一种新型多成分补充剂可减轻眼部炎症并改善人类泪液的分泌及质量。
A Novel Multi-Ingredient Supplement Reduces Inflammation of the Eye and Improves Production and Quality of Tears in Humans.
作者信息
Radkar Pranav, Lakshmanan Prabhu Shankar, Mary Jenet Jemila, Chaudhary Sunil, Durairaj Sathish Kumar
机构信息
Lifepoint Multispeciality Hospital, 145/1, Mumbai-Bangalore Highway, Wakad, Pune, Maharashtra, 411057, India.
G7 Synergon Private Limited, 537, 5th Main, 9th Cross, Sahakarnagar Post, Tatanagar, Bangalore, Karnataka, 560092, India.
出版信息
Ophthalmol Ther. 2021 Sep;10(3):581-599. doi: 10.1007/s40123-021-00357-y. Epub 2021 Jun 15.
INTRODUCTION
Dry eye is a multifactorial condition of the eye caused by insufficient tear production and imbalance in tear composition leading to faster evaporation of tear fluid. It is also associated with inflammation that often leads to ocular surface damage. Symptoms of dry eyes include itchiness, soreness, red eyes, a burning sensation, eye fatigue and blurred vision. The objective of this study was to evaluate the efficacy and safety of our multi-ingredient supplement in subjects with dry eye syndrome (DES).
METHODS
We recruited 60 subjects with mild to moderate DES who were randomized in a 1:1 ratio in a single-center study to receive LCD (lutein 20 mg, zeaxanthin 4 mg, curcumin 200 mg curcuminoids, vitamin D3 600 IU) or placebo (soybean oil) capsules for 8 weeks. The primary outcomes evaluated were changes in tear volume by Schirmer's test and ocular symptoms by the Ocular Surface Disease Index (OSDI); secondary outcomes included evaluation of changes in Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, tear film break-up time (TBUT), corneal and conjunctival staining, tear osmolarity, matrix metalloproteinase-9 (MMP-9), artificial tear use and safety assessments. The outcomes were compared between the LCD and placebo groups at baseline and day 56 of supplementation.
RESULTS
Fifty-nine subjects, 30 from LCD and 29 from placebo group, completed the study. The LCD group showed significant improvements (P < 0.0001) for Schirmer's test, OSDI, TBUT, SPEED, ocular staining scores, tear osmolarity (P = 0.0005), MMP-9 (P = 0.0017) and reduced artificial tear use (P = 0.0004) and its frequency of use (P < 0.0001) in subjects compared to placebo from baseline to day 56. No safety issues were observed in the study.
CONCLUSION
The LCD supplement showed significant improvements in the production, stability and quality of tears by reducing ocular surface damage and tear inflammation and can be used as an adjuvant to artificial tears in subjects with DES.
TRIAL REGISTRATION
Clinical Trials Registry of India (http://ctri.nic.in/) identifier: CTRI/2021/01/030493.
引言
干眼症是一种多因素导致的眼部疾病，由泪液分泌不足和泪液成分失衡引起，导致泪液更快蒸发。它还与炎症相关，炎症常导致眼表损伤。干眼症的症状包括瘙痒、酸痛、眼红、烧灼感、眼疲劳和视力模糊。本研究的目的是评估我们的多成分补充剂对干眼症综合征（DES）患者的疗效和安全性。
方法
我们招募了60名轻度至中度DES患者，在一项单中心研究中，他们以1:1的比例随机分组，接受LCD（叶黄素20毫克、玉米黄质4毫克、姜黄素200毫克姜黄素类、维生素D3 600国际单位）或安慰剂（大豆油）胶囊，为期8周。评估的主要结局是通过泪液分泌试验测定的泪液量变化以及通过眼表疾病指数（OSDI）评估的眼部症状；次要结局包括评估干眼标准患者评估（SPEED）问卷的变化、泪膜破裂时间（TBUT）、角膜和结膜染色、泪液渗透压、基质金属蛋白酶-9（MMP-9）、人工泪液使用情况和安全性评估。在补充剂服用的基线和第56天，比较LCD组和安慰剂组之间的结局。
结果
59名受试者完成了研究，其中30名来自LCD组，29名来自安慰剂组。与安慰剂组相比，从基线到第56天，LCD组在泪液分泌试验、OSDI、TBUT、SPEED、眼部染色评分、泪液渗透压（P = 0.0005）、MMP-9（P = 0.0017）方面有显著改善，人工泪液使用量减少（P = 0.0004）及其使用频率降低（P < 0.0001）。研究中未观察到安全问题。
结论
LCD补充剂通过减少眼表损伤和泪液炎症，在泪液的产生、稳定性和质量方面有显著改善，可作为DES患者人工泪液的辅助用药。
试验注册
印度临床试验注册中心（http://ctri.nic.in/）标识符：CTRI/2021/01/030493。
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