Department of Ophthalmology, Tel-Aviv Medical Center, Tel-Aviv, Israel, affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Graefes Arch Clin Exp Ophthalmol. 2014 May;252(5):811-6. doi: 10.1007/s00417-014-2611-9. Epub 2014 Apr 4.
To determine the safety and efficacy of topical 0.03% tacrolimus ointment treatment for subepithelial corneal infiltrates (SEIs).
This prospective non-controlled interventional case series included patients with SEIs who had been previously treated with topical corticosteroids with either no improvement or the medication being withdrawn due to associated intraocular pressure (IOP) elevation. The patients were treated with 0.03% tacrolimus ointment twice daily for 22 weeks (including a 1-month washout). The objective data were best-corrected Snellen visual acuity (BCVA), IOP, and full ocular examination results, including SEI severity and the Schirmer test. The subjective data were the patients' responses to a questionnaire at all follow-up visits.
The patients consisted of five males (45%) and six females (55%) (mean age 50 ± 11 years) who were followed up for an average of 22 weeks. The mean BCVA (logarithm of the minimum angle of resolution [logMAR]) before and after treatment was 0.34 ± 0.09 and 0.08 ± 0.04 respectively (p = 0.042). All the patients evidenced significant objective clinical improvement, and none had a severe degree of SEI at the end of the treatment. The patients reported considerable reduction in the severity of their symptoms (foreign body sensation, glare, etc.). Three patients were excluded due to side-effects (one had severe dizziness and discomfort), and their data were excluded from the study.
Topical tacrolimus 0.03% is a safe and effective alternative treatment in patients with SEIs who do not respond to other treatment modalities or have untoward side-effects from topical steroids.
评估 0.03%他克莫司软膏治疗上皮下角膜浸润（SEI）的安全性和有效性。
本前瞻性非对照干预性病例系列研究纳入了先前接受过局部皮质类固醇治疗但未改善或因眼压升高而停药的 SEI 患者。患者接受 0.03%他克莫司软膏，每日 2 次，治疗 22 周（包括 1 个月洗脱期）。客观数据为最佳矫正视力（BCVA）、眼压和全面眼部检查结果，包括 SEI 严重程度和 Schirmer 试验。主观数据为患者在所有随访时的问卷调查应答。
患者包括 5 名男性（45%）和 6 名女性（55%）（平均年龄 50±11 岁），平均随访 22 周。治疗前后 BCVA（最小分辨角对数[logMAR]）的平均值分别为 0.34±0.09 和 0.08±0.04（p=0.042）。所有患者均表现出显著的客观临床改善，且在治疗结束时无一例 SEI 严重程度达重度。患者报告症状严重程度明显减轻（异物感、畏光等）。由于副作用（1 例出现严重头晕和不适），有 3 例患者被排除，其数据被排除在研究之外。
对于对其他治疗方法无反应或局部皮质类固醇有不良反应的 SEI 患者，0.03%他克莫司软膏是一种安全有效的替代治疗方法。
