CAJ | 학술논문

目的：观察 Cervista 高危型人乳头瘤病毒（HR-HPV）检测技术及 HR-HPV 分型对宫颈癌筛查的有效性及临床价值。方法对1000名妇女同时行液基细胞学（TCT）及 Cervista 技术检测 HR-HPV，对细胞学检测大于或等于 ASC-US 的患者行病理活组织检查（活检）。评价细胞学级别、病理学级别，记录不同 TCT 级别及不同病理学级别的 HR-HPV 分型（A9、A7、A5／A6），分析 HR-HPV 分型与 CINⅢ级或以上级别的关系。结果ASC-US 及以上级别者的 HR-HPV 阳性率均高于正常或炎症级别者，LSIL 及 HSIL 级别者的 HR-HPV 阳性率均高于 ASC-US 级别者，HSIL 级别者的 HR-HPV 阳性率高于 ASC-H 级别者，P 均＜0.005。LSIL 及 HSIL 级别者 A9型阳性率高于正常或炎症级别者，HSIL 级别者 A9型阳性率高于 ASC-US 者，P 均＜0.005。对细胞学结果为 ASC-US 及以上的246例患者进行活检，HR-HPV 的阳性率从炎症时的40.9％逐渐升高到 CINⅢ级别时的92.9％。CINⅡ、CINⅢ者 A9型 HR-HPV 感染阳性率均高于炎症及 CINⅠ者（P 均＜0.005）。针对 CINⅢ或以上级别病变，HR-HPV 的敏感度为93.3％、特异度为48.8％，阳性预测值6.7％，阴性预测值99.0％，约登指数0.42。各 HR-HPV 分型中，HR-HPV A9的敏感度及约登指数较高。结论Cervista HR-HPV 对 CINⅢ或以上病变检测的敏感度、阴性预测值较高，可用于宫颈癌的筛查。当患者检出 A9型 HR-HPV 感染时，需建议患者进一步检查或加强随访。
목적：관찰 Cervista 고위형인유두류병독（HR-HPV）검측기술급 HR-HPV 분형대궁경암사사적유효성급림상개치。방법대1000명부녀동시행액기세포학（TCT）급 Cervista 기술검측 HR-HPV，대세포학검측대우혹등우 ASC-US 적환자행병리활조직검사（활검）。평개세포학급별、병이학급별，기록불동 TCT 급별급불동병이학급별적 HR-HPV 분형（A9、A7、A5／A6），분석 HR-HPV 분형여 CINⅢ급혹이상급별적관계。결과ASC-US 급이상급별자적 HR-HPV 양성솔균고우정상혹염증급별자，LSIL 급 HSIL 급별자적 HR-HPV 양성솔균고우 ASC-US 급별자，HSIL 급별자적 HR-HPV 양성솔고우 ASC-H 급별자，P 균＜0.005。LSIL 급 HSIL 급별자 A9형양성솔고우정상혹염증급별자，HSIL 급별자 A9형양성솔고우 ASC-US 자，P 균＜0.005。대세포학결과위 ASC-US 급이상적246례환자진행활검，HR-HPV 적양성솔종염증시적40.9％축점승고도 CINⅢ급별시적92.9％。CINⅡ、CINⅢ자 A9형 HR-HPV 감염양성솔균고우염증급 CINⅠ자（P 균＜0.005）。침대 CINⅢ혹이상급별병변，HR-HPV 적민감도위93.3％、특이도위48.8％，양성예측치6.7％，음성예측치99.0％，약등지수0.42。각 HR-HPV 분형중，HR-HPV A9적민감도급약등지수교고。결론Cervista HR-HPV 대 CINⅢ혹이상병변검측적민감도、음성예측치교고，가용우궁경암적사사。당환자검출 A9형 HR-HPV 감염시，수건의환자진일보검사혹가강수방。
Objective To observe the validity and clinical value of the Cervista high-risk human pap-illomaviral infection (HR-HPV)testing and HPV genotyping in the screening of cervical cancer.Methods A total of 1 000 women simultaneously received liquid-based cytology (TCT)and Cervista technology for detection of HR-HPV.Patitents suspected with cytological characteristics of atypicai squamous cells of unknown signifi-cance (ASC-US)grade or above underwent histopathological biopsy.Cytological and pathological grades were evaluated.HR-HPV genotypes (A9,A7 and A5 /A6)of different TCT and pathological grades were recorded.The relationship between HR-HPV genotype and CINⅢ grade or above was analyzed.Results The positive rate of HR-HPV in subjects with ASCUS grade or above was significantly higher compared with those of normal and inflammatory counterparts.Compared with ASC-US subjects,those with LSIL and HSIL grade had a signif-icantly higher positive rate of HR-HPV.The positive rate of HR-HPV in those with HSIL grade was considera-bly higher than that of the subjects with ASC-H grade (all P <0.005).The positive rate of type A9 HPV in-fection in the subjects with LSIL and HSIL grade was significantly higher than that in normal and inflammation counterparts.The positive rate of type A9 HPV infection in the HSIL subjects was apparently higher than that in the ASC-US counterparts (both P <0.005).Cytological testing revealed that 246 subjects developed ASC-US grade or above and subsequently received pathological biopsy.The positive rate of HR-HPV was gradually increased from 40.9% during the inflammation stage to 92.9% in the CINⅢ stage.The subjects with CINⅡand CINⅢ grade had significantly higher positive rates of type A9 HR-HPV compared with their counterparts with inflammation and CIN I (all P <0.005).For CINⅢ grade or above,the sensitivity,specificity,positive and negative predictive values of Cervista HR-HPV were 93.8%,48.8%,6.7% and 99.0%,respectively.Youden's index was 0.42.Among different HR-HPV genotypes,the sensitivity and Youden's index of A9 type HR-HPV were the highest.Conclusion Cervista HR-HPV has a high sensitivity and negative predictive value in the screening of CIN III grade or above HR-HPV,which can be applied in the screening of cervical cancer.If detected with type A9 HR-HPV infection,the patients should receive further examination and should be closely followed up.