Cornea and Ocular Surface Unit, Ospedale San Raffaele di Milano, IRCCS, Milan, Italy.
GB Bietti Eye Foudation IRCCS, Rome, Italy.
Br J Ophthalmol. 2014 Aug;98(8):1016-22. doi: 10.1136/bjophthalmol-2013-304072. Epub 2013 Dec 16.
Topical ciclosporin A (CsA) is a therapeutic option for dry eye disease (DED) to control ocular surface inflammation and improve tear function. The aim of this study is to systematically review data from randomised clinical trials (RCTs) evaluating efficacy and safety of topical CsA treatment for DED.
Articles published up to December 2012 were identified from Medline, Embase and the Cochrane Controlled Trials Register. A total of 18 RCTs that evaluated the efficacy and safety of different topical CsA formulations for the treatment of DED were selected according to the set criteria. The Jadad score was calculated to assess RCT quality.
The mean Jadad score of the included RCTs was 2.8±0.6. All CsA formulations proved safe for the treatment of DED. Symptoms improved in 100% (9/9) RCTs, tear function improved in 72% (13/18) RCTs and ocular surface damage was ameliorated in 53% (9/17) RCTs in patients with DED. No improvements with CsA treatment versus control were observed in DED resulting from surgical procedures, contact lens use and thyroid orbitopathy. Statistical comparison of CsA efficacy through a meta-analysis of data was not possible due to a lack of standardised criteria and comparable outcomes among studies.
Although topical CsA appears to be a safe treatment for DED, evidence emerging from RCTs is limited, and this affects the strength of recommendations to healthcare providers and policymakers for optimal management. Standardised diagnostic criteria to assess the efficacy of topical CsA are recommended to improve the design of future RCTs in DED.
局部环孢素 A（CsA）是治疗干眼（DED）的一种治疗选择，可以控制眼表炎症并改善泪液功能。本研究旨在系统评价评估局部 CsA 治疗 DED 的疗效和安全性的随机临床试验（RCT）的数据。
从 Medline、Embase 和 Cochrane 对照试验登记处检索截至 2012 年 12 月发表的文章。根据设定的标准，选择了 18 项评估不同局部 CsA 制剂治疗 DED 的疗效和安全性的 RCT。使用 Jadad 评分评估 RCT 质量。
纳入 RCT 的平均 Jadad 得分为 2.8±0.6。所有 CsA 制剂均被证明可安全治疗 DED。100%（9/9）的 RCT 中症状得到改善，72%（13/18）的 RCT 中泪液功能得到改善，53%（9/17）的 RCT 中眼表损伤得到改善。在因手术、隐形眼镜使用和甲状腺眼病引起的 DED 中，CsA 治疗与对照组相比没有改善。由于缺乏标准化标准和研究间可比的结果，无法通过对数据进行荟萃分析来比较 CsA 的疗效。
尽管局部 CsA 似乎是治疗 DED 的安全治疗方法，但 RCT 提供的证据有限，这影响了向医疗保健提供者和决策者推荐最佳管理方法的建议力度。建议制定评估局部 CsA 疗效的标准化诊断标准，以改进 DED 中未来 RCT 的设计。
