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局部小剂量无防腐剂的氢化可的松对伴有或不伴有青光眼的眼表疾病患者眼压的影响。

Effects of topical low-dose preservative-free hydrocortisone on intraocular pressure in patients affected by ocular surface disease with and without glaucoma.

机构信息

Department of Medicine and Health Sciences "Vincenzo Tiberio", University of Molise, Campobasso, Italy.

"Villa Dei Fiori" Hospital, Acerra, Naples, Italy.

出版信息

Graefes Arch Clin Exp Ophthalmol. 2022 Jan;260(1):247-253. doi: 10.1007/s00417-021-05345-3. Epub 2021 Aug 18.

Abstract

PURPOSE

This study aims to investigate the safety and efficacy of short-term treatment for ocular surface disease (OSD) with topical low-dose (1,005 mg) preservative-free hydrocortisone in one hundred patients with and without glaucoma.

METHODS

This was an open label non-randomized clinical trial. Patients with OSD with and without primary open-angle glaucoma (POAG) received topical low-dose (1,005 mg) preservative-free hydrocortisone twice daily in each eye for 2 weeks. All patients underwent a complete ophthalmological examination at baseline (T0) and at 1 (T1) and 2 (T2) weeks post-treatment. At each visit, the intraocular pressure (IOP) and the ocular surface disease index (OSDI) questionnaire scores were recorded; the Schirmer test was performed only at T0 and T2.

RESULTS

The OSDI score significantly decreased in both the POAG and no-POAG groups (both p < 0.0001) after hydrocortisone treatment, with no difference between the two groups (p = 0.72). There were no significant differences in IOP and Schirmer test results between T0 and T2 in both treatment groups (p = 0.68 and p = 0.83, respectively).

CONCLUSIONS

Topical low-dose (1,005 mg) preservative-free hydrocortisone is safe and effective for improving OSD symptoms both in patients with and without POAG.

TRIAL REGISTRATION

The trial was registered at clinicaltrials.gov under NCT04536129 on 01/09/2020 ("retrospectively registered").

摘要

目的

本研究旨在探讨短期局部应用低剂量(1005 毫克)无防腐剂氢可酮治疗伴有或不伴有开角型青光眼(POAG)的眼表疾病(OSD)的安全性和有效性。

方法

这是一项开放标签、非随机的临床试验。伴有或不伴有原发性开角型青光眼(POAG)的 OSD 患者每天每只眼接受两次局部应用低剂量(1005 毫克)无防腐剂氢可酮治疗,共 2 周。所有患者在基线(T0)和治疗后 1 周(T1)和 2 周(T2)时均接受全面眼科检查。每次就诊时,记录眼内压(IOP)和眼表疾病指数(OSDI)问卷评分;仅在 T0 和 T2 时进行 Schirmer 试验。

结果

在 POAG 和非 POAG 组中,OSDI 评分在应用氢可酮治疗后均显著降低(两组均 p<0.0001),两组间无差异(p=0.72)。在两个治疗组中,T0 与 T2 时的 IOP 和 Schirmer 试验结果均无显著差异(p=0.68 和 p=0.83,分别)。

结论

局部应用低剂量(1005 毫克)无防腐剂氢可酮治疗对伴有和不伴有 POAG 的 OSD 患者的 OSD 症状均安全且有效。

试验注册

该试验于 2020 年 9 月 1 日在 clinicaltrials.gov 上注册为 NCT04536129(“回溯性注册”)。

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