Cairo University Kasr Alainy Faculty of Medicine, Cairo, Egypt.
Cairo University Faculty of Pharmacy, Cairo, Egypt.
Eur J Ophthalmol. 2022 Jan;32(1):673-679. doi: 10.1177/1120672121992680. Epub 2021 Feb 2.
To compare the effect of topical application of tacrolimus 0.03% eyedrops versus cyclosporine 0.05% in Sjogren syndrome subjects with severe dry eyes.
A prospective single-blinded simply randomized controlled study.
60 Sjogren patients were randomized intoGroup A: 30 patients were instructed to put tacrolimus 0.03% eyedrops in one eye for 6 months and placebo eyedrops in the other eye, ( = 30, 44.9 ± 12.58 years).Group B: 30 patients were instructed to put cyclosporine 0.05% eyedrops in one eye for 6 months and placebo eyedrops in the other eye ( = 30, 49.4 ± 12.92 years).Main outcome measures: Patients were evaluated at day 0, 90, and 180 for Ocular Surface Disease Index Questionnaire (OSDI), frequency of use of artificial tears, average fluorescein tear break up time (TBUT), ocular surface staining scores, Schirmer I test, meibum quality, and expressibility scores.
Upon comparing both eyedrops, the mean value of OSDI decrease was 38.25 ± 18.29% versus 31.69 ± 18.57% (-value 0.09), SICCA score decrease was 2.97 ± 1.92 versus 2.27 ± 2.02 (-value 0.124) the decrease in artificial tear substitute use was 3.90 ± 2.22 versus 3.63 ± 1.92 (-value 0.616), increase in Schirmer I values were 4.10 ± 4.21 and 4.26 ± 2.00 (-value 0.590) in eyes treated with tacrolimus and cyclosporine respectively. Neither of them affected meibum quality or expressibility scores.
Both tacrolimus and cyclosporine significantly improved patient symptoms, frequency of artificial tears use and ocular surface staining compared to placebo-controlled eyes. However, no significant difference regarding the efficacy of both eyedrops at the end of 6 months treatment of severe dry eyes of Sjögren syndrome patients.
ClinicalTrials.gov. Identifier: NCT03865888.
比较他克莫司 0.03%滴眼剂和环孢素 0.05%滴眼剂在严重干眼症干燥综合征患者中的疗效。
前瞻性单盲随机对照研究。
60 例干燥综合征患者随机分为 A 组：30 例患者被指示在一只眼睛中滴用他克莫司 0.03%滴眼剂，在另一只眼睛中滴用安慰剂滴眼剂（ = 30，44.9 ± 12.58 岁）。B 组：30 例患者被指示在一只眼睛中滴用环孢素 0.05%滴眼剂，在另一只眼睛中滴用安慰剂滴眼剂（ = 30，49.4 ± 12.92 岁）。主要观察指标：在第 0、90 和 180 天，患者使用眼表疾病指数问卷（OSDI）、人工泪液使用频率、平均泪膜破裂时间（TBUT）、眼表染色评分、Schirmer I 试验、睑板腺质量和分泌评分进行评估。
比较两种滴眼剂后，OSDI 均值下降分别为 38.25 ± 18.29%与 31.69 ± 18.57%（-值 0.09），SICCA 评分下降分别为 2.97 ± 1.92 与 2.27 ± 2.02（-值 0.124），人工泪液替代物使用减少分别为 3.90 ± 2.22 与 3.63 ± 1.92（-值 0.616），用他克莫司和环孢素治疗的眼睛的 Schirmer I 值增加分别为 4.10 ± 4.21 和 4.26 ± 2.00（-值 0.590）。两者均未影响睑板腺质量或分泌评分。
与安慰剂对照眼相比，他克莫司和环孢素均能显著改善患者症状、人工泪液使用频率和眼表染色。然而，在 6 个月治疗严重干燥综合征患者的干眼症后，两种滴眼剂的疗效并无显著差异。
ClinicalTrials.gov。标识符：NCT03865888。
