■干眼病(DED)是多因素的,其特征是泪膜稳态的丧失,导致泪膜不稳定的循环,泪液高渗透压,和炎症。虽然人工泪液是传统的治疗方法,解决潜在的病理生理学可以缓解症状并防止进展。越来越多的证据表明口服营养补充剂在多种眼科疾病中的作用,包括DED。叶黄素,玉米黄质,姜黄素,和维生素D3已在眼部模型中表现出保护和抗炎特性。这个未来,随机化,双盲,平行,安慰剂对照研究评估了叶黄素专有混合物的疗效和安全性,玉米黄质异构体,姜黄素,和维生素D3(LCD)作为成人DED参与者的每日补充剂。
■参与者被随机分配接受一种LCD补充胶囊(叶黄素20mg,玉米黄质异构体4毫克,姜黄素200毫克姜黄素,和维生素D3600IU)或安慰剂每天8周(LCD,n=77;安慰剂,n=78)。主要结果为泪液体积变化(Schirmer试验)和眼部症状(眼表疾病指数[OSDI])。
该研究达到了其主要终点:LCD组表现出明显更好的Schirmer测试成绩和OSDI总评分的改善,与安慰剂相比,在第56天(两者的p<0.001)。总OSDI的分数,症状和视觉领域,到第14天,LCD与安慰剂相比有显著改善,(全部p<0.05)并维持至第56天(p<0.001)。此外,LCD组显着改善泪膜破裂时间(TBUT)和泪膜渗透压,与安慰剂相比,到第56天(p<0.001),随着角膜和结膜染色的显着改善(两者p<0.001),和炎症(基质金属蛋白酶-9;每只眼睛p<0.001)。总标准患者眼干评价(SPEED)评分,以及频率和严重性域的分数,到第14天,LCD相对于安慰剂显著改善(全部p<0.05),并维持至第56天(p<0.001)。人工泪液的使用在组间没有差异。补充剂耐受性良好。
■每日补充一次LCD可显著改善泪液产生,稳定性和质量,减少眼表损伤和炎症,和改善参与者的症状。LCD补充剂可以为DED患者提供有用的辅助人工泪液(NCT05481450)。
UNASSIGNED: Dry eye disease (DED) is multifactorial and characterized by a loss of tear film homeostasis that causes a cycle of tear film instability, tear hyperosmolarity, and inflammation. While artificial tears are the traditional mainstay of treatment, addressing the underlying pathophysiology could relieve symptoms and prevent progression. Increasing evidence indicates a role for oral nutritional supplementation in multiple ophthalmic diseases, including DED.
Lutein, zeaxanthin, curcumin, and vitamin D3 have demonstrated protective and anti-inflammatory properties in ocular models. This prospective, randomized, double-blind, parallel, placebo-controlled study evaluated the efficacy and safety of a proprietary blend of
lutein, zeaxanthin isomers, curcumin, and vitamin D3 (LCD) as a daily supplement in adult participants with DED.
UNASSIGNED: Participants were randomized to receive one LCD supplement capsule (
lutein 20 mg, zeaxanthin isomers 4 mg, curcumin 200 mg curcuminoids, and vitamin D3 600 IU) or placebo per day for 8 weeks (LCD, n=77; placebo, n=78). Primary outcomes were changes in tear volume (Schirmer\'s test) and ocular symptoms (Ocular Surface Disease Index [OSDI]).
UNASSIGNED: The study met its primary endpoints: the LCD group demonstrated significantly better Schirmer\'s test scores and improvement in overall OSDI score, versus placebo, at Day 56 (p<0.001 for both). Scores for total OSDI, and symptoms and vision domains, significantly improved by Day 14 for LCD versus placebo, (p<0.05 for all) and were maintained to Day 56 (p<0.001). In addition, the LCD group demonstrated significantly improved tear film break-up time (TBUT) and tear film osmolarity, versus placebo, by Day 56 (p<0.001), along with significant improvements in corneal and conjunctival staining (p<0.001 for both), and inflammation (matrix metalloproteinase-9; p<0.001 for each eye). Total Standard Patient Evaluation of Eye Dryness (SPEED) score, and scores for the frequency and severity domains, were significantly improved by Day 14 for LCD versus placebo (p<0.05 for all) and maintained to Day 56 (p<0.001). There was no difference between groups for artificial tear usage. The supplement was well-tolerated.
UNASSIGNED: Once-daily LCD supplementation significantly improved tear production, stability and quality, reduced ocular surface damage and inflammation, and improved participants\' symptoms. LCD supplementation could offer a useful adjunct to artificial tears for patients with DED (NCT05481450).