背景:一种含有0.2%透明质酸和低浓度氢化可的松(0.001%;以下简称HALH)的创新滴眼剂最近已投放市场(Idroflog®,AlfaIntes,意大利)管理干眼症(DED)患者的副炎症失调。在本论文中,回顾性评估了HALH对DED体征和症状的有效性,并通过低技术和高科技(Keratograph®)评估与使用标准泪液代用品(STS)获得的HALH的有效性进行了比较.
方法:这是一项在2023年2月至4月之间进行的多中心回顾性研究,涉及由于白内障手术后而诊断为DED的成年患者。睑板腺功能障碍,过敏,或青光眼药物。主要目的是比较不同疗法对Keratograph®参数(非侵入性角膜造影撕裂破裂时间[NIKBUT],撕裂弯月面高度[TMH],眼睑动脉造影,结膜充血,和结膜松弛)或通过传统的低技术措施收集(泪液破裂时间[TBUT],Schirmer试验,埃夫隆得分,和上皮改变)和眼表疾病指数评分。
结果:分析了来自155例患者的数据。HALH和STS的有效性是通过高科技和低技术措施报告的。NIKBUT-first在15天的HALH组比STS组有显着改善(6.4±3.6vs5.4±3.7s,p=0.02),而这种差异在低技术TBUT中一直潜伏到45天(6.8±2.6vs5.6±2.3s,p=0.03)。白内障手术后发生DED的患者报告HALH与STS的活性增强,特别是对于NIKBUT-First,TMH,Schirmer试验,和充血阶段。
结论:这些发现强调了HALH在所有DED亚型中的有效性,尤其是白内障术后患者,以及它在改善泪膜稳定性方面相对于STS的优势。我们建议观察时间更长(即,3-6个月),以充分确定即使使用低技术测试,高科技措施检测到的早期改善是否会在随后的时间点得到证实。
BACKGROUND: An innovative eye drops formulation containing 0.2% hyaluronic acid and a low concentration of hydrocortisone (0.001%; hereafter HALH) has been recently placed on the market (Idroflog®, Alfa Intes, Italy) to manage the dysregulated parainflammation in patients with dry eye disease (
DED). In the present paper, the effectiveness of HALH on the signs and symptoms of
DED was retrospectively evaluated and compared with that one obtained using standard tear substitutes (STS) by means of low- and high-tech (Keratograph®) assessments.
METHODS: This was a multicenter retrospective study carried out between February and April 2023, involving adult patients with
DED diagnosis owing to post-cataract surgery, meibomian gland dysfunction, allergy, or glaucoma medications. The primary aim was to compare the changes induced by different therapies on Keratograph® parameters (noninvasive Keratograph tear breakup time [NIKBUT], tear meniscus height [TMH], eyelid meibography, conjunctival hyperemia, and conjunctivochalasis) or collected by traditional low-tech measures (tear breakup time [TBUT], Schirmer test, Efron score, and epithelial alterations) and the Ocular Surface Disease Index score.
RESULTS: Data from 155 patients were analyzed. The effectiveness of HALH and STS was reported by both high- and low-tech measures. NIKBUT-first showed a significant improvement in the HALH group versus the STS one at 15 days (6.4 ± 3.6 vs 5.4 ± 3.7 s, p = 0.02), whereas this difference was latent with low-tech TBUT until 45 days (6.8 ± 2.6 vs 5.6 ± 2.3 s, p = 0.03). Patients with
DED occurring after cataract surgery reported an enhanced activity of HALH versus STS, particularly for NIKBUT-first, TMH, Schirmer test, and hyperemia stage.
CONCLUSIONS: These findings highlighted the effectiveness of HALH in all
DED subtypes, especially in patients with post-cataract surgery, as well as its superiority versus STS in terms of tear film stability improvement. We recommend longer observation (i.e., 3-6 months) to fully ascertain whether the early improvement detected by high-tech measures will be confirmed in subsequent time points even using low-tech tests.