Abstract:Objective: To explore the feasibility of p16/ cell proliferating nuclear antigen (Ki67) double staining test for cervical disease screening in TCT negative combined HPV16 and HPV18 positive patients. Methods: A total of 100 patients with negative TCT results but positive HPV16 and HPV18 tests were collected from March 2016 to January 2018. Both p16/Ki67 double staining and colposcopic pathological biopsy were performed within 6 weeks after TCT. The sensitivity and specificity of p16/Ki67 double staining for screening cervical lesions were analyzed based on the gold standard of biopsy results. Results: Pathological biopsy showed cervical intraepithelial neoplasia over grade 2 (CIN2+) were 39 cases (39.00%), including 1 case of cervical adenocarcinoma (1.00%), 21 cases of CIN3 (21.00%), 17 cases of CIN2 (17.00%). The result of pathological biopsy was as the gold standard, the sensitivity of p16/Ki67 double staining test for screening CIN2+ cervical lesions was 89.74%, the specificity was 96.72%, the positive predictive value was 94.59%, the negative predictive value was 93.65%. Conclusion: P16/Ki67 double staining test has high sensitivity and specificity for screening CIN2+ cervical lesions, it can be used for early screening of cervical lesions, and has a certain early warning effect.
[1] 周晖,卢淮武,彭永排,等.《2015年NCCN宫颈癌临床实践指南》解读[J].中国实用妇科与产科杂志,2015,30(3):185~191. [2] 魏丽惠,赵昀,沈丹华,等.中国子宫颈癌筛查及异常管理相关问题专家共识(一)[J].中国妇产科临床杂志,2017,11(2):190~192. [3] Dijkstra MG, Snijders PJF, Arbyn M, et al. Cervical cancer screening: on the way to a shift from cytology to full moLecular screening[J]. Ann Oncol, 2014, 25(5):927~935. [4] Nijhuis ER, Nathalie RP, Wisman G B A, et al. An overview of innovative techniques to improve cervical cancer screening[J]. Cell Oncol, 2016, 28(5~6):233~246. [5] Wentzensen N, Fetterman B, Tokugawa D, et al. Interobserver reproducibility and accuracy of p16/Ki-67 dual-stain cytology in cervical cancer screening[J]. Cancer Cytopathol, 2015, 122(12):914~920. [6] WHO. Guidelines for screening and treatment of precancerous lesions for cervical cancer prevention[M]. Geneva: World Health Organization, 2013. [7] 王霞,李霞斌,李宗恒.HPV16/18在宫颈上皮内瘤变及宫颈癌中表达[J].中国病原生物学杂志,2017,12(2):182~184. [8] 王霞.宫颈癌及癌前病变中的HPV-16整合人宿主基因组的发生情况及其在宫颈癌筛查中的应用[J].河北医学,2017,23(11):1768~1772. [9] Ahmad A, Raish M, Shahid M, et al. The synergic effect of HPV infection and epigenetic anomaly of the p16 gene in the development of cervical cancer[J]. Cancer Biomarker, 2017, 19(4):1~7. [10] Duangkaew P, Tapaneeyakorn S, Apiwat C, et al. Ultrasensitive electrochemical immunosensor based on dual signal amplification process for p16(INK4a) cervical cancer detection in clinical samples[J]. Biosens Bioelectron, 2015, 74(3):673~679. [11] Fujii T, Saito M, Hasegawa T, et al. Performance of p16INK4a/Ki-67 immunocytochemistry for identifying CIN2+ in atypical squamous cells of undetermined significance and low-grade squamous intraepithelial lesion specimens: a japanese gynecologic oncology group study[J]. Int Clin Oncol, 2015, 20(1):134~142. [12] Park T, Fujiwara H, Wright TC. moLecular biology of cervical cancer and its precursors[J]. Cancer, 2015, 76(10):1902~1913.