吸入性糖皮质激素与β受体激动剂联合应用于急性呼吸窘迫综合征高危患者的随机临床试验
Randomized Clinical Trial of a Combination of an Inhaled Corticosteroid and Beta Agonist in Patients at Risk of Developing the Acute Respiratory Distress Syndrome.
作者信息
Festic Emir, Carr Gordon E, Cartin-Ceba Rodrigo, Hinds Richard F, Banner-Goodspeed Valerie, Bansal Vikas, Asuni Adijat T, Talmor Daniel, Rajagopalan Govindarajan, Frank Ryan D, Gajic Ognjen, Matthay Michael A, Levitt Joseph E
机构信息
1Department of Critical Care, Mayo Clinic, Jacksonville, FL. 2Division of Pulmonary and Critical Care, Department of Medicine, University of Arizona, Tucson, AZ. 3Department of Critical Care, Mayo Clinic, Scottsdale, AZ. 4Division of Pulmonary and Critical Care, Department of Medicine, Mayo Clinic, Rochester, MN. 5Department of Anesthesia, Beth Israel Deaconess Medical Center, Boston, MA. 6Division of Pulmonary and Critical Care, Department of Medicine, Stanford University, Stanford, CA. 7Department of Immunology, Mayo Clinic, Rochester, MN. 8Department of Health-Science Research/Biostatistics, Mayo Clinic, Jacksonville, FL. 9Departments of Medicine and Anesthesia, Cardiovascular Research Institute, University of California, San Francisco, CA.
出版信息
Crit Care Med. 2017 May;45(5):798-805. doi: 10.1097/CCM.0000000000002284.
OBJECTIVES
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.
DESIGN
Double-blind, randomized clinical trial (ClinicalTrials.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.
SETTING
Five academic centers in the United States.
PATIENTS
Adult patients admitted through the emergency department at risk for acute respiratory distress syndrome.
INTERVENTIONS
Aerosolized budesonide/formoterol versus placebo bid for up to 5 days.
MEASUREMENTS AND MAIN 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%).
CONCLUSIONS
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.
目的
目前缺乏直接针对急性呼吸窘迫综合征患者肺损伤的有效药物治疗方法。早期使用吸入性糖皮质激素和β受体激动剂进行治疗，可能通过减轻肺部炎症和增强肺泡液体清除能力，降低进展为急性呼吸窘迫综合征的风险。
设计
双盲、随机临床试验（ClinicalTrials.gov：NCT01783821）。主要结局指标是至第5天氧饱和度除以吸入氧分数值（S/F）的纵向变化。我们还分析了S/F分类变化超过20%的情况。其他结局指标包括机械通气需求和急性呼吸窘迫综合征的发生情况。
地点
美国的五个学术中心。
患者
通过急诊科收治的有急性呼吸窘迫综合征风险的成年患者。
干预措施
雾化布地奈德/福莫特罗与安慰剂，每日两次，持续至多5天。
测量指标及主要结果
2013年9月3日至2015年6月9日共纳入61例患者。从就诊到首次使用研究药物的中位时间少于9小时。对照组中更多患者在入组时出现休克（14例 vs 3例）。治疗组S/F的纵向增加幅度更大（p = 0.02），且与休克无关（p = 0.04）。S/F的分类变化有所改善（p = 0.01），但在对休克进行校正后无改善（p = 0.15）。安慰剂组更多患者发生急性呼吸窘迫综合征（7例 vs 0例）并需要机械通气（53% vs 21%）。
结论
对于有急性呼吸窘迫综合征风险的患者，早期使用吸入性布地奈德/福莫特罗治疗是可行的，并且通过S/F评估显示氧合情况得到改善。这些结果支持进一步研究以检验吸入性糖皮质激素和β受体激动剂预防急性呼吸窘迫综合征的疗效。
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