Department of Obstetrics and Gynecology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.
Department of Gynecology, The First Central Hospital of Baoding City, Baoding, 071000, Hebei, China.
BMC Womens Health. 2022 Apr 27;22(1):138. doi: 10.1186/s12905-022-01714-0.
This study aims to evaluate the value of p16 immunostaining for high-grade squamous intraepithelial lesions in human papillomavirus-negative patients in Beijing, China.
In this study, we evaluated the value of p16 immunostaining, as well as cytology and colposcopy, for predicting high-grade squamous intraepithelial lesions (HSIL) in human papillomavirus (HPV)-negative patients by comparing the methods with the haematoxylin and eosin (H&E) staining pathological diagnosis of HPV-negative patients.
Of 122 patients negative for the high-risk HPV (hrHPV) subtype, 26 (21.3%) underwent colposcopically directed multiple punch cervical biopsies with H&E pathological diagnoses of HSIL and above (HSIL+), 11 patients (9.0%) had cervical intraepithelial neoplasia (CIN)2, nine patients (7.4%) had CIN3 and six patients (4.9%) had infiltrating carcinomas. Cytology, colposcopy and p16 immunostaining had 52.4%, 38.5% and 92.3% sensitivity, respectively, and 76.2%, 94.8% and 99% specificity, respectively. The positive predictive value of the cytology, colposcopy and p16 immunostaining was 31.4%, 66.7% and 96%, respectively, and the negative predictive value was 88.5%, 85.1% and 97.9%, respectively. Compared with H&E staining, the kappa of the cytology, colposcopy and p16 immunostaining was 0.327, 0.323 and 0.926, respectively.
Positive p16 immunostaining is very strongly consistent with an H&E diagnosis of CIN2+, and it can be used as an objective detection index for HSIL+ diagnoses of HPV-negative patients with CIN2+.
本研究旨在评估 p16 免疫组化在 HPV 阴性的中国北京地区患者中诊断高级别鳞状上皮内病变（HSIL）的价值。
本研究通过比较 p16 免疫组化、细胞学和阴道镜检查预测 HPV 阴性患者 HSIL 的价值，与 HPV 阴性患者的苏木精和伊红（H&E）染色病理诊断进行比较。
122 例高危型 HPV（hrHPV）阴性患者中，26 例（21.3%）行阴道镜下多点宫颈活检，H&E 病理诊断为 HSIL 及以上（HSIL+），11 例（9.0%）为宫颈上皮内瘤变（CIN）2 级，9 例（7.4%）为 CIN3 级，6 例（4.9%）为浸润性癌。细胞学、阴道镜和 p16 免疫组化的敏感度分别为 52.4%、38.5%和 92.3%，特异度分别为 76.2%、94.8%和 99%。细胞学、阴道镜和 p16 免疫组化的阳性预测值分别为 31.4%、66.7%和 96%，阴性预测值分别为 88.5%、85.1%和 97.9%。与 H&E 染色相比，细胞学、阴道镜和 p16 免疫组化的κ 值分别为 0.327、0.323 和 0.926。
p16 免疫组化阳性与 CIN2+的 H&E 诊断非常一致，可作为 HPV 阴性患者 CIN2+HSIL+诊断的客观检测指标。
