Randomized Clinical Trial of a Combination of an Inhaled Corticosteroid and Beta Agonist in Patients at Risk of Developing the Acute Respiratory Distress Syndrome.

        吸入糖皮质激素联合β受体激动剂治疗对发展为急性呼吸窘迫综合征病人的风险评估的一项随机临床试验

        PURPOSE

        Effective pharmacologic treatments directly targeting lung injury in patients with the acute respiratory distress syndrome are lacking. Early treatment with inhaled corticosteroids and beta agonists may reduce progression to acute respiratory distress syndrome by reducing lung inflammation and enhancing alveolar fluid clearance.

        目前缺乏针对急性呼吸窘迫综合征患者的肺损伤的直接有效药物治疗。吸入糖皮质激素联合β受体激动剂的早期治疗可通过降低肺部炎症、提高肺泡液体清除率而减少进展为急性呼吸窘迫综合征。

        METHODS

        Five academic centers in the United States.Adult patients admitted through the emergency department at risk for acute respiratory distress syndrome.Aerosolized budesonide/formoterol versus placebo bid for up to 5 days.Double-blind, randomized clinicaltrial (Clinical Trials.gov:NCT01783821). The primary outcome was longitudinal change in oxygen saturation divided by the FIO2 (S/F) through day 5. We also analyzed categorical change in S/F by greater than 20%. Other outcomes included need for mechanical ventilation and development of acute respiratory distress syndrome.

        研究在美国的五个学术中心进行。主要为进入急诊科存在急性呼吸窘迫综合征风险的成人患者。干预措施为雾化吸入布地奈德/福莫特罗或安慰剂，每日两次，共应用5天。进行随机双盲临床试验 (CLINICALTRIALS.GOV: NCT01783821)。主要结局是5天内的氧合指数(SPO2/FIO2，S/F)的纵向变化。对S/F超过 20%的绝对变化进行分析。其他结局包括是否需要进行机械通气及是否进展为急性呼吸窘迫综合征。

        RESULTS

        Sixty-one patients were enrolled from September 3, 2013, to June 9, 2015. Median time from presentation to first study drug was less than 9 hours. More patients in the control group had shock at enrollment (14 vs 3 patients). The longitudinal increase in S/F was greater in the treatment group (p = 0.02) and independent of shock (p = 0.04). Categorical change in S/F improved (p = 0.01) but not after adjustment for shock (p = 0.15). More patients in the placebo group developed acute respiratory distress syndrome (7 vs 0) and required mechanical ventilation (53% vs 21%).

        入选了从2013年9月3日到2015年6月9日共61名患者。从入院到第一次应用药物的中位数时间小于9小时。入选患者中对照组休克患者更多(14 VS 3 例)。治疗组S/F纵向升幅更大(P = 0.02)，并与休克独立相关(P = 0.04)。S/F的绝对变化改善 (P = 0.01)而调整休克因素后P值= 0.15。对照组中更多的患者进展为急性呼吸窘迫综合征 (7 VS 0) 及需要机械通气(53%VS 21%)。

        CONCLUSION

        Early treatment with inhaled budesonide/formoterol in patients at risk for acute respiratory distress syndrome is feasible and improved oxygenation as assessed by S/F. These results support further study to test the efficacy of inhaled corticosteroids and beta agonists for prevention of acute respiratory distress syndrome.

        早期吸入布地奈德/福莫特罗在急性呼吸窘迫综合征的高危患者中是可行的，以S/F进行评估时可以改善氧合。这些结果支持进一步研究以检测吸入糖皮质激素和 β 受体激动剂预防急性呼吸窘迫综合征的疗效。