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p16/Ki-67双染监测在高危型人乳头瘤病毒阳性人群中的分流效果评价
作者:贾漫漫 赵冬梅 郭珍 吴泽妮 陈佩佩 郭沛沛 孙星媛 张韶凯

摘要:

目的  评估p16/Ki-67双染检测在高危(HR)人乳头瘤病毒(HPV)阳性人群中的分流效果。方法  于2016年4—12月,选取在郑州大学第二附属医院妇科就诊,并进行阴道镜检查且HPV DNA检测结果为HR-HPV感染的女性为调查对象,收集其宫颈脱落细胞标本,并分别进行p16/Ki-67双染检测、HPV16/18检测、LBC检测和活检病理诊断。以活检病理结果为结局指标,计算和比较3种检测分流HR-HPV阳性者的灵敏度、特异度、阳性预测值和阴性预测值。结果  共发现HR-HPV阳性女性295例,年龄为(44.29±11.48)岁,其中p16/Ki-67双染检测、HPV16/18检测和LBC检测的阳性率分别为70.17%(207例)、56.95%(168例)和85.76%(253例)。以CIN2+为疾病终点指标时,3种检测方法中,p16/Ki-67双染检测的灵敏度为90.00%(95%CI:85.06%~93.43%),高于HPV16/18检测,低于LBC检测;特异度最高,为71.58%(95%CI:61.81%~79.67%);阳性预测值最高,为86.96%(95%CI:81.69%~90.88%);阴性预测值最高,为77.27%(95%CI:67.49%~84.78%)。以CIN3+为疾病终点指标时,p16/Ki-67双染检测的灵敏度为92.90%(95%CI:87.74%~95.99%),低于LBC检测,高于HPV16/18检测;特异度为55.00%(95%CI: 46.74%~63.00%),低于HPV16/18检测,高于LBC检测;阳性预测值为69.57%(95%CI:62.99%~75.43%),低于HPV16/18检测,高于LBC检测;阴性预测值为87.50%(95%CI:78.99%~92.87%),高于HPV16/18检测,低于LBC检测。结论  p16/Ki-67双染检测技术作为HPV阳性妇女分流措施的效果优于HPV16/18检测和LBC检测方法。

关键词:宫颈上皮内瘤样病变;子宫颈;高危型人乳头瘤病毒阳性;p16/Ki-67双染;实验性研究

Abstract:

Objective  This study aimed to evaluate the clinical performance of p16/Ki-67 dual staining for triage high risk HPV (HR-HPV) infected women.Method  Target objects were women who infected HR-HPV and received colposcopy examination between April and December of 2016 at the Second Affiliated Hospital of Zhengzhou University. Gynecologists collected the cervical exfoliated cells from eligible women for p16/Ki-67 dual staining, LBC testing and HPV DNA testing. Histology diagnosis were used as gold standard. Sensitivities, specificities, positive predictive values (PPVs), negative predictive values (NPVs) of p16/Ki-67 dual staining, LBC testing and HPV16/18 testing for triage of HR-HPV positive population were calculated and compared.Results  A total of 295 HR-HPV infected women were selected, and the mean age was (44.29±11.48) years old. Positive rates of p16/Ki-67 dual staining, HPV16/18 testing and LBC testing were 70.17% (207), 56.95% (168) and 85.76% (253), respectively. When CIN2+as the endpoint, among the three triage methods, sensitivity of p16/Ki-67 dual staining was 90.00% (95%CI: 85.06%-93.43%), higher than the value of HPV 16/18 testing, but lower than the value of LBC testing. Specificity, PPV and NPV of p16/Ki-67 dual staining were the highest [71.58% (95%CI: 61.81%-79.67%), 86.96% (95%CI:81.69%-90.88%) and 77.27% (95%CI: 67.49%-84.78%)]. When detection for CIN3+, sensitivity of p16/Ki-67 dual staining was 92.90% (95%CI: 87.74%-95.99%), lower than the value of LBC testing, but higher than the value of HPV16/18 testing. Specificity of p16/Ki-67 dual staining was 55.00% (95%CI: 46.74%-63.00%), lower than the value of HPV16/18 testing, but higher than the value of LBC testing. PPV of p16/Ki-67 dual staining was 69.57% (95%CI: 62.99%-75.43%), lower than the value of HPV 16/18 testing, but higher than the value of LBC testing. NPV of p16/Ki-67 dual staining was 87.50% (95%CI: 78.99%-92.87%), higher than value of HPV 16/18 testing, but lower than the value of LBC testing.Conclusion  p16/Ki-67 dual staining has better clinical effects than HPV 16/18 testing and LBC testing for triage women with HR-HPV infection.

Key words: Cervical intraepithelial neoplasia;Ervix Uteri;HR-HPV positive;p16/Ki-67 dual staining;Experiment study

发表日期:2020/2

引用本文:

图/表:

  • 10.3760/cma.j.issn.0253-9624.2020.02.015.T001:表1 不同病理诊断级别调查对象p16/Ki-67双染检测、HPV16/18检测和LBC检测的阳性率

    10.3760/cma.j.issn.0253-9624.2020.02.015.T001:表1 不同病理诊断级别调查对象p16/Ki-67双染检测、HPV16/18检测和LBC检测的阳性率

  • 10.3760/cma.j.issn.0253-9624.2020.02.015.T002

    10.3760/cma.j.issn.0253-9624.2020.02.015.T002

  • 10.3760/cma.j.issn.0253-9624.2020.02.015.T003

    10.3760/cma.j.issn.0253-9624.2020.02.015.T003

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