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
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摘要
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.
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.
引文
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[8]崔韶海,李洋洋,王珍,等.女性下段生殖道自取样用于高危型人乳头瘤病毒检测的研究.中国妇幼保健,2018,33(5)1191-1194.
[9]Wu RF,Du H,Belinson SE,et al.Secondary Screen in after primary self-sampling for HPV from SHENCCAST II[J].J Low Genit Tract Dis,2012,16(4):416-420.
[10]Du H,Yi J,Wu RF,et al.A new PCR-based mass spectrometry system for high-risk HPV,Part II clinical trial[J].Am J Clin Pathol,2011,136(6):920-923.
[11]吴瑞芳,魏丽惠.基于HPV检测的自取样方法是子宫颈癌筛查的可行之路[J].中国妇产科临床杂志,2018,19(1):1-3.
[12]Belinson JL,Wang G,Qu X,et al.The development and evaluation of a community based model for cervical cancer screening based on self-sampling[J].Gynecol Oncol,2014,132(3):636-642.
[2]Wang B,He M,Chao A,et al.Cervical cancer screening among adult women in China[J].Oncologist,2015,20(6):627-634.
[3]Wright TC,Denny L,Kuhn L,et al.HPV DNA testing of selfcollected vaginal samples compared with cytologic screening to detect cervical cancer[J].JAMA,2000,283(1):81–86.
[4]Wu RF,Qu XF,Du H,et al.A pilot study to evaluate aninternetbased cervical cancer screening model based on self-sampling[J].Health,2016,8(7):672-679.
[5]Wright TC,Stoler MH,Behrens CM,et al.Primary cervical cancer screening with human papillomavirus:end of study results from the ATHENA study using HPV as the first-line screening test[J].Gynecol Oncol,2015,136(2):189-197.
[6]Arbyn M,Verdoodt F,Snijders PJ,et al.Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples:a meta-analysis[J].The Lancet Oncology,2014,15(2):172-183.
[7]Belinson JL,Du H,Yang B,et al.Improved sensitivity of vaginal self-collection and high-risk human papillomavirus testing[J].Int J Cancer,2012,130(8):1855–1860.
[8]崔韶海,李洋洋,王珍,等.女性下段生殖道自取样用于高危型人乳头瘤病毒检测的研究.中国妇幼保健,2018,33(5)1191-1194.
[9]Wu RF,Du H,Belinson SE,et al.Secondary Screen in after primary self-sampling for HPV from SHENCCAST II[J].J Low Genit Tract Dis,2012,16(4):416-420.
[10]Du H,Yi J,Wu RF,et al.A new PCR-based mass spectrometry system for high-risk HPV,Part II clinical trial[J].Am J Clin Pathol,2011,136(6):920-923.
[11]吴瑞芳,魏丽惠.基于HPV检测的自取样方法是子宫颈癌筛查的可行之路[J].中国妇产科临床杂志,2018,19(1):1-3.
[12]Belinson JL,Wang G,Qu X,et al.The development and evaluation of a community based model for cervical cancer screening based on self-sampling[J].Gynecol Oncol,2014,132(3):636-642.