hrHPV E6/E7 mRNA检测用于宫颈癌联合筛查的横断面研究

Cross-sectional study of hr HPV E6/E7 mRNA in cervical cotesting

目的:研究hrHPV E6/E7 mRNA在宫颈癌联合筛查中的准确性,探索其用于宫颈癌联合筛查的临床价值。方法:选取2013年1月至2015年12月在青岛市市立医院和青岛市城阳区人民医院妇科门诊行宫颈癌机会性筛查的女性共6223例。根据宫颈筛查方法分组:宫颈液基薄层细胞学检查(LBC)+HC2组(LBC+HC2组);LBC+HPV分型组;LBC+hrHPV E6/E7 mRNA(LBC+E6E7组)。比较3种HPV+细胞学联检策略和细胞学单独筛查的灵敏度、特异度、阳性预测值、阴性预测值、阴道镜转诊率、CIN2+/CIN3+检出率及曲线下面积(AUC)。结果:LBC+E6E7联检CIN2+的灵敏度、特异度、PPV、NPV、阴道镜转诊率、CIN2+/CIN3+检出率分别为91.28%、95.50%、56.07%、99.43%、9.64%和5.40%;CIN3+分别为93.10%、92.06%、19.29%、99.85%、9.64%和1.86%。3种联合筛查策略之间比较,上述指标均无统计学差异(P>0.05)。LBC+E6E7联检CIN2+/CIN3+的AUC分别为0.969和0.973,大于LBC单筛,差异有统计学意义(P<0.05)。结论:hrHPV E6/E7 mRNA与细胞学联合筛查的准确性与HC2、HPV分型+LBC联检无明显差异,可作为HPV-DNA的替代用于宫颈癌机会性筛查的联检方案。

Objective： To explore the clinical value of hrHPV E6 /E7 mRNA in cervical cotesting,to research its performance in cervical cancer cotesting. Methods： 6223 women for opportunistic cervical cancer screening in Qingdao Municipal Hospital and Qingdao Chengyang People＇s Hospital gynecology clinic row were collect from Jan. 2013 to Dec. 2015. According to the cervical screening methods,patients were divided into three groups： LBC ＋HC2,LBC ＋HPV genotyping,LBC＋E6E7. The accuracy of three cotesting strategies and cytology alone,including sensitivity,specificity,positive predictive value,negative predictive value,colposcopy referral rate,CIN2 ＋/CIN3 ＋ detection rate and AUC were compared. Results： The sensitivities,specificities,PPVs,NPVs,colposcopy referral rate,CIN2 ＋/CIN3 ＋ detection rates of LBC ＋ E6E7 for CIN2 ＋/CIN3 ＋ were 91. 28% 、95. 50% 、56. 07% 、99. 43% 、9. 64% 、5. 40% and 93. 10% 、92. 06% 、19. 29% 、99. 85% 、9. 64% 、1. 86%,respectively. These outcome index were not statistically different between three cotesting strategies（ P〉 0. 05）. The AUC of LBC ＋ E6E7 for CIN2 ＋/CIN3 ＋ were 0. 969 and 0. 973,higher than LBC statistically（ P〈 0. 05）. Conclusion：The accuracy of hrH PV E6E7 mRNA and LBC contesting is as well as HC2,HPV typing cotesting with LBC so that it could be an alternative as HPV-DNA in cotesting program of opportunistic screening.