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

期刊介绍： Aims and Scope Ophthalmology and Therapy is an international, open access, peer-reviewed (single-blind), and rapid publication journal. The scope of the journal is broad and will consider all scientifically sound research from preclinical, clinical (all phases), observational, real-world, and health outcomes research around the use of ophthalmological therapies, devices, and surgical techniques. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/series, trial protocols and short communications such as commentaries and editorials. Ophthalmology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. 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