Department of Ophthalmology, Tokyo Dental College Ichikawa General Hospital, Chiba, Japan.
Ophthalmology. 2012 Apr;119(4):668-73. doi: 10.1016/j.ophtha.2011.10.016. Epub 2012 Jan 20.
Endothelial rejection remains a major cause of graft failure after penetrating keratoplasty (PKP). Topical corticosteroids are the gold standard for preventing rejection; however, protocols for corticosteroid treatment have been diverse. The aim of the present study was to examine the efficacy and safety of long-term use of corticosteroid eye drops after PKP in a randomized, clinical trial.
Randomized, nonblinded, clinical trial.
We enrolled 42 patients (21 males and 21 females) with a mean age of 65.3 years who underwent PKP and maintained graft clarity for >1 year with topical steroid eye drops.
Patients were randomly assigned to 1 of 2 groups: Administration of 0.1% fluorometholone 3 times a day (steroid group) or discontinuation of steroid eye drops (no steroid group). All patients were followed for 12 months.
Proportion of eyes without endothelial rejection and the proportion of eyes with clear grafts and the incidence of local or systemic side effects.
Of the initial 42 patients, 4 in the steroid group and 6 in the no steroid group did not complete the trial. Of the patients who completed the trial, 1 patient in the steroid group and 6 in the no steroid group developed endothelial rejection at an average of 5.2±4.5 (mean ± standard deviation) months after study enrollment. The difference in the incidence of rejection between groups was found to be significant by both chi-square (P = 0.027) and Kaplan-Meier analyses (log-rank test, P = 0.032). No difference was observed between the 2 groups in visual acuity, intraocular pressure, epithelial damage, tear-film break-up time, cataract progression, infection, or incidence of systemic side effects.
Prolonged use of 0.1% fluorometholone was beneficial for the prevention of rejection after PKP. Because no adverse consequences were noted, we recommend continuing use of the low-dose corticosteroids, even in non-high-risk cases.
穿透性角膜移植（PKP）后，内皮排斥反应仍然是移植物失功的主要原因。局部皮质类固醇是预防排斥反应的金标准；然而，皮质类固醇治疗方案一直存在差异。本研究旨在通过随机临床试验研究 PKP 后长期使用皮质类固醇滴眼液的疗效和安全性。
随机、非盲、临床试验。
我们招募了 42 名患者（21 名男性和 21 名女性），平均年龄 65.3 岁，他们接受了 PKP 治疗，并用皮质类固醇滴眼液维持移植物清晰 1 年以上。
患者随机分为 2 组：每天滴 0.1%氟米龙 3 次（皮质类固醇组）或停止使用皮质类固醇滴眼液（无皮质类固醇组）。所有患者均随访 12 个月。
无内皮排斥反应的眼比例、有清晰移植物的眼比例以及局部或全身不良反应的发生率。
在最初的 42 名患者中，皮质类固醇组有 4 名和无皮质类固醇组有 6 名患者未完成试验。完成试验的患者中，皮质类固醇组有 1 名患者和无皮质类固醇组有 6 名患者在研究入组后平均 5.2±4.5（平均±标准差）个月时发生内皮排斥反应。χ2 检验（P = 0.027）和 Kaplan-Meier 分析（对数秩检验，P = 0.032）均显示两组之间的排斥反应发生率存在显著差异。两组之间的视力、眼压、上皮损伤、泪膜破裂时间、白内障进展、感染或全身不良反应发生率无差异。
延长使用 0.1%氟米龙有利于预防 PKP 后排斥反应。由于没有观察到不良后果，我们建议即使在非高危情况下，也继续使用低剂量皮质类固醇。
