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[目的]评估HPV16/18 DNA分型检测对宫颈未明确意义的非典型鳞状细胞(atypical squamous cells of undetermined significance,ASC-US)女性癌前病变风险预测的分层作用。[方法 ]在山西省宫颈癌筛查方法研究Ⅰ队列基础上开展,该队列所有随访对象均接受了hr HPV DNA检测(hybird capture 2,HC2)、液基细胞学检查和醋酸染色肉眼观察,任一结果阳性者转诊阴道镜,必要时取活检;同时对HC2阳性者进行HPV型别检测(Li PA)。以2005年和2014年随访时检出416例ASC-US女性为研究对象计算hr HPV DNA阴性组、hr HPV DNA阳性组、HPV16/18阳性组和其他hr HPV型别阳性组的中度及以上宫颈上皮内瘤样病变(cervical intraepithelial neoplasia grade 2 or worse,CIN2+)检出率,以及HPV16/18筛查CIN2+的临床效果。以2005年随访发现的253例ASC-US为研究对象,计算以上各组的5年CIN2+累计发病风险和相对危险度。[结果]ASC-US且hr HPV阳性者中HPV16/18阳性占27.4%,其CIN2+检出率(9.7%)高于其他hr HPV型别阳性者(3.8%),但差异无统计学意义(OR=2.7,95%CI:0.4~17.3),hr HPV阴性者中无CIN2+检出。基线hr HPV阴性组CIN2+5年累积发病风险为1.9%,与之相比,其他hr HPV型别阳性组、hr HPV阳性组、HPV16/18阳性组的5年发病风险逐渐增加,分别为5.3%(RR=2.7,95%CI:0.3~23.0)、8.5%(RR=4.5,95%CI:1.1~17.8)和11.8%(RR=6.2,95%CI:1.1~33.9)。与hr HPV DNA检测相比,HPV 16/18检测筛查CIN2+的灵敏度下降,特异度升高[相对灵敏度0.6(95%CI:0.3~1.2),相对特异度1.3(95%CI:1.2~1.4)]。[结论 ]在ASC-US人群中利用HPV16/18分型检测筛查CIN2+,在获得较高特异度的同时会损失灵敏度;HPV16/18能有效区分ASC-US且hr HPV阳性人群的即时和长期发病风险,可用于ASC-US人群的临床分流管理。
[Objective] To evaluate the stratification effect of HPV16 / 18 DNA typing on the risk prediction of precancerous lesion in women with atypical squamous cells of undetermined significance (ASC-US). [Methods] Based on the cohort of screening methods for cervical cancer in Shanxi province Ⅰ, all the follow-up subjects in this cohort received hr HPV DNA test (HC2), liquid-based cytology and acetic acid staining for visual observation. One positive result was referred to the colposcopy, biopsy was taken when necessary, and HPV type test (Li PA) was performed on HC2 positive patients at the same time. A total of 416 ASC-US women were examined at 2005 and 2014 follow-up for hr HPV DNA negative, hr HPV DNA positive, HPV16 / 18 positive, and other hr HPV positive The detection rate of cervical intraepithelial neoplasia grade 2 or worse (CIN2 +) and the clinical effect of HPV16 / 18 screening CIN2 +. A total of 253 ASC-US patients were followed up in 2005, and the cumulative 5-year CIN2 + cumulative risk and relative risk were calculated. [Results] The positive rate of HPV16 / 18 in ASC-US and hr HPV positive patients was 27.4%, and the positive rate of CIN2 + was 9.7% in ASC-US and hr HPV positive patients (3.8%), but the difference was not statistically significant OR = 2.7, 95% CI: 0.4 to 17.3), no HPV positive for HPV negative. At baseline, the 5-year cumulative risk of CIN2 + was 1.9% in the hr hr negative group compared with 5 hr in the other hr HPV positive, hr HPV positive and HPV16 / 18 positive groups, respectively (RR = 2.7, 95% CI: 0.3-23.0), 8.5% (RR = 4.5, 95% CI: 1.1-17.8) and 11.8% (RR = 6.2,95% CI: 1.1-33.9). Compared with the hr HPV DNA test, the sensitivity and specificity of HPV16 / 18 screening for screening CIN2 + were lower (relative sensitivity 0.6 (95% CI: 0.3-1.2) and relative specificity 1.3 (95% CI: 1.2-1.4 )]. [Conclusion] The screening of CIN2 + by HPV16 / 18 typing in ASC-US population will lead to loss of sensitivity while obtaining high specificity. HPV16 / 18 can effectively distinguish between immediate and long-term ASC-US and hr HPV positive population The risk of onset can be used for clinical shunt management in ASC-US populations.