Topical FK506 as immunoprophylaxis after allogeneic penetrating normal-risk keratoplasty: A randomized clinical pilot study

Transplant International

Volumn 18, Issue 2, 2005, Pages 193-197

  Reinhard, Thomas ^a   Mayweg, Susanne ^b   Reis, Alexander ^b   Sundmacher, Rainer ^b  

^a UNIVERSITY OF FREIBURG   (Germany)

^b HEINRICH HEINE UNIVERSITY   (Germany)

Author keywords

Cyclosporin A; FK506; Interleukin 2; Keratoplasty

Indexed keywords

FLUOCORTOLONE; PREDNISOLONE ACETATE; TACROLIMUS; DRUG DERIVATIVE; EYE DROPS; IMMUNOSUPPRESSIVE AGENT; PREDNISOLONE;

ADULT; AGED; ALLOGRAFT; ARTICLE; BURNING SENSATION; CATARACT; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; FEMALE; GRAFT FAILURE; GRAFT SURVIVAL; HUMAN; IMMUNITY; IMMUNOPROPHYLAXIS; MALE; PENETRATING KERATOPLASTY; POSTOPERATIVE CARE; PRIORITY JOURNAL; PUNCTATE KERATITIS; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; ALLOTRANSPLANTATION; DRUG EFFECT; IMMUNOLOGY; MIDDLE AGED; PILOT STUDY; PROSPECTIVE STUDY;

ADULT; AGED; AGED, 80 AND OVER; FEMALE; FLUOCORTOLONE; GRAFT SURVIVAL; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KERATOPLASTY, PENETRATING; MALE; MIDDLE AGED; OPHTHALMIC SOLUTIONS; PILOT PROJECTS; PREDNISOLONE; PROSPECTIVE STUDIES; TACROLIMUS; TRANSPLANTATION, HOMOLOGOUS;

EID: 20444431549     PISSN: 09340874     EISSN: 14322277     Source Type: Journal    
DOI: 10.1111/j.1432-2277.2004.00006.x     Document Type: Article

References (39)

