Moscovici Bernardo Kaplan, Holzchuh Ricardo, Sakassegawa-Naves Fernando Eiji, Hoshino-Ruiz Diego Ricardo, Albers Marcos Bottene Villa, Santo Ruth Miyuki, Hida Richard Yudi
Department of Ophthalmology, University of São Paulo, School of Medicine (Hospital das Clínicas of da Universidade de São Paulo-São Paulo - HC-USP), Brazil; Department of Ophthalmology, Santa Casa de São Paulo, Brazil.
Department of Ophthalmology, University of São Paulo, School of Medicine (Hospital das Clínicas of da Universidade de São Paulo-São Paulo - HC-USP), Brazil; Department of Ophthalmology, Santa Casa de São Paulo, Brazil.
Cont Lens Anterior Eye. 2015 Oct;38(5):373-8. doi: 10.1016/j.clae.2015.04.004. Epub 2015 May 5.
To describe the clinical efficacy of the treatment of Sjögren's syndrome dry eye using 0.03% tacrolimus eye drop.
Prospective double-blind randomized study.
Institutional outpatient clinic.
Forty-eight eyes of twenty-four patients with dry eye related to Sjögren syndrome were enrolled in this study. The patients were randomized in 2 groups: tacrolimus (n=14) and vehicle (n=10) group.
The tacrolimus group received a vial containing tacrolimus 0.03% (almond oil as vehicle) and the other group received the almond oil vehicle. All patients were instructed to use the eye drops every 12h in the lower conjunctival sac.
Schirmer I test, break-up-time (BUT), corneal fluorescein and Rose Bengal staining scores were evaluated in all patients one day before the treatment (baseline), 7, 14, 28 and 90 days after treatment with the eye drops.
The average fluorescein and Rose Bengal scores improved statistically after 7 days of treatment and even more after 90 days. The average Schirmer I and BUT values were unchanged after 7, 14 and 21 days but did show an improvement relative to baseline after 28 days of treatment. Schirmer I, BUT, fluorescein and Rose Bengal did not show any statistical significance in the vehicle group.
Topical 0.03% tacrolimus eye drop improved tear stability and ocular surface status in cases of inflammatory or SS-related dry eye.
ClinicalTrials.gov Identifier: NCT01850979.
描述使用0.03%他克莫司滴眼液治疗干燥综合征干眼的临床疗效。
前瞻性双盲随机研究。
机构门诊。
24例干燥综合征相关性干眼患者的48只眼纳入本研究。患者随机分为2组：他克莫司组（n = 14）和赋形剂组（n = 10）。
他克莫司组接受一瓶含0.03%他克莫司（以杏仁油为赋形剂），另一组接受杏仁油赋形剂。所有患者均被指示每12小时在下结膜囊滴用眼药水。
在使用眼药水治疗前1天（基线）、治疗后7、14、28和90天对所有患者评估泪液分泌试验（Schirmer I试验）、泪膜破裂时间（BUT）、角膜荧光素和孟加拉玫瑰红染色评分。
治疗7天后荧光素和孟加拉玫瑰红平均评分有统计学意义的改善，90天后改善更明显。治疗7、14和21天后Schirmer I试验和BUT平均值无变化，但治疗28天后相对于基线有改善。赋形剂组的Schirmer I试验、BUT、荧光素和孟加拉玫瑰红评分无统计学意义。
局部应用0.03%他克莫司滴眼液可改善炎症性或干燥综合征相关性干眼的泪液稳定性和眼表状况。
ClinicalTrials.gov标识符：NCT01850979。
