Dexamethasone and length of hospital stay in patients with community-acquired pneumonia The Lancet Vol 377, P2023-2030, June 11, 2011 Reporter: R1 謝智凱 本檔僅供內部教學使用檔案內所使用之照片之版權仍屬於原期刊公開使用時, 須獲得原期刊之同意授權
Background Whether addition of corticosteroids to antibiotic treatment benefits patients with community-acquired pneumonia (CAP) who are not in intensive care units is unclear. Variable results were seen from controlled trials of corticosteroid as adjunctive treatment to antibiotics in pneumonia.
Method Diagnosis of pneumonia: Cough, sputum production, temperature >38 0 C or <35 0 C, auscultatory findings consistent with pneumonia, CRP >15 mg/l, WBC count >10X10 9 cells/l or <4x10 9 cells/l, >10% of rods in leucocyte differentiation.
Method Exclusion criteria: - Immunodeficiency, chemotherapy, took corticosteroid, immunosuppressive agent in previous 6 weeks. - ICU admission, pregnant, breastfeeding, pneumonia diagnosed >24 hours after admission.
Method Randomisation: Randomly allocated to receive dexamethasone or placebo by the Department of Clinical Pharmacy (St Antonius Hospital) in blocks of 20 according to a computer-generated random-number table.
Method Dexamethasone group: 5mg (1ml) of dexamethasone given intravenously at ER. Placebo group: 1ml of sterile water given intravenously at ER. All above complete in a maximum of 12 hours, and the patient received IV antibiotic within 4 hours of admission.
Method Primary end point: Length of hospital stay in days until hospital discharge or death. Secondary end point: Mortality, admission to ICU, development of empyema, superinfection, readmission, IL-6, IL-10, CRP concentrations, pulmonary function at day 30, and health related quality of life measured by RAND-36.
Statistical analyses On the basis of the assumption that dexamethasone could reduce the overall length of stay by 2 days and with a reference length of stay of 10 days, we calculated that 150 patients were needed in each group to detect this difference with a power of 80% and a type 1 error of 5% (two-sided).
Results 132 134
Results 133 79 64
Results
Results Mean time of switching antibiotic: Dexamethasone: 5.0 days Placebo : 5.1 days Mibrobial: Streptococcus pneumoniae, Coxiella burnetii, Chlamydophila spp, and Legionella spp. Mixed infection in 21(7%) patients.
Results
Results
Results
Results
Results Cortisol concentration of 10 μg/dl or lower: Placebo: 18 (12%) Dexamethasone: 12 (9%) Lung function test on day 30: Placebo: 93 (61%) Dexamethasone: 86 (57%) RAND-36: Day 3: no difference (114/95) Day 30: significant improved in social functioning (79/78, p=0.0091)
Results Hyperglycemia: Placebo: 35(23%) Dexamethasone: 67(44%) Superinfection: Placebo: 5(3%) Dexamethasone: 7(5%) Gastric ulcer, MDS=>AML.
Discussion An apparent rebound effect of dexamethasone on C-reactive protein concentrations by day 10. Most patients in the dexamethasone group had been discharged, whereas the remaining patients had a complicated clinical course.
Discussion The microorganism C burnetii is somewhat overrepresented in this study because of an outbreak of Q fever in the Netherlands in spring 2009.
Discussion Amoxicillin is standard therapy for CAP of pneumonia severity index class 1 and 2 and is combined with a fluoroquinolone or macrolide antibiotic in patients with more severe CAP.
Discussion Hyperglycemia was noted more often in the dexamethasone group than it was in the control group. The benefits of corticosteroids should be weighed against the potential disadvantages of these drugs.
Discussion The study protocol allowed health-care professionals to stop the IV administration of dexamethasone if patients were switched to oral antibiotics, most patients received the full course of study medication. Therefore, participation in the trial might have resulted in longer administration of intravenous antibiotics.
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The New England Journal of Medicine Volume 336, Number 4, January 23, 1997.
The New England Journal of Medicine Volume 336, Number 4, January 23, 1997.