Nassau University, Rockville Centre, NY, USA.
Cornea. 2011 Oct;30(10):1098-104. doi: 10.1097/ICO.0b013e318206caee.
To evaluate the effect of decreasing topical cyclosporine 0.05% (tCSA) (Restasis; Allergan, Irvine, CA) from twice-daily dosing to once-daily dosing in patients who have already completed 12 months of twice-daily therapy for dry eye disease.
Prospective, randomized, single-masked, parallel group comparison.
One hundred patients who had already been treated with tCSA twice daily for more than 1 year were randomized either to continue tCSA twice daily (n = 50) or to decrease tCSA once daily (n = 50).
Clinical measurement of dry eye variables was performed for all patients at baseline, 3 months, and 6 months. Mean data were used for within-group (longitudinal analysis) and between-group comparisons (once daily vs. twice daily).
Fluorescein tear break-up time, corneal fluorescein staining score, lissamine green staining score, Schirmer tear test, and ocular surface disease index.
At the end of the study, patients whose treatment dose was decreased to once daily demonstrated statistically significant improvement in tear break-up time [4.13 seconds (n = 37) vs. 3.11 seconds at baseline (n = 50); P = 0.0003] and lissamine green staining score [4.42 (n = 37) vs. 6.51 at baseline (n = 50); P = 0.024]; fluorescein staining score, Schirmer test results, and ocular surface disease index did not change significantly (P > 0.05). Furthermore, the once-daily group demonstrated significantly superior ocular surface disease index compared with the twice daily group [15.91 (n = 37) vs. 22.62 (n = 48); P = 0.0496]. The remaining outcome measures between once daily and twice daily were not significantly different (P > 0.05). Seven of 50 patients (14%) in the once-daily group (vs. 0% in the twice-daily group) ended the study early because of worsening dry eye symptoms (P < 0.05) and went back to twice-daily dosing.
For patients with dry eye that has been controlled with tCSA twice daily for at least 1 year, decreasing to tCSA once daily may still allow suppression of the dry eye disease.
评估环孢素 0.05%（tCSA）（Restasis；Allergan，尔湾，CA）从每日两次剂量减少到每日一次剂量在已经完成 12 个月干眼症治疗的患者中的效果。
前瞻性、随机、单盲、平行组比较。
100 名已经接受 tCSA 每日两次治疗超过 1 年的患者被随机分为继续 tCSA 每日两次（n = 50）或减少 tCSA 每日一次（n = 50）。
所有患者在基线、3 个月和 6 个月时进行干眼变量的临床测量。使用均值数据进行组内（纵向分析）和组间比较（每日一次与每日两次）。
泪膜破裂时间、角膜荧光素染色评分、丽丝胺绿染色评分、泪液分泌试验和眼表疾病指数。
研究结束时，治疗剂量减少至每日一次的患者泪膜破裂时间有统计学显著改善[4.13 秒（n = 37）vs. 基线时的 3.11 秒（n = 50）；P = 0.0003]和丽丝胺绿染色评分[4.42（n = 37）vs. 基线时的 6.51（n = 50）；P = 0.024]；荧光素染色评分、泪液分泌试验结果和眼表疾病指数无显著变化（P > 0.05）。此外，每日一次组的眼表疾病指数明显优于每日两次组[15.91（n = 37）vs. 22.62（n = 48）；P = 0.0496]。每日一次组和每日两次组之间的其余结局指标无显著差异（P > 0.05）。每日一次组有 7 名患者（14%）（vs. 每日两次组 0%）因干眼症状恶化而提前结束研究（P < 0.05）并恢复每日两次剂量。
对于已经用 tCSA 每日两次治疗至少 1 年控制良好的干眼症患者，减少至 tCSA 每日一次可能仍能抑制干眼症。
