阴道自取样人乳头瘤病毒检测用于子宫颈癌筛查的有效性研究

The efficacy of human papillomavirus testing of vaginal self-sampling for cervical cancer screening

目的研究阴道自取样人乳头瘤病毒（human papillomavirus,HPV）检测用于宫颈癌筛查的有效性,以探讨宫颈癌筛查的新模式。方法收集2017年8月28—29日北京大学人民医院对内蒙通辽地区1 101例25-65岁女性进行阴道自取样（自取样）和医生宫颈取样（医取样）两种取样方法宫颈癌筛查的资料。采用荧光定量PCR法检测自取样和对应医取样15种高危HPV亚型;采用RT-PCR法检测同一医取样本14种高危HPV亚型作为对照;对HPV16/18阳性或其他12种HPV阳性＋宫颈液基细胞学（TCT）异常（ASC-US及以上）者进行阴道镜检查及活检。结果 1101例阴道自取样本的合格率为100%,其中荧光定量PCR法自取样HPV阳性率为17.44%（192/1 101）,医取样HPV阳性率为16.35%（180/1 101）,自取样与医取样HPV检测的符合率为97.28%（1071/1 101）,其中自取样阴性而医取样阳性9例（0.82%）,自取样阳性而取样阴性21例（1.91%）;RT-PCR法医取样HPV阳性率为14.82%（163/1 101）;两种检测方法医取样HPV阳性的符合率为95.91%（1 055/1 101）,两者比较,差异无统计学意义（P〉0.05）。55例行阴道镜检查及活检,其中CIN1、CIN2/3和宫颈炎的检出率分别为49.09%（27/55）、23.64%（13/55）和27.27%（15/55）,自取样和医取样检出CIN2/3的敏感度均为100%,特异度分别为83.33%和90.48%。自取样和医取样检出高危HPV型别的分布一致,前5位者均依次为HPV52、HPV16、HPV58、HPV18和HPV31型。自取样检出双重及以上HPV阳性的比例增加8.33%（16/192）。结论荧光定量PCR法检测阴道自取样与医生宫颈取样HPV感染的符合率较高,自取样可有效检出HPV和高级别宫颈上皮内病变感染者,其可成为一种宫颈癌筛查的新模式。

Objective To investigate the effectiveness of human papillomavirus（HPV） detection of vaginal selfsampling in cervical cancer screening, and to explore the new model of cervical cancer screening. Methods 1 101 eligible women aged 25-65 years were recruited in Tongliao area of Inner Mongolia by Peking University people＇s hospital from August 28 to 29, 2017, conducting cervical cancer screening by vaginal self-sampling and clinician-sampling. Fluorescence quantitative PCR was used to detect 15 high-risk HPV subtypes in vaginal self-sampling and clinician-samples. Fourteen high-risk subtypes were detected by using the Roche Cobas 4800 HPV DNA method, and genotyping of HPV16 and HPV18. Women with HPV16/18, or other 12 types of HPV positive and cervical liquid based cytology ASC-US or above referred into colposcopy examination and biopsy, compare the coincidence rate, sensitivity, specificity, positive and negative predictive value. Results Among 1 101 women, the HPV positive rate of self-sampling by fluorescence quantitative PCR was 17.44%（192/1 101）, and that of clinician-sampling was 16.35%（180/1 101）. The coincidence rate between self-sampling and medical HPV testing was 97.28%（1 071/1 101）, among which 9 cases（0.82%） were negative for self-sampling and positive for medical sampling, and 21 cases（1.91%） were positive for self-sampling and negative for medical sampling.The positive rate of HPV in clinician-sampling by Cobas was 14.82%（163/1 101）.The coincidence rate of HPV positive was 95.91%（1 055/1 101） between the two methods, and the difference was not statistically significant（P 0.05）. 55 cases colposcope examination and biopsy, the detection rate of CIN1, CIN2/3 and cervical inflammation was 49.09%（27/55）, 23.64%（13/55） and 27.27%（15/55）. The sensitivity of the detection CIN2/3 in two sampling were 100%,the specificity was 83.33% and 90.48%, respectively.The distribution of high-risk HPV types detected by self-sampling and clinician-sampling was consistent. The top 5 were HPV52, HPV16, HPV58, HPV18 and HPV31, respectively. Conclusions The detection of human papillomavirus in vaginal selfsampling has a high conformance rate with clinician-sampling, which can be used for cervical cancer screening.