Ophthalmology Clinic, Department of Biomedical Sciences, University Hospital of Messina, 98125 Messina, Italy.
Ophthalmology Department, Andrzej Frycz Modrzewski Krakow University, 30-705 Krakow, Poland.
Front Biosci (Landmark Ed). 2022 Jun 27;27(7):202. doi: 10.31083/j.fbl2707202.
The purpose of this study is to investigate the effects of the treatment with eye-drops based on a combination of antioxidant and mucomimetic molecules, namely 0.1% alpha-lipoic acid (ALA) and 0.3% hydroxy-propyl-methylcellulose (HPMC) on the ocular surface of diabetic patients with dry eye symptoms.
Seventy patients, 42 M and 28 F, aged from 50 to79 years (mean 62.1 ± 10.5), affected by type II diabetes mellitus, were enrolled and divided in two groups treated for 2 months as follows: Group 1 (35 patients), received topical ALA/HPMC three times a day, Group 2 (35 patients) received topical HPMC (0.3%) alone, three times a day. The main outcome measures were: Ocular Surface Disease Index (OSDI), tear film break-up time (TBUT), corneal fluorescein staining, Schirmer I test, corneal sensitivity. An examination of tear film morphology with confocal microscopy was carried out in a subset of patients of each group at baseline and after two months. Statistical analysis was performed with -test for the parametric data and Mann-Whitney U-test or chi-squared test for the nonparametric data.
Both treatments resulted in significant improvements of BUT, OSDI and tear film morphology, although the improvements observed in group 1 showed a higher trend than what observed for group 2. Moreover, only in group 1 a significant improvement was visible for corneal staining, and no significant improvements were observed in any group for Schirmer I and sensitivity.
These results confirmed the efficacy of HPMC in the treatment of diabetic dry eye and indicated that the addition of a strong self-regenerating antioxidant like ALA may give a distinctive advantage for the healing of corneal defects (as evidenced by corneal staining), beside improving HPMC efficacy on three other parameters (BUT, OSDI score, tear morphology). Therefore, the addition of a strong antioxidant like ALA can be helpful in preventing or treating ocular surface defects in diabetic patients, in which the oxidative damage is predominant.
本研究旨在探讨基于抗氧化和粘弹性模拟分子（即 0.1%α-硫辛酸（ALA）和 0.3%羟丙基甲基纤维素（HPMC））的滴眼剂治疗对糖尿病干眼症患者眼表的影响。
共纳入 70 名患者，42 名男性和 28 名女性，年龄 50-79 岁（平均 62.1±10.5 岁），均患有 2 型糖尿病，将其分为两组，分别接受为期 2 个月的治疗：组 1（35 例），接受 ALA/HPMC 滴眼，每日 3 次；组 2（35 例），接受 HPMC（0.3%）滴眼，每日 3 次。主要观察指标为：眼表疾病指数（OSDI）、泪膜破裂时间（TBUT）、角膜荧光素染色、泪液分泌试验、角膜知觉。在每组的一部分患者中，在基线和 2 个月后进行了泪膜形态的共焦显微镜检查。对参数数据进行 t 检验，对非参数数据进行 Mann-Whitney U 检验或卡方检验。
两种治疗均显著改善 BUT、OSDI 和泪膜形态，但组 1 的改善趋势高于组 2。此外，只有组 1 的角膜染色有显著改善，而任何一组的 Schirmer I 和知觉均无显著改善。
这些结果证实了 HPMC 治疗糖尿病干眼症的疗效，并表明添加像 ALA 这样的强自再生抗氧化剂可能对角膜缺陷的愈合（如角膜染色所示）具有明显优势，同时改善 HPMC 在其他三个参数（BUT、OSDI 评分、泪膜形态）上的疗效。因此，在以氧化损伤为主的糖尿病患者中，添加像 ALA 这样的强抗氧化剂有助于预防或治疗眼表缺陷。
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