Randomized Clinical Trial of a Combination of an Inhaled Corticosteroid and Beta Agonist in Patients at Risk of Developing the Acute Respiratory Distress Syndrome.
吸入糖皮質激素聯合β受體激動劑治療對發展為急性呼吸窘迫綜合征病人的風險評估的一項隨機臨床試驗
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.
目前缺乏針對急性呼吸窘迫綜合征患者的肺損傷的直接有效藥物治療。吸入糖皮質激素聯合β受體激動劑的早期治療可通過降低肺部炎症、提高肺泡液體清除率而減少進展為急性呼吸窘迫綜合征。
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.
研究在美國的五個學術中心進行。主要為進入急診科存在急性呼吸窘迫綜合征風險的成人患者。幹預措施為霧化吸入布地奈德/福莫特羅或安慰劑，每日兩次，共應用5天。進行隨機雙盲臨床試驗 (CLINICALTRIALS.GOV: NCT01783821)。主要結局是5天內的氧合指數(SPO2/FIO2，S/F)的縱向變化。對S/F超過 20%的絕對變化進行分析。其他結局包括是否需要進行機械通氣及是否進展為急性呼吸窘迫綜合征。
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%).
入選了從2013年9月3日到2015年6月9日共61名患者。從入院到第一次應用藥物的中位數時間小於9小時。入選患者中對照組休克患者更多(14 VS 3 例)。治療組S/F縱向升幅更大(P = 0.02)，並與休克獨立相關(P = 0.04)。S/F的絕對變化改善 (P = 0.01)而調整休克因素後P值= 0.15。對照組中更多的患者進展為急性呼吸窘迫綜合征 (7 VS 0) 及需要機械通氣(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/福莫特羅在急性呼吸窘迫綜合征的高危患者中是可行的，以S/F進行評估時可以改善氧合。這些結果支持進一步研究以檢測吸入糖皮質激素和 β 受體激動劑預防急性呼吸窘迫綜合征的療效。
