메뉴 건너뛰기




Volumn 113, Issue 1 I, 2004, Pages 7-17

Safety, Pharmacokinetics, and Pharmacodynamics of Drotrecogin Alfa (Activated) in Children with Severe Sepsis

(21)  Barton, Phil a   Kalil, Andre C b,m   Nadel, Simon c   Goldstein, Brahm d   Okhuysen Cawley, Regina e   Brilli, Richard J f   Takano, Jeanne S g   Martin, Lynn D h   Quint, Peter i   Yeh, Timothy S j,n   Dalton, Heidi J k   Gessouron, Morris R l   Brown, Kellie E a   Betts, Helen c   Levin, Michael c   Macias, William L b   Small, David S b   Wyss, Virginia L b   Bates, Becky M b   Utterback, Barbara G b   more..


Author keywords

Activated protein C; Drotrecogin alfa (activated); Pediatric; Sepsis; Xigris

Indexed keywords

ANTITHROMBIN; D DIMER; DROTRECOGIN; PLACEBO; PROTEIN C;

EID: 9144264948     PISSN: 00314005     EISSN: None     Source Type: Journal    
DOI: 10.1542/peds.113.1.7     Document Type: Article
Times cited : (103)

References (34)
  • 1
    • 0030442743 scopus 로고    scopus 로고
    • Age-related differences in outcome and severity of DIC in children with septic shock and purpura
    • Hazelzet JA, Risseeuw-Appel IM, Kornelisse RF, et al. Age-related differences in outcome and severity of DIC in children with septic shock and purpura. Thromb Haemost. 1996;76:932-938
    • (1996) Thromb Haemost , vol.76 , pp. 932-938
    • Hazelzet, J.A.1    Risseeuw-Appel, I.M.2    Kornelisse, R.F.3
  • 2
    • 0031058488 scopus 로고    scopus 로고
    • Advances in the therapy for sepsis in children
    • Anderson MR, Blumer JL. Advances in the therapy for sepsis in children. Pediatr Clin North Am. 1997;44:179-205
    • (1997) Pediatr Clin North Am , vol.44 , pp. 179-205
    • Anderson, M.R.1    Blumer, J.L.2
  • 4
    • 0034927826 scopus 로고    scopus 로고
    • Sepsis and evolution of the innate immune response
    • Beutler B, Poltorak A. Sepsis and evolution of the innate immune response. Crit Care Med. 2001;29(7 suppl):S2-S6
    • (2001) Crit Care Med , vol.29 , Issue.7 SUPPL.
    • Beutler, B.1    Poltorak, A.2
  • 5
    • 0034922242 scopus 로고    scopus 로고
    • New therapeutic targets revealed through investigations of innate immunity
    • Ulevitch RJ. New therapeutic targets revealed through investigations of innate immunity. Crit Care Med. 2001;29(7 suppl):S8-S12
    • (2001) Crit Care Med , vol.29 , Issue.7 SUPPL.
    • Ulevitch, R.J.1
  • 6
    • 0034918411 scopus 로고    scopus 로고
    • The endothelium in sepsis: Source of and a target for inflammation
    • Hack CE, Zeerleder S. The endothelium in sepsis: source of and a target for inflammation. Crit Care Med. 2001;29(7 suppl):S21-S27
    • (2001) Crit Care Med , vol.29 , Issue.7 SUPPL.
    • Hack, C.E.1    Zeerleder, S.2
  • 7
    • 0034913357 scopus 로고    scopus 로고
    • Vascular bed-specific hemostasis: Role of endothelium in sepsis pathogenesis
    • Aird WC. Vascular bed-specific hemostasis: role of endothelium in sepsis pathogenesis. Crit Care Med. 2001;29(7 suppl):S28-S34
    • (2001) Crit Care Med , vol.29 , Issue.7 SUPPL.
    • Aird, W.C.1
  • 8
    • 0035815747 scopus 로고    scopus 로고
    • Gene expression profile of antithrombotic protein C defines new mechanisms modulating inflammation and apoptosis
    • Joyce DE, Gelbert L, Ciaccia A, DeHoff B, Grinnell BW. Gene expression profile of antithrombotic protein C defines new mechanisms modulating inflammation and apoptosis. J Biol Chem. 2001;276:11199-11203
    • (2001) J Biol Chem , vol.276 , pp. 11199-11203
