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评估源自蜗牛黏液的格力可宝泪液替代品在缓解重度干眼病中的作用:一项关于角膜感觉测量恢复和眼痛缓解的首例人体研究。

Evaluating GlicoPro Tear Substitute Derived from Snail Mucus in Alleviating Severe Dry Eye Disease: A First-in-Human Study on Corneal Esthesiometry Recovery and Ocular Pain Relief.

作者信息

Ballesteros-Sánchez Antonio, Sánchez-González José-María, Tedesco Giovanni Roberto, Rocha-de-Lossada Carlos, Murano Gianluca, Spinelli Antonio, Mazzotta Cosimo, Borroni Davide

机构信息

Department of Physics of Condensed Matter, Optics Area, University of Seville, 41004 Seville, Spain.

Department of Ophthalmology, Clínica Novovisión, 30008 Murcia, Spain.

出版信息

J Clin Med. 2024 Mar 12;13(6):1618. doi: 10.3390/jcm13061618.

Abstract

To evaluate the effects of 10% GlicoPro tear substitute therapy in patients with severe dry eye disease (DED). In this prospective longitudinal study, 30 individuals receiving 10% GlicoPro four times daily for DED were evaluated. The ocular surface disease index (OSDI) questionnaire, average non-invasive break-up time (A-NIBUT), non-anesthetic and anesthetic corneal esthesiometry (CE), ocular pain, and the presence of conjunctivochalasis (CCH) were used as clinical endpoints. Treatment compliance using dosing diaries and AEs was assessed. A significant improvement was observed in the clinical endpoints: the ΔOSDI questionnaire was -39.27 ± 13.22 [-65 to -15] points, ΔA-NIBUT was 3.10 ± 1.31 [1 to 5] s, Δnon-anesthetic CE was 14 ± 6.35 [5 to 25] mm, and Δanesthetic CE was 13 ± 5.35 [5 to 20] mm ( < 0.001 for all comparisons). Ocular pain was reduced in 92.5% of the patients at the end of the follow-up. However, there was no change in the presence of CCH. In addition, all the patients were fully compliant with the dosing and no AEs related to the use of the 10% GlicoPro tear substitute were reported. The 10% GlicoPro tear substitute has the potential to achieve beneficial effects in ocular surface treatments.

摘要

评估10%葡萄糖酸丙酯泪液替代疗法对重度干眼症(DED)患者的疗效。在这项前瞻性纵向研究中,对30名因DED每天接受4次10%葡萄糖酸丙酯治疗的个体进行了评估。眼表疾病指数(OSDI)问卷、平均非侵入性泪膜破裂时间(A-NIBUT)、非麻醉和麻醉状态下的角膜感觉测量(CE)、眼痛以及结膜松弛症(CCH)的存在情况被用作临床终点。通过用药日记评估治疗依从性,并评估不良事件(AE)。观察到临床终点有显著改善:OSDI问卷的变化量为-39.27±13.22[-65至-15]分,A-NIBUT的变化量为3.10±1.31[1至5]秒,非麻醉状态下CE的变化量为14±6.35[5至25]毫米,麻醉状态下CE的变化量为13±5.35[5至20]毫米(所有比较均P<0.001)。随访结束时,92.5%的患者眼痛减轻。然而,CCH的存在情况没有变化。此外,所有患者用药完全依从,未报告与使用10%葡萄糖酸丙酯泪液替代物相关的不良事件。10%葡萄糖酸丙酯泪液替代物在眼表治疗中具有产生有益效果的潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0fae/10971458/9bb73c2a0075/jcm-13-01618-g001.jpg

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