P16/Ki-67双染检测技术在宫颈癌及癌前病变筛查中的价值  

Value of P16/Ki-67 double staining detection in screening cervical cancer and precancerous lesions

作　　者：宋明泽 程一鸣 李刚[2] 王振明[2] 李世荣[2] Song Mingze;Cheng Yiming;Li Gang;Wang Zhenming;Li Shirong(Department of Laboratory Medicine,Weifang Medical College,Weifang 261000,China;Department of Laboratory Medicine,Weifang People′s Hospital of Shandong Province,Weifang 261000,China)

机构地区：[1]潍坊医学院医学检验学系,261000 [2]山东省潍坊市人民医院检验科,261000

出　　处：《国际肿瘤学杂志》2020年第11期675-681,共7页Journal of International Oncology

基　　金：潍坊市卫生和计划生育委员会科研项目计划(2017wsjs103)。

摘　　要：目的探讨P16/Ki-67双染检测技术在宫颈癌及癌前病变筛查中的价值和临床意义。方法选取2018年9月至2019年5月山东省潍坊市人民医院妇科收治的110例宫颈上皮内瘤变(CIN)2级以下的患者、31例CIN2级患者、27例CIN3级患者和12例宫颈癌患者,分别评估人乳头瘤病毒(HPV)DNA、液基细胞学技术(TCT)和P16/Ki-67双染检测作为宫颈癌及癌前病变初筛方法的敏感性、特异性、阳性预测值和阴性预测值,并探讨P16/Ki-67双染检测技术用作高危型HPV阳性患者分流的可行性。结果HPV DNA、TCT和P16/Ki-67双染检测诊断<CIN2级的敏感性分别为80.91%、75.45%、81.82%,特异性分别为91.43%、87.14%、97.14%,阳性预测值分别为93.68%、90.22%、97.83%,阴性预测值分别为75.29%、69.32%、77.27%,差异均具有统计学意义(χ^(2)=1.593,P=0.042;χ^(2)=4.736,P=0.034;χ^(2)=4.667,P=0.037;χ^(2)=1.564,P=0.048),P16/Ki-67双染检测的特异性高于HPV DNA及TCT,敏感性及阳性预测值均高于TCT(均P<0.0125)。3种方法诊断CIN2级的敏感性分别为90.32%、83.87%、96.77%,差异具有统计学意义(χ^(2)=2.952,P=0.029);特异性分别为80.91%、75.45%、81.82%,差异无统计学意义(χ^(2)=2.505,P=0.066);阳性预测值分别为57.10%、49.10%、60.00%,差异无统计学意义(χ^(2)=1.939,P=0.079);阴性预测值分别为96.70%、94.30%、98.90%,差异具有统计学意义(χ^(2)=3.175,P=0.013);P16/Ki-67双染检测的敏感性、阴性预测值均高于TCT(均P<0.0125)。3种方法诊断CIN3级的敏感性分别为92.59%、96.30%、96.30%,差异无统计学意义(χ^(2)=0.497,P=0.780);特异性分别为80.91%、75.45%、81.82%,差异具有统计学意义(χ^(2)=4.677,P=0.036);阳性预测值分别为54.30%、49.10%、56.50%,差异具有统计学意义(χ^(2)=1.760,P=0.045);阴性预测值分别为97.80%、98.80%、98.90%,差异无统计学意义(χ^(2)=0.441,P=0.802);P16/Ki-67双染检测的特异性、阳性预测值均高于TCT(均P<0.0125)。3种方法诊断宫颈癌的敏�Objective To explore the value and clinical significance of double staining detection of P16/Ki-67 in the screening of cervical cancer and precancerous lesions.Methods Patients admitted to Department of Gynecology of Weifang People′s Hospital of Shandong Province from September 2018 to May 2019 were selected,including 110 patients with cervical intraepithelial neoplasia(CIN)below grade 2,31 patients with CIN2,27 patients with CIN3,and 12 patients with cervical cancer.The sensitivity,specificity,positive predictive value and negative predictive value of human papillomavirus(HPV)DNA,thinprep cytologic test(TCT)and P16/Ki-67 double staining detection as primary screening method for cervical cancer and precancerous lesions were evaluated,and the feasibility of P16/Ki-67 double staining detection as shunt for high-risk HPV positive patients was discussed.Results The sensitivities of HPV DNA,TCT and P16/Ki-67 double staining detection in the diagnosis of<CIN2 grade were 80.91%,75.45%,81.82%,the specificities were 91.43%,87.14%,97.14%,the positive predictive values were 93.68%,90.22%,97.83%,and the negative predictive values were 75.29%,69.32%,77.27%respectively,with statistically significant differences(χ^(2)=1.593,P=0.042;χ^(2)=4.736,P=0.034;χ^(2)=4.667,P=0.037;χ^(2)=1.564,P=0.048).The specificity of P16/Ki-67 double staining detection was higher than that of HPV DNA and TCT,and the sensitivity and positive predictive value were higher than those of TCT(all P<0.0125).The sensitivities of HPV DNA,TCT and P16/Ki-67 double staining detection in the diagnosis of CIN2 grade were 90.32%,83.87%,96.77%,with a statistically significant difference(χ^(2)=2.952,P=0.029);the specificities were 80.91%,75.45%,81.82%,with no significant difference(χ^(2)=2.505,P=0.066);the positive predictive values were 57.10%,49.10%,60.00%,with no significant difference(χ^(2)=1.939,P=0.079);and the negative predictive values were 96.70%,94.30%,98.90%,with a statistically significant difference(χ^(2)=3.175,P=0.013).The sensitivity and negat

关 键 词：宫颈肿瘤 人乳头状瘤病毒DNA检测 基因 p16 KI-67抗原 

分 类 号：R737.33[医药卫生—肿瘤]