Wada Eye Clinic, Houjyo 2578-27, Tateyama-shi, Chiba, 294-0045, Japan.
Itoh Clinic, Saitama, 337-0042, Japan.
Adv Ther. 2024 Jun;41(6):2477-2485. doi: 10.1007/s12325-024-02871-4. Epub 2024 May 6.
This study aimed to investigate the tolerability of high-viscosity diquafosol tetrasodium (DQS) ophthalmic solution (DIQUAS LX; DQSLX) and examine its usability and effect on clinical findings in patients with dry eye disease (DED).
This interventional retrospective study included 66 eyes of 66 patients with DED who switched from conventional DQS to DQSLX ophthalmic solution. Tear function assessments (tear film breakup time [BUT], keratoconjunctival vital staining [VS] score), evaluations of DED symptom relief, and a four-item usability questionnaire ("comfort upon instillation," "irritation upon instillation," "eye mucus discharge," "convenience of instillation frequency") assessed using a visual analog scale from 0 (worst) to 10 (best) were administered 4 weeks after switching to DQSLX. Factors associated with drug tolerability were assessed using multiple regression analysis.
The symptoms improved by 64.2% after switching to DQSLX. The BUT value, VS score, and the questionnaire items "comfort upon instillation" and "convenience of instillation frequency" were significantly improved after switching to DQSLX. DQSLX tolerability was reported as acceptable in 56 (84.8%) and unacceptable in 10 (15.2%) patients. Overall, DQSLX tolerability was significantly associated with "comfort upon instillation" and "convenience of instillation frequency" and tended to be associated with a VS score ≥ 1. DQSLX tolerability depended on symptom and VS score improvements and absence of excessive "eye mucus discharge" in patients with a VS score ≥ 1 (39 patients), but on "comfort upon instillation" and absence of excessive "eye mucus discharge" in patients with a VS score = 0 (27 patients).
The high-viscosity DQSLX ophthalmic solution was generally considered acceptable in the study population. However, drug tolerability seemingly differed between patients with DED with and without epithelial damage. The former were affected by improvements in symptoms and clinical findings, whereas the latter were affected by comfort upon instillation.
University Hospital Medical Information Network identifier, UMIN000051390.
本研究旨在探讨高黏度双氯非那酸钠（DQS）滴眼剂（DIQUAS LX；DQSLX）的耐受性，并考察其在干眼症（DED）患者中的临床应用和效果。
这是一项干预性回顾性研究，纳入了 66 例 DED 患者的 66 只眼，这些患者从常规 DQS 转换为 DQSLX 滴眼剂。在转换为 DQSLX 滴眼剂 4 周后，通过泪膜破裂时间（BUT）、角结膜染色评分（VS）、DED 症状缓解评估以及一项四项目可用性调查问卷（“滴注时舒适度”、“滴注时刺激感”、“眼部黏液排出”、“滴注频率方便性”），对患者的泪液功能、DED 症状缓解效果以及滴眼剂的使用舒适度和便利性进行评估。0（最差）至 10（最好）的视觉模拟量表来评估这些项目的评分。使用多元回归分析评估与药物耐受性相关的因素。
转换为 DQSLX 滴眼剂后，患者的症状改善了 64.2%。BUT 值、VS 评分、“滴注时舒适度”和“滴注频率方便性”这几个项目在转换为 DQSLX 滴眼剂后均有显著改善。56 例（84.8%）患者报告 DQSLX 滴眼剂的耐受性可接受，10 例（15.2%）患者报告不可接受。总体而言，DQSLX 滴眼剂的耐受性与“滴注时舒适度”和“滴注频率方便性”显著相关，且与 VS 评分≥1 相关。在 VS 评分≥1（39 例）的患者中，DQSLX 滴眼剂的耐受性取决于症状和 VS 评分的改善以及是否存在过度的“眼部黏液排出”，而在 VS 评分=0（27 例）的患者中，DQSLX 滴眼剂的耐受性取决于“滴注时舒适度”和是否存在过度的“眼部黏液排出”。
在本研究人群中，高黏度 DQSLX 滴眼剂通常被认为是可接受的。然而，DED 患者的药物耐受性似乎因是否存在上皮损伤而不同。前者的药物耐受性受症状和临床发现的改善影响，而后者则受滴眼剂使用舒适度影响。
日本大学医院医疗信息网络数据库注册号，UMIN000051390。
