新型国产杂交捕获HPV检测技术在ASC-US人群分流中的应用效果评价  

Performance evaluation of a new domestic hybrid capture HPV detection technology for the management of ASC-US population

作　　者：徐慧芳 刘茵 赵冬梅 罗艳林 陈佩佩 郭珍 贾漫漫 郑黎阳 张璐瑶 李梦洁 张韶凯 XU Huifang;LIU Yin;ZHAO Dongmei;LUO Yanlin;CHEN Peipei;GUO Zhen;JIA Manman;ZHENG Liyang;ZHANG Luyao;LI Mengjie;ZHANG Shaokai(Henan Cancer Center,Affiliated Cancer Hospital of Zhengzhou University,Henan Cancer Hospital,Henan Engineering Research Center of Cancer Prevention and Control,Henan International Joint Laboratory of Cancer Prevention,Zhengzhou 450008,China)

机构地区：[1]河南省癌症中心,郑州大学附属肿瘤医院,河南省肿瘤医院,河南省肿瘤防控工程研究中心,河南省肿瘤预防国际联合实验室,郑州450008

出　　处：《实用肿瘤学杂志》2022年第2期133-136,共4页Practical Oncology Journal

基　　金：河南省科技攻关计划项目(编号:192102310105);河南省高等学校重点科研项目计划(编号:20A330005)。

摘　　要：目的探讨基于杂交捕获原理的DH2检测技术在未明确意义的不典型鳞状细胞(Atypical squamous cells of undetermined significance,ASC-US)人群中的分流应用效果。方法本研究于2016年10月—2018年10月在河南省新密市招募21~64岁普通女性参加研究。所有女性在签署知情同意书后完成妇科检查及宫颈脱落细胞学采集,并采用DH2进行高危HPV检测。同时,所有研究对象均进行阴道镜检查,并在必要时进行组织活检。阴道镜检查结果及病理诊断结果作为DH2的应用效果评价的金标准。结果研究共入组302例女性,中位年龄为52岁。DH2检测结果为阳性者49例(16.2%)、3例(1%)被确诊为宫颈鳞状上皮内瘤样病变Ⅱ级(Cervical intraepithelial neoplasia grade 2,CIN2)、14例(4.6%)被确诊为宫颈鳞状上皮内瘤样病变Ⅲ级及以上(Cervical intraepithelial neoplasia grade 3 or worse,CIN3+)病变。以CIN2+为临床终点时,DH2的灵敏度、特异度、阳性预测值和阴性预测值分别为82.4%、87.7%、28.6%及98.8%;以CIN3+为临床终点时,DH2的灵敏度、特异度、阳性预测值和阴性预测值分别为85.7%、87.2%、24.5%、99.2%。结论DH2在ASC-US人群中检出CIN2+病变、CIN3+病变的灵敏度和特异度均较高,是ASC-US人群分流的有效方法,有望与细胞学筛查联合,减轻宫颈癌的健康危害。Objective The objective of this study was to explore the performance of DH2 detection technology based on the principle of hybrid capture for the management of atypical squamous cells of undetermined significance(ASC-US)population.Methods This study recruited participants from 21 to 64 years old general women in Xinmi county,Henan province from October 2016 to October 2018.All women would be subjected to gynecological examination and cervical exfoliative cytology collection after signing informed consent form.All cytological samples were detected by DH2 for high-risk HPV testing.At the same time,all subjects underwent colposcopy and tissue biopsy if necessary.The results of colposcopy and pathological diagnosis would be used as the gold standard for performance evaluation of DH2.Results A total of 302 women were enrolled with a median age of 52 years in the study.The DH2 test results were positive in 49 women(16.2%),3(1%)women were diagnosed with cervical intraepithelial neoplasia grade 2(CIN2),and 14(4.6%)women were diagnosed with cervical intraepithelial neoplasia grade 3 or worse(CIN3+)lesions.When CIN2+was used as the clinical endpoint,the sensitivity,specificity,positive predictive value,and negative predictive value of DH2 were 82.4%,87.7%,28.6%and 98.8%respectively;when CIN3+was used as the clinical endpoint,the sensitivity,specificity,and positive and negative predictive values of DH2 were 85.7%,87.2%,24.5%and 99.2%,respectively.Conclusion DH2 has high sensitivity and specificity in detecting CIN2+and CIN3+lesions in ASC-US population.Therefore,DH2 is promising in the management of ASC-US population and could reduce the health hazards of cervical cancer by combining with cytological screening methods.

关 键 词：宫颈癌 未明确意义的不典型鳞状细胞 分流 筛查 

分 类 号：R737.33[医药卫生—肿瘤]