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Evaluation of the Efficacy and Safety of A Novel 0.05% Cyclosporin A Topical Nanoemulsion in Primary Sjögren's Syndrome Dry Eye.

评价新型 0.05% 环孢菌素A局部纳米乳治疗原发性干燥综合征干眼的疗效和安全性。

  • 影响因子:1.52
  • DOI:10.1080/09273948.2019.1587470
  • 作者列表:"Kang MJ","Kim YH","Chou M","Hwang J","Cheon EJ","Lee HJ","Chung SH
  • 发表时间:2020-04-02
Abstract

:Purpose: To evaluate the efficacy and safety of a novel topical cyclosporin A 0.05% nanoemulsion in comparison with a conventional emulsion in primary Sjögren's syndrome dry eyes.Methods: Prospective, randomized, double-blinded study was conducted.Results: Corneal and conjunctival staining score was improved in both groups, with a faster change noted in the nanoemulsion group at 12 weeks (p < 0.05). Tear film break-up time was significantly improved in the nanoemulsion group at 12 weeks (p < 0.05), while ocular surface disease index score was improved in both groups without a difference at 12 weeks. Schirmer I value and goblet cell grade did not change in both groups. IL-6 and MMP-9 were significantly decreased in both groups at 12 weeks.Conclusions: Both nanoemulsion and conventional cyclosporin A improved ocular signs, symptoms, and conjunctival inflammation. However, the novel cyclosporin A nanoemulsion showed faster improvement of ocular surface staining scores than the conventional emulsion.

摘要

目的: 评价新型局部用环孢菌素a 0.05% 纳米乳与传统乳相比在原发性干燥综合征干眼症中的疗效和安全性。方法: 采用前瞻性、随机、双盲研究方法。结果: 两组角膜和结膜染色评分均有改善,纳米乳组在 12 周时观察到更快的变化 (p <0.05)。12 周时,纳米乳组泪膜破裂时间明显改善 (p <0.05),12 周时两组眼表疾病指数评分均改善,无差异。两组Schirmer I值和杯状细胞分级均无变化。结论: 纳米乳和常规环孢素a均能改善眼部体征、症状和结膜炎症。两组 12 周时IL-6 和MMP-9 均显著下降。然而,新型环孢菌素A纳米乳显示出比常规乳剂更快的眼表染色评分改善。

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作者列表:["Beltai A","Barnetche T","Daien C","Lukas C","Gaujoux-Viala C","Combe B","Morel J"]

METHODS:OBJECTIVE:Patients with immune-mediated inflammatory diseases such as rheumatoid arthritis or systemic lupus erythematosus are at increased risk of cardiovascular disease. However, the cardiovascular risk of patients with primary Sjögren's syndrome (SS) remains poorly studied. We aimed to investigate the association between primary SS and cardiovascular morbidity and mortality. METHODS:We performed a systematic review of articles in Medline and the Cochrane Library and recent abstracts from US and European meetings, searching for reports of randomized controlled studies of cardiovascular morbidity and cardiovascular mortality in primary SS. The relative risk (RR) values for cardiovascular morbidity and mortality associated with primary SS were collected and pooled in a meta-analysis with a random-effects model by using Review Manager (Cochrane collaboration). RESULTS:The literature search revealed 484 articles and abstracts of interest; 14 studies (67,124 patients with primary SS) were included in the meta-analysis. With primary SS versus control populations, the risk was significantly increased for coronary morbidity (RR 1.34 [95% confidence interval (95% CI) 1.06-1.38]; P = 0.01), cerebrovascular morbidity (RR 1.46 [95% CI 1.43-1.49]; P < 0.00001), heart failure rate (odds ratio 2.54 [95% CI 1.30-4.97]; P < 0.007), and thromboembolic morbidity (RR 1.78 [95% CI 1.41-2.25]; P < 0.00001), with no statistically significant increased risk of cardiovascular mortality (RR 1.48 [95% CI 0.77-2.85]; P = 0.24). CONCLUSION:This meta-analysis demonstrates that primary SS is associated with increased cardiovascular morbidity, which suggests that these patients should be screened for cardiovascular comorbidities and considered for preventive interventions, in a multidisciplinary approach with cardiologists.

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发表时间:2020-01-01
DOI:10.1002/acr.23824
作者列表:["Chen SK","Liao KP","Liu J","Kim SC"]

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影响因子:4.13
发表时间:2020-01-01
DOI:10.1002/acr.23827
作者列表:["Lee RR","Rashid A","Thomson W","Cordingley L"]

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