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一项关于交联透明质酸凝胶(Lacrifill)与0.05%环孢素A(Restasis)治疗干眼病的回顾性交叉研究。

A Retrospective Crossover Study on Cross-Linked Hyaluronic Acid Gel (Lacrifill) Versus Cyclosporine A 0.05% (Restasis) for Dry Eye Disease.

作者信息

Nordin Bradley A

机构信息

Ophthalmology, Huffman and Huffman Eye Physicians and Surgeons, London, USA.

出版信息

Cureus. 2025 Aug 31;17(8):e91343. doi: 10.7759/cureus.91343. eCollection 2025 Aug.

Abstract

PURPOSE

This retrospective crossover study compares two-month outcomes of cyclosporine A ophthalmic emulsion 0.05% (Restasis) versus cross-linked hyaluronic acid gel (Lacrifill), a novel canalicular occlusive device, in 20 patients with refractory aqueous-deficient dry eye disease (DED) at a rural optometry clinic.

METHODS

In patients with moderate to severe DED, two-month outcomes for Restasis and Lacrifill (after a washout period) were compared using tear breakup time (TBUT), Schirmer scores, corneal staining (Efron scale), and Ocular Surface Disease Index (OSDI) scores. Paired t-tests or Wilcoxon signed-rank tests were used (p<0.05), with strict adherence to ethical compliance.

RESULTS

Both treatments improved TBUT, Schirmer scores, corneal staining, and OSDI from baseline (p<0.001). Lacrifill outperformed Restasis: TBUT (+2.28 vs. +1.30 s, p<0.001), Schirmer (+2.33 vs. +1.08 mm, p=0.001), staining (-1.03 vs. -0.55 grade, p=0.003), and OSDI (-33.33 vs. -10.83 points, p<0.001). Eye-level analyses (N=40) confirmed these findings, with no age or sex associations (p>0.05).

CONCLUSION

Lacrifill provided superior tear retention and symptom relief during the first two months of treatment compared to Restasis in refractory aqueous-deficient DED, supporting occlusion therapies in DED management. Larger prospective trials are needed to confirm efficacy and explore the use of combination therapies (typically three to six months).

摘要

目的

本回顾性交叉研究比较了在一家农村验光诊所中,20例难治性水液缺乏型干眼病(DED)患者使用0.05%环孢素A眼用乳剂(Restasis)与新型泪小管阻塞装置交联透明质酸凝胶(Lacrifill)两个月后的疗效。

方法

在中重度DED患者中,使用泪膜破裂时间(TBUT)、Schirmer评分、角膜染色(Efron分级)和眼表疾病指数(OSDI)评分,比较Restasis和Lacrifill(经过洗脱期后)两个月的疗效。采用配对t检验或Wilcoxon符号秩检验(p<0.05),严格遵守伦理规范。

结果

两种治疗方法均使TBUT、Schirmer评分、角膜染色和OSDI较基线水平有所改善(p<0.001)。Lacrifill的疗效优于Restasis:TBUT(+2.28秒对+1.30秒,p<0.001)、Schirmer评分(+2.33毫米对+1.08毫米,p=0.001)、角膜染色(-1.03级对-0.55级,p=0.003)和OSDI(-33.33分对-10.83分,p<0.001)。单眼分析(N=40)证实了这些结果,且无年龄或性别相关性(p>0.05)。

结论

在难治性水液缺乏型DED的治疗中,与Restasis相比,Lacrifill在治疗的前两个月提供了更好的泪液潴留和症状缓解效果,支持在DED管理中采用阻塞疗法。需要更大规模的前瞻性试验来证实疗效并探索联合疗法的应用(通常为三到六个月)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/148c/12399288/d9c06dd2b17f/cureus-0017-00000091343-i01.jpg

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