从含防腐剂的环孢素 0.1%到不含防腐剂的环孢素 0.1%增强型三联青光眼治疗方案的转换：对眼表疾病的影响——一项随机对照试验。
Changing from preserved, to preservative-free cyclosporine 0.1% enhanced triple glaucoma therapy: impact on ocular surface disease-a randomized controlled trial.
机构信息
1st University Department of Ophthalmology, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Department of Epidemiology, Aristotle University of Thessaloniki, Thessaloniki, Greece.
出版信息
Eye (Lond). 2023 Dec;37(17):3666-3674. doi: 10.1038/s41433-023-02578-w. Epub 2023 May 23.
OBJECTIVE
Halting and reversing glaucoma therapy-related ocular surface disease (GTR-OSD) will improve the success of long-term medical therapy, impacting millions of patients worldwide.
METHODS
A single-centre, masked, prospective, placebo-controlled, crossover trial of 41 well-controlled open-angle glaucoma subjects with moderate to severe GTR-OSD on preserved latanoprost and dorzolamide/timolol fixed combination (DTFC) therapy was conducted. Subjects were randomized to preservative-free (PF) tafluprost and DTFC with either placebo or cyclosporine 0.1% drops for 6 months and were then crossed over to the opposite therapy. Oxford score of ocular staining was the primary outcome; osmolarity, matrix-metalloproteinase-9 (MMP-9) testing, tear film break-up time (TFBUT), meibomian gland dysfunction (MGD), punctum evaluation, adverse events and diurnal intraocular pressure (IOP) comprised secondary outcomes.
RESULTS
GTR-OSD findings improved with PF therapy. At 6 months the triple PF with placebo group showed improvement compared to baseline in mean Oxford score (mean difference [MD]:-3.76; 95% confidence interval [CI]:-4.74 to -2.77; p < 0.001), osmolarity (MD:-21.93; 95%CI:-27.61 to -16.24 mOsm/l; p < 0.001), punctum stenosis (p = 0.008) and conjunctival hyperaemia (p < 0.001). Similar improvements occurred in the cyclosporine enhanced period, which also provided greater improvement in MMP-9 positivity (24 vs 66%; p < 0.001) and TFBUT (p = 0.022). The cyclosporine group was superior vs placebo in mean Oxford score (MD:-0.78; 95%CI:-1.40 to -0.15); p < 0.001), itchiness and objective adverse events (p = 0.034). Cyclosporine elicited more stinging vs placebo (63 vs 24%; p < 0.001). Both PF regimens reduced mean diurnal IOP more than preserved therapy (14.7 vs 15.9 mmHg; p < 0.001).
CONCLUSIONS
Changing from preserved to PF glaucoma medications improves ocular surface health and IOP control. Topical cyclosporine 0.1% further reverses GTR-OSD.
目的
停止和逆转青光眼治疗相关的眼表面疾病（GTR-OSD）将提高长期药物治疗的成功率，影响全球数以百万计的患者。
方法
对 41 名患有中度至重度 GTR-OSD 的开角型青光眼患者进行了一项单中心、盲法、前瞻性、安慰剂对照、交叉试验，这些患者正在接受保存型拉坦前列素和多佐胺/噻吗洛尔固定组合（DTFC）治疗。将受试者随机分为无防腐剂（PF）他氟前列素和 DTFC 治疗，分别给予安慰剂或环孢素 0.1%滴眼剂治疗 6 个月，然后交叉至相反的治疗。眼染色的牛津评分是主要结局；渗透压、基质金属蛋白酶-9（MMP-9）检测、泪膜破裂时间（TFBUT）、睑板腺功能障碍（MGD）、泪小点评估、不良事件和日间眼压（IOP）构成次要结局。
结果
PF 治疗可改善 GTR-OSD 发现。在 6 个月时，三重 PF 联合安慰剂组与基线相比，牛津评分（平均差异 [MD]：-3.76；95%置信区间 [CI]：-4.74 至 -2.77；p<0.001）、渗透压（MD：-21.93；95%CI：-27.61 至 -16.24 mOsm/l；p<0.001）、泪小点狭窄（p=0.008）和结膜充血（p<0.001）均有改善。在环孢素增强期也出现了类似的改善，MMP-9 阳性（24 对 66%；p<0.001）和 TFBUT（p=0.022）也有更大的改善。与安慰剂相比，环孢素组在平均牛津评分（MD：-0.78；95%CI：-1.40 至 -0.15）、瘙痒和客观不良事件（p=0.034）方面更具优势。与安慰剂相比，环孢素引起的刺痛更多（63 对 24%；p<0.001）。两种 PF 方案均比保存治疗更能降低日间平均 IOP（14.7 对 15.9mmHg；p<0.001）。
结论
从保存型青光眼药物转为 PF 药物可改善眼表面健康和 IOP 控制。局部环孢素 0.1%进一步逆转 GTR-OSD。
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