利奈唑胺与万古霉素治疗院内获得性肺炎的比较解释.ppt

既往众多研究证实斯沃治疗MRSA感染疗效显著。 此外，迄今为止全球最大关于院内MRSA肺炎的研究同样证实了：斯沃治疗MRSA肺炎疗效优于万古霉素。 Definitions: Cure: Resolution of clinical SS of pneumonia compared to baseline. No additional antibacterial treatment required for the disease under study Improvement: Improvement in 2 or more, but not all, clinical SS of pneumonia compared with baseline. No additional MRSA-active antibacterial treatment was required for the disease under study (used only at the EOT) Failure: Persistence or progression of baseline clinical SS of pneumonia after at least 2d (48h) of treatment, or progression of baseline radiographic abnormalities; development of new pulmonary or extrapulmonary findings consistent with active infection Unknown: Extenuating circumstances precluded classification to one of the above Those who received abx active against their specific MRSA were considered failures and carried forward * * ~ 1200 subjects planned originally, to enroll 340 evaluable subjects (assuming 30% have MRSA and 80% of these would be evaluable) Randomized to receive either: Linezolid IV infusion (600 mg every 12 hours) Vancomycin IV infusion 30 mg/kg/day in two divided doses every 12 hours in subjects with normal renal function. Dose and interval were adjusted based on standard renal function nomograms. As a double-blind study, only the research pharmacist and unblinded monitor were aware of the assignment Study treatment administered for 7 to 14d, unless bacteremia present at baseline, when 21 days was permitted EOT visit to occur within 5d of end of treatment EOS visit to occur 7-30d after last day of study drug Coverage for Gram-negative organisms was required (cefepime or other antibiotic NOT active against MRSA) Reference(s): Colhoun HM, Betteridge DJ, Durrington PN, et al. for the CARDS Investigators. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet