多种检测方法在子宫颈癌及癌前病变筛查中的应用评估

目的评估多种检测方法在子宫颈癌及癌前病变筛查中的应用价值及可行性，为子宫颈癌筛查方案提供依据。方法对子宫颈癌高发区江西省修水县大桥乡妇女进行以人群为基础的研究，对已登记的2499名年龄为30～49岁农村已婚妇女分别做人乳头瘤病毒（HPV）检测、新柏氏薄层液基细胞学（TCT）、醋酸染色后肉眼观察（VIA）、碘染色后肉眼观察（VILI）以及电子阴道镜检查。全部检查方法均以独立、双盲方式进行。对VIA、VILI及电子阴道镜三项检查中任何一项存在子宫颈可疑病变的妇女行子宫颈活检；对以上三项检查均未发现可疑病变，但子宫颈脱落细胞HPV阳性或TCT结果阳性（ASCUS以上级别）的妇女，2周后给予子宫颈活检。观察HPV、TCT、VIA、VILI、电子阴道镜等筛查方法单独使用或联合使用进行子宫颈癌及其癌前病变筛查的敏感度、特异度、阳性预测值、阴性预测值。宫颈组织病理诊断均经国际癌症研究所病理确诊。筛查时将病理诊断为子宫颈上皮内瘤变（CIN）1级（CINl）纳入阴性结果，将CIN2以上（包括CIN2）病变纳入阳性结果。宫颈细胞学按TCT（thinprep cytology test）标准制片，细胞学诊断按照2001年TBS（The Bethesda System）细胞病理分类标准判读诊断。结果2499名受检妇女中，2432名纳入研究（67名妇女因HPV或TCT阳性未行活检故未列入统计），其中HPV阳性妇女387例；TCT阳性妇女153例。宫颈活检病理诊断共检出CIN及子宫颈癌99例，其中CIN237例，CIN359例，宫颈癌3例。HPV、TCT、HPV＋TCT、VIA、VILI、VIA＋VILI、阴道镜检等筛查方法的敏感度分别为96．67％、89．47％、97．98％、56．57％、36．36％、63．64％、39．39％。特异度分别为85．00％、96．91％、86．97％、94．60％、96．23％、92．97％、98．14％。结论HPV＋TCT用于宫颈癌及癌前病变筛查的敏感度高于其他筛查方法。

Study on the value assessment of various screening programs regarding cervical cancer screening strategy in the rural areas of China

OBJECTIVE: To evaluate the application value and feasibility of various cervical screening methods and to explore a rapid and efficient cervical cancer screening program for the women in the rural areas of China. METHODS: We sequentially conducted human papillomavirus (HPV) DNA test by hybrid capture-2 (hc2) with cervical cells, liquid-based thinprep cytology test (TCT), visual inspection with acetic acid (VIA), visual inspection with iodine (VILI), colposcopy respectively for the 2499 married women between 30 and 49 years from Xiushui county of Jiangxi province. All the detection methods were performed independently under double-blind design. Women who were diagnosed positive for having any VIA,VILI and colposcopy inspection or for those women who were diagnosed negative for VIA, VILI and colposcopy but with positive result of HPV or TCT test underwent cervical biopsy directly and endocervical curettage (ECC)when necessary. We performed cervical biopsy endocervical curettage within two weeks to observe the sensitive (SE), specificity (SP), negative predict value (NPV) and positive predict value (PPV) of these detection methods when used alone or combined each other, including HPV test, TCT inspection, VIA, VILI, and colposcopy, the pathological diagnosises of cervical tissue were confirmed by IARC (International Agency for Research on Cancer) while the cytological findings were underegone through the updated program of TBS (The Bethesda System) in 2001. RESULTS: A total of 2499 women underwent the screening and found 443 women who were diagnosed as HPV positive, 337 women with abnormal cervical cytology and 27 women with ASC-H, 157 cases with ASCUS; 103 cases with HSIL, 49 cases with LSIL and 1 cervical cancer. According to the pathological findings. There were 181 women diagnosed as cervical intraepithelial neoplasia (CIN) or cervical cancer, including 81 cases with CIN1 37 cases with CIN2,60 case cervical cancer. The sensitivity rates of HPV, TCT, HPV+ TCT, VIA, VILI, VIA+VILI and colposcopy were 96.67%, 89.47%, 97.98%, 56.57%, 36.36%, 63.64% and 39.39%, and the specificity rates were 85.00%, 96.91%, 86.97%, 94.60%, 96.23%, 92.97% and 98.14% respectively. CONCLUSION: HPV + TCT seemed to be more sensitive than other screening methods in the cervical cancer screening program.