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0.05%环孢素A滴眼液局部应用治疗春季角结膜炎——随机安慰剂对照试验

Topical cyclosporine a 0.05% eyedrops in the treatment of vernal keratoconjunctivitis - randomized placebo-controlled trial.

作者信息

Keklikci Ugur, Dursun Birgul, Cingu Abdullah Kursat

机构信息

Department of Ophthalmology, Dicle University Faculty of Medicine, Diyarbakir, Turkey.

出版信息

Adv Clin Exp Med. 2014 May-Jun;23(3):455-61. doi: 10.17219/acem/37145.

DOI:10.17219/acem/37145
PMID:24979519
Abstract

BACKGROUND

Vernal keratoconjunctivitis (VKC) is a chronic, bilateral inflammation of the conjunctiva that mostly affects children and young adult males. Management of VKC is primarily aimed at reducing symptoms and preventing serious vision threatening sequelae.

OBJECTIVES

To assess the efficacy of topical cyclosporine A (CsA) 0.05% on the signs and symtomps in the management of VKC.

MATERIAL AND METHODS

This is a placebo-controlled, randomized prospective study. Sixty-two patients with VKC were included in this study. Patients were randomly assigned (1 : 1) to treatment with topical 0.05% CsA eyedrops or a placebo (artificial tears) for a period of 4 weeks, 4 times daily. Ocular signs and symptoms were in all patients scored at entry and at the end of 4 weeks.

RESULTS

When pre-treatment mean signs and symptoms scores were compared in both groups, there was no significant difference (p > 0.05). However, mean post-treatment scores as regards signs and symptoms were found to be lower in cyclosporine group than those in placebo group (p < 0.001). No side effects of the treatment with CsA 0.05% eyedrops were observed.

CONCLUSIONS

It was found that topical CsA 0.05% eyedrops were safe and effective in the treatment of patients with VKC.

摘要

背景

春季角结膜炎(VKC)是一种慢性双侧性结膜炎症,主要影响儿童和年轻成年男性。VKC的治疗主要旨在减轻症状并预防严重威胁视力的后遗症。

目的

评估0.05%环孢素A(CsA)滴眼液对VKC患者体征和症状的治疗效果。

材料与方法

这是一项安慰剂对照的随机前瞻性研究。本研究纳入了62例VKC患者。患者被随机(1:1)分配接受局部0.05% CsA滴眼液或安慰剂(人工泪液)治疗,为期4周,每日4次。在研究开始时和4周结束时对所有患者的眼部体征和症状进行评分。

结果

比较两组治疗前的平均体征和症状评分,无显著差异(p>0.05)。然而,发现环孢素组治疗后的体征和症状平均评分低于安慰剂组(p<0.001)。未观察到0.05% CsA滴眼液治疗的副作用。

结论

发现局部应用0.05% CsA滴眼液治疗VKC患者安全有效。

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