    • Joyce, D.E.1    Gelbert, L.2    Ciaccia, A.3    DeHoff, B.4    Grinnell, B.W.5
  • 10
    • 0019729432 scopus 로고
    • Human protein C: Inactivation of factors V and VIII in plasma by the activated molecule
    • Marlar RA, Kleiss AJ, Griffin JH. Human protein C: inactivation of factors V and VIII in plasma by the activated molecule. Ann N Y Acad Sci. 1981;370:303-310
    • (1981) Ann N Y Acad Sci , vol.370 , pp. 303-310
    • Marlar, R.A.1    Kleiss, A.J.2    Griffin, J.H.3
  • 11
    • 0025030398 scopus 로고
    • Inhibition of thrombus formation by activated recombinant protein C in a primate model of arterial thrombosis
    • Gruber A, Hanson SR, Kelly AB, et al. Inhibition of thrombus formation by activated recombinant protein C in a primate model of arterial thrombosis. Circulation. 1990;82:578-585
    • (1990) Circulation , vol.82 , pp. 578-585
    • Gruber, A.1    Hanson, S.R.2    Kelly, A.B.3
  • 14
    • 0029810712 scopus 로고    scopus 로고
    • An antifibrinolytic mechanism describing the prothrombotic effect associated with factor V Leiden
    • Bajzar L, Kalafatis M, Simioni P, Tracy PB. An antifibrinolytic mechanism describing the prothrombotic effect associated with factor V Leiden. J Biol Chem. 1996;271:22949-22952
    • (1996) J Biol Chem , vol.271 , pp. 22949-22952
    • Bajzar, L.1    Kalafatis, M.2    Simioni, P.3    Tracy, P.B.4
  • 15
    • 0033675696 scopus 로고    scopus 로고
    • Thrombin activatable fibrinolysis inhibitor and an antifibrinolytic pathway
    • Bajzar L. Thrombin activatable fibrinolysis inhibitor and an antifibrinolytic pathway. Arterioscler Thromb Vasc Biol. 2000;20:2511-2518
    • (2000) Arterioscler Thromb Vasc Biol , vol.20 , pp. 2511-2518
    • Bajzar, L.1
  • 16
    • 0033830963 scopus 로고    scopus 로고
    • The anticoagulant and anti-inflammatory roles of the protein C anticoagulant pathway
    • Esmon CT. The anticoagulant and anti-inflammatory roles of the protein C anticoagulant pathway. J Autoimmun. 2000;15:113-116
    • (2000) J Autoimmun , vol.15 , pp. 113-116
    • Esmon, C.T.1
  • 17
    • 0027998013 scopus 로고
    • Selective inhibitory effects of the anticoagulant activated protein C on the responses of human mononuclear phagocytes to LPS, IFN-gamma, or phorbol ester
    • Grey ST, Tsuchida A, Hau H, Orthner CL, Salem HH, Hancock WW. Selective inhibitory effects of the anticoagulant activated protein C on the responses of human mononuclear phagocytes to LPS, IFN-gamma, or phorbol ester. J Immunol. 1994;153:3664-3672
    • (1994) J Immunol , vol.153 , pp. 3664-3672
    • Grey, S.T.1    Tsuchida, A.2    Hau, H.3    Orthner, C.L.4    Salem, H.H.5    Hancock, W.W.6
  • 18
    • 0029626658 scopus 로고
    • Binding of activated protein C to a specific receptor on human mononuclear phagocytes inhibits intracellular calcium signaling and monocyte-dependent proliferative responses
    • Hancock WW, Grey ST, Hau L, et al. Binding of activated protein C to a specific receptor on human mononuclear phagocytes inhibits intracellular calcium signaling and monocyte-dependent proliferative responses. Transplantation. 1995;60:1525-1532
    • (1995) Transplantation , vol.60 , pp. 1525-1532
    • Hancock, W.W.1    Grey, S.T.2    Hau, L.3
  • 19
    • 0030909690 scopus 로고    scopus 로고
    • Activated protein C prevents LPS-induced pulmonary vascular injury by inhibiting cytokine production
    • Murakami K, Okajima K, Uchiba M, et al. Activated protein C prevents LPS-induced pulmonary vascular injury by inhibiting cytokine production. Am J Physiol. 1997;272(pt 1):L197-L202
