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量子分子共振治疗睑板腺功能障碍疗效及安全性的随机、双盲、假手术对照试验

Randomized, double-masked, sham-controlled trial of efficacy and safety of quantum molecular resonance for treating meibomian gland dysfunction.

作者信息

Uthaithammarat Lita, Kasetsuwan Ngamjit, Reinprayoon Usanee, Chongpison Yuda, Quanchareonsap Wiyada, Dissaneevate Paphaphat

机构信息

Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Bangkok, Thailand.

Center of Excellence for Cornea and Stem Cell Transplantation, Department of Ophthalmology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

出版信息

Eye (Lond). 2025 Jun 27. doi: 10.1038/s41433-025-03890-3.

DOI:10.1038/s41433-025-03890-3
PMID:40579435
Abstract

BACKGROUND

This randomized, double-blind, sham-controlled trial aimed to evaluate the novel quantum molecular resonance (QMR) device for meibomian gland dysfunction (MGD) treatment.

METHODS

Eighty participants diagnosed with MGD were randomized into QMR or sham-QMR groups. Each procedure was performed on days 0, 7, 14, and 21. Primary (meibum quality score) and other secondary outcomes were examined at baseline and weeks 7 and 11. Tear osmolarity and interleukin (IL)-6 and IL-1 receptor agonist levels were evaluated at baseline and week 7. Adverse events were recorded. A multilevel mixed-effect linear regression model was used for data analysis.

RESULTS

Meibum quality (p = 0.008), corneal/conjunctival fluorescein staining score (p = 0.036), telangiectatic vessel area (p = 0.008), and superior (p = 0.011) and inferior (p = 0.020) lid meiboscale were significantly improved in the QMR group than those in the sham-treated group at week 11. Superior lid meiboscale (p = 0.027) and meibomian gland plugging grade (MGPG) (p = 0.017) were significantly improved in the QMR group at week 7. In the QMR group, Ocular Surface Disease Index (OSDI) scores and lid margin thickening grades were significantly lesser at weeks 7 (p = 0.002 and <0.001, respectively) and 11 (both p < 0.001) than the baseline values. At week 7, IL-6 levels were significantly decreased only in the QMR group (p = 0.016). All other parameters did not significantly differ. No serious adverse event occurred.

CONCLUSIONS

The QMR device was effective for MGD treatment, with improvements in meibum quality, corneal/conjunctival staining, telangiectatic vessels, MGPG, superior and inferior lid meiboscale, and decreased OSDI score, lid margin thickening grade, and tear IL-6 level.

摘要

背景

这项随机、双盲、假对照试验旨在评估新型量子分子共振(QMR)设备治疗睑板腺功能障碍(MGD)的效果。

方法

80名被诊断为MGD的参与者被随机分为QMR组或假QMR组。在第0、7、14和21天进行每次治疗。在基线以及第7周和第11周检查主要指标(睑脂质量评分)和其他次要指标。在基线和第7周评估泪液渗透压、白细胞介素(IL)-6和IL-1受体激动剂水平。记录不良事件。采用多水平混合效应线性回归模型进行数据分析。

结果

在第11周时,QMR组的睑脂质量(p = 0.008)、角膜/结膜荧光素染色评分(p = 0.036)、毛细血管扩张面积(p = 0.008)以及上睑(p = 0.011)和下睑睑板腺评分(p = 0.020)均较假治疗组有显著改善。在第7周时,QMR组的上睑睑板腺评分(p = 0.027)和睑板腺堵塞分级(MGPG)(p = 0.017)有显著改善。在QMR组中,第7周(p分别为0.002和<0.001)和第11周(p均<0.001)时,眼表疾病指数(OSDI)评分和睑缘增厚分级均显著低于基线值。在第7周时,仅QMR组的IL-6水平显著降低(p = 0.016)。所有其他参数无显著差异。未发生严重不良事件。

结论

QMR设备对MGD治疗有效,可改善睑脂质量、角膜/结膜染色、毛细血管扩张、MGPG、上睑和下睑睑板腺评分,并降低OSDI评分、睑缘增厚分级和泪液IL-6水平。

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本文引用的文献

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Cureus. 2023 May 30;15(5):e39695. doi: 10.7759/cureus.39695. eCollection 2023 May.
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Association of meibomian gland morphology with orifice plugging and lid margin thickening in meibomian gland dysfunction patients.睑板腺形态与睑板腺功能障碍患者泪小点堵塞和睑缘增厚的相关性。
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Corneal Neuro-Regenerative Effect of Transcutaneous Electrical Stimulation in Rabbit Lamellar Keratectomy Model.兔板层角膜切除术模型中经皮电刺激的角膜神经再生作用。
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