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Efficacy of topical ophthalmic drugs in the treatment of dry eye disease: A systematic literature review

机译：局部眼科药物治疗干眼症的疗效：系统文献综述

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摘要

Dry eye disease (DED) is a multifactorial and complex disease of the ocular surface, with a high prevalence in adults. We systematically reviewed efficacy and safety data from published articles reporting results from prospective, controlled trials of topical ophthalmic drugs for DED. PubMed was searched for articles from January 1997 to October 2017. Twenty-six unique trials investigating 13 ophthalmic drugs were identified, including trials of the approved drugs cyclosporine A, cyclosporine A cationic emulsion, diquafosol, rebamipide and lifitegrast. All identified studies provided level 1 evidence. None of the large (N > 100) studies demonstrated statistical significance of primary endpoints for both a sign and a symptom endpoint versus a control treatment in the same published trial. Publications on lifitegrast reported statistical superiority in a symptom or sign endpoint versus the control group in a large (N > 200), multicenter trial, with results repeated in trials of similar design. The most common adverse events associated with the approved drugs related to ocular discomfort upon instillation, especially burning/stinging and ocular irritation. The trial design and endpoints used across the studies varied considerably, highlighting the importance of standardization in clinical trials for DED. Recent advances in drug delivery and improved understanding of DED should contribute to new ophthalmic drug approvals.
机译：干眼症（DED）是眼表面的多重型和复杂的疾病，在成人中具有很高的流行。我们系统地审查了来自已发表的文章报告结果的疗效和安全数据来自预期，对照试验的局部眼科药物的预示。 Pubmed于1997年1月至2017年10月搜查了文章。确定了调查13种眼科药物的二十六项独特试验，包括批准的药物环孢菌素A，环孢菌素阳离子乳液，己孢素醇，重生和LifiteGrast的试验。所有确定的研究都提供了1级证据。大（N> 100）的研究都没有表现出符号和症状终点与同一公开试验中的对照治疗的统计学意义。 LifiteGrast上的出版物报告了症状或标志端点的统计优势与对照组在大（n> 200），多中心试验中，在类似设计的试验中重复的结果。与灌注的批准药物有关的最常见的不良事件，特别是滴注，特别是燃烧/刺痛和眼睛刺激。这些研究中使用的试验设计和终点大大变化，突出了标准化在临床试验中的重要性。药物交付的最新进展和改善对李帝的理解应该有助于新的眼科毒品批准。

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