Department of General Surgery and Medical Surgery Specialties, Gynecological Clinic, University of Catania, Catania, Italy.
Multidisciplinary Research Center in Papillomavirus Pathology, University of Catania, Catania, Italy.
Virol J. 2022 May 27;19(1):95. doi: 10.1186/s12985-022-01822-1.
The aim of this study was to evaluate the regression rate of CIN2 p16 positive lesions in women over 25 years of age and identify possible predictors of regression.
A total of 128 CIN2 p16 positive patients over 25 years old were considered. The women met the following inclusion criteria: HPV genotype 16, 18, 31, 33, 45 positive, HPV E6 / E7 mRNA test positive, without immune system pathologies, not pregnant and had completed at least two years of follow-up. At each follow-up examination patients were examined by colposcopy, HPV test, E6/E7mRNA, targeted biopsy and p16 protein detection. The final state after the two years of follow-up was classified as progression if the histology showed a CIN3, persistence if the lesion was a CIN2, regression if negative or LSIL. The predicted regression factors evaluated were: HPV E6/E7mRNA, protein p16.
Overall, we had 35.1% (45 cases) of progression to CIN3, 41.4% (53 cases) of persistence and 23.4% (30 cases) of regression. The regression rate was higher in women with negative mRNA 92.8% (26/28), OR 312 (34.12-1798.76) p = 0.0001, while women with p16 negative had a regression of 22.6% (7/31), OR 0.94 (95% CI 0.36-2.46), p was not significant. We found no significant difference in regression between p16 positive (23.7%) and p16 negative (22.6%) CIN2 p16 lesions. p16 had a VPN of 22.6 (CI 95% 0.159-0.310), indicating that a p16 negative lesion does not exclude a CIN2 + .
We had a regression rate of 23.4%, which was low if we consider that in the literature the regression rates vary from 55 to 63%. The discrepancy in the results may indeed be explained by the fact that all lesions in our study were hr-HPV positive and belonged to "older women" reflecting a more "high-risk" population. As regression factors we studied p16 and HPV E6/E7 mRNA. The results of our study show that HPV mRNA, if negative, appears to be able to identify CIN2 lesions with a higher probability of regression and underlines how a p16 negative is not an indicator of regression.
本研究旨在评估 25 岁以上 CIN2 p16 阳性病变的消退率，并确定可能的消退预测因素。
共纳入 128 例 25 岁以上 CIN2 p16 阳性患者。这些女性符合以下纳入标准：HPV 基因型 16、18、31、33、45 阳性，HPV E6/E7mRNA 检测阳性，无免疫系统疾病，未怀孕且完成至少两年的随访。在每次随访检查中，患者均接受阴道镜检查、HPV 检测、E6/E7mRNA、靶向活检和 p16 蛋白检测。如果组织学显示 CIN3，则将两年随访后的最终状态归类为进展；如果病变为 CIN2，则为持续；如果为阴性或 LSIL，则为消退。评估的预测消退因素为：HPV E6/E7mRNA、p16 蛋白。
总体而言，我们有 35.1%（45 例）进展为 CIN3，41.4%（53 例）持续存在，23.4%（30 例）消退。mRNA 阴性的女性消退率更高，为 92.8%（26/28），OR 312（34.12-1798.76），p=0.0001，而 p16 阴性的女性消退率为 22.6%（7/31），OR 0.94（95%CI 0.36-2.46），p 无统计学意义。我们发现 p16 阳性（23.7%）和 p16 阴性（22.6%）CIN2 p16 病变之间的消退无显著差异。p16 的 VPN 为 22.6（95%CI 0.159-0.310），表明 p16 阴性病变并不能排除 CIN2+。
我们的消退率为 23.4%，如果考虑到文献中消退率从 55%到 63%不等，这个数字较低。结果的差异可能确实可以用以下事实来解释：我们研究中的所有病变均为高危型 HPV 阳性，属于“老年女性”，反映了更“高危”的人群。作为回归因素，我们研究了 p16 和 HPV E6/E7mRNA。我们的研究结果表明，如果 HPVmRNA 阴性，似乎能够更有可能识别出具有较高消退率的 CIN2 病变，并强调了 p16 阴性并不是消退的指标。
