Randomized, placebo-controlled, double-blind, multicenter trial of efficacy and safety of granulocyte colony-stimulating factor in liver transplant recipients

Transplantation

Volumn 68, Issue 9, 1999, Pages 1298-1304

  Winston, Drew J ^a   Foster, Preston F ^b   Somberg, Kenneth A ^c   Busuttil, Ronald W ^a   Levy, Marlon F ^d   Sheiner, Patricia A ^e   Reddy, K Rajender ^f   Fotheringham, Nick ^g   Armstrong, Mitzi ^g   Logan, Eileen ^g  

^a UCLA MEDICAL CENTER   (United States)

^b RUSH UNIVERSITY MEDICAL CENTER   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d BAYLOR UNIVERSITY MEDICAL CENTER   (United States)

^e MOUNT SINAI MEDICAL CENTER   (United States)

^f JACKSON MEMORIAL HOSPITAL   (United States)

^g AMGEN INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GRANULOCYTE COLONY STIMULATING FACTOR; PLACEBO; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ADULT; AGED; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; GRAFT INFECTION; GRAFT REJECTION; GRAFT SURVIVAL; HOSPITAL INFECTION; HUMAN; LIVER TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEPSIS;

EID: 0033571269     PISSN: 00411337     EISSN: None     Source Type: Journal    
DOI: 10.1097/00007890-199911150-00014     Document Type: Article

References (34)

