李 莉,王 林,李菊晓.宫颈细胞内p16/Ki67表达与宫颈癌及癌前病变的关系及其用于HPV阳性人群分流的诊断价值[J].中国肿瘤,2018,27(4):311-315.
宫颈细胞内p16/Ki67表达与宫颈癌及癌前病变的关系及其用于HPV阳性人群分流的诊断价值
Expression of p16/Ki67 in Cervical Cancer and Precancerous Tissue and its Diagnostic Value for HPV Positive Women
投稿时间:2017-12-19  
DOI:10.11735/j.issn.1004-0242.2018.04.A012
中文关键词:  p16/Ki67双染  HPV E6/E7mRNA检测  LBC检测  宫颈上皮内瘤变
英文关键词:p16/Ki-67 dual staining  HPV E6/E7mRNA  LBC  CIN
基金项目:
作者单位
李 莉 新疆医科大学公共卫生学院 
王 林 厦门大学分子疫苗学与分子诊断学国家重点实验室国家传染病诊断试剂及疫苗工程技术研究中心 
李菊晓 华中科技大学同济医学院 
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中文摘要:
      摘 要:[目的] 探讨p16/Ki67双染技术对宫颈癌及癌前病变的检出能力,比较其用于HPV阳性人群分流的诊断价值。[方法] 选取2016年9月至2017年5月山西长治三家三甲医院21~70岁参加宫颈癌筛查的妇女及门诊患者共计497例,所有入组研究对象均进行HPV E6/E7mRNA检测、液基细胞学检测(LBC)与p16/Ki67双染。[结果] p16/Ki67双染的阳性率随细胞学诊断及病理诊断的严重程度的增加而升高(P<0.05);p16/Ki67对62例宫颈上皮内瘤变2级及以上(CIN2+)研究对象检出的灵敏度、特异性分别为69.4%、83.6%,HPV E6/E7mRNA检测分别为82.3%、74.6%,LBC检测分别为80.6%、65.2%。对49例CIN3+研究对象检出的灵敏度、特异性分别为69.4%、81.9%,HPV E6/E7mRNA检测分别为85.7%、73.3%。在CIN2+/CIN3+病例中p16/Ki67的灵敏度与LBC均衡可比,但其特异性明显高于 LBC 和HPV E6/E7mRNA检测。在HPV E6/E7mRNA检测阳性人群中p16/Ki67双染对CIN2+检出的灵敏度和特异性分别为82.4%和56.9%,LBC检测为90.2%和29.4%;p16/Ki67双染对CIN3+检出的灵敏度和特异性分别为81.0%和53.2%,LBC检测为88.1%和27.0%。p16/Ki67双染中对CIN2+及CIN3+检出的灵敏度与LBC检测相比均无明显差异(P>0.05),但其特异性明显高于LBC检测(P<0.001)。[结论] p16/Ki67双染技术用于HPV阳性人群的分流具有优于LBC的特异性和与LBC检测相似灵敏度的特性。在经济条件允许或者缺乏病理医生的地区,可以考虑使用p16/Ki67代替细胞学用于宫颈癌的初筛或HPV阳性人群的分流。
英文摘要:
      Abstract:[Purpose] To investigate the expression of p16/Ki67 in cervical cancer and precancerous tissues and its diagnostic value for HPV positive women. [Methods] A total of 497 women aged 21~70 years were enrolled in this study. The expression of HPV E6/E7mRNA was detected. Liquid based cytology (LBC) was performed and the p16/Ki67 expression was determined by dual staining immunohistochemistry. [Results] The positive rate of p16/Ki67 dual stain increased with the increase of cytologic and pathologic categories (P<0.05). For diagnosis of CIN2+,the sensitivity and specificity of p16/Ki67 were 69.4% and 83.6%,those of HPV E6/E7 mRNA were 82.3% and 74.6%,those of the LBC were 80.6% and 65.2%,respectively. For diagnosis of CIN3+,the sensitivity and specificity of p16/Ki67 were 69.4% and 81.9%,those of HPV E6/E7mRNA were 85.7% and 73.3%,those of LBC were 85.75% and 73.3%,respectively. For diagnosis of CIN2+/CIN3+,the sensitivity of p16/Ki67 was equal to LBC,but the specificity of p16/Ki67 dual stain was higher than that of LBC and HPV E6/E7 mRNA (P<0.05). In the HPV positive women the sensitivity and specificity of p16/Ki67 were 82.4% and 56.9%,those of LBC were 90.2% and 29.4%. McNemar test showed that there was no significant difference in sensitivity for diagnosis of CIN2+/CIN3+ between p16/Ki67 and LBC,but the specificity of p16/Ki67 dual staining was higher than that of LBC(P>0.05). [Conclusion] In HPV positive women the p16/Ki67 dual stain has a higher specificity than LBC. Therefore p16/Ki67 dual staining can be considered as a screening method for cervical cancer in HPV positive women.
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