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A Soares-Wulf, B Aboalchamat, R Krüger, K Engelmann; Long-term Results of Immunosuppressive Therapy with Mycophenolate Mofetil (CellCept®) for Keratoplasty in High-risk Patients . Invest. Ophthalmol. Vis. Sci. 2002;43(13):2241.
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Purpose: Conventional long-term immunosuppressive treatment in high-risk patients undergoing keratoplasty may cause severe systemic side effects. In solid organ transplantation Mycophenolate mofetil (MMF) has been proven to be an efficient agent with few side effects. We investigated the potential role of MMF for prevention of transplant rejection after keratoplasty in high risk patients. Methods: In this study, 36 patients (39 eyes), (mean age: 57.6 16,7 y, range: 22-86 y) were treated with MMF (2 g/d) in addition to initial steroid therapy. Immunosuppression was performed for at least 6 months and at longest until sutures were removed. Mean follow-up duration was 23,3 11,0 months (range: 6-38 mo). Ophthalmological examinations and blood tests were performed at every visit and patients were asked for side effects in standardised questions. Criteria of high-risk for keratoplasty included re-keratoplasty, a chaud keratoplasty, vascularisation of host cornea, and history of herpetic keratitis. Furthermore, 8 patients suffered from atopic dermatitis, psoriasis, rosacea, rheumatoid arthritis and were also regarded as high risk patients. Results: 27 of 36 patients received continuous immunosuppression with MMF. 23 of these 27 patients showed no signs of rejection during the follow-up time. 4 of these 27 patients showed a transplant failure, of which one had multiple surgery prior to keratoplasty. In 2 patients of these 4, reasons for this failure were secondary glaucoma, cataract extraction and multiple surgery. Therapy was interrupted 9 patients, with 3 patients having severe side effects, 5 patients had non-compliance and 1 patient was switched to another therapy by the internist. Among these 9 patients, transplant was rejected in 4, while 5 showed no signs of transplant failure. No adverse effects were reported in 27 patients. During the first weeks after starting the therapy with MMF, 6 patients suffered from reversible side effects e.g. transient gastrointestinal problems. 3 patients suffered from severe side effects (e.g. profuse sweating, fatigue, hypertension, sleep disturbance, weight loss or leucopenia) and had to terminate MMF therapy. Conclusion: MMF is an effective immunosuppressant for the prevention of transplant rejection in high-risk patients after keratoplasty with only mild side effects. We found a high rate of transplant survival in high risk keratoplasty patient without tissue matching. Mild side effects are important to achieve high compliance of patients. Meanwhile, a consecutive comparative multi-center study was initiated in Germany.
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