*Department of Ophthalmology, Tokyo Dental College, Ichikawa, Japan; and †Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan.
Cornea. 2014 Nov;33(11):1157-63. doi: 10.1097/ICO.0000000000000258.
The aim of this study was to investigate the efficacy and safety of systemic tacrolimus for the treatment of eyes that developed graft failure despite treatment with cyclosporine (CsA).
Ten eyes of 10 patients who underwent high-risk penetrating keratoplasty (PKP) and developed graft failure despite treatment with systemic CsA were included in this study. The patients underwent PKP and were treated with systemic tacrolimus according to the standardized protocol.
Treatment with tacrolimus was continued for 18.1 ± 13.9 months. The median duration of corneal graft clarity was 34.5 months. Graft rejection occurred in 2 of 10 eyes during a mean follow-up period of 48.9 ± 22.9 months. Kaplan-Meier survival plots showed significantly fewer graft rejection episodes (P = 0.033) and longer graft survival (P = 0.042) after treatment with tacrolimus compared those with CsA. Tacrolimus was discontinued in 2 patients; 1 had renal dysfunction and the other had muscle pain and fatigue. These side effects subsided after discontinuation of tacrolimus.
Treatment with systemic tacrolimus is possibly safe and effective in reducing graft rejection and prolonging graft survival in patients with high-risk PKP after graft failure with systemic CsA.
本研究旨在探讨环孢素（CsA）治疗失败后全身应用他克莫司治疗移植失败眼的疗效和安全性。
本研究纳入 10 例 10 眼高危穿透性角膜移植（PKP）患者，这些患者在接受 CsA 全身治疗后发生移植失败。根据标准化方案，这些患者接受了 PKP 并接受了全身他克莫司治疗。
他克莫司治疗持续了 18.1±13.9 个月。角膜移植透明度的中位数持续时间为 34.5 个月。在平均 48.9±22.9 个月的随访期间，有 2 只眼（20%）发生了 2 次移植排斥反应。Kaplan-Meier 生存曲线显示，与 CsA 相比，他克莫司治疗后移植排斥反应次数明显减少（P=0.033），移植存活时间更长（P=0.042）。有 2 例患者停用了他克莫司；1 例出现肾功能障碍，另 1 例出现肌肉疼痛和疲劳。停用他克莫司后，这些副作用消退。
对于高危 PKP 移植失败后 CsA 全身治疗失败的患者，全身应用他克莫司治疗可能安全有效，可减少移植排斥反应，延长移植物存活时间。
