外伤及复杂伤口病患之处理及治疗原则课件.ppt

Tigecycline Phase III Clinical Studies Primary Efficacy Endpoints: Clinical response rates at the TOC visit in the CE and c-mITT populations 5-14 days Tigecycline 100 mg IV, then 50 mg IV q12h Vancomycin 1 g IV q12h plus aztreonam 2 g IV q12h Randomization or Objective: To compare the efficacy and safety of tigecycline vs V/A in patients with known or suspected cSSSI Ellis-Grosse EJ et al. Clin Infect Dis. 2005:41(Suppl 5):S341-353. Tigecycline Registration Study Study Design: Two double-blind, randomized, multicenter studies c-mITT=clinically modified ITT; V/A=vancomycin plus aztreonam. Clinical Cure* Rates in the CE Population in cSSSI Studies V/A Tigecycline Cure Rate (%) Overall Soft Tissue Infections? Infected Ulcers Abscesses Burns Other 100 100 N = 9 9 263 86 87 259 30 80 83 23 116 87 91 116 4 100 100 4 87 89 422 411 0 20 40 60 80 100 *Cure=resolution of all signs and symptoms of infection or improvement to such an extent that no further antibacterial therapy was necessary. ?Soft tissue infection=complicated cellulitis and wound infections. Tigecycline Registration Study Ellis-Grosse EJ et al. Clin Infect Dis. 2005:41(Suppl 5):S341-353. Cure Rates by Mono/Polymicrobial Infection in the ME Population in cSSSI Studies Monomicrobial Polymicrobial N = 161 150 118 111 Tigecycline Registration Study V/A Tigecycline Ellis-Grosse EJ et al. Clin Infect Dis. 2005:41(Suppl 5):S341-353. Initial Treatment Considerations Avoid prescribing antibiotics for uninfected ulcerations To reduce antimicrobial resistance, costs, drug-related adverse effects Determine need for hospitalization Admit if severe infection or critical limb ischemia Stabilize the patient Choose an antibiotic regimen Determine the need for surgery Formulate a wound-care plan Adjunctive treatments Lipsky BA et al. Clin Infect Dis. 2004;39:885–910. When Are Surgical Therapies Warranted? Seek urgent surgical consultation for: Life- or limb-threatening infections: Necrotizing fasciitis, gas g