羟丙基纤维素眼科植入物(lacrisert)减少干眼综合征的体征和症状,提高患者的生活质量。

Marguerite McDonald, Gerard D'Aversa, Henry D Perry, John R Wittpenn, Eric D Donnenfeld, Donald S Nelinson
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摘要

目的:进行了一项多中心、2次就诊、开放标签、为期4周的研究,以确定有干眼综合征(DES)病史的成年患者羟丙基纤维素眼膜植入物的可接受性。方法:在就诊1时,对患者(N = 520)进行评估,通过裂隙灯生物显微镜进行筛选,并完成眼表疾病指数(OSDI),这是一种有效的生活质量衡量指标。培训患者正确放置和使用羟丙基纤维素眼科植入物,并在研究的第3天通过电话联系患者。在第4周,患者接受临床评估并完成第二份问卷。答案决定了症状和生活质量的变化。在整个研究过程中监测不良事件。结果:418名患者完成了研究,并报告在使用羟丙基纤维素眼科植入物4周后,不适、灼烧、干燥、沙砾、刺痛和光敏性显著改善(P = 0.05)。据报道,临床症状(角膜炎、结膜染色和泪液体积)有显著改善。与不戴隐形眼镜的人相比,佩戴隐形眼镜的人的视力有了明显的改善,对光线的敏感度也有明显的改善趋势。衡量生活质量的平均OSDI总分显著提高21.3%(从41.8 +/- 22.38降至32.9 +/- 21.97,P < or = 0.0215)。最常见的导致停药的不良事件是视力模糊,8.7%的患者(n = 45)出现视力模糊。研究期间依从性良好;41.5%的受试者完全依从。在58.5%未注射的受试者中,大多数(69.4%)只注射了一到五剂。结论:羟丙基纤维素眼科植入物可显著减轻中重度DES的症状和临床体征,并可显著改善佩戴隐形眼镜患者的DES。根据OSDI测量,患者的生活质量在统计学上有显著改善,改善率为21.3%。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Hydroxypropyl cellulose ophthalmic inserts (lacrisert) reduce the signs and symptoms of dry eye syndrome and improve patient quality of life.

Purpose: A multicenter, 2-visit, open-label, 4-week study was conducted to determine the acceptability of hydroxypropyl cellulose ophthalmic inserts in adult patients with a history of dry eye syndrome (DES).

Methods: At visit 1, patients (N = 520) were evaluated, screened by slit-lamp biomicroscopy, and completed the Ocular Surface Disease Index (OSDI), a validated measure of quality of life. Patients were trained in the proper placement and use of hydroxypropyl cellulose ophthalmic inserts and were contacted by telephone on day 3 of the study. At week 4, patients were given a clinical evaluation and completed a second questionnaire. Answers determined changes in symptoms and quality of life. Adverse events were monitored throughout the study.

Results: Four hundred eighteen patients completed the study and reported significant improvements in discomfort, burning, dryness, grittiness, stinging, and light sensitivity (P = .05) after 4 weeks use of hydroxypropyl cellulose ophthalmic inserts. Significant improvements in clinical signs (keratitis, conjunctival staining, and tear volume) were reported. Contact lens wearers reported significant improvements similar to nonwearers, with a strong trend toward improvement in light sensitivity. Mean OSDI total scores, measuring quality of life, significantly improved by 21.3% (from 41.8 +/- 22.38 to 32.9 +/- 21.97, P < or = .0215). The most commonly reported adverse event leading to discontinuation was blurred vision, observed in 8.7% of patients (n = 45). Compliance during the study was good; 41.5% of subjects were fully compliant. Of the 58.5% of subjects who missed doses, the majority (69.4%) missed only one to five.

Conclusions: Hydroxypropyl cellulose ophthalmic inserts significantly reduced symptoms and clinical signs of moderate to severe DES. They also significantly improved DES in patients wearing contact lenses. Patients experienced a statistically significant improvement in quality of life, as measured by the OSDI, of 21.3%.

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