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脂质体眼喷雾在结膜激发试验诱发的过敏性鼻结膜炎患者中与抗组胺眼药水效果相当。

Liposomal Eye Spray Is as Effective as Antihistamine Eye Drops in Patients with Allergic Rhinoconjunctivitis Induced by Conjunctival Provocation Testing.

作者信息

Grzella Anne-Nele, Schleicher Sabine, Shah-Hosseini Kija, Astvatsatourov Anatoli, Raskopf Esther, Allekotte Silke, Mösges Ralph

机构信息

Institute of Medical Statistics and Computational Biology (IMSB), Faculty of Medicine, University of Cologne, Cologne, Germany.

CRI - Clinical Research International Ltd., Cologne, Germany.

出版信息

Int Arch Allergy Immunol. 2019;179(2):123-131. doi: 10.1159/000496938. Epub 2019 Mar 25.

Abstract

BACKGROUND

Liposomal eye spray (LS) has been introduced for the treatment of dry eye. Whether LS can also relieve symptoms due to allergic rhinoconjunctivitis (ARC) has not yet been sufficiently investigated.

OBJECTIVES

The aim of this study was to assess the onset of action, the reduction of allergy symptoms, and the safety of LS - a nonpharmacological treatment option - compared with those of antihistamine eye drops (AD).

METHODS

In this open, prospective, controlled, monocenter noninterventional study, adults with ARC received either LS or AD for the relief of eye irritation after a positive conjunctival provocation test (CPT). All patients completed a questionnaire before and after the CPT. Eye irritation was rated on a visual analogue scale (VAS) at 6 time points. Conjunctival redness was analyzed using objective digital analysis based on images taken during the study visit.

RESULTS

Data were collected from 40 patients (20 per group). In both groups, 80% of patients perceived an onset of action within 0-2 min after application of LS or AD following the CPT. Relief of eye irritation (as determined by VAS) increased throughout the visit for both groups. In the digital analysis, the mean proportion of redness of the eye decreased from 10.3 to 7.0% for LS and from 10.4 to 6.5% for AD, with the largest difference observed 10 min after application (LS: 8.9%; AD: 6.0%; p = 0.094).

CONCLUSIONS

LS is a nonpharmacological treatment option for ARC, showing no significant difference or relevant numerical inferiority to AD in any parameter studied. It was generally safe and well tolerated.

摘要

背景

脂质体眼喷雾(LS)已被用于治疗干眼症。LS是否也能缓解过敏性鼻结膜炎(ARC)引起的症状尚未得到充分研究。

目的

本研究旨在评估LS(一种非药物治疗选择)与抗组胺眼药水(AD)相比的起效时间、过敏症状减轻情况及安全性。

方法

在这项开放、前瞻性、对照、单中心非干预性研究中,患有ARC的成年人在结膜激发试验(CPT)呈阳性后接受LS或AD治疗以缓解眼部刺激。所有患者在CPT前后均完成一份问卷。在6个时间点使用视觉模拟量表(VAS)对眼部刺激进行评分。基于研究访视期间拍摄的图像,使用客观数字分析对结膜充血情况进行分析。

结果

收集了40例患者的数据(每组20例)。在两组中,80%的患者在CPT后应用LS或AD后0 - 2分钟内感觉到起效。两组在整个访视期间眼部刺激的缓解情况(由VAS确定)均有所增加。在数字分析中,LS组眼部充血的平均比例从10.3%降至7.0%,AD组从10.4%降至6.5%,应用后10分钟差异最大(LS组:8.9%;AD组:6.0%;p = 0.094)。

结论

LS是ARC的一种非药物治疗选择,在任何研究参数上与AD相比均无显著差异或数值上的明显劣势。它总体上安全且耐受性良好。

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