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局部用0.05%环孢素滴眼液治疗干眼综合征的疗效与安全性:一项系统评价和Meta分析

Efficacy and Safety of Topical 0.05% Cyclosporine Eye Drops in the Treatment of Dry Eye Syndrome: A Systematic Review and Meta-analysis.

作者信息

Wan Kelvin H, Chen Li Jia, Young Alvin L

机构信息

Department of Ophthalmology, Tuen Mun Eye Center and Tuen Mun Hospital, Hong Kong; Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong.

Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital and Alice Ho Liu Ling Nethersole Hospital, Hong Kong; Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong.

出版信息

Ocul Surf. 2015 Jul;13(3):213-25. doi: 10.1016/j.jtos.2014.12.006. Epub 2015 Apr 11.

DOI:10.1016/j.jtos.2014.12.006
PMID:26045239
Abstract

A systematic review was performed to evaluate the safety and efficacy of topical 0.05% cyclosporine in treating patients with dry eye syndrome (DES). Twelve qualified randomized-controlled trials incorporating 1367 patients were analyzed. In comparison to controls, patients who were on topical 0.05% cyclosporine eye drops had lower Ocular Surface Disease Index scores (mean difference [MD]=4.10, 95% CI: 0.25-7.96, P=.04), longer tear film breakup time (MD=2.30 seconds, 95% CI: 0.75-3.86, P=.004), improved Schirmer I scores (MD=2.77 mm/5min, 95% CI: 1.63-3.91, P=.00001), reduced corneal fluorescein staining (standardized mean difference [SMD]=0.61, 95% CI: 0.07-1.15, P=.03), and higher goblet cell densities (SMD=1.68, 95% CI: 0.54-2.81, P=.004). However, there were more adverse effects in the cyclosporine patient group (odds ratio=1.64, 95% CI: 1.17-2.30, P=.004). Topical 0.05% cyclosporine eye drops twice daily significantly improved both the objective and subjective outcomes in DES patients. The study limitations in the clinical, methodological and statistical heterogeneities are discussed.

摘要

进行了一项系统评价,以评估局部用0.05%环孢素治疗干眼综合征(DES)患者的安全性和有效性。分析了纳入1367例患者的12项合格随机对照试验。与对照组相比,使用局部0.05%环孢素滴眼液的患者眼表疾病指数得分更低(平均差[MD]=4.10,95%置信区间:0.25 - 7.96,P = 0.04),泪膜破裂时间更长(MD = 2.30秒,95%置信区间:0.75 - 3.86,P = 0.004),泪液分泌试验I型评分改善(MD = 2.77 mm/5分钟,95%置信区间:1.63 - 3.91,P = 0.00001),角膜荧光素染色减少(标准化平均差[SMD]=0.61,95%置信区间:0.07 - 1.15,P = 0.03),杯状细胞密度更高(SMD = 1.68,95%置信区间:0.54 - 2.81,P = 0.004)。然而,环孢素患者组的不良反应更多(优势比=1.64,95%置信区间:1.17 - 2.30,P = 0.004)。每天两次局部使用0.05%环孢素滴眼液可显著改善DES患者的客观和主观结局。讨论了该研究在临床、方法学和统计学异质性方面的局限性。

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