BACKGROUND: To evaluate the efficacy of topical administration of immunosuppressants and corticosteroids with concentration gradients in the management of patients with high-risk keratoplasty.METHODS: One hundred and six patients treated with topical immunosuppressants (50 eyes in FK506 group and 56 eyes in CsA group) and corticosteroids eye drops with concentration gradients were enrolled in the study. The rate of rejection episodes and irreversible rejection, the graft survival, and related

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... fluential factors were evaluated.RESULTS: The mean follow-up period was 48.1±7.9 months (range, 36-60 months). The rate of rejection episodes (P=0.043) and irreversible rejection (P=0.062) was 14.0% and 6.00% in FK506 group, and 37.5% and 7.1% in CsA group, respectively.Kaplan-Meier survival analysis demonstrated a significantly higher graft survival rate of FK506 group (81.6%±5.3%, 71.1%±6.3%), compared with that of CsA group (71.1%±6.3%, 57.5%±7.5%) at 3, 5 years after surgery (P=0.006). The multivariate logistic regression revealed that poor medication compliance with preoperative risk score (≥ 3, P=0.016), and endothelial immune rejection (P=0.033) were risk factors associated with graft survival.CONCLUSIONS: Topical administration of tacrolimus and corticosteroids with concentration gradients is effective in decreasing the incidence of immune rejection in high-risk keratoplasty. Careful instruction of reasonable use of topical tacrolimus to patients is critical to avoid immune rejection induced by stop taking in sudden.