 2 h after the first dose (58 from baseline vs. 9), at 48 h there was a trend towards a higher ratio (38 from baseline vs. 22). The rate of rescue therapy was significantly lower in the surfactant group. Outcome criteria were not affected by a second surfactant dose (n=11). A significant difference in PaO(2)/FIO(2) in favor of surfactant at 48 h was found in the subgroup with an initial PaO(2)/FIO(2) ratio higher than 65 and in patients without pneumonia. CONCLUSIONS. Surfactant therapy in severe ARDS improves oxygenation immediately after administration. This improvement is sustained only in the subgroup of patients without pneumonia and that with an initial PaO(2)/FIO(2) ratio higher than 65
确定在小儿严重急性呼吸窘迫综合征（ARDS）病例中给予牛肺表面活性物质是否能改善氧合。
对19例患者进行单中心研究，随后将肺表面活性物质与标准化治疗方案进行多中心随机对照比较。主要终点为48小时时的动脉血氧分压（PaO₂）/吸入氧分数值（FIO₂），次要终点为2、4、12和24小时时的PaO₂/FIO₂、生存率、无需抢救的生存率、机械通气天数，通过方差分析对亚组进行分析以确定可能从肺表面活性物质中获益的患者。
在19个ARDS参考中心进行的多中心研究。
孕龄44周后且年龄在14岁以下的儿童，入院至少4小时，机械通气12 - 120小时，且无心力衰竭或慢性肺部疾病。在多中心研究中招募了35例患者；20例被随机分配到肺表面活性物质组，15例被分配到非肺表面活性物质组。患者招募人数减少导致本研究提前结束。
一旦PaO₂/FIO₂比值持续2小时低于100（在初步研究中，只要PaO₂/FIO₂未增加20%，肺表面活性物质剂量每次增加50mg/kg），在持续通气和呼气末正压通气（PEEP）下经气管内给予100mg/kg牛肺表面活性物质。允许在48小时内给予第二剂等量药物。
在初步研究中，48小时时PaO₂/FIO₂平均升高100（n = 19）。在第一剂后2小时，肺表面活性物质组观察到较高的PaO₂/FIO₂比值（从基线升高58 vs. 9），48小时时有升高比值的趋势（从基线升高38 vs. 22）。肺表面活性物质组的抢救治疗率显著较低。第二剂肺表面活性物质未影响结局指标（n = 11）。在初始PaO₂/FIO₂比值高于65的亚组和无肺炎的患者中，48小时时发现PaO₂/FIO₂存在显著差异，有利于肺表面活性物质组。结论：严重ARDS患者的肺表面活性物质治疗在给药后立即改善氧合。这种改善仅在无肺炎的患者亚组以及初始PaO₂/FIO₂比值高于65的患者中持续存在
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