[Activated protein C--recent addition to therapy of sepsis].
Human recombinant activated protein C (Xigris) represents a new concept in adjuvant therapy for patients with severe sepsis. In the large randomized controlled trial on which the registration is based, 28 day mortality was significantly reduced by 6.1% from 30.8% in the placebo group to 24.7% in the treatment group. Treatment benefit seemed to be restricted to those patients with the most severe disease. Side effects in terms of intracerebral hemorrhage and procedure related bleeding were seen during the 4 day infusion period. Until further data becomes available from ongoing studies, we recommend that treatment be restricted to those patients for whom benefit has been shown in the clinical trial, i.e. adult patients with septic shock and at least one additional sign of organ dysfunction as defined in the study. Patients with septic organ dysfunctions with a longer duration than 24 h were not evaluated in the study.
Gårdlund
Bengt
B
Infektionskliniken, Huddinge Universitetssjukhus, Stockholm. bengt.gardlund@hs.se
Sjölin
Jan
J
D000276:Adjuvants, Immunologic / Q000009:adverse effects / Q000627:therapeutic use; D000328:Adult; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use*; D000075202:Contraindications; D003362:Cost-Benefit Analysis; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D009102:Multiple Organ Failure / Q000188:drug therapy / Q000401:mortality; D017410:Practice Guidelines as Topic; D011486:Protein C / Q000009:adverse effects / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use*; D018805:Sepsis / Q000188:drug therapy* / Q000401:mortality
D000276:Adjuvants, Immunologic; D000890:Anti-Infective Agents; D000894:Anti-Inflammatory Agents, Non-Steroidal; D005343:Fibrinolytic Agents; D011486:Protein C; D011994:Recombinant Proteins; C421124:drotrecogin alfa activated