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Title: [Significance of p16/Ki-67 double immunocytochemical staining in cervical cytology ASCUS, LSIL, and ASC-H].
Author: Wu Y, Zhao J, Hu J, Wu XW, Zhu LR.
Journal: Zhonghua Fu Chan Ke Za Zhi; 2017 Nov 25; 52(11):734-739. PubMed ID: 29179267.
Abstract:
Objective: To investigate the application value of p16/cell proliferation associated nuclear antigen (Ki-67) double-staining and human papillomavirus mRNA in the cytological screening. Methods: Two hundred and fifty-one cases who suffered from atypical squamous cell of undetermined significance (ASCUS), low-grade squamous intraepithelial lesion (LSIL), atypical squamous cell-cannot exclude high-grade squamous intraepithelial lesion (ASC-H) in ThinPrep cytologic test (TCT) were collected in Peking University First Hospital between October 2015 and March 2016. And p16/Ki-67 double-staining and hybrid capture Ⅱ (HC-Ⅱ) detection were performed on the cervical cells. The result was compared with the pathological result of colposcope guided biopsy. All statistical analysis was completed by Stata 12.0 statistical software analysis. The results of diagnostic tests were described by using the sensitivity, specificity, positive predictive value,negative predictive value, and the area under the receiver operating characteristic (ROC) curve. Results: (1) One hundred and eight cases of liquid based cytology diagnosis of ASCUS patients, the positive rate of p16/Ki-67 was 13.9% (15/108), 102 cases of liquid based cytology diagnosis of LSIL patients, the positive rate of p16/Ki-67 was 21.6% (22/102), 41 cases of liquid based cytology diagnosis of ASC-H patients, the positive rate of p16/Ki-67 was 39.0% (16/41), compared amongthree groups, the difference was statistically significant (χ(2)=78.516, P<0.05); cervical exfoliated cells p16/Ki-67 expression rate was 13.0%(28/215) in cervical low-grade lesions [cervical intraepithelial neoplasia (CIN) Ⅰ], which was 69.4%(25/36) in high level lesions (CIN Ⅱ-Ⅲ), the difference was statistically significant (χ(2)=7.932, P<0.05). (2) The specificity of p16/Ki-67 detection and diagnosis were higher than those of HC-Ⅱ in ASCUS, LSIL, and ASC-H (89.8% vs 71.4%, 83.3% vs 15.6%, 88.9% vs 40.7%; all P<0.05), meanwhile, the positive predictive value of p16/Ki-67 detection and diagnosis exceed those of HC-Ⅱ in ASCUS, LSIL, and ASC-H (33.3% vs 26.3%, 31.8% vs 12.6%, 81.3% vs 38.5%; all P<0.05). Moreover, the ROC curve of p16/Ki-67 were bigger than those of HC-Ⅱ in ASCUS, LSIL, and ASC-H (0.799 vs 0.696, 0.708 vs 0.531, 0.909 vs 0.561; all P<0.05). Conclusion: For patients with cytological diagnosis of ASCUS, LSIL, and ASC-H, p16/Ki-67 double staining method could be used as an effective method to assist in the diagnosis of high-grade cervical lesions, and the screening efficiency is superior to that of high-rist HPV. 目的： 在细胞学诊断为未明确诊断意义的不典型鳞状上皮细胞（ASCUS）、低级别鳞状上皮内病变（LSIL）、不除外高度病变的不典型鳞状上皮细胞（ASC-H）的患者中，评价免疫细胞化学p16/细胞增殖相关核抗原（Ki-67）双染色法对其中高级别子宫颈病变[包括子宫颈上皮内瘤变（CIN）Ⅱ、CINⅢ]的筛查效能，并分析p16/Ki-67双染色法对于ASCUS、LSIL、ASC-H患者分流的意义。 方法： 收集2015年10月—2016年3月在北京大学第一医院妇科门诊就诊的液基薄层细胞学检查（TCT）结果为ASCUS、LSIL、ASC-H的患者共251例，对其子宫颈脱落细胞分别行p16/Ki-67双染色法检测、高危型HPV（HR-HPV）检测[采用第2代杂交捕获技术（HC-Ⅱ）检测HR-HPV DNA]，并行阴道镜活检组织的病理检查，以组织学病理诊断为"金标准"，采用敏感度、特异度、阳性预测值、阴性预测值和受试者工作特征（ROC）曲线下面积比较p16/Ki-67双染色法和HR-HPV检测的筛查效能。 结果： （1）251例患者的子宫颈脱落细胞中，p16/Ki-67双染色的总阳性率为21.1%（53/251）。其中，细胞学诊断为ASCUS患者的子宫颈脱落细胞中p16/Ki-67双染色的阳性率为13.9%（15/108），LSIL患者为21.6%（22/102），ASC-H患者为39.0%（16/41），3者比较，差异有统计学意义（χ(2)=78.516，P<0.05）；阴道镜活检后病理诊断为低级别子宫颈病变（包括正常子宫颈、CINⅠ）患者的子宫颈脱落细胞中p16/Ki-67双染色的阳性率为13.0%（28/215），高级别子宫颈病变患者为69.4%（25/36），两者比较，差异有统计学意义（χ(2)=7.932，P<0.05）。（2）以阴道镜活检后的病理诊断为"金标准"，在细胞学诊断为ASCUS、LSIL、ASC-H的患者中，p16/Ki-67双染色法筛查高级别子宫颈病变的特异度（分别为89.8%、83.3%、88.9%）及阳性预测值（分别为33.3%、31.8%、81.3%）均明显高于HR-HPV检测（特异度分别为71.4%、15.6%、40.7%，阳性预测值分别为26.3%、12.6%、38.5%；P均<0.05），其受试者工作特征（ROC）曲线下面积（分别为0.799、0.708、0.909）也均明显大于HR-HPV检测（分别为0.696、0.531、0.561；P均<0.05）。 结论： 对于细胞学诊断为ASCUS、LSIL、ASC-H的患者，p16/Ki-67双染色法可作为筛查其高级别子宫颈病变的有效检测手段，其筛查效能明显优于HR-HPV检测。.

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