评估含 ST-Lysyal 的眼表调节剂与透明质酸眼药水在干眼症患者中的效果：试点研究。

IF 2.6 3区医学 Q2 OPHTHALMOLOGY

Ophthalmology and Therapy Pub Date : 2024-11-19 DOI:10.1007/s40123-024-01062-2

Stefano Barabino, Andrea Rosa, Sara Marini, Carlo Domenico Bianchi, Maurizio Rolando

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引用次数: 0

摘要

导言：干眼症（DED）是一种由多种因素引起的眼表疾病，主要通过泪液替代品进行治疗，但并不能完全恢复天然泪液的功能。在这项试验性研究中，我们测试了 T-Lysyal (T-Lys) 能否改善 DED 患者症状和体征的假设。此外，我们还对T-Lys在眼科和非眼科疾病中的作用进行了文献综述，以阐明其作用机制：方法：我们对使用 T-Lys 或 0.2% 透明质酸（HA）联合罗望子多糖（对照组）治疗 2 个月的 DED 患者进行了一项双盲随机试验研究。纳入标准为：诊断为 DED，症状持续时间≥ 6 个月；干眼症状评估 (SANDE) 评分≥ 30 分；至少具备以下一项：角膜荧光素染色（NEI 评分≥ 3 分）、结膜染色（利沙明绿，评分≥ 3 分）或泪液破裂时间 (T-BUT) ≤ 10 秒。此外，还在PubMed上对T-Lys研究进行了文献检索，没有出版年份限制：共有 12 名 T-Lys 组和 15 名对照组患者完成了研究（平均年龄为 67 ± 11 岁）。通过视觉模拟量表（T-Lys：V0 时为 4.58 ± 2.57 mm，V2 时为 2.92 ± 1.38 mm，P 结论：该研究首次提供了 T-Lys 治疗慢性阻塞性肺疾病的临床证据：本研究首次提供了T-Lys对DED患者疗效的临床证据，为临床前数据提供了支持，凸显了其作为一种前景广阔的眼表调节剂的潜力：该研究已在 ISRCTN 临床研究注册中心注册，注册号为 13587929。

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Evaluation of the Performance of an Ocular Surface Modulator Containing ST-Lysyal Versus Hyaluronic Acid Eyedrops in Patients with Dry Eye Disease: A Pilot Study.

Introduction: Dry eye disease (DED) is a multifactorial condition of the ocular surface, primarily treated with tear substitutes, which do not fully restore natural tear functions. In this pilot study, we tested the hypothesis that T-Lysyal (T-Lys) improves symptoms and signs in patients with DED. Additionally, we provide a literature overview on the effects of T-Lys in ophthalmology and non-ophthalmology conditions to elucidate its mechanisms of action.

Methods: A double-masked, randomized pilot study was conducted in patients with DED treated with T-Lys or hyaluronic acid (HA) 0.2% combined with tamarind seeds polysaccharide (control group) for 2 months. Inclusion criteria were a diagnosis of DED with symptoms lasting ≥ 6 months, Symptom Assessment in Dry Eye (SANDE) score ≥ 30, and at least one of the following: fluorescein staining of the cornea (score ≥ 3, NEI scale), conjunctival staining (Lissamine Green, score ≥ 3), or tear breakup time (T-BUT) ≤ 10 s. Data from the right eye were used for statistical analysis. A PubMed literature search of T-Lys studies was also performed without publication year restrictions.

Results: Twelve patients in the T-Lys group and 15 in the control group completed the study (mean age 67 ± 11 years). T-Lys treatment resulted in significant improvements from baseline (V0) to 2 months (V2) in symptoms assessed by visual analogue scale (T-Lys: 4.58 ± 2.57 mm at V0, 2.92 ± 1.38 mm at V2, p < 0.05; control: 5.13 ± 2.29 mm at V0, 5.3 ± 2.4 mm at V2), T-BUT (T-Lys: 2.58 ± 1.31 s at V0, 3.58 ± 1.37 s at V2, p < 0.05; control: 3.07 ± 1.43 s at V0, 3 ± 1.13 s at V2), and corneal staining (T-Lys: 2.16 ± 4.17 at V0, 1.41 ± 3.70 at V2, p < 0.05; control: 1.4 ± 2.19 at V0, 1.4 ± 2.16 at V2). No adverse events were reported. Literature findings supported T-Lys's efficacy in managing both ophthalmology and non-ophthalmology conditions.

Conclusion: This study provides the first clinical evidence of T-Lys efficacy in patients with DED, supporting preclinical data and highlighting its potential as a promising ocular surface modulator.

Trial registration: The study was registered in the ISRCTN registry for Clinical Studies with no. 13587929.

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来源期刊

Ophthalmology and Therapy OPHTHALMOLOGY-

CiteScore

4.20

自引率

3.00%

发文量

157

审稿时长

6 weeks

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