Effect of Prolonged Methylprednisolone Therapy in Unresolving Acute Respiratory Distress Syndrome

作者：G. Umberto Meduri, A. Stacey Headley, Emmel B. Golden, Stephanie J. Carson, Reba A. Umberger, Tiffany M. Kelso, Elizabeth A. Tolley · 发表于：JAMA · 年份：1998 · DOI：10.1001/jama.280.2.159 · 被引用次数：1025 · 研究领域：Respiratory Support and Mechanisms、Sepsis Diagnosis and Treatment、Adrenal Hormones and Disorders

CONTEXT: No pharmacological therapeutic protocol has been found effective in modifying the clinical course of acute respiratory distress syndrome (ARDS) and mortality remains greater than 50%. OBJECTIVE: To determine the effects of prolonged methylprednisolone therapy on lung function and mortality in patients with unresolving ARDS. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Medical intensive care units of 4 medical centers. PARTICIPANTS: Twenty-four patients with severe ARDS who had failed to improve lung injury score (LIS) by the seventh day of respiratory failure. INTERVENTIONS: Sixteen patients received methylprednisolone and 8 received placebo. Methylprednisolone dose was initially 2 mg/kg per day and the duration of treatment was 32 days. Four patients whose LIS failed to improve by at least 1 point after 10 days of treatment were blindly crossed over to the alternative treatment. MAIN OUTCOME MEASURES: Primary outcome measures were improvement in lung function and mortality. Secondary outcome measures were improvement in multiple organ dysfunction syndrome (MODS) and development of nosocomial infections. RESULTS: Physiological characteristics at the onset of ARDS were similar in both groups. At study entry (day 9 [SD, 3] of ARDS), the 2 groups had similar LIS, ratios of PaO2 to fraction of inspired oxygen (FIO2), and MODS scores. Changes observed by study day 10 for methylprednisolone vs placebo were as follows: reduced LIS (mean [SEM], 1.7 [0...