Epitropoulos Alice T, Donnenfeld Eric D, Shah Zubin A, Holland Edward J, Gross Michael, Faulkner William J, Matossian Cynthia, Lane Stephen S, Toyos Melissa, Bucci Frank A, Perry Henry D
*Ophthalmic Surgeons & Consultants of Ohio, The Eye Center of Columbus; and Department of Ophthalmology, The Ohio State University Wexner Medical Center, Columbus OH; †Ophthalmic Consultants of Long Island, Long Island, NY; ‡PRN Physician Recommended Nutriceuticals, Plymouth Meeting, PA; §Cincinnati Eye Institute, Cincinnati, OH; ¶Matossian Eye Associates, Pennington, NJ; ‖Associated Eye Care, Stillwater, MN; **Toyos Clinic, Nashville, TN; and ††Bucci Laser Vision Institute, Wilkes-Barre, PA.
Cornea. 2016 Sep;35(9):1185-91. doi: 10.1097/ICO.0000000000000940.
To assess the effect of oral re-esterified omega-3 fatty acids on tear osmolarity, matrix metalloproteinase-9 (MMP-9), tear break-up time (TBUT), Ocular Surface Disease Index (OSDI), fluorescein corneal staining, Schirmer score, meibomian gland dysfunction (MGD) stage and omega-3 index in subjects with dry eyes and confirmed MGD.
This was a multicenter, prospective, interventional, placebo-controlled, double-masked study. Subjects were randomized to receive 4 softgels containing a total of 1680 mg of eicosapentaenoic acid/560 mg of docosahexaenoic acid or a control of 3136 mg of linoleic acid, daily for 12 weeks. Subjects were measured at baseline, week 6, and week 12 for tear osmolarity, TBUT, OSDI, fluorescein corneal staining, and Schirmer test with anesthesia. MMP-9 testing and omega-3 index were done at baseline and at 12 weeks.
One hundred five subjects completed the study. They were randomized to omega-3 (n = 54) and control group (n = 51). Statistically significant reduction in tear osmolarity was observed in the omega-3 group versus control group at week 6 (-16.8 ± 2.6 vs. -9.0 ± 2.7 mOsm/L, P = 0.042) and week 12 (-19.4 ± 2.7 vs. -8.3 ± 2.8 mOsm/L, P = 0.004). At 12 weeks, a statistically significant increase in omega-3 index levels (P < 0.001) and TBUT (3.5 ± 0.5 s vs. 1.2 ± 0.5 s, P = 0.002) was also observed. Omega-3 group experienced a significant reduction in MMP-9 positivity versus control group (67.9% vs. 35.0%, P = 0.024) and OSDI scores decreased significantly in omega-3 (-17.0 ± 2.6) versus control group (-5.0 ± 2.7, P = 0.002).
Oral consumption of re-esterified omega-3 fatty acids is associated with statistically significant improvement in tear osmolarity, omega-3 index levels, TBUT, MMP-9, and OSDI symptom scores.
评估口服重新酯化的ω-3脂肪酸对干眼且确诊有睑板腺功能障碍(MGD)患者的泪液渗透压、基质金属蛋白酶-9(MMP-9)、泪膜破裂时间(TBUT)、眼表疾病指数(OSDI)、荧光素角膜染色、泪液分泌试验评分、睑板腺功能障碍(MGD)分期及ω-3指数的影响。
这是一项多中心、前瞻性、干预性、安慰剂对照、双盲研究。受试者被随机分为两组,一组每天服用4粒软胶囊,共含1680毫克二十碳五烯酸/560毫克二十二碳六烯酸,另一组服用含3136毫克亚油酸的对照剂,为期12周。在基线、第6周和第12周对受试者进行泪液渗透压、TBUT、OSDI、荧光素角膜染色及表面麻醉下的泪液分泌试验测量。MMP-9检测和ω-3指数检测在基线和第12周进行。
105名受试者完成了研究。他们被随机分为ω-3组(n = 54)和对照组(n = 51)。在第6周(-16.8±2.6对-9.0±2.7毫摩尔/升,P = 0.042)和第12周(-19.4±2.7对-8.3±2.8毫摩尔/升,P = 0.004)时,ω-3组与对照组相比,泪液渗透压有统计学意义的降低。在第12周时,还观察到ω-3指数水平有统计学意义的升高(P < 0.001)以及TBUT延长(3.5±0.5秒对1.2±0.5秒,P = 0.002)。与对照组相比,ω-3组MMP-9阳性率显著降低(67.9%对35.0%,P = 0.024),且ω-3组的OSDI评分显著降低(-17.0±2.6),而对照组为(-5.0±2.7,P = 0.002)。
口服重新酯化的ω-3脂肪酸与泪液渗透压、ω-3指数水平、TBUT、MMP-9及OSDI症状评分的统计学显著改善相关。