p16/Ki67双染、HPV E6/E7 mRNA检测对于TCT检查为低级别鳞状上皮内病变及以下且HPV检测为阴性或其他高危型HPV阳性患者的分流作用  

Role of p16/Ki67 dual staining and HPV E6/E7 mRNA detection for triage in patients with LSIL or lower lesions diagnosed by TCT and HPV negative or other high-risk HPV positive

作　　者：李碧军 郭瑞霞[1] 王春芳[1] 陈曦[1] 褚丹霞 王凯丽 杜建敏 白晶[1] LI Bijun;GUO Ruixia;WANG Chunfang;CHEN Xi;CHU Danxia;WANG Kaili;DU Jianmin;BAI Jing(Department of Gynecology,the First Affiliated Hospital,Zhengzhou University,Zhengzhou 450052;Department of Gynecology,the Third Affiliated Hospital,Zhengzhou University,Zhengzhou 450052)

机构地区：[1]郑州大学第一附属医院妇科,郑州450052 [2]郑州大学第三附属医院妇科,郑州450052

出　　处：《郑州大学学报（医学版）》2021年第1期11-15,共5页Journal of Zhengzhou University(Medical Sciences)

基　　金：国家自然科学基金面上项目(31670844);中原千人计划-中原名医项目(ZYQR201810107);河南省科技创新杰出人才项目(2018JR0004);河南省医学科技攻关计划项目(省部共建)(SBGJ2018005)。

摘　　要：目的:探索p16/Ki67双染色法(简称双染)、HPV E6/E7 mRNA(简称E6/E7)检测对于宫颈细胞学检查(TCT)为低级别鳞状上皮内病变(LSIL)及以下且HPV检测为阴性或其他高危型HPV阳性患者的分流作用。方法:收集郑州大学第一附属医院妇科门诊就诊的TCT检查为LSIL及以下且HPV检测为阴性或其他高危型HPV阳性(不包括HPV16、18阳性)的414例患者的宫颈脱落细胞,分别进行双染检测、HPV E6/E7 mRNA检测,并行阴道镜下活检,以组织病理学诊断为“金标准”,采用灵敏度、特异度比较TCT+HPV+双染、TCT+HPV+E6/E7和TCT+HPV检测用于筛查高级别鳞状上皮内病变及以上(HSIL+)患者的效能。结果:根据病理结果,414例中150例为HSIL+。TCT+HPV+双染检出宫颈HSIL+病变的灵敏度、特异度分别为78.7%、50.4%,TCT+HPV+E6/E7分别为74.0%、26.1%,而TCT+HPV为90.0%、8.0%。TCT+HPV+双染和TCT+HPV+E6/E7检出HSIL+病变的灵敏度相近,均略低于TCT+HPV(P<0.05),而TCT+HPV+双染的特异度远高于其他2种方法(P<0.05)。结论:对于TCT检查为LSIL及以下且HPV阴性或其他高危型HPV阳性患者,采用p16/Ki67双染联合检测具有较高的灵敏度,且能显著提高特异度,其筛查效能优于TCT和HPV联合筛查。Aim:To investigate the application value of p16/Ki67 dual staining(dual staining)and HPV E6/E7 mRNA(E6/E7)detection for triage in patients with LSIL or lower lesions diagnosed by TCT and HPV negative or other high-risk HPV positive.Methods:A total of 414 patients with LSIL or lower lesions diagnosed by TCT and HPV negative or other high-risk HPV positive admitted by the First Affiliated Hospital of Zhengzhou University were collected.Cervical exfoliated cells were detected by dual staining and E6/E7 detection,and colposcopy biopsy was also performed.Taking histopathology as the gold standard,the sensitivity and specificity of TCT+HPV+dual staining,TCT+HPV+E6/E7,and TCT+HPV for diagnosing HSIL or higher lesion(HSIL+)were compared.Results:According to the results of biopsy,there were 150 cases of HSIL+among 414 cases.The sensitivity and specificity of TCT+HPV+dual staining for detecting HSIL+were 78.7%and 50.4%,those for TCT+HPV+E6/E7 were 74.0%and 26.1%,and those for TCT+HPV were 90.0%and 8.0%.The sensitivity of TCT+HPV+dual staining and TCT+HPV+E6/E7 were similar,lower than that of TCT+HPV(P<0.05),while the specificity of TCT+HPV+dual staining was higher than those of TCT+HPV+E6/E7 and TCT+HPV(P<0.05).Conclusion:When the screening results of cervical cancer are LSIL or lower lesions diagnosed by TCT and HPV negative or other high-risk HPV positive,p16/Ki67 dual staining combined detection can maintain high sensitivity and improve the specificity;its screening efficiency is better than TCT+HPV combined screening.

关 键 词：TCT p16/Ki67双染色法 高危HPV E6/E7 mRNA 宫颈癌 联合检测 

分 类 号：R737.33[医药卫生—肿瘤]