Prospective, Randomized Study of the Efficacy of Systemic Cyclosporine in High-Risk Corneal Transplantation
Prospective, Randomized Study of the Efficacy of Systemic Cyclosporine in High-Risk Corneal Transplantation
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DOI：
10.1016/j.ajo.2011.01.019
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发表时间：
2011-07-01
影响因子：
4.2
通讯作者：
Tsubota, Kazuo
中科院分区：
文献类型：
--
作者：
Shimazaki, Jun;Den, Seika;Tsubota, Kazuo
目的：免疫排斥反应仍然是高危角膜移植失败的主要原因。本研究旨在阐明系统性环孢素（CsA）在高危角膜移植中的有效性和安全性。设计：前瞻性、随机、开放标签的临床试验与平行组研究。方法：在日本千叶东京牙科学院眼科接受高危角膜移植的患者。高风险定义为角膜新生血管超过1象限或有角膜移植史。患者被分配到系统性CsA组或对照组。持续给予CsA至少6个月，在给予约800 ng/mL后2小时血液CsA浓度，除非出现不良副作用。主要结局指标为移植物清晰度、内皮排斥反应、局部和全身并发症。结果：纳入40例患者，分析39例（男性18例，女性21例，平均年龄67.4±11.9岁）。在CsA组中，7例患者因副作用在6个月内停用CsA。在平均42.7个月的随访中，CsA组和对照组分别有6只和2只眼睛出现内皮排斥反应。两组间移植物清晰度丧失率无差异（P = 0.16， Kaplan-Meier分析）。结论：未观察到系统性CsA对抑制高风险角膜移植排斥反应的积极作用。由于系统副作用的发生率相对较高，结果表明该方案不应推荐用于角膜移植受者，特别是高龄患者。[J]中华眼科杂志，2011;32(2):33-39。(C)爱思唯尔公司2011。版权所有。)
PURPOSE: Immunologic rejection remains a major cause of graft failure in high-risk corneal transplantation. This study was conducted to elucidate the efficacy and safety of systemic cyclosporine (CsA) in high-risk corneal transplantation.DESIGN: Prospective, randomized, open-labeled clinical trial with a parallel-group study.METHODS: Patients underwent high-risk corneal transplantation at the Department of Ophthalmology, Tokyo Dental College, Chiba, Japan. High-risk was defined as corneal neovascularization in more than 1 quadrant or a history of corneal grafting. Patients were assigned to either a systemic CsA group or a control group. Administration of CsA was continued for at least 6 months with blood CsA concentration 2 hours after administration of approximately 800 ng/mL, unless undesirable side effects developed. The main outcome measures were graft clarity, endothelial rejection, and local and systemic complications.RESULTS: Forty patients were enrolled and 39 (18 men, 21 women; mean age, 67.4 +/- 11.9 years) were analyzed. In the CsA group, CsA was discontinued within 6 months in 7 patients because of side effects. With a mean follow-up of 42.7 months, endothelial rejection developed in 6 and 2 eyes in the CsA and control groups, respectively. No differences were observed in the rates of graft clarity loss between the 2 groups (P = .16, Kaplan-Meier analysis).CONCLUSIONS: No positive effect of systemic CsA administration for suppressing rejection in high-risk corneal transplantation was observed. With a relatively high incidence of systemic side effects, the results suggest that this protocol should not be recommended for corneal transplant recipients, especially those of advanced age. (Am J Ophthalmol 2011;152:33-39. (C) 2011 by Elsevier Inc. All rights reserved.)