Objective: to investigate the clinical value of p16/Ki-67 immunocytochemical dual staining (abbreviated as p16/Ki-67 dual staining) in cervical intraepithelial neoplasia (CIN) and cervical cancer screening. Methods: From July to November 2015, a total of 980 women attending cervical cancer screening and receiving high-risk human papillomavirus (HR-HPV) test and thinprep cytologic test (TCT) were included in the study. p16/Ki-67 immunocytochemical dual staining was performed on residual cytologic specimens and compared with histopathology results. Results: The expression risks of p16/Ki-67 in HPV16/18 group and another HR-HPV group were higher than HPV negative group, with an odds ratio of 10.64 (95%CI: 5.66~20.02) and 5.40 (95%CI: 3.62~8.04), respectively. The positive rate of p16/Ki-67 increased with the grade of TCT and histologic diagnosis, and was higher in both CIN2 and CIN3 groups than normal group (P<0.05). The sensitivity of p16/Ki-67 to detect CIN2+ and CIN3+ lesions was 89.3% and 94.1%, respectively, and the specificity was 69.3% and 66.8%, respectively. The sensitivity of TCT to detect CIN2+ and CIN3+ lesions was 60.7% and 64.7%, respectively, and the specificity was 49.3% and 49.1%, respectively. Conclusions: Compared with TCT, p16/Ki-67 dual staining has higher sensitivity and specificity. It can identify high-grade cervical lesions and guide the classification of CIN. p16/Ki-67 dual staining in conjunction with HPV test may be considered as an efficient method for cervical cancer screening.
目的： 探讨p16/Ki－67免疫细胞化学双染(p16/Ki－67双染)在宫颈上皮内瘤变(CIN)和宫颈癌筛查中的应用价值。 方法： 2015年7月至11月间参加宫颈癌筛查并行高危人乳头瘤病毒(HR－HPV)检测和液基细胞学检查(TCT)的980名35～64岁妇女纳入研究，对留存细胞学标本进行p16/Ki－67双染检测，并与宫颈组织病理学结果进行比较。 结果： p16/Ki－67在HPV16/18组和其他HR－HPV组的表达风险均高于HPV阴性组，OR值分别为10.64(95%CI为5.66～20.02)、5.40(95%CI为3.62～8.04)。p16/Ki－67阳性率随着TCT和病理诊断级别的升高而升高，且在CIN2组、CIN3组中均高于正常组(P<0.05)。p16/Ki－67双染诊断CIN2＋和CIN3＋病变的敏感度分别为89.3%和94.1%，特异度分别为69.3%和66.8%。TCT诊断CIN2＋和CIN3＋病变的敏感度分别为60.7%和64.7%，特异度分别为49.3%和49.1%。 结论： 与TCT比较，p16/Ki－67双染具有更高的敏感度和特异度，可识别宫颈高度病变和指导CIN的分级。p16/Ki－67联合HPV检测可作为有效的宫颈癌筛查方法。.
Keywords: Cervical cancer screening; Cervical intraepithelial neoplasia; Human papillomavirus; p16/Ki-67.