Rolando Maurizio, Vagge Aldo
1 ISPRE Oftalmica , Genova, Italy .
2 Dipartimento di Scienze Neurologiche, Oftalmologia, Genetica e Scienze Materno Infantili, Università di Genova , Genova, Italy .
J Ocul Pharmacol Ther. 2017 Jun;33(5):383-390. doi: 10.1089/jop.2016.0147. Epub 2017 Apr 4.
Evaluation of 0.3% cortisol phosphate eye drops in hyaluronic acid vehicle in the treatment of dry eye in Sjogren Syndrome.
This prospective, single-center, masked (single blind), randomized controlled study included 40 female patients divided into 2 groups, group 1 treated with Idracemi, 0.3% cortisol phosphate eye drops twice a day, and group 2 treated with Cortivis, 0.3% cortisol phosphate in hyaluronic acid vehicle, with the same posology. Screening (day -7), randomization (day 0), follow-up (day 7), and termination (day 28) visits were conducted. Symptoms (VAS) questionnaire, tear film breakup time, corneo-conjunctival stain, intraocular pressure (IOP) measurement, and fundus examination were performed at each visit. Conjunctival impression cytology for human leukocyte antigen-DR (HLA-DR) expression at visit 1 and 4 was also performed.
No changes in IOP or fundus examination were observed in either group at each time point. Group 1 showed at day 28 a statistically significant amelioration of symptoms and reduction of HLA-DR expression. Group 2 showed at day 7 statistically significant improvement of corneal and conjunctival stain versus baseline and versus group 1; the symptom score was statistically significantly better than baseline and versus group 1 after 28 days too. The HLA-DR expression and the epithelial cell area were statistically significantly reduced versus baseline and versus group 1 at the same time.
Cortisol phosphate proved to be safe and effective in treating dry eye in Sjogren Syndrome patients in both formulations. However, the formula with hyaluronic acid vehicle proved to be more effective. Both formulations were very well tolerated.
评估含透明质酸载体的0.3%磷酸皮质醇滴眼液治疗干燥综合征干眼的效果。
这项前瞻性、单中心、遮蔽（单盲）、随机对照研究纳入了40名女性患者，分为2组，第1组使用Idracemi，即0.3%磷酸皮质醇滴眼液，每日滴眼两次，第2组使用Cortivis，即含透明质酸载体的0.3%磷酸皮质醇，给药方案相同。进行了筛查（第-7天）、随机分组（第0天）、随访（第7天）和终止（第28天）访视。每次访视时均进行症状（视觉模拟评分）问卷、泪膜破裂时间、角膜结膜染色、眼压测量和眼底检查。在第1次和第4次访视时还进行了结膜印片细胞学检查以检测人类白细胞抗原-DR（HLA-DR）表达。
两组在各时间点眼压或眼底检查均未观察到变化。第1组在第28天症状有统计学意义的改善，HLA-DR表达降低。第2组在第7天角膜和结膜染色较基线及第1组有统计学意义的改善；28天后症状评分较基线及第1组也有统计学意义的改善。同时，HLA-DR表达和上皮细胞面积较基线及第1组有统计学意义的降低。
两种制剂的磷酸皮质醇在治疗干燥综合征患者干眼方面均被证明是安全有效的。然而，含透明质酸载体的制剂被证明更有效。两种制剂耐受性都很好。
