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DOI: 10.1055/s-2008-1027129
© Georg Thieme Verlag KG Stuttgart · New York
Basiliximab als Monotherapie nach perforierender Risikokeratoplastik - eine prospektive randomisierte Pilotstudie
Basiliximab Following Penetrating Risk-Keratoplasty - A Prospective Randomized Pilot StudyPublication History
Eingegangen: 7.11.2007
Angenommen: 1.1.2008
Publication Date:
31 January 2008 (online)
![](https://www.thieme-connect.de/media/klimo/200801/lookinside/thumbnails/10.1055-s-2008-1027129-1.jpg)
Zusammenfassung
Hintergrund: Bei Patienten nach Risikokeratoplastik stehen bislang nur Ciclosporin A (CSA) und Mycophenolatmofetil (MMF) für eine systemische Immunsuppression zur Verfügung. Basiliximab ist ein chimerer monoklonaler Interleukin-2-Rezeptor Antikörper, der die T-Zell-Proliferation nachhaltig inhibiert und für die Nachbehandlung nierentransplantierter Patienten zugelassen ist. Ziel dieser Studie war es, die Sicherheit und Effektivität einer systemischen Immunsuppression mit Basiliximab zur Verhinderung der Abstoßungsreaktion nach Risikokeratoplastik zu untersuchen. Patienten und Methoden: 20 Patienten nach Risikokeratoplastik erhielten als postoperative Basistherapie Fluocortolon 1 mg/kg/d, über drei Wochen ausschleichend sowie lokal Prednisolonacetat 5 ×/d über fünf Monate ausschleichend. Zusätzlich erhielten 10 Patienten am Operationstag sowie vier Tage postoperativ 20 mg Basiliximab intravenös. Die zehn Patienten der Kontrollgruppe erhielten CSA talspiegeladaptiert (Zielspiegel 120 - 150 ng/mL) über ein halbes Jahr. Ergebnisse: Nach einer mittleren Nachbeobachtungszeit von 477 ± 263 Tagen zeigten sich bei 4 Patienten der Basiliximabgruppe Immunreaktionen, von denen zwei nach Kortisontherapie reversibel waren. Nebenwirkungen wurden keine beobachtet. In der CSA-Gruppe traten 2 Abstoßungsreaktionen auf (eine reversible und eine irreversible). Allerdings musste bei 2 Patienten der Gruppe 2 die Medikamenteneinnahme aufgrund von Nebenwirkungen abgebrochen werden. Schlussfolgerungen: Basiliximab zeigte eine etwas schwächere Wirksamkeit bei der Verhinderung von Immunreaktionen nach Risikokeratoplastik als CSA. Die Therapie mit Basiliximab zeigte in dieser Studie keine Nebenwirkungen.
Abstract
Background: Until now cyclosporin A (CSA) and mycophenolate mofetil (MMF) are the only available systemic immunosuppressants for patients undergoing risk keratoplasty. Basiliximab is a chimeric monoclonal interleukin 2-receptor antibody, which inhibits T-cell proliferation. Basiliximab is approved for the treatment in patients after kidney transplantation. The aim of this study was to prove the efficacy and safety of Basiliximab after penetrating risk keratoplasty. Patients and Methods: 20 patients undergoing risk keratoplasty received as postoperative medication fluocortolon 1 mg/kg/d (tapered off within three weeks) and prednisolone acetate eye-drops 5x/d (tapered off within five months). In addition, 10 patients received 20 mg basiliximab immediately following surgery and four days postoperatively. 10 patients in the control group received oral CSA adapted to the blood-trough level (120 - 150 ng/mL) for six months. Results: After a mean follow-up time of 477 ± 263 days 4 patients of the basiliximab group showed corneal immune reactions (2 irreversible), while no side effects were observed. In the CSA group 2 immune reactions occurred (1 irreversible). In 2 CSA-treated patients the CSA administration had to be stopped due to side effects. Conclusions: Basiliximab has a lower efficacy in preventing immune reactions after risk keratoplasty than CSA. However, the side effect profile of basiliximab is more favourable than that of CSA.
Schlüsselwörter
perforierende Keratoplastik - Immunsuppression - Basiliximab
Key words
penetrating keratoplasty - immunosuppression - basiliximab
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Dr. Florian Birnbaum
Augenklinik, Universitätsklinik Freiburg
Killianstr. 5
79106 Freiburg
Phone: ++ 4 97 61/2 70 40 01
Fax: ++ 4 97 61/2 70 40 63
Email: florian.birnbaum@uniklinik-freiburg.de