光学相干层析显微成像技术在口腔癌诊断中应用效果的临床研究

Assessment of optical coherence tomography and optical coherence microscope for oral cancer diagnosis:a clinical study

目的探索和评估应用光学相干层析显微成像技术(OCT/OCM)在口腔癌诊断中的有效性和准确性。方法本研究采用OCT/OCM对口腔黏膜进行成像,共收集2021年1月至2023年2月在首都医科大学口腔医学院口腔颌面头颈肿瘤科住院治疗的68例口腔癌患者的289块离体标本,并得到1445个OCT/OCM图像数据集。观察包括正常口腔黏膜、上皮异常增生(轻度、中度、重度)和口腔癌组织的OCT/OCM图像特征,将其与相应的病理图像进行匹配,制订诊断标准后进行诊断性研究,以病理诊断为金标准,采用双盲实验设计,由3名研究者参与OCT/OCM图像分析和诊断过程。结果OCT/OCM与相应的病理图像匹配良好,并根据对比结果制订了诊断标准和诊断流程。在3名研究者的诊断性试验结果显示,使用OCT/OCM进行低风险和高风险口腔黏膜病变的诊断准确性为82%,敏感度为84%[95%CI为80%~88%],特异度为81%(95%CI为77%~85%);观察者间的一致性较高(kappa=0.614)。结论本研究初步探讨了利用OCT/OCM在口腔癌诊断中的应用前景,提示该技术在区分正常口腔黏膜、上皮异常增生与口腔癌方面具备潜在价值。

Objective To explore and evaluate the feasibility and accuracy of using optical coherence tomography and optical coherence microscope(OCT/OCM)for diagnosis of oral cancer.Methods In this study,OCT/OCM was utilized to image the oral mucosa specimens.A total of 289 ex vivo oral mucosa specimens were collected from 68 patients with oral cancer who were hospitalized at Department of Oral and Maxillofacial Head and Neck Tumors,Capital Medical University School of Stomatology,between January 2021 and February 2023,resulting in a dataset of 1445 OCT/OCM images.By observing the characteristic patterns in the OCT/OCM images,including normal oral mucosa,epithelial abnormal proliferation(mild,moderate,severe),and oral cancer,these patterns were matched with corresponding pathological images.A diagnostic study was conducted,employing pathological diagnosis as the gold standard and utilizing a double-blind experimental design involving three diagnostic evaluators who participated in the analysis and diagnosis of OCT/OCM images.Results The OCT/OCM images demonstrated good correlation with the corresponding pathological images,and diagnostic criteria were established based on the comparative results.In the diagnostic study involving three investigators,the accuracy was 82%,sensitivity was 84%(95%CI:80%-88%),and specificity was 81%(95%CI:77%-85%).There was a high level of agreement among the observers(kappa=0.614),indicating substantial concordance in the diagnostic results among the three investigators.Conclusions This study demonstrates the potential of OCT/OCM for diagnosis of oral cancer.The technology accurately distinguishes between normal oral mucosa,epithelial abnormal proliferation and oral cancer.