Evaluation of p16/Ki-67 dual staining in detection of cervical precancer and cancers: a multicenter study in China.
Evaluation of p16/Ki-67 dual staining in detection of cervical precancer and cancers: a multicenter study in China.
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p16/Ki-67双染色检测宫颈癌前病变和癌症的评价：中国多中心研究
DOI：
10.18632/oncotarget.8307
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发表时间：
2016-04-19
期刊：
影响因子：
--
通讯作者：
Qiao YL
中科院分区：
文献类型：
--
作者：
Yu LL;Chen W;Lei XQ;Qin Y;Wu ZN;Pan QJ;Zhang X;Chang BF;Zhang SK;Guo HQ;Qiao YL
分析p16/Ki-67双染色细胞学检测在中国女性宫颈高度上皮内瘤变（CIN 2+）中的临床应用价值。2014-2015年期间，从中国5家医院入组了1079名接受持续宫颈癌筛查的女性和211名年龄≥ 30岁、经活检证实为CIN 2+的“富集”女性。收集宫颈标本进行高危型人乳头瘤病毒（HR-HPV）DNA检测、液基细胞学（LBC）和p16/Ki-67双染色。对有异常结果的妇女进行阴道镜检查和活检。p16/Ki-67阳性率随组织学严重程度的增加而增加。在正常组织中阳性率为18.4%（183/996），CIN 1为54.0%（34/63），CIN 2为81.0%（34/42），CIN 3为93.3%（111/119），腺癌为71.4%（5/7），鳞癌为95.2%（60/63）。与HR-HPV阴性组相比，HPV 16/18阳性组p16/Ki-67表达显著增高（OR：35.45（95%CI：23.35-53.84）），其他12种HR-HPV阳性组p16/Ki-67表达显著增高（OR：8.01（95%CI：5.81-11.05））。p16/Ki-67检测CIN 2+的敏感性和特异性分别为90.9%和79.5%。在ASC-US和LSIL的女性中，检测CIN 2+的敏感性和特异性分别为87.5%和66.4%，转诊率为43.8%。在HR-HPV检测阳性的妇女中，双重染色检测CIN 2+的敏感性和特异性分别为92.7%和52.7%，转诊率为68.7%。p16/Ki-67双染色细胞学检测宫颈癌前病变和宫颈癌具有较高的敏感性和中等的特异性，可作为我国宫颈癌筛查的有效工具。
To analyze the clinical performance of p16/Ki-67 dual-stained cytology identifying high-grade cervical intraepithelial neoplasia (CIN2+) in Chinese women. 1079 women attending ongoing cervical cancer screening and 211 “enriched” women aged ≥30yrs with biopsy-confirmed CIN2+ from five Chinese hospitals were enrolled during year 2014-2015. Cervical specimens were collected for high-risk human papillomavirus (HR-HPV) DNA analysis, Liquid-based cytology (LBC) and p16/Ki-67 dual staining. Colposcopy and biopsy were performed on women with any abnormal result. p16/Ki-67 positivity increased with histologic severity. It was 18.4%(183/996) in normal histology, 54.0%(34/63) in CIN1, 81.0%(34/42) in CIN2, 93.3%(111/119) in CIN3, 71.4% (5/7) in adenocarcinoma and 95.2%(60/63) in squamous cell carcinoma. Compared with the HR-HPV negatives, p16/Ki-67 expression was significantly higher in the HPV16/18 positive (OR: 35.45(95%CI: 23.35-53.84)) and other 12 HR-HPV types positive group (OR: 8.01(95%CI: 5.81-11.05). The sensitivity and specificity of p16/Ki-67 to detect CIN2+ in the entire population were 90.9% and 79.5%, respectively. In women with ASC-US and LSIL, sensitivity and specificity for detection of CIN2+ were 87.5% and 66.4%, respectively, with a referral rate of 43.8%. In women who tested positive for HR-HPV, sensitivity and specificity of dual-staining for detection of CIN2+ were 92.7% and 52.7%, respectively, and the referral rate was 68.7%. p16/Ki-67 dual-stained cytology provided a high sensitivity and moderate specificity to detect underlying cervical precancer and cancers in various settings, and might be considered as an efficient screening tool in China.
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影响因子：
4.7
作者：
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通讯作者：
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影响因子：
6.4
作者：
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影响因子：
3.4
作者：
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影响因子：
--
作者：
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通讯作者：
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影响因子：
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作者：
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