Abstract:

Objective　To explore the adjunctive diagnostic value of P16/Ki67 dual staining for cervical atypical glandular cells (AGC). Methods　This study included the samples from 47 patients diagnosed with AGC by liquid-based cytology at Gansu Provincial Maternal and Child Health Hospital between June 2019 and December 2020. The corresponding histopathological results were collected, and all the cases were subjected to dual staining for P16/Ki67 and testing for high-risk human papillomavirus (HR-HPV). Histologically confirmed CIN1 and higher lesions were used as the positive standard. This study utilized χ² test to compare the detection rates of cervical CIN1 and higher lesions between the two methods, and the sensitivity, specificity, positive predictive value, and negative predictive value by each testing method were calculated. The receiver operating characteristic curve (ROC) was drawn. Results　Among the 47 patients, 20 (42.6%) had positive histopathological results; 28 (59.6%) were positive in HR-HPV; 14 (29.8%) were positive in P16/Ki67 dual staining. The sensitivity, specificity, positive predictive value, and negative predictive value of P16/Ki67 dual staining for detecting lesions above CIN1 were 70.0% (14/20), 100.0% (27/27), 100.0% (14/14), and 81.8% (27/33), respectively. In contrast, the sensitivity, specificity, positive predictive value, and negative predictive value of HR-HPV were 70.0% (14/20), 48.1% (13/27), 50.0% (14/28), and 68.4% (13/19), respectively. The specificity, positive predictive value, and negative predictive value of P16/Ki67 dual staining exceeded those of HR-HPV, with comparable sensitivity between the two methods. There was statistical difference in the detection rate of lesions above CIN1 between the two methods (P<0.05). The area under the curve (AUC) for HR-HPV detection is 0.591, P=0.292, and the AUC of P16/Ki67 dual staining detection is 0.850, P<0.001. Conclusions　In patients with AGC of cervical cytology, P16/Ki67 dual staining offers superior diagnostic assistance compared to HR-HPV testing.

Key words:

Atypical glandular cell,  , Cervix, P16/Ki67 dual staining, Human papillomavirus, Diagnosis

摘要：

目的　探讨P16/Ki67双染在宫颈非典型腺细胞（AGC）病变中的辅助诊断价值。方法　采用回顾性分析，选取2019年6月至2020年12月甘肃省妇幼保健院收治的宫颈液基薄层细胞学检查为AGC的47例患者样本，获取相应的组织病理学结果，对所有病例行P16/Ki67双染和高危型人乳头瘤病毒（HR-HPV）检测。以组织学宫颈上皮内瘤变（CIN）1以上病变为阳性标准，采用χ²检验比较两者对宫颈CIN1以上病变的检出率，并计算每种检测方法的灵敏度、特异度、阳性预测值、阴性预测值，绘制受试者操作特征曲线（ROC）。结果　47例患者中，组织病理学结果阳性者20例（42.6%），HR-HPV检测阳性者28例（59.6%），P16/Ki67双染阳性者14例（29.8%）。P16/Ki67双染检测法检测CIN1以上病变的灵敏度、特异度、阳性预测值和阴性预测值分别为70.0%（14/20）、100.0%（27/27）、100.0%（14/14）和81.8%（27/33），HR-HPV检测法分别为70.0%（14/20）、48.1%（13/27）、50.0%（14/28）、68.4%（13/19）。P16/Ki67双染检测的特异度、阳性预测值、阴性预测值均高于HR-HPV检测，灵敏度相当。两者对CIN1以上病变的检出率差异有统计学意义（P<0.05）。HR-HPV检测的曲线下面积（AUC）为0.591、P=0.292，P16/Ki67双染检测AUC为0.850，P<0.001。结论　在宫颈细胞学AGC患者中，P16/Ki67双染检测比HR-HPV检测更具有辅助诊断价值。

关键词:

非典型腺细胞, 宫颈, P16/Ki67双染, 人乳头瘤病毒, 诊断