University Hospital of Ioannina, Ioannina, Greece.
Gynecol Oncol. 2011 Apr;121(1):43-8. doi: 10.1016/j.ygyno.2010.12.003. Epub 2011 Jan 8.
This study aims to assess the alterations in various HPV-related biomarkers 6 months post-treatment and how these relate to various risk factors and individual characteristics; their role for the prediction of treatment failure was also evaluated.
Prospective observational study.
Women planning to undergo treatment for cervical intraepithelial neoplasia.
A liquid-based cytology sample was taken pre-operatively. This was tested for HPV genotyping, Nucleic Acid Sequence Based Amplification, flow cytometric evaluation and p16 immunostaining. A repeat LBC sample was obtained 6 months post-treatment and was tested for the same biomarkers.
The alterations of the biomarkers 6 months post-treatment were recorded. Their relation to individual characteristics and risk factors (age, smoking, sexual history, use of condom, CIN grade, excision margin status, crypt involvement) as well as their role for the prediction of residual/recurrent disease were assessed.
The accuracy parameters (sensitivity, specificity, positive and negative predictive value and the likelihood ratios) of each biomarker for the prediction of recurrent/residual CIN were calculated.
A total of 190 women were recruited. All biomarkers had significantly higher negativity rates post-treatment compared to pre-treatment ones. Multivariate analysis demonstrated that consistent condom use post-treatment significantly reduces the high-risk HPV positivity rates in comparison to no use (OR=0.18; 95% CI: 0.09-0.38). Sensitivity and specificity for all high risk HPV DNA testing were 0.5/0.62, respectively; the relevant values for only type 16 or 18 DNA typing were 0.5/0.92, for NASBA 0.5/0.94, for flow 0.5/0.85 and for p16 0.25/0.93.
CIN treatment reduces positivity for all HPV-related biomarkers. Consistent condom use significantly reduces high-risk HPV positivity rates. More cases of treatment failures are required in order to specify whether different combinations of HPV-related biomarkers could enhance the accuracy of follow up, possibly in the form of a Scoring System that could allow tailored post-treatment surveillance.
本研究旨在评估治疗后 6 个月 HPV 相关生物标志物的变化情况，以及这些变化与各种危险因素和个体特征的关系；还评估了它们在预测治疗失败方面的作用。
前瞻性观察研究。
计划接受宫颈上皮内瘤变治疗的女性。
术前采集液基细胞学样本。该样本进行 HPV 基因分型、核酸序列扩增、流式细胞术评估和 p16 免疫染色检测。治疗后 6 个月获取重复的 LBC 样本，并对相同的生物标志物进行检测。
记录治疗后 6 个月生物标志物的变化情况。评估其与个体特征和危险因素（年龄、吸烟、性史、使用避孕套、CIN 分级、切除边缘状态、隐窝受累）的关系，以及它们对预测残留/复发疾病的作用。
计算每个生物标志物预测复发/残留 CIN 的准确性参数（敏感性、特异性、阳性和阴性预测值以及似然比）。
共招募了 190 名女性。与治疗前相比，所有生物标志物的阴性率在治疗后均显著升高。多变量分析表明，与不使用避孕套相比，治疗后持续使用避孕套可显著降低高危 HPV 阳性率（比值比=0.18；95%可信区间：0.09-0.38）。所有高危 HPV DNA 检测的敏感性和特异性分别为 0.5/0.62；仅 16 或 18 型 DNA 分型的相应值为 0.5/0.92，NASBA 为 0.5/0.94，流式细胞术为 0.5/0.85，p16 为 0.25/0.93。
CIN 治疗降低了所有 HPV 相关生物标志物的阳性率。持续使用避孕套可显著降低高危 HPV 阳性率。需要更多的治疗失败病例来确定不同 HPV 相关生物标志物的组合是否能提高随访的准确性，可能以评分系统的形式来实现，该系统可以允许根据需要进行个体化的治疗后监测。