    • (1997) Am J Physiol , vol.272 , Issue.PART 1
    • Murakami, K.1    Okajima, K.2    Uchiba, M.3
  • 20
    • 0028299926 scopus 로고
    • Human protein C inhibits selectin-mediated cell adhesion: Role of unique fucosylated oligosaccharide
    • Grinnell BW, Hermann RB, Yan SB. Human protein C inhibits selectin-mediated cell adhesion: role of unique fucosylated oligosaccharide. Glycobiology. 1994;4:221-225
    • (1994) Glycobiology , vol.4 , pp. 221-225
    • Grinnell, B.W.1    Hermann, R.B.2    Yan, S.B.3
  • 21
    • 0034925134 scopus 로고    scopus 로고
    • Protein C anticoagulant pathway and its role in controlling microvascular thrombosis and inflammation
    • Esmon CT. Protein C anticoagulant pathway and its role in controlling microvascular thrombosis and inflammation. Crit Care Med. 2001;29(7 suppl):S48-S51
    • (2001) Crit Care Med , vol.29 , Issue.7 SUPPL.
    • Esmon, C.T.1
  • 22
    • 0028855106 scopus 로고
    • Coagulation activation and tissue necrosis in meningococcal septic shock: Severely reduced protein C levels predict a high mortality
    • Fijnvandraat K, Derkx B, Peters M, et al. Coagulation activation and tissue necrosis in meningococcal septic shock: severely reduced protein C levels predict a high mortality. Thromb Haemost. 1995;73:15-20
    • (1995) Thromb Haemost , vol.73 , pp. 15-20
    • Fijnvandraat, K.1    Derkx, B.2    Peters, M.3
  • 23
    • 0031945092 scopus 로고    scopus 로고
    • Increased circulating thrombomodulin in children with septic shock
    • Krafte-Jacobs B, Brilli R. Increased circulating thrombomodulin in children with septic shock. Crit Care Med. 1998;26:933-938
    • (1998) Crit Care Med , vol.26 , pp. 933-938
    • Krafte-Jacobs, B.1    Brilli, R.2
  • 24
    • 0034927146 scopus 로고    scopus 로고
    • Coagulation in severe sepsis: A central role for thrombomodulin and activated protein C
    • Faust SN, Heyderman RS, Levin M. Coagulation in severe sepsis: A central role for thrombomodulin and activated protein C. Crit Care Med. 2001;29:S62-S68
    • (2001) Crit Care Med , vol.29
    • Faust, S.N.1    Heyderman, R.S.2    Levin, M.3
  • 25
    • 0035826096 scopus 로고    scopus 로고
    • Efficacy and safety of recombinant human activated protein C for severe sepsis
    • Bernard GR, Vincent JL, Laterre PF, et al. Efficacy and safety of recombinant human activated protein C for severe sepsis. N Engl J Med. 2001;344:699-709
    • (2001) N Engl J Med , vol.344 , pp. 699-709
    • Bernard, G.R.1    Vincent, J.L.2    Laterre, P.F.3
  • 26
    • 0346128425 scopus 로고    scopus 로고
    • Rockville, MD: Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), US Department of Health and Human Services, Food and Drug Administration
    • US Department of Health and Human Services. General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products, Draft Guidance. Rockville, MD: Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), US Department of Health and Human Services, Food and Drug Administration; 1998
    • (1998) General Considerations for Pediatric Pharmacokinetic Studies for Drugs and Biological Products, Draft Guidance
  • 28
    • 0035164538 scopus 로고    scopus 로고
    • Safety and dose relationship of recombinant human activated protein C (rhAPC) on coagulopathy in severe sepsis
