Guan Yanfei, Peng Jianming, Yuan Chunlei, Mi Xianjun, Chen Zhiqiang, Chen Jianfeng, Chen Ang, Liu Jun
Department of Clinical Laboratory, Zhongshan Boai Hospital Affiliated to Southern Medical University, Zhongshan 528400, China.
Department of Pathology, Zhongshan Boai Hospital Affiliated to Southern Medical University, Zhongshan 528400, China.
Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi. 2020 Jan;36(1):63-68.
Objective To explore the value of double labeling of P16/ki67, E6/E7 mRNA of human papillomavirus (HPV) and combined detection in shunt diagnosis of low-grade squamous intraepithelial lesions (LSIL) by thin-layer cervical cytology (TCT). Methods The study enrolled 239 patients who underwent colposcopy and biopsy within 4 weeks after primary TCT diagnosis. The remaining cytological samples were double-labeled with P16/ki67 immunocytochemical staining and the HPV E6/E7 mRNA was detected by Panther automatic HPV E6/E7 mRNA detection system. Using SPSS22.0 software, the positive rates of P16/ki67 double-labeling, HPV E6/E7 mRNA and combined detection were analyzed in different cervical lesions, and the positive rates in the same cervical lesions were compared horizontally to evaluate the efficiency of double labeling of P16/ki67, HPV E6/E7 and combined detection in the diagnosis of high-grade squamous intraepithelial lesions (HSIL) and above lesions. Results The diagnostic results of HE staining for the 239 cases of LSIL were 71 cases of chronic cervicitis (29.71%), 143 cases of LSIL (59.83%), 22 cases of HSIL (9.20%) and 3 cases of cervical cancer (1.26%). There were 46 cases of P16ki67 lesions (19.25%), 41 cases of ki67P16 lesions (17.15%), 33 cases of ki67P16 lesions (13.81%) and 119 cases of P16-ki67- lesions (49.79%). The positive rates of P16/ki67 double-labeling, HPV E6/E7 mRNA and combined detection increased with the severity of cervical lesions. The positive rate of combined detection was the highest in the HSIL lesions, which was higher than that of P16/ki67 double-labeling and HPV E6/E7 mRNA detection. The sensitivity of combined detection was higher than that of P16/ki67 double-labeling and HPV E6/E7 mRNA detection. The Youden index of joint detection was 0.7850. Conclusion The combined detection of P16/ki67 double labeling, HPV E6/E7 mRNA and HPV E6/E7 mRNA had a certain clinical value in the management of cell LSIL shunt diagnosis. The combined detection significantly improved the sensitivity and Youden index of HSIL and above lesions, while maintaining a high specificity and coincidence rate.
目的 探讨人乳头瘤病毒（HPV）的P16/ki67、E6/E7 mRNA双标记及联合检测在薄层液基细胞学检查（TCT）分流诊断低级别鳞状上皮内病变（LSIL）中的价值。方法 本研究纳入239例在初次TCT诊断后4周内接受阴道镜检查及活检的患者。剩余细胞学样本采用P16/ki67免疫细胞化学染色进行双标记，并使用Panther自动HPV E6/E7 mRNA检测系统检测HPV E6/E7 mRNA。采用SPSS22.0软件分析不同宫颈病变中P16/ki67双标记、HPV E6/E7 mRNA及联合检测的阳性率，并对同一宫颈病变中的阳性率进行横向比较，以评估P16/ki67、HPV E6/E7双标记及联合检测在高级别鳞状上皮内病变（HSIL）及以上病变诊断中的效能。结果 239例LSIL患者的HE染色诊断结果为慢性宫颈炎71例（29.71%），LSIL 143例（59.83%），HSIL 22例（9.20%），宫颈癌3例（1.26%）。P16ki67病变46例（19.25%），ki67P16病变41例（17.15%），ki67P16病变33例（13.81%），P16 - ki67 -病变119例（49.79%）。P16/ki67双标记、HPV E6/E7 mRNA及联合检测的阳性率随宫颈病变严重程度增加而升高。联合检测在HSIL病变中的阳性率最高，高于P16/ki67双标记及HPV E6/E7 mRNA检测。联合检测的敏感度高于P16/ki67双标记及HPV E6/E7 mRNA检测。联合检测的约登指数为0.7850。结论 P16/ki67双标记、HPV E6/E7 mRNA及联合检测在LSIL细胞分流诊断管理中具有一定临床价值。联合检测显著提高了HSIL及以上病变的敏感度和约登指数，同时保持了较高的特异度和符合率。
