To evaluate the clinical efficacy of topical tacrolimus 0.1% and cyclosporine 1% on high-risk penetrating keratoplasty (PKP) patients. A series of 49 high-risk PKP patients (49 eyes), 20 males, 29 females from the age of 4 months to 74 years of age with the mean of 32.5 from 2012 to 2017 were recruited in this study. The patients were randomly divided into two groups by receiving either topical tacrolimus 0.1% or cyclosporine 1% respectively. Twenty five patients were treated with topical tacrolimus 0.1% and 24 patients with topical cyclosporine 1%. The traditional baseline management on these two groups were Tobramycin and Dexamethasone eye drops in the first 3 weeks and then tapered off. Clinical procedures and postoperative follow-up were documented. After 6–54 months follow-up, with the average of 24 months, 11 of 24 high-risk patients (11 eyes) had graft rejection, the rejection rate was 45.8% in topical cyclosporine 1% group. The rejections occurred from 35 days to 20 months after PKP. Three patients had irreversible rejection. On topical tacrolimus 0.1% group, the rejection occurred in four patients (four eyes) with rejection rate of 16%, and no irreversible rejection was observed. The graft rejection episodes were documented between 23 days and 24 months. As compared with the topical cyclosporine 1%, topical tacrolimus 0.1%, a key immunosuppressant, significantly decreased corneal graft rejection rate (p = 0.02). Topical tacrolimus 01% on high-risk PKP patients significantly prevented corneal graft rejection, and it had less adverse effects and was very safe to high-risk patients as to topical cyclosporine 1%. Further case controlled randomized clinical trial studies are needed to establish the best management option for these high-risk patients.

中文翻译：

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外用他克莫司对高危穿透性角膜移植患者的观察：一项随机临床试验研究

评估外用 0.1% 他克莫司和 1% 环孢素对高危穿透性角膜移植术 (PKP) 患者的临床疗效。本研究共纳入2012-2017年4个月至74岁的49例高危PKP患者（49眼），男20例，女29例，平均32.5岁。患者被随机分为两组，分别接受外用 0.1% 的他克莫司或 1% 的环孢素。25 名患者接受了 0.1% 的他克莫司局部治疗，24 名患者接受了 1% 的局部环孢素治疗。这两组的传统基线管理是在前 3 周内使用妥布霉素和地塞米松滴眼液，然后逐渐减少。记录了临床程序和术后随访。经过 6-54 个月的随访，平均 24 个月，24例高危患者中有11例（11眼）发生移植排斥反应，局部环孢素1%组排斥率为45.8%。拒绝发生在 PKP 后 35 天到 20 个月。三名患者有不可逆的排斥反应。外用他克莫司0.1%组4例（4眼）发生排斥反应，排斥反应率为16%，未见不可逆排斥反应。移植排斥事件记录在 23 天和 24 个月之间。与外用环孢素 1%、外用他克莫司 0.1%（一种关键的免疫抑制剂）相比，角膜移植排斥率显着降低（p = 0.02）。外用他克莫司 01% 对高危 PKP 患者可显着预防角膜移植排斥反应，并且其副作用较小，对高危患者非常安全，与外用 1% 环孢素相比。