hrHPV E6/E7 mRNA用于宫颈癌机会性筛查的临床价值

目的:研究hrHPVE6/E7 mRNA在宫颈筛查中的准确性,探索其用于宫颈癌机会性筛查的临床价值。方法:选取2013年1月至2015年12月在青岛市市立医院及城阳区人民医院妇科门诊行机会性筛查的女性共7791例,年龄25~65岁。所有受试女性均行宫颈液基薄层细胞学检查(LBC)。每位受试者同时行HPV检测,根据采取的HPV方法不同分为3组:HC2组(2417例),HPV分型组(2456例),E6/E7组(2906例)。比较4种筛查方法的灵敏度、特异度、阳性预测值、阴性预测值、阴道镜转诊率、CINⅡ+/CINⅢ+检出率。结果:E6/E7检测CINⅡ+/CINⅢ+的灵敏度分别为93.02%和94.83%,NPV分别为99.52%和99.88%,与HC2及HPV分型之间无统计学差异(P0.05)。E6/E7检测CINⅡ+/CINⅢ+的特异度分别为90.20%和86.90%,与LBC、HC2及HPV分型两两比较均有统计学差异(P0.01)。以HC2和HPV分型为参照时,E6/E7检测CINⅡ+/CINⅢ+的RR均1。E6/E7的阴道镜转诊率为14.73%,低于另两种HPV检测方法,高于LBC,差异有统计学意义(P0.01)。3种HPV检测方法的CINⅡ+/CINⅢ+检出率无统计学差异(P0.05)。结论:hrHPV E6/E7 mRNA与HC2和HPV分型相比,灵敏度相同、特异度高,阴道镜转诊率低,CINⅡ+/CINⅢ+检出率无差别,可用于宫颈癌的机会性筛查。

Clinical value of hrHPV E6/E7 mRNA in cervical opportunistic screening

Objective:To explore the clinical value and feasibility of hrHPV E6/E7 mRNA in cervical opportunistic screening, and to research its performance in cervical cancer screening. Methods:7791 women for opportunistic cervical cancer screening in gynecology clin-ic rowing from Jan. 2013 to Dec. 2015 were closen,between the ages of 21~65 years old. Ac-cording to the cervical screening methods, patients were divided into three groups. Group A:LBC+HC2;Group B:LBC+HPV genotyping;Group C:LBC+E6/E7 . All the tested women ' s LBC data was set to Group LBC. We compared the accuracy of four screening methods,inclu-ding sensitivity,specificity,positive predictive value,negative predictive value,colposcopy refer-ral rate,CINⅡ+/CINⅢ+detection rate. Results:The sensitivities of E6/E7 detecting CINⅡ+/CINⅢ+ were 93 . 02% and 94 . 83%, NPVs were 99 . 52% and 99 . 88%, without significant difference (P>0. 05) compared with HC2 and genotyping. The specificities of E6/E7 detecting CINⅡ+/CINⅢ+were 90. 20% and 86. 90%,the differences were statistically significant com-pared with LBC,HC2 and genotyping in pair match (P<0. 01). When HC2 and genotyping as references,the RRs of E6/E7 detecting CINⅡ+/CINⅢ+ were greater than 1,the differences were statistically significant. The colposcopy referral rate of E6E7 was 14. 73%,which was low-er than the other two HPV test and higher than LBC,the differences were statistically significant ( P<0 . 01 ) . The CINⅡ+/CINⅢ+ detecting rates of three HPV tests were no significant differ-ence(P>0. 05). Conclusion:Compared with HC2 and genotyping,hrHPV E6/E7 mRNA has the same sensitivity,higher specificity and lower colposcopy referral rate,the same CINⅡ+/CINⅢ+ detection rate so that it can be used for cervical opportunistic screening.