TearLab Corporation, San Diego, CA, USA.
Cornea. 2012 Sep;31(9):1000-8. doi: 10.1097/ICO.0b013e318242fd60.
To evaluate the efficacy of commonly used biomarkers in dry eye disease management in a longitudinal observational case series study followed by an interventional study in a subset of subjects treated with cyclosporine A (0.05%).
Bilateral tear osmolarity, Schirmer, tear film breakup time (TBUT), staining, meibomian grading, and Ocular Surface Disease Index were measured for a period of 3 consecutive months in participants recruited from a clinic-based population at 2 study sites. Fifty-two subjects completed the study (n = 16 mild/moderate, n = 36 severe; age, 47.1 ± 16.1 years). After the 3-month observation period, severe dry eye patients were prescribed topical cyclosporine A and evaluated for an additional 3 months.
Tear osmolarity (8.7 ± 6.3%) exhibited significantly less variability over a 3-month period than corneal staining (12.2 ± 8.8%, P = 0.040), conjunctival staining (14.8 ± 8.9%, P = 0.002), and meibomian grading (14.3 ± 8.8%, P < 0.0001) across the entire patient population. Osmolarity also demonstrated less variation than TBUT (11.7 ± 9.0%, P = 0.059), Schirmer tests (10.7 ± 9.2%, P = 0.67), and Ocular Surface Disease Index (9.3 ± 7.8%, P = 0.94), although the differences were not significant. Variation in osmolarity was less for mild dry eye patients (5.9 ± 3.1%) than severe dry eye patients (10.0 ± 6.9%, P = 0.038). After treatment, average osmolarity and variability were lowered from 341 ± 18 mOsm/L to 307 ± 8 mOsm/L (P < 0.0001, n = 10). A downward trend in symptoms followed changes in osmolarity, declining from 44 ± 17 mOsm/L to 38 ± 18 mOsm/L (P = 0.35). None of the other signs demonstrated a change after treatment.
Over a 3-month period, tear film osmolarity was found to have the lowest variability among commonly used signs of dry eye disease. Reductions in osmolarity preceded changes in symptoms during therapy.
在一项纵向观察性病例系列研究中评估常用于干眼症管理的生物标志物的疗效，然后在接受环孢素 A（0.05%）治疗的受试者亚组中进行干预研究。
在两个研究地点的诊所人群中招募参与者，在连续 3 个月的时间内测量双侧泪液渗透压、泪液分泌试验、泪膜破裂时间（TBUT）、染色、睑板腺分级和眼表疾病指数。52 名受试者完成了研究（轻度/中度 16 名，重度 36 名；年龄 47.1 ± 16.1 岁）。在 3 个月的观察期后，严重干眼症患者被处方局部环孢素 A 并再评估 3 个月。
与角膜染色（12.2 ± 8.8%，P = 0.040）、结膜染色（14.8 ± 8.9%，P = 0.002）和睑板腺分级（14.3 ± 8.8%，P < 0.0001）相比，整个患者人群的泪液渗透压（8.7 ± 6.3%）在 3 个月内的变化差异显著。渗透压的变化也小于 TBUT（11.7 ± 9.0%，P = 0.059）、Schirmer 试验（10.7 ± 9.2%，P = 0.67）和眼表疾病指数（9.3 ± 7.8%，P = 0.94），尽管差异无统计学意义。轻度干眼症患者的渗透压变化（5.9 ± 3.1%）小于重度干眼症患者（10.0 ± 6.9%，P = 0.038）。治疗后，平均渗透压和变异性从 341 ± 18 mOsm/L 降低至 307 ± 8 mOsm/L（P < 0.0001，n = 10）。渗透压变化后，症状呈下降趋势，从 44 ± 17 mOsm/L 降至 38 ± 18 mOsm/L（P = 0.35）。治疗后，其他体征均无变化。
在 3 个月的时间内，泪膜渗透压在常用的干眼症体征中显示出最低的变异性。在治疗期间，渗透压的降低先于症状的变化。
