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新型 0.05%环孢素 A 眼用纳米乳治疗原发性干燥综合征干眼的疗效和安全性评价。

Evaluation of the Efficacy and Safety of A Novel 0.05% Cyclosporin A Topical Nanoemulsion in Primary Sjögren's Syndrome Dry Eye.

机构信息

Department of Ophthalmology and Visual Science, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.

Catholic Institute for Visual Science, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.

出版信息

Ocul Immunol Inflamm. 2020 Apr 2;28(3):370-378. doi: 10.1080/09273948.2019.1587470. Epub 2019 Apr 15.

Abstract

: To evaluate the efficacy and safety of a novel topical cyclosporin A 0.05% nanoemulsion in comparison with a conventional emulsion in primary Sjögren's syndrome dry eyes.: Prospective, randomized, double-blinded study was conducted.: Corneal and conjunctival staining score was improved in both groups, with a faster change noted in the nanoemulsion group at 12 weeks (p < 0.05). Tear film break-up time was significantly improved in the nanoemulsion group at 12 weeks (p < 0.05), while ocular surface disease index score was improved in both groups without a difference at 12 weeks. Schirmer I value and goblet cell grade did not change in both groups. IL-6 and MMP-9 were significantly decreased in both groups at 12 weeks.: Both nanoemulsion and conventional cyclosporin A improved ocular signs, symptoms, and conjunctival inflammation. However, the novel cyclosporin A nanoemulsion showed faster improvement of ocular surface staining scores than the conventional emulsion.

摘要

:评估新型环孢素 A 0.05%纳米乳与传统乳剂在原发性干燥综合征干眼症中的疗效和安全性。:前瞻性、随机、双盲研究。:两组的角膜和结膜染色评分均有所改善,纳米乳组在 12 周时变化更快(p<0.05)。纳米乳组在 12 周时泪膜破裂时间显著改善(p<0.05),而两组的眼表面疾病指数评分在 12 周时均有所改善,无差异。两组的 Schirmer I 值和杯状细胞分级均无变化。两组在 12 周时 IL-6 和 MMP-9 均显著降低。:纳米乳和传统环孢素 A 均改善了眼部体征、症状和结膜炎症。然而,新型环孢素 A 纳米乳显示出比传统乳剂更快的改善眼表面染色评分。

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