tailieunhanh - Báo cáo y học: "Pulsed moxifloxacin for the prevention of exacerbations of chronic obstructive pulmonary disease: a randomized controlled trial"

Tuyển tập các báo cáo nghiên cứu về y học được đăng trên tạp chí y học 'Respiratory Research cung cấp cho các bạn kiến thức về ngành y đề tài:Pulsed moxifloxacin for the prevention of exacerbations of chronic obstructive pulmonary disease: a randomized controlled trial. | Sethi et al. Respiratory Research 2010 11 10 http content 11 1 10 RESPIRATORY RESEARCH RESEARCH Open Access Pulsed moxifloxacin for the prevention of exacerbations of chronic obstructive pulmonary disease a randomized controlled trial Sanjay Sethi1 Paul W Jones2 Marlize Schmitt Theron3 Marc Miravitlles4 Ethan Rubinstein5 Jadwiga A Wedzicha6 Robert Wilson7 the PULSE Study group Abstract Background Acute exacerbations contribute to the morbidity and mortality associated with chronic obstructive pulmonary disease COPD . This proof-of-concept study evaluates whether intermittent pulsed moxifloxacin treatment could reduce the frequency of these exacerbations. Methods Stable patients with COPD were randomized in a double-blind placebo-controlled trial to receive moxifloxacin 400 mg PO once daily N 573 or placebo N 584 once a day for 5 days. Treatment was repeated every 8 weeks for a total of six courses. Patients were repeatedly assessed clinically and microbiologically during the 48-week treatment period and for a further 24 weeks follow-up. Results At 48 weeks the odds ratio OR for suffering an exacerbation favoured moxifloxacin per-protocol PP population N 738 OR 95 confidence interval CI p intent-to-treat ITT population N 1149 OR 95 CI p and a post-hoc analysis of per-protocol PP patients with purulent mucopurulent sputum production at baseline N 323 OR 95 CI p . There were no significant differences between moxifloxacin and placebo in any pre-specified efficacy subgroup analyses or in hospitalization rates mortality rates lung function or changes in St George s Respiratory Questionnaire SGRQ total scores. There was however a significant difference in favour of moxifloxacin in the SGRQ symptom domain ITT vs p PP vs p . Moxifloxacin treatment was not associated with consistent changes in moxifloxacin susceptibility. There were more .