Proteína C activada recombinante humana | 16 JUL 12

Drotrecogin alfa (activado) en adultos con shock séptico

El Drotrecogin alfa (activado) administrado a pacientes con shock séptico no disminuyó significativamente la mortalidad a 28 o 90 días, en relación con el placebo.
Autor/a: Dres. Ranieri VM, Thompson T, Barie PS May 22, 2012
INDICE:  1.  | 2. Referencias

1. Bernard GR, Vincent J-L, Laterre P-F, et al. Efficacy and safety of recombinant human activated protein C for severe sep -sis. N Engl J Med 2001;344:699-709.
2. Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med 1985;13:818-29.
3. Abraham E, Laterre P-F, Garg R, et al. Drotrecogin alfa (activated) for adults with severe sepsis and a low risk of death. N Engl J Med 2005;353:1332-41.
4. Nadel S, Goldstein B, Williams MD, et al. Drotrecogin alfa (activated) in chil -dren with severe sepsis: a multicentre phase III randomised controlled trial. Lancet 2007;369:836-43.
5. Martí-Carvajal AJ, Solà I, Lathyris D, Cardona AF. Human recombinant activated protein C for severe sepsis. Cochrane Database Syst Rev 2011;4:CD004388.
6. Gårdlund B. Activated protein C (Xigris) treatment in sepsis: a drug in trouble. Acta Anaesthesiol Scand 2006;50:907-10.
7. European Medicines Agency. Marketing authorization. Drotrecogin alfa (acti -vated). 2002 ( human/medicines/000396/human_med_ 001160.jsp#authorisation).
8. 4th Annual reassessment of Xigris. 2007 _Scientific_Discussion_ _Variation/human/000396/WC500058072.pdf).
9. Finfer S, Ranieri VM, Thompson BT, et al. Design, conduct, analysis and reporting of a multi-national placebo-controlled trial os activated protein C por persistent septic shock. Intensive Care Med 2008;34:1935-47. [Erratum, Intensive Care Med 2011;37:372.]
10. Thompson BT, Ranieri VM, Finfer S, et al. Statistical analysis plan of PROWESS SHOCK study. Intensive Care Med 2010; 36:1972-3.
11. Ranieri VM, Thompson BT, Finfer S, et al. Unblinding plan of PROWESS-SHOCK trial. Intensive Care Med 2011;37:1384-5.
12. Ely EW, Laterre PF, Angus DC, et al. Drotrecogin alfa (activated) administra -tion across clinically important subgroups of patients with severe sepsis. Crit Care Med 2003;31:12-9.
13. Bernard GR, Macias WL, Joyce DE, Williams MD, Bailey J, Vincent JL. Safety assessment of drotrecogin alfa (activated) in the treatment of adult patients with severe sepsis. Crit Care 2003;7:155-63.
14. Dhainaut JF, Laterre PF, Janes JM, et al. Drotrecogin alfa (activated) in the treatment of severe sepsis patients with multiple-organ dysfunction: data from the PROWESS trial. Intensive Care Med 2003; 29:894-903.
15. Vincent JL, Angus DC, Artigas A, et al. Effects of drotrecogin alfa (activated) on organ dysfunction in the PROWESS trial. Crit Care Med 2003;31:834-40.
16. Fry DE, Beilman G, Johnson S, et al. Safety of drotrecogin alfa (activated) in surgical patients with severe sepsis. Surg Infect (Larchmt) 2004;5:253-9.
17. Levi M, Levy M, Williams MD, et al. Prophylactic heparin in patients with se -vere sepsis treated with drotrecogin alfa (activated). Am J Respir Crit Care Med 2007;176:483-90.
18. Barie PS, Hydo LJ, Shou J, Eachempati SR. Efficacy of therapy with recombinant human activated protein C of critically ill surgical patients with infection complicated by septic shock and multiple organ dysfunction syndrome. Surg Infect (Larchmt) 2011;12:443-9.
19. Russell JA, Walley KR, Singer J, et al. Vasopressin versus norepinephrine infusion in patients with septic shock. N Engl J Med 2008;358:877-87.
20. Escarce JJ, Kelley MA. Admission source to the medical intensive care unit predicts hospital death independent of APACHE II score. JAMA 1990;264:2389-94.
21. Koperna T, Semmler D, Marian F. Risk stratification in emergency surgical patients: is the APACHE II score a reliable marker of physiological impairment? Arch Surg 2001;136:55-9.
22. Maharaj R. Vasopressors and the search for the optimal trial design. Contemp Clin Trials 2011;32:924-30.
23. De Backer D, Biston P, Devriendt J, et al. Comparison of dopamine and norepinephrine in the treatment of shock. N Engl J Med 2010;362:779-89.
24. Sprung CL, Annane D, Keh D, et al. Hydrocortisone therapy for patients with septic shock. N Engl J Med 2008;358:111-24.
25. Rao SR, Schoenfeld DA. Survival methods. Circulation 2007;115:109-13.
26. Dhainaut JF, Yan SB, Joyce DE, et al. Treatment effects of drotrecogin alfa (activated) in patients with severe sepsis with or without overt disseminated intravascular coagulation. J Thromb Haemost 2004;2:1924-33.
27. Macias WL, Nelson DR. Severe protein C deficiency predicts early death in severe sepsis. Crit Care Med 2004;32: Suppl:S223-S228.
28. Shorr AF, Bernard GR, Dhainaut JF, et al. Protein C concentrations in severe sepsis: an early directional change in plasma levels predicts outcome. Crit Care 2006;10:R92.
29. Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, out -come, and associated costs of care. Crit Care Med 2001;29:1303-10.
30. Martin GS, Mannino DM, Eaton S, Moss M. The epidemiology of sepsis in the United States from 1979 through 2000. N Engl J Med 2003;348:1546-54.
31. Vincent JL, Sakr Y, Sprung CL, et al. Sepsis in European intensive care units: results of the SOAP study. Crit Care Med 2006;34:344-53.
32. Australasian Resuscitation in Sepsis Evaluation (ARISE) Investigators. The outcome of patients with sepsis and septic shock presenting to emergency departments in Australia and New Zealand. Crit Care Resusc 2007;9:8-18.
33. Levy MM, Dellinger RP, Townsend SR, et al. The Surviving Sepsis Campaign: results of an international guideline-based performance improvement program targeting severe sepsis. Crit Care Med 2010; 38:367-74.
34. Rice TW, Wheeler AP, Bernard GR, et al. A randomized, double-blind, placebo-controlled trial of TAK-242 for the treatment of severe sepsis. Crit Care Med 2010; 38:1685-94.
35. Tidswell M, Tillis W, Larosa SP, et al. Phase 2 trial of eritoran tetrasodium (E5564), a toll-like receptor 4 antagonist, in patients with severe sepsis. Crit Care Med 2010;38:72-83. [Erratum, Crit Care Med 2010;38:1925-6.]
36. Angus DC, Laterre PF, Helterbrand J, et al. The effect of drotrecogin alfa (activated) on long-term survival after severe sepsis. Crit Care Med 2004;32:2199-206.
37. Food and Drug Administration. Voluntary market withdrawal of Xigris [drotrecogin alfa (activated)] due to failure to show a survival benefit. 2011 (



Usted debe ingresar al sitio con su cuenta de usuario IntraMed para ver los comentarios de sus colegas o para expresar su opinión. Si ya tiene una cuenta IntraMed o desea registrase, ingrese aquí

Términos y condiciones de uso | Todos los derechos reservados | Copyright 1997-2020