干眼症诊断中炎症测试的真实表现:对1515名患者的分析

IF 2.4 3区 医学 Q2 OPHTHALMOLOGY
Germán Mejía-Salgado, William Rojas-Carabali, Carlos Cifuentes-González, Laura Zárate-Pinzón, Camilo Andrés Rodríguez-Rodríguez, Guillermo Marroquín-Gómez, Martha Lucía Moreno-Pardo, Juliana Tirado-Ángel, Alejandra de-la-Torre
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引用次数: 0

摘要

目的:评估使用不同诊断标准和不同严重程度的InflammaDry试验诊断干眼病(DED)的诊断性能。方法:对1515例患者进行回顾性研究。根据干眼Workshop-II (DEWS-II)将受试者分为三组:(1)DED组:眼表疾病指数(OSDI)≥13且至少有一项异常临床体征(非侵入性泪液破裂时间[NIBUT] 308 mOsm/L,或角膜/结膜染色)。(2)基于既往临床试验标准的DED: OSDI bbb13, Schirmer结果:1组1363例,2组401例,3组152例。在使用先前临床试验标准诊断的人群中,敏感性为81.30%,但在应用DEWS-II标准时,敏感性降至69.99%。两组特异性为38.16%,假阴性分别为409/467例。结论:InflammaDry对多临床体征的重度症状患者的DED检测具有良好的敏感性,但当使用DEWS-II等更广泛的标准时,其检测性能下降。虽然对检测炎症很有价值,但常规用于DED诊断可能导致假阴性,特别是在较轻的病例中。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Real-world performance of the inflammadry test in dry eye diagnosis: an analysis of 1,515 patients.

Purpose: To assess the diagnostic performance of the InflammaDry test in diagnosing dry eye disease (DED) using different diagnostic criteria and across varying severities.

Methods: A retrospective study was conducted on 1,515 patients. Subjects were categorized into three groups: Group (1) DED based on Dry Eye Workshop-II (DEWS-II): Ocular Surface Disease Index (OSDI) ≥ 13 and at least one abnormal clinical sign (non-invasive tear break-up time [NIBUT] < 10 s, osmolarity > 308 mOsm/L, or corneal/conjunctival staining). Group (2) DED based on criteria used in prior clinical trials: OSDI > 13, Schirmer < 10 mm in 5 min, NIBUT < 10 s, and keratoconjunctival staining. Group (3) Healthy controls: OSDI ≤ 7, NIBUT ≥ 10 s, Schirmer ≥ 10 mm, and no keratoconjunctival staining. DED severity was classified using the ODISSEY European Consensus Group's definitions into severe and non-severe. Sensitivity, specificity, and predictive values were calculated for both criteria.

Results: 1,363 patients were included in Group 1, 401 in Group 2, and 152 in Group 3. Sensitivity was 81.30% in the population diagnosed using previous clinical trial criteria but decreased to 69.99% when applying the DEWS-II criteria. Specificity was 38.16% in both groups, with 409/467 false negatives respectively.

Conclusion: InflammaDry shows good sensitivity in detecting DED in highly symptomatic cases with multiple clinical signs, but its performance decreases when broader criteria like DEWS-II are used. While valuable for detecting inflammation, routine use for DED diagnosis may lead to false negatives, especially in milder cases.

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来源期刊
CiteScore
5.40
自引率
7.40%
发文量
398
审稿时长
3 months
期刊介绍: Graefe''s Archive for Clinical and Experimental Ophthalmology is a distinguished international journal that presents original clinical reports and clini-cally relevant experimental studies. Founded in 1854 by Albrecht von Graefe to serve as a source of useful clinical information and a stimulus for discussion, the journal has published articles by leading ophthalmologists and vision research scientists for more than a century. With peer review by an international Editorial Board and prompt English-language publication, Graefe''s Archive provides rapid dissemination of clinical and clinically related experimental information.
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