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智能镜®视觉筛查试验与肉眼视觉筛查和巴氏涂片检查的比较研究。

Comparative Study of Smart Scope® Visual Screening Test with Naked Eye Visual Screening and Pap Test.

机构信息

Department of Gynecology, Deenanath Mangeshkar Hospital and Research Centre, Pune, Maharashtra, India.

Department of Research, Deenanath Mangeshkar Hospital and Research Centre, Pune, Maharashtra, India.

出版信息

Asian Pac J Cancer Prev. 2020 Dec 1;21(12):3509-3515. doi: 10.31557/APJCP.2020.21.12.3509.

DOI:10.31557/APJCP.2020.21.12.3509
PMID:33369446
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8046303/
Abstract

BACKGROUND

Cervical cancer is a major contributor to mortality and morbidity in women. Naked eye visual screening (NE test) and Pap test are commonly used for cervical cancer screening.  Both tests have inherent limitations like low sensitivity (Pap test) and subjectivity in interpretation, lack of permanent record and overestimation (NE test). Here, Smart Scope® visual screening test (SS test) was compared with NE and Pap tests. Smart Scope® is a small, hand-held device that captures cervical images attached to a tablet to store data.

OBJECTIVE

To compare SS test with Pap and NE tests.

STUDY DESIGN

This prospective observational study was conducted at a tertiary care hospital in India, over 16 months. A total of 509 women in the age group of 25 to 65 years were included in the study as per the inclusion criteria. All the participants underwent Pap test, NE test and SS test. Screen positives on any one test were advised colposcopy and biopsy.

RESULTS

Out of 154 screen-positive women, 49 visited for follow-up colposcopy-guided biopsy. Nine incidental biopsies of screen-negative women were included in the data.  Thus, statistical analysis was carried out based on 58 available histopathology results. Out of 58 biopsies, 8 were normal, 30 were benign lesions, 18 were precancerous and 2 were cancerous lesions. SS test was found to have a sensitivity and NPV of 100% each, PPV of 45.4% and a specificity of 36.8%. Sensitivity and specificity of NE test was 90% and 39.5% respectively, PPV was 43.9% and NPV was 88.2%. Pap smear had a sensitivity of 25% and specificity of 84.2%, PPV of 45.5% and NPV of 68.08%.

CONCLUSION

SS test has great potential to be a primary screening test in low-resource settings due to its better sensitivity and NPV as compared to NE and Pap tests.
.

摘要

背景

宫颈癌是导致女性死亡和发病的主要原因之一。肉眼视觉筛查(NE 测试)和巴氏涂片检查是常用的宫颈癌筛查方法。这两种检测都存在固有局限性,如巴氏涂片检查的敏感性较低,解释存在主观性,缺乏永久性记录和高估(NE 测试)。在此,将智能窥镜®视觉筛查试验(SS 测试)与 NE 和巴氏涂片检查进行了比较。智能窥镜®是一种小型手持式设备,可捕捉到附在平板电脑上的宫颈图像以存储数据。

目的

比较 SS 测试与巴氏涂片检查和 NE 测试。

研究设计

这是一项在印度一家三级保健医院进行的前瞻性观察研究,历时 16 个月。根据纳入标准,共纳入了 509 名年龄在 25 至 65 岁之间的女性。所有参与者均接受了巴氏涂片检查、NE 测试和 SS 测试。任何一项检测呈阳性的患者均建议进行阴道镜检查和活检。

结果

在 154 名筛查阳性的女性中,有 49 名患者接受了随访阴道镜引导活检。对筛查阴性的 9 名女性的偶然活检也包括在数据中。因此,基于 58 份可获得的组织病理学结果进行了统计分析。在 58 例活检中,8 例为正常,30 例为良性病变,18 例为癌前病变,2 例为癌症病变。SS 测试的敏感性和 NPV 均为 100%,PPV 为 45.4%,特异性为 36.8%。NE 测试的敏感性和特异性分别为 90%和 39.5%,PPV 为 43.9%,NPV 为 88.2%。巴氏涂片检查的敏感性为 25%,特异性为 84.2%,PPV 为 45.5%,NPV 为 68.08%。

结论

由于 SS 测试的敏感性和 NPV 优于 NE 和巴氏涂片检查,因此它具有成为资源匮乏环境中初级筛查测试的巨大潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/720f/8046303/05090ca07d53/APJCP-21-3509-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/720f/8046303/69206eed69c3/APJCP-21-3509-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/720f/8046303/b8c54094d5d1/APJCP-21-3509-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/720f/8046303/cef5790db6f0/APJCP-21-3509-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/720f/8046303/819c94e76083/APJCP-21-3509-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/720f/8046303/05090ca07d53/APJCP-21-3509-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/720f/8046303/69206eed69c3/APJCP-21-3509-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/720f/8046303/b8c54094d5d1/APJCP-21-3509-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/720f/8046303/cef5790db6f0/APJCP-21-3509-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/720f/8046303/819c94e76083/APJCP-21-3509-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/720f/8046303/05090ca07d53/APJCP-21-3509-g005.jpg

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