Safety and Efficacy of 0.1% Cyclosporine Solutions in Dry Eye Syndrome: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

IF 1.9 4区 医学 Q2 OPHTHALMOLOGY
Yuri Aleksander-Ivanov, Dillan Cunha Amaral, Lidia Cheidde, Gabriel Nery Lima, Carolina Carvalho Soares Valentim, Michel Sebba Chater, Denisse J Mora-Paez, Jaime Guedes
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引用次数: 0

Abstract

Purpose: Cyclosporine A (CsA) is a primary treatment for dry eye disease (DED). Ophthalmic solutions containing CsA are available in concentrations of 0.05%, 0.09%, and 0.1%. While 0.1% CsA solutions have been used to treat DED, their safety and effectiveness remains somewhat uncertain. Therefore, we conducted a meta-analysis to evaluate their safety and efficacy. Methods: We searched PubMed, Cochrane Database, Embase, and Web of Science for randomized controlled trials (RCTs) that compared 0.1% CsA solutions with their vehicle. Statistical analysis was performed using Review Manager 5.4.1. Results: We included six RCTs (2,170 patients) with follow-up periods ranging from 4 weeks to 6 months. A total of 1,119 patients (51.56%) with DED were treated with 0.1% CsA. The mean age of patients was 57.9 ± 4.8 years, with 79.7% being female. The total corneal fluorescein staining (tCFS) at last follow-up [mean differences (MD) -0.49; 95% confidence interval (CI) (-0.73, -0.24); P < 0.0001], at 4 weeks [MD -0.64; 95% CI (-1.07, -0.22); P = 0.003], and central corneal fluorescein staining (cCFS) [MD -0.19; 95% CI (-0.35, -0.03); P = 0.02] scores were lower in patients treated with 0.1% CsA compared with vehicle. The Lissamine Green conjunctival staining (LGCS) [MD -0.51; 95% CI (-0.78, -0.24); P = 0.0002] and ocular surface disease index (OSDI) scores [MD -3.04; 95% CI (-5.84, -0.23); P = 0.03] were lower in the 0.1% CsA group compared with vehicle. Adverse events associated with 0.1% CsA solution in the treatment of DED varied across studies, but were generally mild to moderate. Notably, similar events were also significantly present in the vehicle group, supporting the safety profile of this treatment. Conclusion: Ophthalmic 0.1% CsA seems safe for treating DED, and significantly reduced tCFS, cCFS, LGCS, and OSDI scores compared with vehicle solutions.

0.1%环孢素溶液治疗干眼综合征的安全性和有效性:随机临床试验的系统评价和荟萃分析。
目的:环孢素A (CsA)是干眼病(DED)的主要治疗药物。含CsA的眼科溶液浓度为0.05%、0.09%和0.1%。虽然0.1%的CsA溶液已被用于治疗DED,但其安全性和有效性仍不确定。因此,我们进行了一项荟萃分析来评估它们的安全性和有效性。方法:我们检索PubMed、Cochrane数据库、Embase和Web of Science中比较0.1% CsA溶液与其载体的随机对照试验(rct)。使用Review Manager 5.4.1进行统计分析。结果:我们纳入了6项随机对照试验(2170例患者),随访时间从4周到6个月不等。共有1119例(51.56%)DED患者接受0.1% CsA治疗。患者平均年龄57.9±4.8岁,女性占79.7%。最后一次随访时角膜荧光素总染色(tCFS)[平均差值(MD) -0.49;95%置信区间(CI) (-0.73, -0.24);P < 0.0001], 4周时[MD -0.64;95% ci (-1.07, -0.22);P = 0.003],中央角膜荧光素染色(cCFS) [MD -0.19;95% ci (-0.35, -0.03);P = 0.02]与对照组相比,0.1% CsA组的评分较低。结膜染色(LGCS) [MD -0.51;95% ci (-0.78, -0.24);P = 0.0002]和眼表疾病指数(OSDI)评分[MD -3.04;95% ci (-5.84, -0.23);P = 0.03], 0.1% CsA组与对照组相比均较低。在不同的研究中,与0.1% CsA溶液治疗DED相关的不良事件各不相同,但一般为轻度至中度。值得注意的是,在车辆组中也显著存在类似事件,支持该治疗的安全性。结论:0.1%眼用CsA治疗DED似乎是安全的,与载药溶液相比,可显著降低tCFS、cCFS、LGCS和OSDI评分。
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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来源期刊
CiteScore
4.60
自引率
4.30%
发文量
72
审稿时长
1 months
期刊介绍: Journal of Ocular Pharmacology and Therapeutics is the only peer-reviewed journal that combines the fields of ophthalmology and pharmacology to enable optimal treatment and prevention of ocular diseases and disorders. The Journal delivers the latest discoveries in the pharmacokinetics and pharmacodynamics of therapeutics for the treatment of ophthalmic disorders. Journal of Ocular Pharmacology and Therapeutics coverage includes: Glaucoma Cataracts Retinal degeneration Ocular infection, trauma, and toxicology Ocular drug delivery and biotransformation Ocular pharmacotherapy/clinical trials Ocular inflammatory and immune disorders Gene and cell-based therapies Ocular metabolic disorders Ocular ischemia and blood flow Proliferative disorders of the eye Eyes on Drug Discovery - written by Gary D. Novack, PhD, featuring the latest updates on drug and device pipeline developments as well as policy/regulatory changes by the FDA.
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