    • Bernard GR, Ely EW, Wright TJ, Fraiz J, Stasek JE, Russel JA. Safety and dose relationship of recombinant human activated protein C (rhAPC) on coagulopathy in severe sepsis. Crit Care Med. 2001;29:2051-2059
    • (2001) Crit Care Med , vol.29 , pp. 2051-2059
    • Bernard, G.R.1    Ely, E.W.2    Wright, T.J.3    Fraiz, J.4    Stasek, J.E.5    Russel, J.A.6
  • 29
    • 0023618699 scopus 로고
    • Mortality associated with multiple organ system failure and sepsis in pediatric intensive care unit
    • Wilkinson JD, Pollack MM, Glass NL, Kanter RK, Katz RW, Steinhart CM. Mortality associated with multiple organ system failure and sepsis in pediatric intensive care unit. J Pediatr. 1987;111:324-328
    • (1987) J Pediatr , vol.111 , pp. 324-328
    • Wilkinson, J.D.1    Pollack, M.M.2    Glass, N.L.3    Kanter, R.K.4    Katz, R.W.5    Steinhart, C.M.6
  • 30
    • 0031039458 scopus 로고    scopus 로고
    • Paediatric index of mortality (PIM): A mortality prediction model for children in intensive care
    • Shann F, Pearson G, Slater A, Wilkinson K. Paediatric index of mortality (PIM): a mortality prediction model for children in intensive care. Intensive Care Med. 1997;23:201-207
    • (1997) Intensive Care Med , vol.23 , pp. 201-207
    • Shann, F.1    Pearson, G.2    Slater, A.3    Wilkinson, K.4
  • 31
    • 0036795261 scopus 로고    scopus 로고
    • Pharmacokinetic-pharmacodynamic analysis of drotrecogin alfa (activated) (recombinant human activated protein C) in patients with severe sepsis
    • Macias WL, Dhainaut JF, Yan SC, et al. Pharmacokinetic-pharmacodynamic analysis of drotrecogin alfa (activated) (recombinant human activated protein C) in patients with severe sepsis. Clin Pharmacol Ther. 2002;72:391-402
    • (2002) Clin Pharmacol Ther , vol.72 , pp. 391-402
    • Macias, W.L.1    Dhainaut, J.F.2    Yan, S.C.3
  • 32
    • 0000441931 scopus 로고    scopus 로고
    • Mortality reduction associated with recombinant human activated protein C [drotrecogin alfa (activated)] in patients with severe sepsis as assessed by markers of disease severity
    • Paper presented; September 30; Geneva, Switzerland
    • Vincent JL, Ely EW, Bernard GR. Mortality reduction associated with recombinant human activated protein C [drotrecogin alfa (activated)] in patients with severe sepsis as assessed by markers of disease severity. Paper presented at: 14th Annual Conference of European Society of Intensive Care Medicine; September 30, 2001; Geneva, Switzerland
    • (2001) 14th Annual Conference of European Society of Intensive Care Medicine
    • Vincent, J.L.1    Ely, E.W.2    Bernard, G.R.3
  • 33
    • 0037352375 scopus 로고    scopus 로고
    • Effects of drotrecogin alfa (activated) on organ dysfunction in the PROWESS trial
    • Vincent JL, Angus DC, Artigas A. Effects of drotrecogin alfa (activated) on organ dysfunction in the PROWESS trial. Crit Care Med. 2003;31: 834-840
    • (2003) Crit Care Med , vol.31 , pp. 834-840
    • Vincent, J.L.1    Angus, D.C.2    Artigas, A.3
  • 34
    • 0346128428 scopus 로고    scopus 로고
    • Nutrition: General considerations
    • Beers MH, Berkow R, eds. Whitehouse Station, NJ
    • Olson RE. Nutrition: general considerations. In: Beers MH, Berkow R, eds. The Merck Manual of Diagnosis and Therapy. 17th ed. Whitehouse Station, NJ: Merck & Co Inc; 1999. Available at: http://www.merck. com/mrkshared/mmanual/section1/chapter1/1b.jsp. Accessed April 11, 2003
    • (1999) The Merck Manual of Diagnosis and Therapy. 17th Ed.
    • Olson, R.E.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.