Abstract:

Objective　To investigate the application value of double staining of suppressor gene protein 16 (P16)/proto-oncogene cell proliferation nuclear antigen (Ki-67) in screening cervical cancer. Methods　The clinical data of 100 patients with cervical lesions who were treated at Zhengzhou Maternal and Child Health Hospital from October 2020 to May 2022 were retrospectively analyzed. The patients were (55.65±2.14) years old. All the patients received P16/Ki-67 double staining test, liquid based cytology (TCT) examination, and high-risk human papillomavirus (HR-HPV) detection. The biopsy results under colposcopy were used as the gold standard. The measurement data were analyzed by t test, and the enumeration data by χ² test. The value of HR-HPV, TCT, and P16/Ki-67 double staining in the diagnosis of cervical lesions was analyzed by the receiver operating characteristic curve (ROC). Results　Among the 100 patients with cervical lesions, 14 cases (14.00%) were found with inflammatory lesions by colposcopy, 26 cases (26.00%) cervical intraepithelial neoplasia (CIN) Ⅰ, 26 cases (26.00%) CIN Ⅱ, 28 cases (28.00%) CIN Ⅲ, and 6 cases (6.00%) cervical squamous cell carcinoma (SCC). The sensitivity, specificity, and accuracy of HR-HPV in the diagnosis of cervical lesions were 97.6%(84/86), 85.71(12/14), and 96.00%(96/100), respectively; the sensitivity, specificity, and accuracy of TCT in the diagnosis of cervical lesions were 88.37%(76/86), 78.57%(11/14), and 87.00%(87/100), respectively; the sensitivity, specificity, and accuracy of P16/Ki-67 double staining in the diagnosis of cervical lesions were 91.86%(79/86), 85.71%(12/14), and 91.00%(91/100), respectively; there were no statistical differences between HR-HPV, TCT, and P16/Ki-67 double staining (all P>0.05). The areas under the curves (AUC) of HR-HPV, TCT, and P16/Ki-67 double staining in the diagnosis of cervical lesions were 0.917, 0.835, and 0.888, respectively. There were no statistical differences in AUC between P16/Ki-67 double staining on one hand and TCT and HR-HPV examination on the other hand (both P>0.05). Conclusion　P16/Ki-67 double staining in screening cervical cancer and precancerous lesions is as effective as TCT and HR-HPV. It has the advantages of high efficiency, objectivity, simplicity, and repeatability, and can be used as a new choice for screening cervical cancer and precancerous lesions.

Key words:

Cervical cancer, P16/Ki-67 double staining, High-risk human papillomavirus, Liquid based cytology

摘要：

目的　探讨抑制基因蛋白16（P16）/原癌基因细胞增殖核抗原（Ki-67）双染在宫颈癌筛查中的应用价值。方法　回顾性分析2020年10月至2022年5月就诊于郑州市妇幼保健院的100例宫颈病变患者的临床资料，患者年龄（55.65±2.14）岁，均接受P16/Ki-67双染检测、液基细胞学（TCT）检查、高危人乳头瘤病毒（HR-HPV）检测，以阴道镜下活检结果为金标准，计量资料采用t检验，计数资料采用χ²检验，利用受试者工作特征曲线（ROC），分析HR-HPV、TCT、P16/Ki-67双染诊断宫颈病变价值。结果　100例宫颈病变患者，经阴道镜活检发现14例（14.00%）为炎症病变，宫颈上皮内瘤变（CIN）Ⅰ 26例（26.00%），CIN Ⅱ 26例（26.00%），CIN Ⅲ 28例（28.00%），宫颈鳞状细胞癌（SCC）6例（6.00%）。HR-HPV对宫颈病变诊断的灵敏度为97.67%（84/86）、特异度为85.71%（12/14）、准确度为96.00%（96/100），TCT对宫颈病变诊断的灵敏度为88.37%（76/86）、特异度为78.57%（11/14）、准确度为87.00%（87/100），P16/Ki-67双染对宫颈病变诊断的灵敏度为91.86%（79/86）、特异度为85.71%（12/14）、准确度为91.00%（91/100）；HR-HPV、TCT、P16/Ki-67双染相比，差异均无统计学意义（均P>0.05）。HR-HPV、TCT、P16/Ki-67双染诊断宫颈病变的曲线下面积（AUC）分别为0.917、0.835、0.888，P16/Ki-67双染检测分别与TCT、HR-HPV检查相比，AUC的差异均无统计学意义（均P>0.05）。结论　P16/Ki-67双染筛查宫颈癌及癌前病变效果与TCT、HR-HPV相似，其具有高效、客观、简便、易重复等优点，可作为宫颈癌及癌前病变初筛的新选择。

关键词:

宫颈癌, P16/Ki-67双染, 高危人乳头瘤病毒, 液基细胞学