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核黄素共轭修饰透明质酸钠（Har® 0.1%）作为润滑眼药水治疗干眼症：一项前瞻性随机研究。

Modified Sodium hyaluronate conjugated to riboflavin (Har® 0.1 %) as lubricant eyedrops in the treatment of dry eye: A prospective randomised study.

作者信息

Caruso Ciro, D'Andrea Luca, Rinaldi Michele, Senese Ivana, Piscopo Raffaele, Costagliola Ciro

机构信息

Corneal Transplant Center, Pellegrini Hospital, Naples, Italy.

Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples "Federico II", Department of Public Health, Naples, Italy.

出版信息

Heliyon. 2024 Jul 31;10(15):e35527. doi: 10.1016/j.heliyon.2024.e35527. eCollection 2024 Aug 15.

DOI:10.1016/j.heliyon.2024.e35527
PMID:39170271
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11336708/
Abstract

BACKGROUND

This study evaluates the therapeutic efficacy of HAr® (a novel ophthalmic solution containing modified hyaluronic acid covalently linked to riboflavin) compared to hyaluronic acid eye drops in patients with dry eye disease (DED).

METHODS

Sixteen consecutive patients with bilateral medium to severe DED were divided into two groups. Group 1 received HAr® 0.1 % (Ribohyal®), while Group 2 received HA 0.1 % eye drops. Parameters such as Ocular Surface Disease Index (OSDI) score, osmolarity, break-up time (BUT), non-invasive BUT (NIBUT), tear meniscus measurement, Schirmer test, and Oxford Staining were evaluated. This study has been successfully registered on ClinicalTrials.gov public (Identifier NCT06122428).

RESULTS

The Ribohyal group showed faster improvement in OSDI scores, with a statistically significant difference at 2 h (mean classification difference: -51.75; p = 0.0003). Photophobia significantly reduced at 2 h, 4 weeks, and 8 weeks in the Ribohyal group compared to baseline (p < 0.0001). Osmolarity improved significantly after 8 weeks in both groups (p < 0.0001).

CONCLUSIONS

HAr® 0.1 % (Ribohyal®) effectively reduced DED symptoms and improved photophobia within 2 h of instillation, lasting up to 8 weeks.

摘要

背景

本研究评估了HAr®（一种含有与核黄素共价连接的改性透明质酸的新型眼科溶液）与透明质酸滴眼液相比，对干眼症（DED）患者的治疗效果。

方法

连续纳入16例双侧中重度DED患者，分为两组。第1组接受0.1%的HAr®（Ribohyal®），而第2组接受0.1%的透明质酸滴眼液。评估了眼表疾病指数（OSDI）评分、渗透压、泪膜破裂时间（BUT）、非侵入性泪膜破裂时间（NIBUT）、泪液弯月面测量、Schirmer试验和牛津染色等参数。本研究已在ClinicalTrials.gov上成功注册（标识符NCT06122428）。

结果

Ribohyal组的OSDI评分改善更快，在2小时时具有统计学显著差异（平均分类差异：-51.75；p = 0.0003）。与基线相比，Ribohyal组在2小时、4周和8周时畏光症状明显减轻（p < 0.0001）。两组在8周后渗透压均有显著改善（p < 0.0001）。

结论

0.1%的HAr®（Ribohyal®）可有效减轻DED症状，并在滴注后2小时内改善畏光症状，持续长达8周。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1bf6/11336708/79f829295b1e/gr6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1bf6/11336708/2f66eed0b6a4/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1bf6/11336708/726ff1ba2c31/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1bf6/11336708/b4f796d79e88/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1bf6/11336708/e2322fb2c932/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1bf6/11336708/1a180b782cb9/gr5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1bf6/11336708/79f829295b1e/gr6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1bf6/11336708/2f66eed0b6a4/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1bf6/11336708/726ff1ba2c31/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1bf6/11336708/b4f796d79e88/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1bf6/11336708/e2322fb2c932/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1bf6/11336708/1a180b782cb9/gr5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1bf6/11336708/79f829295b1e/gr6.jpg

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