Objective: To evaluate and compare the screening performance of primary high-risk HPV(HR-HPV) screening and HR-HPV screening plus liquid-based cytology (LBC) cotesting in diagnosis of cervical cancer and precancerous lesions (CIN2+). Methods: We pooled 17 population-based cross-sectional studies which were conducted across China from 1999 to 2008. After obtaining informed consent, all women received liquid-based cytology(LBC)testing, HR-HPV DNA testing. Totally 28 777 women with complete LBC, HPV and biopsy results were included in the final analysis. Screening performance of primary HR-HPV DNA screening and HPV screening plus LBC co-testing in diagnosis of CIN2+ were calculated and compared among different age groups. Results: Among the whole population, the detection rates of primary HR-HPV screening and HR-HPV screening plus LBC co-testing are 3.05% (879 CIN2+) and 3.13%(900 CIN2+), respectively. The sensitivity were 96.4% and 98.7% (χ(2)=19.00, P<0.001), and the specificity were 86.2% and 78.8% (χ(2)=2 067.00, P<0.001), respectively. Areas under the receiver operating characteristic (ROC) curve (AUC) showed that the primary HR-HPV screening performed better than co-testing (AUC were 0.913 and 0.888; Z=6.16, P<0.001). Compared with primary HR-HPV screening, co-testing showed significantly higher colposcopy referral rates (16.5% and 23.6%, respectively, χ(2)=132.00, P<0.001) and the number of colposcopy examination for detecting per CIN2+ (5.4 and 7.6, respectively).In the group aged 25-29, the colposcopy referral rates was 8.7 (10.9%(199 cases) vs 1.3%(23 cases)) times as much as the detection rate of primary HR-HPV screening in diagnosis of CIN2+, and was 12.5 (15.7%(288 cases) vs 1.3%(23 cases)) times as much as the detection rate of HR-HPV screening plus cytology contesting. Conclusion: Compared with primary HR-HPV screening, HR-HPV screening plus cytology co-testing does not show better results in the screening performance for CIN2+ detection, and the cost-effectiveness is not good enough, especially in younger age group.
目的： 比较高危型HPV DNA单独检测（HPV单独检测）及与薄层液基细胞学（LBC）联合筛查对宫颈癌及宫颈高度病变（CIN2+）的筛查效果。 方法： 在1999—2008年，中国医学科学院肿瘤医院分别与美国克利夫兰医学中心、国际癌症研究署等机构合作，开展了以17项人群研究为基础的宫颈癌筛查横断面研究，采用整群抽样方法，以我国9个省份中5个城市和9个农村地区共计28 777名女性为研究对象，所有研究对象均进行了LBC、HPV检测。分别比较各年龄组HPV单独检测及与LBC联合检测两种筛查方法对CIN2+的筛查效果。 结果： 所有研究对象中，HPV单独检测CIN2+的检出率为3.05%（879例），其与LBC联合检测CIN2+的检出率为3.13%（900例）；灵敏度分别为96.4%和98.7%（χ(2)=19.00，P<0.001）；特异度分别为86.2%、78.8%（χ(2)=2 067.00，P<0.001）；受试者工作曲线面积（AUC）显示，HPV单独检测优于其与LBC联合检测（AUC分别为0.913、0.888；Z=6.16，P<0.001）。与HPV单独检测相比，其与LBC联合检测CIN2+的阴道镜转诊率提高（分别为16.5%、23.6%；χ(2)=132.00，P<0.001），检出1例CIN2+所需检测阴道镜个数也高于HPV单独检测（分别为5.4和7.6）。25~29岁年龄组HPV单独检测CIN2+的阴道镜转诊率（10.9%，199例）是检出率（1.3%，23例）的8.7倍，而与LBC联合检测时阴道镜转诊率（15.7%，288例）是检出率（1.3%，23例）的12.5倍。 结论： 与HPV单独检测相比，HPV与LBC联合检测对CIN2+的筛查效果未明显提高，成本效益不佳，尤其是在低年龄组。.
Keywords: Cervical cancer; Cervical intraepithelial neoplasia; HR-HPV DNA testing; Liquid-based cytology.