光学相干断层扫描成像系统应用于子宫颈病变评估的多中心研究

Application of optical coherence tomography in the evaluation of cervical lesions:a multicenter study

目的探讨光学相干断层扫描(OCT)成像系统评估子宫颈病变的价值。方法收集2020年1月至2021年12月在郑州大学第三附属医院、河南省信阳市固始县妇幼保健院及河南省商丘市睢县妇幼保健院就诊的1214例子宫颈病变患者,其年龄为(38.9±10.5)岁(范围:16~77岁)。所有患者均行在体子宫颈OCT检查及子宫颈活检病理检查,总结在体子宫颈病变的OCT图像特征。以病理诊断为"金标准",评价OCT图像判读结果的准确率、敏感度、特异度、阳性预测值及阴性预测值,以及OCT图像诊断与病理诊断的一致性;同时,在体子宫颈OCT图像系统作为一种新兴的筛查工具,与传统的人乳头状瘤病毒(HPV)+液基薄层细胞学检查(TCT)联合筛查进行比较,评价其筛查效果。结果通过在体子宫颈OCT图像与对应位置HE图像的比对,总结了正常子宫颈及各类子宫颈病变的OCT图像特征。OCT图像诊断高级别鳞状上皮内病变(HSIL)及以上病变(HSIL+)的准确率为93.4%、敏感度为88.5%、特异度为95.0%,阳性预测值及阴性预测值分别为85.0%及96.2%,诊断低级别鳞状上皮内病变(LSIL)的准确率为84.7%、敏感度为61.7%、特异度为96.3%,阳性预测值及阴性预测值分别为89.3%及83.2%。OCT图像诊断与病理诊断的一致性较强(Kappa值为0.701)。OCT筛查与HPV+TCT联合筛查的准确率分别为83.7%和64.9%(χ^(2)=128.82,P<0.001),敏感度分别为77.8%和64.5%(χ^(2)=39.01,P<0.001),特异度分别为91.8%和65.4%(χ^(2)=98.12,P<0.001),分别比较,差异均有统计学意义。结论OCT成像系统对子宫颈病变的评估具有较高的敏感度及特异度,且具有无创、实时及高效等特点,OCT检查有望成为子宫颈病变诊断及子宫颈癌筛查的有效方法。

Objective To explore the value of optical coherence tomography(OCT)imaging system in evaluating cervical lesions in vivo.Methods A total of 1214 patients with cervical lesions were collected from January 2020 to December 2021 in the Third Affiliated Hospital of Zhengzhou University,Maternal and Chlid Heaith Hospital of Gushi County,Xinyang City,Henan Province,and Maternal and Chlid Heaith Hospital of Sui County,Shangqiu City,Henan Province.The age of the patients was(38.9±10.5)years(range:16-77 years).All patients underwent in vivo cervical OCT examination and cervical biopsy pathology examination,and summarized the OCT image features of in vivo cervical lesions.Using the pathological diagnosis as the“gold standard”,the accuracy,specificity,sensitivity,positive predictive value(PPV)and negative predictive value(NPV)of OCT image interpretation results were evaluated,as well as the consistency of OCT image diagnosis and pathological diagnosis.At the same time,the in vivo cervical OCT imaging system,as a newly developed screening tool,was compared with the traditional combined screening of human papillomavirus(HPV)and Thinprep cytologic test(TCT),to assess the screening effect.Results By comparing the OCT images of the cervix in vivo with the corresponding HE images,the OCT image characteristics of the normal cervix and various types of cervical lesions in vivo were summarized.The accuracy,sensitivity,specificity,PPV and NPV of OCT image in the diagnosis of high-grade squamous intraepithelial lesion(HSIL)and above(HSIL+)were 93.4%,88.5%,95.0%,85.0%and 96.2%,respectively.The accuracy,sensitivity,specificity,PPV and NPV of OCT for low-grade squamous intraepithelial lesion(LSIL)were 84.7%,61.7%,96.3%,89.3%and 83.2%,respectively.The consistency between OCT image diagnosis and pathological diagnosis was strong(Kappa value was 0.701).The accuracy,sensitivity and specificity of OCT screening,HPV and TCT combined screening were 83.7%vs 64.9%(χ^(2)=128.82,P<0.001),77.8%vs 64.5%(χ^(2)=39.01,P<0.001),91.8%vs 65.4%(χ^(2)=98.12,P<0.001),respectively.The differences were statistically significant.Conclusions OCT imaging system has high sensitivity and specificity in the evaluation of cervical lesions in vivo,and has the characteristics of non-invasive,real-time and high efficiency.OCT examination is expected to become an effective method for the diagnosis of cervical lesions and cervical cancer screening.