| 胡尚英,热米拉·热扎克,张 倩.HPV16/18 DNA分型对宫颈细胞学ASC-US女性的风险分层管理作用研究[J].肿瘤学杂志,2017,23(9):780-784. |
| HPV16/18 DNA分型对宫颈细胞学ASC-US女性的风险分层管理作用研究 |
| HPV16/18 DNA Genotyping for Risk Stratification of Women with ASC-US Cervical Cytological Results |
| 投稿时间：2017-07-26 |
| DOI：10.11735/j.issn.1671-170X.2017.09.B008 |
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| 中文关键词: 未明确意义的非典型鳞状细胞 高危型人乳头瘤病毒 基因分型 分流 |
| 英文关键词:atypical squamous cells of undetermined significance high-risk human papillomavirus genotyping triage |
| 基金项目:国家自然科学基金（81050018，81322040，81402748）；中国医学科学院医学与健康科技创新工程重大协同创新项目（CAMS-I2M-1-019）；北京希望马拉松专项基金课题（LC2011Y43） |
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| 中文摘要: |
| 摘 要：［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hrHPV 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（LiPA）。以2005年和2014年随访时检出416例ASC-US女性为研究对象计算hrHPV DNA阴性组、hrHPV DNA阳性组、HPV16/18阳性组和其他hrHPV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hrHPV阳性者中HPV16/18阳性占27.4%，其CIN2+检出率（9.7%）高于其他hrHPV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），hrHPV阴性者中无CIN2+检出。基线hrHPV阴性组CIN2+ 5年累积发病风险为1.9%，与之相比，其他hrHPV型别阳性组、hrHPV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hrHPV 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hrHPV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。 |
| 英文摘要: |
| Abstract：［Objective］ To evaluate the role of HPV16/18 DNA genotyping in predicting the risk of cervical precancerous or cancerous lesions in women with atypical squamous cells of undetermined significance(ASC-US)，compared with hrHPV DNA testing. ［Methods］ The current study was conducted based on the cohort of Shanxi Province Cervical Cancer Screening Study I (SPOCCS I). During the follow-up，women received hrHPV DNA testing (hybird capture 2，HC2)，liquid-based cytology and visual inspection with acetic acid concurrently. Those with any positive screening result would be transferred to colposcopy and take biopsies if necessary. Meanwhile，HPV genotyping was performed on residual cervical exfoliated cell samples in HC2-positive women using reverse linear probe hybridization assay (LiPA). 416 ASC-US women from the cohort were included to estimate the immediate risk of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) by hrHPV DNA，HPV16/18 genotyping status，as well as their clinical performances. The 5-year cumulative risk of CIN2+ and relative risk were assessed in the 253 ASC-US women detected in 2005. ［Results］ Among women with positive hrHPV，those infected with HPV16/18 had higher immediate risk of CIN2+ (9.7%) than those with other hrHPV infections (3.8%)，but there was no significantly statistical difference(OR=2.7，95%CI：0.4~17.3). No case was found in hrHPV-negative women. Compared with hrHPV-negative women (1.9%)，the 5-year cumulative risks of CIN2+ increased in groups of other hrHPV type positive ［5.3%，RR=2.7(95%CI：0.3~23.0)］，hrHPV positive ［8.5%，RR=4.5(95%CI：1.1~17.8)］ and HPV16/18 positive(11.8%，RR=6.2(95%CI：1.1~33.9)］. Compared with hrHPV DNA testing，the sensitivity of HPV16/18 genotyping for detecting CIN2+ declined ［relative sensitivity：0.6(95%CI：0.3~1.2)］，and the specificity to exclude CIN2+ increased ［relative specificity：1.3(1.2~1.4)］. ［Conclusion］ Triaging ASC-US women with HPV16/18 genotyping can obtain higher specificity while losing some sensitivity. HPV16/18 genotyping can discriminate the instant and long-term CIN2+ risk in hrHPV-positive population，so it can be used to manage or triage ASC-US women. |
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