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p16/Ki-67双染对高危型人乳头瘤病毒阳性妇女的分流作用

Role of p16/Ki-67 dual-stained cytology in triaging women with high-risk human papilloma virus

    摘要
  • 摘要:
    目的 探讨p16/Ki-67免疫细胞化学双染对高危型人乳头瘤病毒（high-risk human papilloma virus，HR-HPV）阳性妇女的分流作用。
    方法 选取2019年9月至2020年5月于上海闵行区中心医院妇科门诊就诊的HR-HPV阳性女性776例，行p16/Ki-67免疫细胞化学双染和宫颈液基薄层细胞学检测（thinprep cytologic test，TCT），同时进行阴道镜下宫颈活检。以宫颈活检组织病理结果为金标准，比较p16/Ki-67免疫细胞化学双染和TCT对HR-HPV阳性女性宫颈病变筛查的预测价值。计算不同阴道镜转诊策略每发现1例宫颈高级别鳞状上皮内病变（high-grade squamous intraepithelial lesion，HSIL）阳性所需的阴道镜转诊频数。
    结果 p16/Ki-67（趋势χ2=141.324，P < 0.001）和TCT（趋势χ2=81.328，P < 0.001）的预测阳性率均随宫颈病变病理级别的升高而升高。p16/Ki-67与TCT比较预测宫颈病变的特异度（80.3%vs 84.0%，P=0.07）和阳性预测值（28.9%vs 24.8%，P=0.405）相当，p16/Ki-67灵敏度（75.7%vs 50.0%，P=0.001）和阴性预测值（96.9%vs 94.1%，P=0.019）更高。其他12种HR-HPV阳性受试者中，p16/Ki-67每检出1例宫颈HSIL+（HSIL及以上病变）所需的阴道镜转诊例数少于TCT（P=0.036）。
    结论 对于下生殖道HR-HPV阳性的女性，p16/Ki-67双染操作简单、结果易判读，且较TCT有更高的灵敏度和阴性预测值及较低的阴道镜转诊率，有望成为阴道镜医师缺乏地区HR-HPV阳性女性分流的新方法。

     

    Abstract:
    Objective To assess the performance of p16/Ki-67 dual-stained cytology in triaging high-risk human papilloma virus (HR-HPV) positive women.
    Methods A total of 776 HR-HPV positive women in Shanghai Minhang Central Hospital from September 2019 to May 2020 were included. The cervical exfoliated cells from eligible women were collected for p16/Ki-67 dual-stained cytology and thinprep cytologic test (TCT), and cervical biopsy using colposcopy was conducted. Histology diagnosis was used as the gold standard, the predictive value of p16/Ki-67 dual-stained cytology and TCT for cervical lesion in HR-HPV positive women was compared. Furthermore, the number of colposcopies required per high-grade squamons intraepithelial lesion (HSIL+) detected was calculated.
    Results The positive rates of p16/Ki-67 dual-stained cytology (χ2=141.324, P < 0.001) and TCT (χ2=81.328, P < 0.001) were significantly increased with the increased histologic severity of the cervical lesion. For detection of HSIL+, p16/Ki-67 dual-stained cytology and TCT had similar specificity (80.3% vs 84.0%, P=0.070) and positive predictive value (28.9% vs 24.8%, P=0.405), but p16/Ki-67 dual-stained cytology had higher sensitivity (75.7% vs 50.0%, P=0.001) and negative predictive value (96.9% vs 94.1%, P=0.019). In other 12 types of HR-HPV, p16/Ki-67 dual-stained cytology required fewer colposcopies per HSIL+ detected compared with TCT (P=0.036).
    Conclusions Among HR-HPV positive women, compared with TCT, p16/Ki-67 dual-stained cytology has higher sensitivity, negative predictive value, and requires fewer colposcopies, with simple operation and easy interpretation of results. This method will be beneficial for the regions where there is in shortage of cytologists and colposcopy physicians.

     

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