1. Paufique L, Sourdille GP, Offret G, eds. Les greffes de la corneè. La maladie du greffon. Paris, France: Maison et Cie, 1948: 131-136.
2. Hill JC. The use of cyclosporine in high risk keratoplasty. Am J Ophthalmol 1989; 107: 506.
3. Hill JC. Systemic cyclosporine in high risk keratoplasty. Short- versus long-term therapy. Ophthalmology 1994; 101: 128.
4. Reinhard T, Sundmacher R, Heering P. Systemic ciclosporin A in high-risk keratoplasties. Graefe's Arch Clin Exp Ophththalmol 1996; 234(Suppl. 1): 115.
5. Reinhard T, Hutmacher M, Sundmacher R, Godehardt E. Akute und chronische Immunreaktionen nach perforierender Keratoplastik mit normalem Immunrisiko. Klin Monatsbl Augenheilkd 1997; 210: 139.
6. Sundmacher R, Stefansson A, Mackensen G. Verlaufsbeo-bachtungen nach Keratoplastik. Fortschr Ophthalmol 1983; 80: 224.
7. Opremcak EM. Antiinflammatory agents. In: Mauger F, Craig EL, eds. Ocular Pharmacology. Mosby, St Louis, MO, 1994; 397.
8. Hoffmann F. Topical cyclosporin A in corneal transplantation. In: Zierhut M, Pleyer U, Thiel J, eds. Immunology of Corneal Transplantation. Buren, the Netherlands, 1994; 253-262.
9. Holland EJ, Olsen TW, Ketcham JM. Topical cyclosporin A in the treatment of anterior segment inflammatory disease. Cornea 1993; 12: 413.
10. Mayer DJ, Casey TA. Reducing the risk of corneal graft rejection. A comparison of different methods. Cornea 1987; 6: 261.
11. Reinhard T, Möller M, Sundmacher R. Penetrating keratoplasty in endogenous ekzema with and without systemic cyclosporin A. Cornea 1999; 18: 645.
12. Reinhard T, Reis A, Böhringer D, et al. Systemic mycophenolate mofetil (MMF) in comparison to systemic cyclosporin A (CsA) in high risk keratoplasty patients. Three years' results of a randomised prospective clinical trial. Graefe's Arch Clin Exp Ophthalmol 2001; 239: 367.
13. Reis A, Reinhard T, Godehardt E, Braunstein S, Sundmacher R. Effect of mycophenolate mofetil, ciclosporin A, and both in a murine corneal graft rejection model. Br J Ophthalmol 1998; 82: 700.
14. Reis A, Reinhard T, Voiculescu A, Kutkuhn B, Sundmacher R. Mycophenolate mofetil versus ciclosporin A in high-risk keratoplasty patients: a prospective, randomized clinical trial. Br J Ophthalmol 1999; 83: 1268-1271.
15. Reis A, Megahed H, Reinhard T, et al. Coadministration of the new macrolide RAD and mycophenolate mofetil in experimental corneal transplantation. Transplantation 2000; 70: 1397-1401.
16. Kino T, Hatayama H, Hashimoto M. FK506, a novel immunosuppressant isolated from Streptomyces. 1. Fermentation, isolation, and physio-chemical and biological characteristics. J Antibiot 1987; 40: 1249.
17. Tanaka H, Kuroda A, Marusawa H. Physicochemical properties of FK506, a novel immunosuppressant isolated from Streptomyces tsukubaensis. Transplant Proc 1987; 19(Suppl.): 11.
18. Clipstone NA, Crabtree GR. Identification of calcineurin as a key signalling enzyme in T-lymphocyte activation. Nature 1992; 25,357: 695.
19. Ruhlmann A, Nordheim A. Effects of the immunosuppressive drugs CsA and FK506 on intracellular signalling and gene regulation. Immunobiology 1997; 198: 192.
20. Williams DL. A comparative approach to topical cyclosporine therapy. Eye 1997; 11: 453.
21. Sawada S, Suzuki G, Kawase Y, Takaku F. Novel immunosuppressive agent, FK506: in vitro effects on the cloned T cell activation. J Immunol 1987; 40: 1249-1255.
22. Yoshimura N, Matsui S, Hamashima T, Oka T. Effects of a new immunosuppressive agent, FK506, on human lymphocyte-responsiveness in vitro: inhibition of expression of alloantigen-activated suppressor cells, as well as induction of alloreactivity. Transplantation 1989; 47: 351.
23. Lauerma AI, Surber C, Maibach HI. Absorption of topical tacrolimus (FK506) in vitro through human skin: comparison with cyclosporin A. Skin Pharmacol 1997; 10: 230.
24. Pleyer U, Lutz S, Jusko WJ, et al. Ocular absorption of topically applied FK506 from liposomal and oil formulations in the rabbit eye. Invest Ophthalmol Vis Sci 1993; 34: 2737.
25. Starzl T. Allograft and xenograft acceptance under FK506 and other immunosuppressant treatment. Ann NY Acad Sci 1993; 685: 46.
26. Starzl T, Fung J, Tzakis A. Baboon-to-human liver transplantation. Lancet 1993; 341: 65.
27. Ruzicka T, Assmann T, Homey B. Tacrolimus - the drug for the turn of the millennium? Arch Dermatol 1999; 135: 574.
28. Hikita N, Lopez JS, Chan CC, Mochizuki M, Nussenblatt RB, de Smet MD. Use of topical FK506 in a corneal graft rejection model in Lewis rats. Invest Ophthalmol Vis Sci 1997; 38: 901.
29. Mills RA, Jones DB, Winkler CR, Wilhelmus KR. Topical FK506 prevents experimental corneal allograft rejection. Cornea 1995; 14: 157.
30. Okada K, Sakata H, Minamoto A, Fujihara M. Effect of FK506 administered topically versus intramuscularly on suppression of the corneal immune reaction in rats. Ophthalmologica 1996; 210: 175.
31. Reinhard T, Reis A, Mayweg S, Oberhuber H, Mathis G, Sundmacher R. Lokales Fk506 bei entzündlichen Erkrankungen von Hornhaut und Bindehaut. Klin Monatsbl Augenheilkd 2002; 219: 125.
32. Pels L, Maas H, Tullo A. European Eye Bank Association Directory, 8th edn. Amsterdam: EEBA, 2000.
33. Böhnke M. Spendergewebe für die Keratoplastik. Klin Monatsbl Augenheilkd 1991; 198: 563.
34. Reinhard T, Holzwarth D, Spelsberg H, Dahmen N, Sundmacher R. Wissensbasierte Bildanalyse von Hornhauttransplantaten. Klin Monatsbl Augenheilkd 1999; 214: 407.
35. Hoffmann F. Nahttechnik bei perforierender Keratoplastik. Klin Monatsbl Augenheilkd 1976; 169: 584.
36. Allredge OC, Krachmer JH. Clinical types of corneal transplant reaction. Arch Ophthalmol 1981; 99: 599.
37. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457.
38. Kawamura A, Teramura Y, Fujita Y, Iwasaki K, Terakawa M, Hata T. Blood and ocular tissue concentration of FK506 in rabbits after single and repeated instillation of FK506 ophthalmic suspension. Fujisawa Pharmaceutical Co., Ltd, Osaka, Japan, unpublished report CRD980048.
39. Celli S, Valdivia J, Fung J. Long-term survival of heart and liver xenografts with splenectomy and FK506. Transplant Proc 1993; 25: 647.