Chen Kai-Yang, Chan Hoi-Chun, Chan Chi-Ming
School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.
School of Pharmacy, China Medical University, Taichung, Taiwan.
Ther Adv Ophthalmol. 2025 May 10;17:25158414251338775. doi: 10.1177/25158414251338775. eCollection 2025 Jan-Dec.
BACKGROUND: Dry eye disease is a common condition that causes symptoms such as dryness, irritation, and blurry vision. The pathophysiology of dry eye disease features both aqueous deficiency (loss of aqueous tear production) and increased evaporation (loss of the lipid layer), with the latter mechanism responsible for most of the disease presentation. Ocular surface disease (OSD) is a prevalent condition, often linked to meibomian gland dysfunction (MGD), characterized by tear film instability and symptoms like dryness and irritation. Thermal pulsation therapy, an FDA-approved treatment for MGD, uses heat and pressure to restore gland function, improving tear film stability and ocular health. Studies show its benefits last up to a year, enhancing Ocular Surface Disease Index (OSDI), tear break-up time (TBUT), and Meibomian Glands Yielding Secretion Score (MGYSS) scores. This systematic review evaluates LipiFlow compared to placebo, warm compresses, and other devices, focusing on safety, efficacy, and its impact on recovery and long-term outcomes. METHODS: A comprehensive search was performed across PubMed, MEDLINE, Embase, and Scopus until December 2024. Only randomized controlled trials (RCTs) evaluating LipiFlow were included. The primary outcomes assessed were OSDI and TBUT, with secondary outcomes including meibomian gland expression scores, corneal fluorescein staining (CFS), MGYSS, and lipid layer thickness (LLT). Meta-analyses were conducted using a random-effects model, and heterogeneity was assessed using ² statistics. RESULTS: Thirteen studies reported OSDI (Std diff -0.076, 95% CI -0.277 to 0.125, = 0.255, ² = 71.21%). Twelve studies evaluated MGYSS, showing significant improvement (Std diff 0.449, 95% CI 0.173-0.725, = 0.001, ² = 78.49%). TBUT results from twelve studies were not statistically significant (Std diff 0.211, 95% CI -0.017 to 0.440, = 0.8350, ² = 0%). CFS showed significant improvement in six studies (Std diff -0.130, 95% CI -0.248 to -0.012, = 0.031, ² = 0%). LLT changes were insignificant (Std diff -0.071, 95% CI -0.381 to 0.239, = 0.653, ² = 0%). CONCLUSION: LipiFlow effectively improves meibomian gland function, as indicated by TBUT, MGYSS, and CFS, but its impact on LLT and OSDI is not significant. The therapy is most beneficial for patients with severe baseline MGD. Further research is needed to establish long-term benefits and patient-specific outcomes.
背景：干眼症是一种常见病症，会引发眼睛干涩、刺痛和视力模糊等症状。干眼症的病理生理学特征包括泪液分泌不足（泪液分泌减少）和蒸发增加（脂质层缺失），后一种机制是导致该病的主要原因。眼表疾病（OSD）是一种常见病症，通常与睑板腺功能障碍（MGD）有关，其特征是泪膜不稳定以及出现干涩和刺痛等症状。热脉动疗法是一种经美国食品药品监督管理局（FDA）批准用于治疗MGD的方法，它利用热量和压力来恢复腺体功能，改善泪膜稳定性和眼部健康。研究表明，其疗效可持续长达一年，可提高眼表疾病指数（OSDI）、泪膜破裂时间（TBUT）和睑板腺分泌评分（MGYSS）。本系统评价将LipiFlow与安慰剂、热敷及其他设备进行比较，重点关注其安全性、有效性以及对恢复和长期预后的影响。 方法：截至2024年12月，在PubMed、MEDLINE、Embase和Scopus数据库中进行了全面检索。仅纳入评估LipiFlow的随机对照试验（RCT）。评估的主要结局指标为OSDI和TBUT，次要结局指标包括睑板腺排出评分、角膜荧光素染色（CFS）、MGYSS和脂质层厚度（LLT）。采用随机效应模型进行荟萃分析，并使用I²统计量评估异质性。 结果：13项研究报告了OSDI（标准化差异-0.076，95%可信区间-0.277至0.125，P = 0.255，I² = 71.21%）。12项研究评估了MGYSS，显示有显著改善（标准化差异0.449，95%可信区间0.173至0.725，P = 0.001，I² = 78.49%）。12项研究的TBUT结果无统计学意义（标准化差异0.211，95%可信区间-0.017至0.440，P = 0.8350，I² = 0%）。6项研究显示CFS有显著改善（标准化差异-0.130，95%可信区间-0.248至-0.012，P = 0.031，I² = 0%）。LLT变化不显著（标准化差异-0.071，95%可信区间-0.381至0.239，P = 0.653，I² = 0%）。 结论：如TBUT、MGYSS和CFS所示，LipiFlow能有效改善睑板腺功能，但其对LLT和OSDI的影响不显著。该疗法对基线MGD严重的患者最为有益。需要进一步研究以确定其长期益处和针对患者的具体结局。
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