文章摘要
王海瑞,廖光东,江宇,李雨聪,乔友林,陈汶.p16/mcm2双染在宫颈上皮内瘤变的诊断价值及其与高危型HPV感染的关系[J].中华流行病学杂志,2017,38(9):1241-1245
p16/mcm2双染在宫颈上皮内瘤变的诊断价值及其与高危型HPV感染的关系
Diagnostic value of p16/mcm2 dual staining in cervical intraepithelial neoplasia and its association with high-risk HPV infection
收稿日期:2017-01-26  出版日期:2017-09-09
DOI:10.3760/cma.j.issn.0254-6450.2017.09.020
中文关键词: p16  mcm2  宫颈上皮内瘤变  人乳头瘤病毒  宫颈癌筛查
英文关键词: p16  mcm2  Cervical intraepithelial neoplasia  HPV  Cervical cancer screening
基金项目:
作者单位E-mail
王海瑞 100730 北京, 中国医学科学院北京协和医学院公共卫生学院  
廖光东 610041 成都, 四川大学华西第二医院妇产科  
江宇 100730 北京, 中国医学科学院北京协和医学院公共卫生学院  
李雨聪 400030 重庆, 重庆市癌症中心/重庆市肿瘤医院妇瘤科  
乔友林 100021 北京, 国家癌症中心/中国医学科学院北京协和医学院肿瘤医院流行病学研究室  
陈汶 100021 北京, 国家癌症中心/中国医学科学院北京协和医学院肿瘤医院流行病学研究室 chenwen@cicams.ac.cn 
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中文摘要:
      目的 研究p16/mcm2免疫细胞化学双染在宫颈病变中的表达及其与HPV感染的关联,并探讨其在宫颈癌筛查中的应用价值。方法 将2015年5-12月参加宫颈癌筛查并行高危型HPV(HR-HPV)检测和液基细胞学检查的1 127名女性纳入研究,对留存细胞学标本进行p16/mcm2免疫细胞化学双染检测,并与宫颈组织病理学结果进行比较。结果 p16/mcm2在HPV16/18阳性组和其他HR-HPV阳性组的表达风险均高于HPV阴性组,OR值分别为15.95(95%CI:9.59~26.51)、10.53(95%CI:7.41~14.98);p16/mcm2阳性率随宫颈上皮内瘤变(CIN)级别的升高而升高,且在CIN2组、CIN3组中均高于良性病变组(P<0.05);p16/mcm2阳性者中检出CIN2及以上(CIN2+)和CIN3及以上(CIN3+)病变的灵敏度分别为86.1%、92.0%,特异度分别为46.1%、44.4%;在细胞学诊断为非典型鳞状细胞和低度鳞状上皮内病变人群中检出CIN2+和CIN3+病变的灵敏度分别为85.7%、87.5%,特异度分别为45.5%、44.1%。结论 p16/mcm2双染灵敏度高于细胞学检查,特异度优于HPV检测,可识别宫颈高度病变和指导CIN的分级,有望成为新的宫颈癌筛查标志物。
英文摘要:
      Objective To study the expression of p16/mcm2 immunocytochemical dual staining in cervical lesions and its association with high-risk HPV infection, and discuss its clinical value in cervical cancer screening. Methods From May to December 2015, a total of 1 127 women receiving cervical cancer screening, high-risk HPV (HR-HPV) test and liquid-based cytology test were included in the study. p16/mcm2 immunocytochemical dual staining was performed on residual cytology specimens and the results were compared with histopathology results. Results p16/mcm2 had a higher expression risk in HPV16/18 group and other HR-HPV group compared with HPV negative group, with OR of 15.95 (95%CI:9.59-26.51) and 10.53 (95%CI:7.41-14.98), respectively. The positive rate of p16/mcm2 increased with cervical intraepithelial neoplasia (CIN) severity, and was higher in both CIN2 group and CIN3 group than in benign lesion group (P<0.05). The overall sensitivity of p16/mcm2 to detect CIN2+ and CIN3+ lesions were 86.1% and 92.0%, respectively, and the overall specificity were 46.1% and 44.4%, respectively. In group with cytologic diagnoses of atypical squamous cells (ASC) and low-grade squamous intraepithelial lesion (LSIL), the sensitivity to detect CIN2+ and CIN3+ lesions were 85.7% and 87.5%, respectively, and the specificity were 45.5% and 44.1%, respectively. Conclusions p16/mcm2 dual staining has higher sensitivity than cytology test and better specificity than HPV test. It can identify high-grade cervical lesions and guide the classification of CIN. p16/mcm2 might be used as an innovative biomarker for cervical cancer screening.
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