Atikah A, Suzana M, Wan Haslina W A H, Norshamsiah M D, Mushawiahti M, Birinder K S S, Tang S F, Bastion M L C
Department of Ophthalmology, UKM Medical Centre, 56000 Kuala Lumpur, Malaysia.
Department of Biochemistry, UKM Medical Centre, 56000 Kuala Lumpur, Malaysia.
Cont Lens Anterior Eye. 2025 Apr;48(2):102346. doi: 10.1016/j.clae.2024.102346. Epub 2024 Dec 15.
To assess the short-term effects of topical insulin (TI) as compared to topical Systane Ultra (Alcon, USA) as artificial tears (AT) and topical normal saline (NS) on tear inflammatory mediators; interleukin 1-alpha (IL-1a), interleukin 6 (IL-6) and matrix metalloproteinase 9 (MMP-9) and clinical dry eye parameters in diabetics with dry eye disease (DDED).
In this randomized, multi-arm parallel single-centre trial, 73 diabetics with dry eye disease (30 female and 43 male) aged 18 to 50 years were recruited. They were randomly assigned to four weeks of treatment of either TI 0.5 unit/drop, AT or NS four times per day. Tear sample analysis and clinical parameters of dry eye (Ocular Surface Disease Index (OSDI), tear break-up time (TBUT), corneal Oxford score and Schirmers test) were evaluated at baseline and four weeks later. Objective clinical parameters for corneal Oxford score and tear break-up time were assessed by two masked investigators.
Significant reduction was seen in all inflammatory biomarkers (IL-1a, IL-6 and MMP-9) in all treatment groups at 4 weeks. In addition, inflammatory biomarkers demonstrated a significant reduction with TI (p < 0.001). Meanwhile, in AT and NS groups, reduction was also significant but less than TI group. Similarly, significant improvements were seen in all clinical parameters evaluated with all 3 treatments at 4 weeks; with TI group showing largest improvement as compared to AT and NS groups (p < 0.001). This is supported with the results as follows: mean difference -20.90 for OSDI as compared to -11.38 and -6.78 for AT and NS groups, respectively, 5.55 s for TBUT as compared to 3.00 s and 1.00 s for AT and NS group respectively, -2.40 for Oxford score as compared to -0.38 and -1.39 for AT and NS group respectively, and 5.20 mm for Schirmers test as compared to 3.00 mm and 1.00 mm for AT and NS group respectively.
Treatment with TI resulted in the greatest reduction in inflammatory biomarkers and ocular eye parameters, as compared to AT and NS. TI was most effective in improving clinical parameters of DDED, although all topical therapies showed significant improvements, suggesting that use of TI may be beneficial in treating DDED.
评估局部应用胰岛素（TI）与局部应用美国爱尔康公司的思然倍润（Systane Ultra）人工泪液（AT）以及局部应用生理盐水（NS）相比，对干眼患者泪液炎症介质白细胞介素1-α（IL-1α）、白细胞介素6（IL-6）和基质金属蛋白酶9（MMP-9）以及临床干眼参数的短期影响。
在这项随机、多组平行单中心试验中，招募了73名年龄在18至50岁之间的干眼糖尿病患者（30名女性和43名男性）。他们被随机分配接受为期四周的治疗，分别为每天4次，每次滴入TI 0.5单位、AT或NS。在基线和四周后评估泪液样本分析和干眼的临床参数（眼表疾病指数（OSDI）、泪膜破裂时间（TBUT）、角膜牛津评分和泪液分泌试验）。角膜牛津评分和泪膜破裂时间的客观临床参数由两名盲法研究者评估。
在4周时，所有治疗组的所有炎症生物标志物（IL-1α、IL-6和MMP-9）均显著降低。此外，TI治疗组的炎症生物标志物显著降低（p < 0.001）。同时，AT组和NS组也有显著降低，但低于TI组。同样，在4周时，所有3种治疗方法评估的所有临床参数均有显著改善；与AT组和NS组相比，TI组的改善最大（p < 0.001）。结果如下：OSDI的平均差异为-20.90，而AT组和NS组分别为-11.38和-6.78；TBUT分别为5.55秒，而AT组和NS组分别为3.00秒和1.00秒；牛津评分为-2.40，而AT组和NS组分别为-0.38和-1.39；泪液分泌试验为5.20毫米，而AT组和NS组分别为3.00毫米和1.00毫米。
与AT和NS相比，TI治疗导致炎症生物标志物和眼部参数的降低幅度最大。TI在改善干眼糖尿病患者的临床参数方面最有效，尽管所有局部治疗均显示出显著改善，这表明使用TI可能对治疗干眼糖尿病患者有益。
