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用于评估干眼疾病体征和症状的高科技参数:临床临界值的确定以及与低技术检测方法的一致性

High-Tech Parameters for the Evaluation of Signs and Symptoms of Dry Eye Disease: Identification of Clinical Cut-Offs and Agreement with Low-Tech Tests.

作者信息

Fogagnolo Paolo, Aragona Pasquale, Strianese Alfonso, Villani Edoardo, Giannaccare Giuseppe, Orfeo Vincenzo, Mirisola Valentina, Mencucci Rita

机构信息

Health Sciences Department, University of Milan, Milan, Italy.

Section of Ophthalmology, Department of Biochemical Sciences, University of Messina, Messina, Italy.

出版信息

Ophthalmol Ther. 2024 Nov;13(11):2999-3011. doi: 10.1007/s40123-024-01034-6. Epub 2024 Sep 28.

Abstract

INTRODUCTION

High-tech devices for the assessment of dry eye disease (DED) are increasingly available. However, the agreement between high- and low-tech parameters has been poorly explored to date. Trying to fill these gaps, we conducted a post hoc analysis on a recently published retrospective study on patients with DED receiving both low- and high-tech (Keratograph) assessments, and treatment with different lubricating eyedrops.

METHODS

Six clinical questions were defined by the authors, considering literature gaps and their clinical experience, namely: (1) are NIKBUT-i and T-BUT interchangeable parameters? (2) What was the correlation between low- and high-tech parameters in untreated and treated patients with DED? (3) What was the correlation between signs and symptoms at baseline and during/after treatment? (4) Which parameters were better associated with symptoms? And with symptoms change over time? (5) What was the performance of NIKBUT-i and T-BUT in detecting clinically relevant changes? (6) What was the clinical advantage of adding other high- and low-tech parameters, respectively, to NIKBUT-i and T-BUT?

RESULTS

Low-tech measures were the best descriptors of the Ocular Surface Disease Index (OSDI) at baseline. In contrast, high-tech assessments demonstrate better performance in detecting changes over time. The distribution of NIKBUT-i data was more dispersed than TBUT both at baseline and follow-up. At a fixed specificity of 80%, the sensitivity in detecting clinically relevant ameliorations of symptoms was 42% for NIKBUT-i and 25% for T-BUT. A battery of high-tech tests could detect 90% of clinical amelioration, compared with 45% with low-tech tests (p < 0.001). Correlation between low- and high-tech parameters in both treated and untreated patients is lacking.

CONCLUSIONS

Low-tech measures are adequate for diagnostic purposes in DED, whereas high-tech showed better performances at follow-up, particularly when different tests are combined. Overall, poor interchangeability among parameters and agreement with symptoms was reported both with high- and low-tech assessments.

摘要

引言

用于评估干眼症(DED)的高科技设备越来越多。然而,迄今为止,高科技和低科技参数之间的一致性尚未得到充分研究。为了填补这些空白,我们对最近发表的一项关于接受低科技和高科技(角膜地形图仪)评估以及不同润滑眼药水治疗的干眼症患者的回顾性研究进行了事后分析。

方法

作者根据文献空白和临床经验定义了六个临床问题,即:(1)非侵入性泪膜破裂时间指数(NIKBUT-i)和泪膜破裂时间(T-BUT)是否为可互换参数?(2)未经治疗和接受治疗的干眼症患者中,低科技和高科技参数之间的相关性如何?(3)基线时以及治疗期间/治疗后的体征和症状之间的相关性如何?(4)哪些参数与症状的相关性更好?以及与症状随时间的变化的相关性如何?(5)NIKBUT-i和T-BUT在检测临床相关变化方面的表现如何?(6)分别将其他高科技和低科技参数添加到NIKBUT-i和T-BUT中,临床优势是什么?

结果

低科技测量是基线时眼表疾病指数(OSDI)的最佳描述指标。相比之下,高科技评估在检测随时间的变化方面表现更好。在基线和随访时,NIKBUT-i数据的分布比T-BUT更分散。在固定特异性为80%时,NIKBUT-i检测症状临床相关改善的敏感性为42%,T-BUT为25%。一组高科技测试可以检测到90%的临床改善,而低科技测试为45%(p < 0.001)。在接受治疗和未接受治疗的患者中,低科技和高科技参数之间均缺乏相关性。

结论

低科技测量足以用于干眼症的诊断目的,而高科技在随访时表现更好,特别是当不同测试结合使用时。总体而言,高科技和低科技评估均报告参数之间的互换性差以及与症状的一致性差。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d999/11494620/ca6db21a4a74/40123_2024_1034_Fig1_HTML.jpg

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