伐尼克兰鼻喷雾剂治疗干燥病干眼病的初步研究。

Clinical ophthalmology (Auckland, N.Z.) Pub Date : 2025-03-27 eCollection Date: 2025-01-01 DOI:10.2147/OPTH.S512364
Angela S Gupta, Taylor J Linaburg, Emma Iacobucci, Patrick A Augello, Vivian L Qin, Gui-Shuang Ying, Vatinee Y Bunya, Mina Massaro
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引用次数: 0

摘要

目的:评价伐尼克兰鼻喷雾剂(VNS)治疗干眼病合并中重度干燥病的疗效,分析VNS使用前后干眼病合并干燥病患者泪膜细胞因子水平的变化。方法:这是一项涉及单中心、单臂研究者发起的试验的初步研究。中度至重度干燥病患者给予VNS 0.03 mg,每日2次,连用28天。分别于使用VNS前第0天、第14天和第28天对患者进行评估。在基线和第28天评估临床检查结果、以眼干评分衡量的症状学和泪液细胞因子。结果:纳入39例受试者。在第0天至第28天期间,眼睛干燥评分(p = 0.01)、角膜染色(p < 0.001)和结膜染色(p = 0.04)均有统计学意义的改善。基线席默氏≤5 mm的未麻醉席默氏患者泪液分泌增加有统计学意义(n = 35眼,p = 0.02),基线席默氏≤6-10 mm的未麻醉席默氏患者泪液分泌增加无统计学意义(n = 16眼,p = 0.79)。泪膜细胞因子IFNγ (p = 0.0003)、IL-12p70 (p < 0.0001)、IL-17a (p = 0.004)、IL-1β (p = 0.007)、IL-2 (p < 0.0001)、IL-4 (p = 0.01)、TNF-α (p = 0.02)浓度降低有统计学意义,IL-6 (p = 0.56)、IL-10 (p = 0.18)浓度变化无统计学意义。结论:我们的研究结果为VNS改善部分泪液缺乏患者主观干眼症状、角膜和结膜染色以及泪液分泌提供了新的证据,同时提供了VNS降低泪液膜中促炎细胞因子浓度的新证据。临床试验注册号:NCT05700422。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Varenicline Solution Nasal Spray for the Treatment of Dry Eye Disease in Sjogren's Disease: A Pilot Study.

Purpose: We evaluated the efficacy of varenicline solution nasal spray (VNS) in treating dry eye disease (DED) associated with moderate to severe Sjogren's disease and analyzed tear film cytokine levels of patients with DED and Sjogren's disease before and after VNS use.

Methods: This was a pilot study involving a single-center, single-arm investigator-initiated trial. Patients with moderate to severe Sjogren's disease were given VNS 0.03 mg twice daily for 28 days. Patients were assessed on day 0 before VNS use, day 14 and day 28. Clinical exam findings, symptomatology as measured by the eye dryness score, and tear cytokines were assessed at baseline and day 28.

Results: Thirty-nine subjects were included. Between day 0 and day 28, there was a statistically significant improvement in the eye dryness score (p = 0.01), corneal staining (p < 0.001), and conjunctival staining (p = 0.04). There was a statistically significant increase in tear secretion by unanesthetized Schirmer's in subjects with a baseline Schirmer's ≤5 mm (n = 35 eyes, p = 0.02) and a non-statistically significant increase in tear secretion in subjects with a baseline Schirmer's of 6-10 mm (n = 16 eyes, p = 0.79). There was a statistically significant decrease in tear film cytokine concentration of IFNγ (p = 0.0003), IL-12p70 (p < 0.0001), IL-17a (p = 0.004), IL-1β (p = 0.007), IL-2 (p < 0.0001), IL-4 (p = 0.01), and TNF-α (p = 0.02), and no significant change in IL-6 (p = 0.56) and IL-10 (p = 0.18).

Conclusion: Our findings add to existing evidence that VNS improves subjective dry eye symptoms, corneal and conjunctival staining, and tear secretion in a subset of tear-deficient patients, while providing new evidence that VNS reduces concentration of pro-inflammatory cytokines in the tear film.

Clinical trial registration number: NCT05700422.

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