1. Winston DJ, Emmanouilides C, Busuttil RW. State-of-the-art article: Infection in liver transplant recipients. Clin Infect Dis 1995; 21: 1077.
2. Ascher NL, Roberts JP. Rejection after transplantation. In: Busuttil RW, Klintmalm GB, eds. Transplantation of the liver. Philadelphia: Saunders, 1996: 265.
3. Klintmalm GB. Induction and maintenance of immunosuppression. In: Busuttil RW, Klintmalm GB, eds. Transplantation of the liver. Philadelphia: Saunders, 1996: 741.
4. Dinarello CA. Cytokines as mediators in the pathogenesis of septic shock. Curr Top Microbiol Immunol 1996; 216: 133.
5. Dale DC, Liles WC, Summer WR, Nelson S. Review: granulocyte colony-stimulating factor: role and relationships in infectious diseases. J Infect Dis 1995; 172: 1061.
6. Dale DC, Lau S, Nash R, Boone T, Osborne W. Effect of endotoxin on serum granulocyte and granulocyte-macrophage colony-stimulating factor levels in dogs. J Infect Dis 1992; 165: 689.
7. Kawakami M, Tsutsumi H, Kumakawa T, Abe H, Hirai M, Kurosawa S, et al. Levels of serum granulocyte colony-stimulating factor in patients with infections. Blood 1990; 76: 1962.
8. Selig C, Nothdurft W. Cytokines and progenitor cells of granulocytopoiesis in peripheral blood of patients with bacterial infections. Infect Immun 1995; 63: 104.
9. Weite K, Gabrilove J, Bronchud MH, Platzer E, Morstyn G. Filgrastim (r-metHuG-CSF): the first 10 years. Blood 1996; 88: 1907.
10. Eichacker PQ, Waisman Y, Natanson C, et al. Cardiopulmonary effects of granulocyte colony-stimulating factor in a canine model of bacterial sepsis. J Appl Physiol 1994; 77: 2366.
11. Gorgen I, Hartung T, Leist M, et al. Granulocyte colony-stimulating factor treatment protects rodents against lipopolysaccharide-induced toxicity via suppression of systemic tumor necrosis factor-alpha. J Immunol 1992; 149: 918.
12. Smith WS, Sumnicht GE, Sharpe RW, Samuelson D, Millard FE. Granulocyte colony-stimulating factor versus placebo in addition to penicillin G in a randomized blinded study of gram-negative pneumonia sepsis: analysis of survival and multisystem organ failure. Blood 1995; 86: 1301.
13. Hebert JC, O'Reilly M, Gamelli RL. Protective effect of recombinant human granulocyte colony-stimulating factor against pneumococcal infections in splenectomized mice. Arch Surg 1990; 125: 1075.
14. Imagawa DK, Millis JM, Olthoff KM, et al. The role of tumor necrosis factor in allograft rejection. I. Evidence that elevated levels of tumor necrosis factor-alpha predict rejection following orthotopic liver transplantation. Transplantation 1990; 50: 219.
15. Foster PF, Kociss K, Shen J, et al. Granulocyte colony-stimulating factor immunomodulation in the rat cardiac transplantation model. Transplantation 1996; 61: 1122.
16. Foster PF, Mital D, Sankary HN, et al. The use of granulocyte colony-stimulating factor after liver transplantation. Transplantation 1995; 59: 1557.
17. International Working Party. Terminology for hepatic allograft rejection. Hepatology 1995; 22: 648.
18. O'Reilly M, Silver GM, Greenhalgh DG, Gamelli RL, Davis JH, Hebert JC. Treatment of intra-abdominal infection with granulocyte colony-stimulating factor. J Trauma 1992; 33: 679.
19. Nelson S, Summer W, Bagby G, et al. Granulocyte colony-stimulating factor enhances pulmonary host defenses in normal and ethanol-treated rats. J Infect Dis 1991; 164: 901.
20. Yasuda H, Ajiki Y, Shimozato T, et al. Therapeutic efficacy of granulocyte colony-stimulating factor alone and in combination with antibiotics against Pseudomonas aeruginosa infections in mice. Infect Immun 1990; 58: 2502.
21. Nelson S, Belknap S, Carlson RW, et al. A randomized controlled trial of filgrastim as an adjunct to antibiotics for treatment of hospitalized patients with community-acquired pneumonia. J Infect Dis 1998; 178: 1075.
22. Gough A, Clapperton M, Rolando N, Foster AV, Philpott-Howard J, Edmonds ME. Randomised placebo-controlled trial of granulocyte-colony stimulating factor in diabetic foot infection. Lancet 1997; 2: 855.
23. Daraiseh F, Shrestha N, Pursell K, Pitrak D, Verral S, Hasan E. Effect of filgrastim (r-metHu G-CSF) on impaired phagocyte respiratory burst capacity in transplant patients. J Invest Med 1998; 46: 217A.
24. Colquhoun SD, Shaked A, Jurim O, Colonna JO, Rosove MH, Busuttil RW. Reversal of neutropenia with granulocyte colony-stimulating factor without precipitating liver allograft rejection. Transplantation 1993; 56: 755.
25. The United States Multicenter FK506 Liver Study Group. A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression in liver transplantation. N Engl J Med 1994; 331: 1110.
26. Winston DJ, Pakrasi A, Busuttil RW. Fluconazole prophylaxis of fungal infections in liver transplant recipients: results of a placebo-controlled, double-blind trial [Abstract 146]. Program and abstracts of the 9th International Symposium on Infections in the Immunosuppressed Host. Assisi, Italy: 1996.
27. Stricker RB, Goldberg B. Increase in lymphocyte subsets following treatment of HIV-associated neutropenia with granulocyte colony-stimulating factor. Clin Immunol Immunopathol 1996; 79: 194.
28. Nielsen SD, Afzelin P, Dam-Larsen S, et al. Effect of granulocyte colony-stimulating factor (G-CSF) in human-immunodeficiency virus-infected patients: increase in number of naive CD4 cells and CD34 cells makes G-CSF a candidate for use in gene therapy or to support antiretroviral therapy. J Infect Dis 1998; 117: 1733.
29. Morstyn G, Campbell L, Souza LM, Alton, NK, Keech J, Green M, et al. Effect of granulocyte colony stimulating factor on neutropenia induced by cytotoxic chemotherapy. Lancet 1988; 1: 667.
30. Hartung T, Docke WD, Gantner F, et al. Effect of granulocyte colony-stimulating factor treatment on ex vivo blood cytokine response in human volunteers. Blood 1995; 85: 2482.
31. Terashima T, Kanazawa M, Sayama K, et al. Granulocyte colony-stimulating factor exacerbates acute lung injury induced by intratracheal endotoxin in guinea pigs. Am J Respir Crit Care Med 1994; 149: 1295.
32. King J, Deboisblanc BP, Mason CM, et al. Effect of granulocyte colony-stimulating factor on acute lung injury in the rat. Am J Respir Crit Care Med 1995; 151: 302.
33. DeBoisblanc BP, Mason CM, Andresen J, Logan E, Bear MB, Johnson S, et al. Phase 1 safety trial of Filgrastim (R-metHuG-CSF) in non-neutropenic patients with severe community-acquired pneumonia. Respir Med 1997; 91: 387.
34. Wunderink RG, Leeper KV, Scheim RMH, et al. Clinical response to Filgrastim (r-metHuG-CSF) in pneumonia with severe sepsis. Am J Respir Crit Care Med 1996; 153(4 Part 2): A61.