超越A型鼓室压图的功能评估：台湾队列中慢性咽鼓管功能障碍的压力吞咽测试

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中文摘要

背景： 咽鼓管功能障碍（ETD）与多种常见耳科疾病相关，但在台湾缺乏标准化的诊断阈值。本研究旨在评估GSI TympStar Pro压力吞咽测试的诊断性能，并确定一个基于ROC的最大峰压差（MPD）截断值，以区分临床诊断的阻塞性咽鼓管功能障碍（oETD）与健康对照。方法：共纳入152名受试者，包括100名健康对照和52名临床诊断的oETD患者，由耳鼻喉科医师评估确认，并辅以ETDQ-7症状评分支持。进行了鼓室压图检查以及基于鼓室压图的咽鼓管功能测试，使用GSI TympStar Pro ETF-Intact压力吞咽模块，即改良的三鼓室压图压力吞咽方案。组间比较采用Mann-Whitney U检验和卡方检验。诊断性能通过受试者工作特征（ROC）曲线分析评估。结果：对照组的中位MPD为11 daPa（IQR 6-17），而ETD组为0 daPa（IQR 0-2）（p < 0.001）。ROC分析显示，截断值≤4 daPa在按人分析中灵敏度为100.0%，特异度为91.0%；在按耳分析中灵敏度为97.5%，特异度为95.5%。在仅A型鼓室压图的按耳分析中，MPD仍保持区分性能，AUC为0.978（95% CI，0.961-0.994）。结论：当结合ETDQ-7症状评估和常规临床评估进行解读时，压力吞咽测试可能为疑似阻塞性咽鼓管功能障碍患者的功能评估提供补充的客观信息，尤其是在静息鼓室压图无异常时。在这个单中心台湾队列中，较低的MPD值可能作为咽鼓管压力平衡受损的辅助指标，且ROC衍生的截断值≤4 daPa在区分有症状的阻塞性ETD与健康对照方面显示出区分价值。该截断值应被解释为探索性的、方案特定的阈值，在更广泛的临床应用之前需要在更大的多中心人群中进行前瞻性验证。

英文摘要

Background: Eustachian tube dysfunction (ETD) is associated with several common otologic conditions but lacks standardized diagnostic thresholds in Taiwan. This study aimed to evaluate the diagnostic performance of the GSI TympStar Pro pressure-swallow test and to identify a ROC-derived maximal peak pressure difference (MPD) cutoff for distinguishing clinically diagnosed obstructive Eustachian tube dysfunction (oETD) from healthy controls. Methods: A total of 152 subjects were enrolled, including 100 healthy controls and 52 patients with clinically diagnosed oETD, confirmed by otolaryngologist assessment and supported by ETDQ-7 symptom scoring. Tympanometry and tympanometry-based Eustachian tube function testing using the GSI TympStar Pro ETF-Intact pressure-swallow module, a modified three-tympanogram pressure-swallow protocol, were performed. Group comparisons were conducted using Mann-Whitney U and Chi-square tests. Diagnostic performance was assessed using receiver operating characteristic (ROC) curve analysis. Results: The median MPD was 11 daPa (IQR 6-17) in the control group, compared to 0 daPa (IQR 0-2) in the ETD group (p < 0.001). ROC analysis demonstrated that a cutoff value of ≤4 daPa yielded a sensitivity of 100.0% and specificity of 91.0% in the per-person analysis, and a sensitivity of 97.5% and specificity of 95.5% in the per-ear analysis. In the Type A-only per-ear analysis, MPD retained discriminatory performance, with an AUC of 0.978 (95% CI, 0.961-0.994). Conclusions: When interpreted in conjunction with ETDQ-7 symptom assessment and routine clinical evaluation, pressure-swallow testing may provide complementary objective information for the functional assessment of patients with suspected obstructive Eustachian tube dysfunction, particularly when resting tympanometry is unremarkable. In this single-center Taiwanese cohort, lower MPD values may serve as an adjunctive indicator of impaired Eustachian tube pressure equalization, and the ROC-derived cutoff of ≤4 daPa showed discriminatory value for differentiating symptomatic obstructive ETD from healthy controls. This cutoff should be interpreted as an exploratory, protocol-specific threshold and requires prospective validation in larger multicenter populations before broader clinical application.