全氟己辛滴眼液治疗与睑板腺功能障碍相关的干眼病：基于症状和体征的亚组反应的事后分析

IF 3 3区医学 Q1 OPHTHALMOLOGY Acta Ophthalmologica Pub Date : 2025-01-19 DOI:10.1111/aos.17205

Ying Jie

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引用次数: 0

摘要

目的/目的：在一项与睑膜腺功能障碍（MGD）相关的干眼病（DED）的随机试验中，患者每天接受四次全氟己烷滴眼液（n = 156）或氯化钠（NaCl）溶液（n = 156）。试验表明，与NaCl相比，全氟己辛烷可显著改善DED的体征和症状，且见效快，安全性满意。这项事后分析评估了基于症状和体征的亚组疗效，特别是不一致的症状和体征。方法：根据基线至治疗后第57天角膜总荧光素染色（tCFS）、眼干评分（EDS）和眼表疾病指数（OSDI）的中位数变化对患者进行分组。第57天的缓解定义为：tCFS缓解，较基线降低≥3个点；EDS反应，较基线降低≥30%；OSDI反应，较基线降低≥30%。结果：在tCFS≤6时；EDS≥60组，tCFS &；全氟己辛烷组的EDS应答率为52.7%（29例），NaCl组为28.4%（19例）（OR 95% CI: 2.82, 1.33-5.96, p = 0.0068）。在tCFS >； 6 &；EDS≥60组，tCFS &；EDS应答率为72.1%（31）比36.6% (15)（OR 95% CI: 4.48, 1.78-11.25, p = 0.0014）。在tCFS≤6 &；OSDI≥60组，tCFS &；OSDI反应为61.4%（27人）比28.2%（11人）（OR 95% CI: 4.58, 1.79-11.74, p = 0.0015）。在tCFS >； 6 &；OSDI <； 60组，tCFS &；OSDI反应为72.2%（26）比42.9% (15)（OR 95% CI: 3.47, 1.29-9.33, p = 0.0138）。结论：事后分析显示，在症状和体征不一致的亚组中，如tCFS≤6的患者，全氟己烷滴眼液可显著改善DED症状和体征；EDS≥60,tCFS≤6 &；OSDI≥60,tCFS > 6 &；OSDI < 60，以及在症状和体征都更严重的情况下，如tCFS >； 6 &；Eds≥60。

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Perfluorohexyloctane eye drops in treating dry eye disease associated with meibomian gland dysfunction: A post-hoc analysis of responses in subgroups based on symptoms and signs

Aims/Purpose: In a randomized trial of dry eye disease (DED) associated with meibomian gland dysfunction (MGD), patients received either perfluorohexyloctane eye drops (n = 156) or sodium chloride (NaCl) solution (n = 156) four times daily. The trial showed that perfluorohexyloctane significantly improved DED signs and symptoms with rapid efficacy and satisfactory safety compared to NaCl. This post hoc analysis evaluated efficacy in subgroups based on signs and symptoms, specifically discordant signs and symptoms.

Methods: Patients were grouped according to median changes in total corneal fluorescein staining (tCFS), eye dryness score (EDS), and ocular surface disease index (OSDI) between baseline and day 57 after treatment. Responses at day 57 were defined as: tCFS Response, decrease of ≥ 3 points from baseline; EDS Response, reduction of ≥ 30% from baseline; OSDI Response, reduction of ≥ 30% from baseline.

Results: In the tCFS ≤ 6 & EDS ≥ 60 group, the tCFS & EDS Response was 52.7% (29 patients) with perfluorohexyloctane vs. 28.4% (19) with NaCl (OR 95% CI: 2.82, 1.33–5.96, p = 0.0068). In the tCFS > 6 & EDS ≥ 60 group, the tCFS & EDS Response was 72.1% (31) vs. 36.6% (15) (OR 95% CI: 4.48, 1.78–11.25, p = 0.0014). In the tCFS ≤ 6 & OSDI ≥ 60 group, the tCFS & OSDI Response was 61.4% (27) vs. 28.2% (11) (OR 95% CI: 4.58, 1.79–11.74, p = 0.0015). In the tCFS > 6 & OSDI < 60 group, the tCFS & OSDI Response was 72.2% (26) vs. 42.9% (15) (OR 95% CI: 3.47, 1.29–9.33, p = 0.0138).

Conclusions: The post hoc analysis showed that perfluorohexyloctane eye drops significantly improved DED symptoms and signs in subgroups where symptoms and signs were discordant, such as those with tCFS ≤ 6 & EDS ≥ 60, tCFS ≤ 6 & OSDI ≥ 60, and tCFS > 6 & OSDI < 60, as well as in cases where both symptoms and signs were more severe, such as tCFS > 6 & EDS ≥ 60.

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来源期刊

Acta Ophthalmologica 医学-眼科学

CiteScore

7.60

自引率

5.90%

发文量

433

审稿时长

6 months

期刊介绍： Acta Ophthalmologica is published on behalf of the Acta Ophthalmologica Scandinavica Foundation and is the official scientific publication of the following societies: The Danish Ophthalmological Society, The Finnish Ophthalmological Society, The Icelandic Ophthalmological Society, The Norwegian Ophthalmological Society and The Swedish Ophthalmological Society, and also the European Association for Vision and Eye Research (EVER). Acta Ophthalmologica publishes clinical and experimental original articles, reviews, editorials, educational photo essays (Diagnosis and Therapy in Ophthalmology), case reports and case series, letters to the editor and doctoral theses.