Upendram Pavani, Sahni Shubhi, Mohiuddin Khaliq, Poornima Subhadra, Gourishankar Bhanumathy, Kumar Vattam Kiran, Boddala Pavani, Jayashankar E, Mohiuddin Shakera, Kamineni Vasundhara, Mohan Vasavi, Houldsworth Jane, Hasan Qurratulain
1 Department of Genetics and Molecular Medicine, Kamineni Hospitals, Hyderabad, India.
2 Department of Genetics and Molecular Medicine, Kamineni Life Sciences, Hyderabad, India.
Tumour Biol. 2017 Oct;39(10):1010428317698363. doi: 10.1177/1010428317698363.
Cervical carcinoma is a frequent malignancy in developing countries despite being a preventable disease. For the first time, four screening tests were used simultaneously for identifying women with a risk of developing cervical cancer, to help clinicians and policy makers to implement the best strategy for reducing the burden of this disease. Women visiting a hospital in India were enrolled after institutional ethics clearance and informed consent. Visual inspection using acetic acid and Pap smear tests were performed on 2683 women, and 104 had abnormal cytology: atypical squamous cells of undetermined significance (n = 29), low-grade squamous intraepithelial lesion (n = 41), high-grade squamous intraepithelial lesion (n = 17), and squamous cell carcinoma (n = 17). These and 96 samples, with normal cytology, were subjected to high-risk human papilloma virus testing and fluorescent in situ hybridization evaluation. Women with abnormal cytology were followed for 5 years and evaluated with colposcopy-guided biopsy. Three accepted methods of screening and one novel fluorescent in situ hybridization assay were carried out in 200 cases. Cutoffs for fluorescent in situ hybridization were established. The screening methods had 88%-96% negative predictive value, while positive predictive value was low (20%) for visual inspection using acetic acid, 47% for fluorescent in situ hybridization, 56% for high-risk human papilloma virus, and 73% for combined high-risk human papilloma virus and fluorescent in situ hybridization. Combined high-risk human papilloma virus and fluorescent in situ hybridization had 94% sensitivity, specificity, and negative predictive value, suggesting that simultaneous screening with these two tests is appropriate for identifying women progressing to cervical cancer and not visual inspection using acetic acid, which has low positive predictive value and Pap cytology which requires to be repeated. Policy makers and clinicians can assess feasibility of incorporating this screening strategy to prevent cervical cancer.
尽管宫颈癌是一种可预防的疾病，但在发展中国家它却是一种常见的恶性肿瘤。首次同时使用四种筛查测试来识别有患宫颈癌风险的女性，以帮助临床医生和政策制定者实施减轻该疾病负担的最佳策略。在印度一家医院就诊的女性在获得机构伦理批准并签署知情同意书后被纳入研究。对2683名女性进行了醋酸肉眼检查和巴氏涂片检查，其中104名女性细胞学异常：意义不明确的非典型鳞状细胞（n = 29）、低级别鳞状上皮内病变（n = 41）、高级别鳞状上皮内病变（n = 17）和鳞状细胞癌（n = 17）。对这些以及96例细胞学正常的样本进行了高危型人乳头瘤病毒检测和荧光原位杂交评估。对细胞学异常的女性进行了5年随访，并通过阴道镜引导下活检进行评估。在200例病例中进行了三种公认的筛查方法和一种新型荧光原位杂交检测。确定了荧光原位杂交的临界值。筛查方法的阴性预测值为88% - 96%，而醋酸肉眼检查的阳性预测值较低（20%），荧光原位杂交为47%，高危型人乳头瘤病毒为56%，高危型人乳头瘤病毒与荧光原位杂交联合检测为73%。高危型人乳头瘤病毒与荧光原位杂交联合检测的敏感性、特异性和阴性预测值均为94%，这表明同时使用这两种检测方法进行筛查适用于识别进展为宫颈癌的女性，而不是阳性预测值较低的醋酸肉眼检查以及需要重复进行的巴氏细胞学检查。政策制定者和临床医生可以评估采用这种筛查策略预防宫颈癌的可行性。
