학술논문
Low-dose methylprednisolone treatment in critically ill patients with severe community-acquired pneumonia.
Document Type
Academic Journal
Author
Meduri GU; Pulmonary, Critical Care and Sleep Medicine Services, Memphis VA Medical Center, Memphis, USA. gmeduri@uthsc.edu.; University of Tennessee Health Science Center, Memphis, USA. gmeduri@uthsc.edu.; Shih MC; VA Cooperative Studies Program Coordinating Center, Palo Alto, USA.; Department of Biomedical Data Sciences, Stanford University, Stanford, USA.; Bridges L; Pulmonary, Critical Care and Sleep Medicine Services, Memphis VA Medical Center, Memphis, USA.; University of Tennessee Health Science Center, Memphis, USA.; Martin TJ; Salem VA Health Care System, Salem, USA.; Virginia Tech Carilion School of Medicine, Roanoke, USA.; Edward Via Virginia College of Osteopathic Medicine, Blacksburg, USA.; El-Solh A; VA Western New York Health Care System, Buffalo, USA.; University at Buffalo, Buffalo, USA.; Seam N; National Institutes of Health Clinical Center, Bethesda, USA.; Davis-Karim A; VA Cooperative Studies Program Pharmacy Coordinating Center, Albuquerque, USA.; Umberger R; University of Tennessee Health Science Center, Memphis, USA.; Anzueto A; South Texas Veterans Health San Antonio, San Antonio, USA.; University of Texas Health Science Center, Houston, USA.; Sriram P; Malcom Randall VA Medical Center, Gainesville, USA.; Lan C; Michael E Debakey VA Medical Center, Houston, USA.; Restrepo MI; South Texas Veterans Health San Antonio, San Antonio, USA.; University of Texas Health Science Center, Houston, USA.; Guardiola JJ; Robley Rex VA Medical Center, Louisville, USA.; University of Louisville, Louisville, USA.; Buck T; Bay Pines VA Healthcare Center, Bay Pines, USA.; Johnson DP; Bay Pines VA Healthcare Center, Bay Pines, USA.; Suffredini A; National Institutes of Health Clinical Center, Bethesda, USA.; Bell WA; Renown Health, Reno, NV, USA.; Lin J; VA Cooperative Studies Program Coordinating Center, Palo Alto, USA.; Zhao L; VA Cooperative Studies Program Coordinating Center, Palo Alto, USA.; Uyeda L; VA Cooperative Studies Program Coordinating Center, Palo Alto, USA.; Nielsen L; VA Cooperative Studies Program Coordinating Center, Palo Alto, USA.; Huang GD; Office of Research and Development, Department of Veterans Affairs, Baltimore, USA.
Source
Publisher: Springer Verlag Country of Publication: United States NLM ID: 7704851 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1432-1238 (Electronic) Linking ISSN: 03424642 NLM ISO Abbreviation: Intensive Care Med Subsets: MEDLINE
Subject
Language
English
Abstract
Purpose: Severe community-acquired pneumonia (CAP) requiring intensive care unit admission is associated with significant acute and long-term morbidity and mortality. We hypothesized that downregulation of systemic and pulmonary inflammation with prolonged low-dose methylprednisolone treatment would accelerate pneumonia resolution and improve clinical outcomes.
Methods: This double-blind, randomized, placebo-controlled clinical trial recruited adult patients within 72-96 h of hospital presentation. Patients were randomized in 1:1 ratio; an intravenous 40 mg loading bolus was followed by 40 mg/day through day 7 and progressive tapering during the 20-day treatment course. Randomization was stratified by site and need for mechanical ventilation (MV) at the time of randomization. Outcomes included a primary endpoint of 60-day all-cause mortality and secondary endpoints of morbidity and mortality up to 1 year of follow-up.
Results: Between January 2012 and April 2016, 586 patients from 42 Veterans Affairs Medical Centers were randomized, short of the 1420 target sample size because of low recruitment. 584 patients were included in the analysis. There was no significant difference in 60-day mortality between the methylprednisolone and placebo arms (16% vs. 18%; adjusted odds ratio 0.90, 95% CI 0.57-1.40). There were no significant differences in secondary outcomes or complications.
Conclusions: In patients with severe CAP, prolonged low-dose methylprednisolone treatment did not significantly reduce 60-day mortality. Treatment was not associated with increased complications.
(© 2022. This is a U.S. Goverment work and not under copyright protection in the US; foreign protection ma apply.)
Methods: This double-blind, randomized, placebo-controlled clinical trial recruited adult patients within 72-96 h of hospital presentation. Patients were randomized in 1:1 ratio; an intravenous 40 mg loading bolus was followed by 40 mg/day through day 7 and progressive tapering during the 20-day treatment course. Randomization was stratified by site and need for mechanical ventilation (MV) at the time of randomization. Outcomes included a primary endpoint of 60-day all-cause mortality and secondary endpoints of morbidity and mortality up to 1 year of follow-up.
Results: Between January 2012 and April 2016, 586 patients from 42 Veterans Affairs Medical Centers were randomized, short of the 1420 target sample size because of low recruitment. 584 patients were included in the analysis. There was no significant difference in 60-day mortality between the methylprednisolone and placebo arms (16% vs. 18%; adjusted odds ratio 0.90, 95% CI 0.57-1.40). There were no significant differences in secondary outcomes or complications.
Conclusions: In patients with severe CAP, prolonged low-dose methylprednisolone treatment did not significantly reduce 60-day mortality. Treatment was not associated with increased complications.
(© 2022. This is a U.S. Goverment work and not under copyright protection in the US; foreign protection ma apply.)