两种含透明质酸的人工泪液治疗白内障术后干眼症的评估：随机对照试验

IF 2.6 3区医学 Q2 OPHTHALMOLOGY

Ophthalmology and Therapy Pub Date : 2024-10-01 Epub Date: 2024-08-10 DOI:10.1007/s40123-024-01015-9

Chi-Chin Sun, Yuan-Hsi Chan, Pei-Wei Huang, Nan-Ni Chen

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引用次数: 0

摘要

简介：本研究比较了羟丙基瓜尔胶（HPG）/透明质酸（HA）和羧甲基纤维素（CMC）/透明质酸润滑剂滴眼液对白内障术后干眼症（DED）的疗效：这是一项前瞻性、开放标签、评估者掩蔽、平行随机对照研究。70名接受白内障手术的DED患者按1:1的比例随机接受1-2滴HPG/HA或CMC/HA润滑剂，每天4次，连续3周。疗效评估包括第1周和第3周的角膜荧光素染色（CFS）评分、眼表疾病指数评分、Schirmer测试评分（无麻醉）、泪液破裂时间和中心角膜敏感度与基线相比的变化：每组各有 35 名患者。第 1 周时，HPG/HA 组的 CFS 评分（以平均值和标准差表示）改善情况优于 CMC/HA 组（- 1.0 [1.7] vs. - 0.1 [1.7]，p = 0.039），第 3 周时，两组结果相当（- 1.6 [1.8] vs. - 1.3 [1.9]，p = 0.552）。在第 1 周和第 3 周，各组间的其他次要结果没有统计学差异（P > 0.05）。本研究仅报告了一起不良事件，发生在 HPG/HA 组。眼压升高的不良反应很轻微，被认为与研究治疗无关，并在一周内缓解：结论：与 CMC/HA 滴眼液相比，HPG/HA 润滑滴眼液在治疗 1 周后的 CFS 评分更高。HPG/HA和CMC/HA滴眼液安全且耐受性良好：Gov identifier：NCT06221345。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Evaluation of Two Artificial Tears Containing Hyaluronic Acid for Post Cataract Surgery Dry Eye Disease: A Randomized Controlled Trial.

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Evaluation of Two Artificial Tears Containing Hyaluronic Acid for Post Cataract Surgery Dry Eye Disease: A Randomized Controlled Trial.

Introduction: This study compared the efficacy of hydroxypropyl guar (HPG)/hyaluronic acid (HA) and carboxymethylcellulose (CMC)/HA lubricant eye drops for post-cataract surgery dry eye disease (DED).

Methods: This was a prospective, open-label, assessor-masked, parallel, randomized controlled study. Seventy patients with DED who underwent cataract surgery were randomized in a 1:1 ratio to receive 1-2 drops of HPG/HA or CMC/HA lubricant four times daily for 3 weeks. Efficacy assessments included changes from baseline in corneal fluorescein staining (CFS) score, Ocular Surface Disease Index score, Schirmer's test score (without anesthesia), tear break-up time, and central corneal sensitivity at weeks 1 and 3.

Results: There were 35 patients in each group. The HPG/HA group demonstrated superior improvements in CFS scores (expressed as means and standard deviations) to the CMC/HA group at week 1 ( - 1.0 [1.7] vs. - 0.1 [1.7], p = 0.039) and demonstrated comparable results at week 3 ( - 1.6 [1.8] vs. - 1.3 [1.9], p = 0.552). No statistical differences were observed in other secondary outcomes between groups at weeks 1 and 3 (p > 0.05). Only one adverse event was reported in this study, which occurred in the HPG/HA group. The AE of ocular hypertension was mild, deemed unrelated to the study treatment, and resolved within a week.

Conclusions: The HPG/HA lubricant eye drops resulted in greater CFS scores at 1 week after treatment compared with CMC/HA drops. The HPG/HA and CMC/HA drops were safe and well tolerated.

Clinicaltrials:

Gov identifier: NCT06221345.

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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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