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使用局部前列腺素类似物的患者中泪点塞对眼表面疾病的影响:一项随机对照试验。

Effect of a punctal plug on ocular surface disease in patients using topical prostaglandin analogues: a randomized controlled trial.

机构信息

Oxford Eye Hospital, John Radcliffe Hospital, Oxford, UK.

Ophthalmology, University of Melbourne Department of Surgery, Melbourne, Australia.

出版信息

Clin Exp Ophthalmol. 2018 Nov;46(8):888-894. doi: 10.1111/ceo.13311. Epub 2018 May 24.

DOI:10.1111/ceo.13311
PMID:29700925
Abstract

IMPORTANCE

Ocular surface disease (OSD) is common and can reduce treatment compliance and quality of life.

BACKGROUND

To determine whether a punctal plug improves OSD and reduces intraocular pressure (IOP) in patients using prostaglandin analogue monotherapy.

DESIGN

Randomized controlled trial.

PARTICIPANTS

Sixty eligible subjects aged >18 years with symptomatic OSD from glaucoma clinics were invited to participate. Lacrimal or glaucoma surgery, lid malposition and contact lens wear were exclusion criteria.

METHODS

One eye received an inferior punctal plug, leaving the fellow eye as a control.

MAIN OUTCOME MEASURES

Ocular surface disease index (OSDI), tear film breakup time (TF-BUT), Oxford cornea score, tear osmolarity and IOP were compared at baseline and 6 weeks by masked investigators.

RESULTS

From 60 eligible, 48 (80.0%) participated (mean age 69.6 years; 60.0% female). OSDI reduced following plug insertion (mean difference [MD] 14.5, 95% confidence interval [CI] 5.06-23.94, P < 0.001). Compared to control eyes, in eyes receiving plugs the TF-BUT increased (MD 2.3 s, 95% CI 1.4-3.2, P < 0.001), the Oxford cornea score decreased (MD 0.5, 95% CI 0.3-0.7, P < 0.001), and tear osmolarity decreased (MD 10 mOsm/L, 95% CI 3.5-16.5, P = 0.003). Punctal plugs resulted in a significantly lowered IOP (MD 1.5 mmHg, 95% CI 0.1-2.9, P = 0.032). Sub-group analyses showed similar efficacy regardless of prostaglandin preservative status or lubricant drop use. Plugs were well tolerated but extrusion occurred in 8.5%, and epiphora increased in 6.5% eyes.

CONCLUSIONS AND RELEVANCE

Punctal plug insertion improves subjective and objective measures of OSD and results in a reduced IOP in patients with symptomatic ocular surface disease using prostaglandin analogue monotherapy.

摘要

重要性

眼表疾病(OSD)很常见,会降低治疗依从性和生活质量。

背景

为了确定泪点塞是否能改善使用前列腺素类似物单药治疗的患者的 OSD 并降低眼内压(IOP)。

设计

随机对照试验。

参与者

从青光眼诊所邀请了 60 名年龄>18 岁、有症状 OSD 的合格受试者参加。泪液或青光眼手术、睑裂位置不正和隐形眼镜佩戴被排除在外。

方法

一只眼接受下泪点塞,另一只眼作为对照。

主要观察指标

由盲法研究者在基线和 6 周时比较眼表疾病指数(OSDI)、泪膜破裂时间(TF-BUT)、牛津角膜评分、泪液渗透压和 IOP。

结果

在 60 名合格的受试者中,有 48 名(80.0%)参与了研究(平均年龄 69.6 岁;60.0%为女性)。塞子插入后 OSDI 降低(平均差异[MD] 14.5,95%置信区间[CI] 5.06-23.94,P<0.001)。与对照眼相比,接受塞子的眼的 TF-BUT 增加(MD 2.3 s,95% CI 1.4-3.2,P<0.001),牛津角膜评分降低(MD 0.5,95% CI 0.3-0.7,P<0.001),泪液渗透压降低(MD 10 mOsm/L,95% CI 3.5-16.5,P=0.003)。泪点塞导致眼压显著降低(MD 1.5 mmHg,95% CI 0.1-2.9,P=0.032)。亚组分析表明,无论前列腺素防腐剂状态或润眼液使用情况如何,疗效均相似。塞子耐受性良好,但有 8.5%的塞子发生了脱出,6.5%的眼睛出现溢泪增加。

结论和相关性

泪点塞插入可改善有症状的眼表疾病患者的主观和客观 OSD 测量指标,并降低使用前列腺素类似物单药治疗的患者的 IOP。

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