Utheim Tor Paaske, Chen Xiangjun, Fineide Fredrik, Steinkjer Tore, Heegaard Steffen, Kolko Miriam, Dartt Darlene A, Khan Ayyad Zartasht
Department of Medical Biochemistry, Oslo University Hospital, Oslo, Norway.
The Norwegian Dry Eye Clinic, Oslo, Norway.
Acta Ophthalmol. 2025 Feb;103(1):93-98. doi: 10.1111/aos.16758. Epub 2024 Sep 30.
To examine the effectiveness and identify clinical response predictors of a short corticosteroid-based regimen consisting of topical preservative-free 0.1% dexamethasone (Monopex®, Théa Laboratories) in conjunction with artificial tears (AT) for dry eyes in a real-life clinical setting.
Patients were recruited from the Norwegian Dry Eye Clinic and were allowed to use ATs of their own choice in addition to the prescribed 14-day topical dexamethasone course. Ocular Surface Disease Index (OSDI), Dry Eye Questionnaire (DEQ-5), Schirmer test (ST), fluorescein tear film break-up time (FBUT), ocular surface staining (OSS), meibum expressibility (ME), meibum quality (MQ), number of expressible meibomian glands among the central eight glands in the lower lids (N) and intraocular pressure (IOP) were measured at baseline and at 1-month follow-up. The average values of clinical parameters from both eyes were used for analyses. A paired t-test and a significance value of p < 0.05 were used for statistical analyses. Associations between sex, age, baseline values and the changes after the intervention (Δ) were explored using linear regression.
A total of 167 patients (124 women, mean age 54 years ±17 (standard deviation)) were included. One month after initiation of intervention, OSDI and DEQ5 scores improved from 39.5 ± 22.1 to 31.4 ± 21.3 (p < 0.001) and from 12.6 ± 4.2 to 11.0 ± 4.6 (p < 0.001), respectively. OSS improved from 2.2 ± 1.4 to 1.8 ± 1.5 (p < 0.001), N increased from 4.8 ± 2.2 to 5.1 ± 2.2 (p < 0.05), while IOP decreased from 12.9 ± 3.3 to 12.4 ± 3.5 mmHg (p < 0.05). Significant associations were found between the change in symptoms and objective measures of DED (Δ, Δ, Δ, Δ, ΔN, Δ) and their respective baseline values (OSDI, DEQ5, OSS, FBUT, N, MQ). The remaining tests did not show statistically significant changes.
Improvement in dry eye symptoms and signs were observed following a short course of topical, preservative-free 0.1% dexamethasone treatment in combination with AT. Individuals exhibiting more pronounced symptoms and signs witnessed the most profound improvements with the treatment regimen, suggesting that poor baseline parameters may serve as response predictors of the treatment regimen. While the real-life data presented herein are valuable, the conclusions are limited by the inherent biases of a non-controlled study.
在实际临床环境中，研究一种基于皮质类固醇的短期治疗方案的有效性，并确定其临床反应预测因素。该方案为由不含防腐剂的0.1%地塞米松滴眼液（商品名Monopex®，法国Thea Laboratories公司生产）联合人工泪液治疗干眼症。
从挪威干眼症诊所招募患者，除了规定的为期14天的局部地塞米松疗程外，允许患者使用自己选择的人工泪液。在基线和1个月随访时，测量眼表疾病指数（OSDI）、干眼问卷（DEQ-5）、泪液分泌试验（ST）、荧光素泪膜破裂时间（FBUT）、眼表染色（OSS）、睑板腺可挤压性（ME）、睑脂质量（MQ）、下睑中央8个腺体中可挤压睑板腺的数量（N）和眼压（IOP）。使用双眼临床参数的平均值进行分析。采用配对t检验，p < 0.05作为统计分析的显著性值。使用线性回归探讨性别、年龄、基线值与干预后变化（Δ）之间的关联。
共纳入167例患者（124例女性，平均年龄54岁±17（标准差））。干预开始1个月后，OSDI和DEQ5评分分别从39.5 ± 22.1改善至31.4 ± 21.3（p < 0.001）和从12.6 ± 4.2改善至11.0 ± 4.6（p < 0.001）。OSS从2.2 ± 1.4改善至1.8 ± 1.5（p < 0.001），N从4.8 ± 2.2增加至5.1 ± 2.2（p < 0.05），而IOP从12.9 ± 3.3降至12.4 ± 3.5 mmHg（p < 0.05）。在干眼症的症状变化与客观指标（ΔOSDI、ΔDEQ5、ΔOSS、ΔFBUT、ΔN、ΔMQ）及其各自的基线值（OSDI、DEQ5、OSS、FBUT、N、MQ）之间发现了显著关联。其余检查未显示出统计学上的显著变化。
在短期局部使用不含防腐剂的0.1%地塞米松联合人工泪液治疗后，观察到干眼症状和体征有所改善。症状和体征更明显的个体在该治疗方案下改善最为显著，这表明较差的基线参数可能是该治疗方案的反应预测指标。虽然本文提供的实际数据很有价值，但结论受到非对照研究固有偏差的限制。
