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一项多中心、随机临床试验,评估补充rTG-ω-3对白内障手术后睑板腺功能障碍患者的影响:rTG-ω-3用于睑板腺功能障碍

A Multicenter, Randomized, Clinical Trial Assessing the Effect of rTG-Omega 3 Supplementation on Meibomian Gland Dysfunction Patients after Cataract Surgery rTG-Omega 3 for Meibomian Gland Dysfunction.

作者信息

Hong Suji, Woo Minji, Eom Youngsub, Kim Hong Kyun, Yoon Kyung Chul, Na Kyung Sun, Cho Kyung Jin, Lee Hyung Keun, Song Jong Suk

机构信息

Department of Ophthalmology, Korea University Guro Hospital, Seoul, Republic of Korea.

Department of Ophthalmology, Seoul Shinsegae Eye Center, Eui Jung Bu, Gyeonggi-do, South Korea.

出版信息

J Ocul Pharmacol Ther. 2025 Mar;41(2):65-74. doi: 10.1089/jop.2024.0160. Epub 2025 Feb 5.

Abstract

To investigate the effectiveness of re-esterified triglyceride form of omega 3 (rTG-omega 3) on patients with meibomian gland dysfunction (MGD) after cataract surgery. This multicenter, randomized, investigator-blinded, clinical study was conducted between June 2021 and March 2023 and enrolled 107 patients with MGD who had undergone cataract surgery within 3 months at seven sites across South Korea. Patients were randomly assigned to rTG-omega 3 group or a control group. We compared (1) tear film break-up time (TBUT) (s), (2) corneal fluorescein staining score [National Eye Institute/Industry (NEI) scale], (3) conjunctival fluorescein staining score (NEI scale), (4) strip meniscometry (SM) tube score (mm), (5) MGD stage, (6) MG quality, (7) MG expressibility, (8) Standard Patient Evaluation of Eye Dryness (SPEED) score, and (9) Ocular Surface Disease Index (OSDI) scores at baseline and 6 and 12 weeks. TBUT, corneal fluorescein staining score, and SM tube score were significantly improved in the rTG-omega 3 group compared with control group ( = 0.005, = 0.003, and = 0.0049, respectively). Subjective questionnaire responses were also improved significantly (SPEED score, = 0.022; OSDI score, = 0.0011). MGD parameters were not significantly different. However, during subanalysis, significant improvements in MG quality and expressibility were observed in the MGD stage 4 group with rTG-omega 3 supplementation ( = 0.0177 and 0.0205, respectively). rTG-omega 3 supplementation facilitated improvements in both objective and subjective parameters. In particular, MG quality and expressibility were significantly improved in the severe MGD group.

摘要

研究ω-3的重新酯化甘油三酯形式(rTG-ω-3)对白内障手术后睑板腺功能障碍(MGD)患者的疗效。这项多中心、随机、研究者盲法的临床研究于2021年6月至2023年3月进行,纳入了韩国七个地点在3个月内接受白内障手术的107例MGD患者。患者被随机分配到rTG-ω-3组或对照组。我们比较了(1)泪膜破裂时间(TBUT)(秒)、(2)角膜荧光素染色评分[美国国立眼科研究所/行业(NEI)量表]、(3)结膜荧光素染色评分(NEI量表)、(4)泪液新月形测量(SM)管评分(毫米)、(5)MGD分期、(6)睑板腺质量、(7)睑板腺可挤压性、(8)干眼标准患者评估(SPEED)评分以及(9)基线时、6周和12周时的眼表疾病指数(OSDI)评分。与对照组相比,rTG-ω-3组的TBUT、角膜荧光素染色评分和SM管评分有显著改善(分别为P = 0.005、P = 0.003和P = 0.0049)。主观问卷回答也有显著改善(SPEED评分,P = 0.022;OSDI评分,P = 0.0011)。MGD参数无显著差异。然而,在亚分析中,补充rTG-ω-3的MGD 4期组睑板腺质量和可挤压性有显著改善(分别为P = 0.0177和P = 0.0205)。补充rTG-ω-3有助于客观和主观参数的改善。特别是,重度MGD组的睑板腺质量和可挤压性有显著改善。

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