宫颈脱落细胞p16/Ki-67双染联合DNA定量分析在宫颈癌筛查中的临床价值

Evaluation of p16/Ki-67 dual-staining of cervical exfoliated cells combined with quantitative analysis of DNA in cervical cancer screening

目的探讨宫颈脱落细胞p16/Ki-67双免疫细胞化学染色(以下简称双染)联合DNA定量分析用于宫颈癌筛查的临床价值。方法选择2020年1月至12月淮安市第二人民医院就诊的可疑病变妇女为研究对象,分别采用宫颈脱落细胞p16/Ki-67双染、DNA定量分析进行宫颈癌筛查。将具有完整宫颈脱落细胞p16/Ki-67双染、DNA定量分析及子宫颈活检病理诊断结果者220例纳入本研究,宫颈组织学病理为慢性宫颈炎56例,低级别鳞状上皮内瘤变(LSIL)36例,高级别鳞状上皮内瘤变(HSIL)119例,子宫颈癌9例。评价宫颈脱落细胞p16/Ki-67双染联合DNA定量分析检出HSIL及以上级别病变的筛查效能。结果宫颈脱落细胞p16/Ki-67双染、DNA定量分析和联合检测三种筛查方案的阳性率随宫颈病变严重度的增高(慢性宫颈炎→LSIL→HSIL→子宫颈癌)而增高,差异有统计学意义(P<0.01)。HSIL组中,联合检测、p16/Ki-67双染和DNA定量分析的阳性率依次为91.60%、82.35%和76.47%,联合检测阳性率最高,差异有统计学意义(χ2=10.031,P<0.01)。以病理结果为准,联合检测、p16/Ki-67双染、DNA定量分析筛查HSIL及以上级别病变的灵敏度分别为92.19%、83.59%、78.13%,联合检测的灵敏度最高,差异有统计学意义(P<0.05);特异度分别为71.74%、76.09%、67.61%,三者差异无统计学意义(P>0.05)。结论宫颈脱落细胞p16/Ki-67双染与DNA定量分析联合检测对于HSIL及以上级别病变有较高的筛查效能,在宫颈癌初筛中有较好的临床价值,适合在基层医院应用。

Objective To explore the clinical value of p16/Ki-67 double immunocytochemical staining(namely dual-staining)of cervical exfoliative cells combined with quantitative DNA analysis in cervical cancer screening.Methods Women with suspicious lesions who visited Huai'an Second People's Hospital from January 2020 to December 2020 were selected as the research subjects.The cervical exfoliated cells were collected from 220 women for p16/Ki-67 dual staining,DNA quantitative analysis and pathological diagnosis of cervical biopsy.Based on cervical histopathology results of chronic cervicitis(56 cases),low-grade squamous intraepithelial neoplasia(LSIN,36 cases),high-grade squamous intraepithelial neoplasia(HSIN,119 cases)and cervical cancer(9 cases),the screening efficiency of p16/Ki-67 double staining combined with DNA quantitative analysis was evaluated in detecting HSIN of cervical exfoliated cells.Results The positive rates of p16/Ki-67 dual-stain,DNA quantitative analysis and combined detection of two methods for cervical exfoliated cells statistically increased with the severity of cervical lesions,namely from chronic cervicitis,LSIL,HSIL to cervical cancer(P<0.01).In HSIL group,the positive rates of combined detection,p16/Ki-67 dual-stain and DNA quantitative analysis were 91.60%,82.35%,76.47%,respectively(χ2=10.031,P<0.01).Based on the pathological results,the sensitivities of combined detection,p16/Ki-67 dual-stain and DNA quantitative analysis to screen HSIL and above-grade lesions were 92.19%,83.59%,78.13%,respectively,and there were statistical differences in them(P<0.05).However,there were no significant differences in specificity(71.74%vs 76.09%vs 67.61%,P>0.05).Conclusions The combined detection of p16/Ki-67 dual-stain and DNA quantitative analysis of cervical exfoliated cells possess higher screening efficiency for HSIL and above-grade lesions,which is suitable for application in primary hospitals.