使用同一新柏氏保存液进行TCT检查和Cervista高危型HPV检测的临床研究  

Clinical investigation of taking Cervista high-risk human Papilloma virus DNA test and cytological test in the same sample

作　　者：吴敏[1] 王华[2] 龚颖萍[1] 吴颖岚 韩婷[3] 朱运红 谢琼[2] 熊敏[5] 石红[6] 

机构地区：[1]湖南省妇幼保健院妇产科,长沙410008 [2]湖南省妇幼保健院遗传科,长沙410008 [3]湖南省妇幼保健院妇女保健科,长沙410008 [4]湖南省妇幼保健院检验科,长沙410008 [5]湖南省妇幼保健院综合治疗科,长沙410008 [6]湖南省妇幼保健院病理科,长沙410008

出　　处：《中国医师杂志》2016年第1期42-46,共5页Journal of Chinese Physician

摘　　要：目的 探讨使用同一新柏氏保存液同时进行新柏氏液基薄层细胞检测（TCT）和Cervista高危型HPVDNA检测（Cervista HR HPVDNA检测）进行宫颈癌及癌前病变筛查的可行性及有效性.方法 采用前瞻性研究方法,选取2012年3月1日至4月30日妇科门诊就诊的TCT检查≥ASCUS（意义未明的不典型鳞状细胞）的148例患者（年龄20 ～65岁）作为研究组,同期TCT检查正常153例作为对照组.两组均采用同一新柏氏保存液完成Cervista HR HPVDNA检测,对于TCT检查或Cervista HR HPVDNA检测结果异常者均行阴道镜检查,必要时阴道镜下多点活检及病理诊断.结果 采用同一新柏氏保存液完成检测的Cervista HR HPVDNA在研究组阳性检出率高于对照组[83.78％ （124/148）vsl8.30％ （28/153）,x2=129.047,P＜0.01].Cervista HR HPVDNA在组织病检无宫颈上皮内瘤变（CIN）、CIN Ⅰ、CIN Ⅱ、CIN Ⅲ以及宫颈癌中的阳性检出率分别为81.69％、71.43％、90.00％、88.89％、100.00％,各组间比较差异无统计学意义（P＞0.05）.研究组各级别中均以A9型组感染为主,且A9型组与高级别宫颈病变（≥CIN Ⅱ）相关（P＜0.05）.Cervista HR HPVDNA检出≥CIN Ⅱ的敏感度90.9％,特异度18.1％,阳性预测值22.7％,阴性预测值88.2％.结论 使用同一新柏氏保存液进行TCT检查和Cervista HR HPVDNA检测,其筛查宫颈癌及癌前病变敏感度高,宫颈病变以A9型感染为主,且与高级别宫颈病变（≥CIN Ⅱ）相关,具有一定的临床应用价值.Objective To explore the feasibility of taking Cervista high-risk human Papilloma virus DNA （Cervista HR HPVDNA） test and Thinprep cytologic test in the same sample,and to assess the availability and significance of Cervista HR HPVDNA in detecting HPV infection in people,also to study the correlation of Cervista A9 group with high grade cervical dysplasia and the value of HPV16/18 in diagnosing cervical dysplasia.Methods Totally 148 cases diagnosed in gynecology clinic during March to April,aging 20 to 65,cytological test ≥ ASCUS （atypical squamous cells undetermined significance） were involved in the investigation group,and 153 cases with normal cytological test at the same time were involved in the control group.Cytological test and Cervista high-risk human Papilloma virus DNA test were implemented at the same time on two groups,cases with one of the test method tested abnormal were further biopsied under the colposcope if necessary.Results Cervista HR HPVDNA infection rate was 83.78% in the investigation group and 18.30% in the control group with statistic difference （P 〈0.05）.Based on criteria of histology and pathology,Cervista HR HPVDNA infection rate was 81.69% in no cervical intraepithelial neoplasia （CIN）,71.43% in CINⅠ,90.00% in CIN Ⅱ,88.89% in CINⅢ and 100.00% in cervical carcinoma without significant difference （Fisher exact Test P 〉 0.05）.We further founded that A9 group take the large proportion of Cervista HR HPVDNA infection,and co-infection by 2 or 3 genotypes tested in part grades and A9 group related with Pathology≥ CIN 1Ⅱ （P 〈 0.05）.The sensitivity,specificity,positive-predictive value and negative-predictive value of Cervista HR HPVDNA for detecting all cases of CIN]Ⅱ were 90.9%,18.1%,22.7%,and 88.2%,respectively.A portion （30.6%） of the Cervista HR HPVDNA positive cases showed HPV16/18 positive,while none showed in the Cervista HR HPVDNA negative cases.HPV16/18 infection rate in normal,CIN Ⅰ,CIN 11,CIN Ⅲ,and Cervical carcinoma were 13.33%,3

关 键 词：活组织检查 宫颈肿瘤/诊断 乳头状瘤病毒科/代谢 

分 类 号：R737.33[医药卫生—肿瘤]