临床时讯 ＞ 临床研究
Am J Respir Crit Care Med. 2010 Feb 4. [Epub ahead of print]
Efficacy of Corticosteroids in Community-acquired Pneumonia - A Randomized Double Blinded Clinical Trial.
Snijders D, Daniels JM, de Graaff CS, van der Werf TS, Boersma WG.
Department of Pulmonary Diseases, Medical Center Alkmaar, Alkmaar, Netherlands.
BACKGROUND: Some studies have shown a beneficial effect of corticosteroids in patients with Community-Acquired Pneumonia (CAP), possibly by diminishing local and systemic anti-inflammatory host response. METHODS: Hospitalized patients, clinically and radiologically diagnosed with CAP using standard clinical and radiological criteria, were randomized to receive 40 mg prednisolone for 7 days or placebo, next to antibiotics. Primary outcome was clinical cure at day 7. Secondary outcomes were clinical cure at day 30, length of stay, time to clinical stability, defervescence and C-reactive protein (CRP). Disease severity was scored using CURB-65 and Pneumonia Severity Index (PSI). Findings: We enrolled 213 patients. Fifty-four (25.4%) patients had a CURB-65 > 2 and 93 (43.7%) patients were in PSI class IV-V. Clinical cure at day 7 and 30 was 84/104 (80.8%) and 69/104 (66.3%) in the prednisolone-group, and 93/109 (85.3%) and 84/109 (77.1%) in the placebo-group (p=0.38 and p=0.08). Patients on prednisolone had faster defervescence and faster decline in serum CRP levels compared to placebo. Sub-analysis of patients with severe pneumonia did not show differences in clinical outcome. Late failure (>72 hours after admittance) was more common in the prednisolone group (20 -19.2%) than in the placebo-group(10 (6.4%), p=0.04). Adverse events were few and not different between the two groups. Interpretation: Prednisolone (at 40 mg) once daily for a week does not improve outcome in hospitalized patients with CAP. A benefit in more severely ill patients cannot be excluded.. Because of its association with increased late failure and lack of efficacy prednisolone should not be recommended as routine adjunctive treatment in CAP. Clinical Trial Registry Information: ID# NCT00170196 registered at www.clinicaltrials.gov.