眼用环孢素的短期疗效：在可控环境下评估 0.1% 阳离子乳剂对干眼症患者的短期疗效。

IF 2.6 3区医学 Q2 OPHTHALMOLOGY Ophthalmology and Therapy Pub Date : 2024-05-01 Epub Date: 2024-03-06 DOI:10.1007/s40123-024-00906-1

Laura Valencia-Nieto, José Pinto-Fraga, Marta Blanco-Vázquez, Itziar Fernández, Alberto López-Miguel, Carmen García-Vázquez, María J González-García, Amalia Enríquez-de-Salamanca, Margarita Calonge

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引用次数: 0

摘要

简介目的：评估环孢素A（CsA）-0.1%阳离子乳剂（CE）对干眼症（DED）患者的短期疗效，以及缓解干燥应激环境引发的炎症复发：在一家三级医疗机构进行了一项单中心非随机临床试验。20名接受CsA 0.1% CE治疗的DED患者在基线、1个月和3个月访视期间分别暴露在正常控制环境（NCE）（23 °C，相对湿度50%）和不良控制环境（ACE）（23 °C，相对湿度10%，局部气流0.43 m/s）中。患者接受了以下评估：结膜充血和染色、使用牛津和角膜与隐形眼镜研究单位（CCLRU）量表的角膜荧光素染色（CFS）、睑板腺（MG）分泌质量、干眼症问卷-5、干眼症症状评估（SANDE II）和干眼症症状变化问卷。多变量模型经过调整后进行统计分析：19 名女性和 1 名男性（平均年龄为 58.9 ± 12.3 岁）完成了研究。治疗 1 个月后，所有症状问卷、CFS、结膜充血和染色以及 MG 分泌物质量均有所改善（p ≤ 0.003）；3 个月后，除 SANDE II（p ≥ 0.07）外，其他症状均有所改善（p ≤ 0.02）。与治疗后1个月（从5.4到5.8）和3个月（从5.0到5.9）相比，基线ACE暴露后（从8.6到10.1）的CFS恶化程度（总CCLRU）更高，但不显著（p = 0.64）：结论：在可控环境条件下，外用 CsA-0.1% CE 治疗 1 个月后可改善 DED 的体征和症状。未来的研究应证实 CsA-0.1% CE 在干燥应激环境中的益处：试验注册：ClinicalTrials.gov标识符，NCT04492878。

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Short-Term Efficacy of Ophthalmic Cyclosporine: A 0.1% Cationic Emulsion in Dry Eye Patients Assessed Under Controlled Environment.

Introduction: To evaluate the short-term efficacy of cyclosporine A (CsA)-0.1% cationic emulsion (CE) in patients with dry eye disease (DED) and mitigation of the inflammatory flares triggered by desiccating stress environments.

Methods: A single-center non-randomized clinical trial was performed at a tertiary care setting. Twenty patients with DED treated with CsA 0.1% CE were exposed to a normal controlled environment (NCE) (23 °C, 50% relative humidity) and an adverse controlled environment (ACE) (23 °C, 10% relative humidity, 0.43 m/s localized airflow) during baseline and the 1- and 3-month visits. Patients underwent the following evaluations: conjunctival hyperemia and staining, corneal fluorescein staining (CFS) using the Oxford and Cornea and Contact Lens Research Unit (CCLRU) scale, meibomian gland (MG) secretion quality, Dry Eye Questionnaire-5, Symptom Assessment in Dry Eye (SANDE II), and Change in Dry Eye Symptoms Questionnaire. Multivariate models were adjusted for statistical analysis.

Results: Nineteen women and one man (mean age, 58.9 ± 12.3 years) completed the study. All symptom questionnaires, CFS, conjunctival hyperemia and staining, and MG secretion quality improved (p ≤ 0.003) with 1 month of treatment; improvements were maintained after 3 months (p ≤ 0.02), except for SANDE II (p ≥ 0.07). The CFS worsening (total CCLRU) after baseline ACE exposure (from 8.6 to 10.1) was higher, although not significant (p = 0.64), compared with 1 month (from 5.4 to 5.8) and 3 months (from 5.0 to 5.9) after treatment.

Conclusion: Topical CsA-0.1% CE improved DED signs and symptoms after 1 month of treatment under controlled environmental conditions. Future studies should confirm the benefit of CsA-0.1% CE in desiccating stress environments.

Trial registration: ClinicalTrials.gov identifier, NCT04492878.

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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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