Department of Ophthalmology, Affiliated Hospital of Yanbian University, Yanji, China.
Yanbian University, Yanji, China.
Medicine (Baltimore). 2023 Sep 8;102(36):e34923. doi: 10.1097/MD.0000000000034923.
To compare the efficacy of 0.15% hyaluronic acid (HA), 0.05% cyclosporine A (CsA) and 3% diquafosol sodium (DQS) ophthalmic solution for the treatment of moderate-to-severe dry eye disease (DED) in college students and the effect on inflammatory factors in tears.
This was a prospective, randomized, multicenter trial. A total of 282 college students diagnosed with moderate-to-severe DED between October 2, 2022 and March 1, 2023 were included. A total of 282 patients were randomized to treatment in the group of 0.15% HA or 0.05% CsA or 3% DQS in a 1:1:1 assignment. There was a main end point which is the variations in the corneal staining score to determine non-inferiority of 0.15% HA. Secondary target end points were ocular surface disease index score, Schirmer test, tear meniscus height and tear film breakup time. In addition, the inflammatory factor levels of Interleukin-1β, Interleukin-6, transforming growth factor-β1 in tears were measured. Effectiveness was assessed at baseline, 4- and 12-weeks.
In our analysis, the average change from baseline in corneal staining score confirmed non-inferiority of 0.15% HA to 0.05% CsA and 3% DQS and manifested obvious improvement of all groups as well (P < .05). Values for ocular surface disease index score, Schirmer test, tear meniscus height and tear film breakup time showed obvious improvements in all groups (P < .05), however, the difference intergroup was not statistically significant. Value for inflammatory factor was significant improvement across all groups, although inflammatory factor scores in the 0.05% CsA group showed a clear trend of better improvement at 12 weeks compared with 0.15% HA groups (P < .01). No serious adverse reactions were observed.
College students taking 0.15% HA had clinically and statistically significant improvement in corneal staining score and other indicators, but it was inferior to 0.05% CsA in anti-inflammatory therapy for moderate to severe DED. However, 0.15% HA is still an effective, safe and well-tolerated treatment option that may offer additional benefits in terms of convenience and compliance.
比较 0.15% 透明质酸（HA）、0.05% 环孢素 A（CsA）和 3% 双氯非那酸钠（DQS）滴眼液治疗大学生中重度干眼（DED）的疗效及对泪液中炎症因子的影响。
这是一项前瞻性、随机、多中心试验。2022 年 10 月 2 日至 2023 年 3 月 1 日，共纳入 282 例被诊断为中重度 DED 的大学生。282 例患者随机分为 0.15%HA 组、0.05%CsA 组和 3%DQS 组，每组 1:1:1 分配。主要终点是角膜染色评分的变化，以确定 0.15%HA 的非劣效性。次要终点为眼表疾病指数评分、泪液分泌试验、泪膜破裂时间和泪膜高度。此外，还测量了泪液中白细胞介素-1β、白细胞介素-6、转化生长因子-β1 的炎症因子水平。在基线、4 周和 12 周时评估疗效。
在我们的分析中，角膜染色评分的平均变化证实了 0.15%HA 对 0.05%CsA 和 3%DQS 的非劣效性，所有组均表现出明显的改善（P<.05）。眼表疾病指数评分、泪液分泌试验、泪膜高度和泪膜破裂时间值均在所有组中明显改善（P<.05），但组间差异无统计学意义。所有组的炎症因子值均有明显改善，尽管 0.05%CsA 组的炎症因子评分在 12 周时较 0.15%HA 组有明显改善趋势（P<.01）。未观察到严重不良反应。
大学生使用 0.15%HA 治疗后，角膜染色评分及其他指标均有临床和统计学意义的改善，但在中重度 DED 的抗炎治疗方面不如 0.05%CsA。然而，0.15%HA 仍然是一种有效、安全且耐受性良好的治疗选择，在便利性和依从性方面可能具有额外的优势。
