Comparative Study of care HPV Assay,Visual Inspection and Pap Smears as Primary Screening in Rural China

农村地区的肿瘤早诊早治,一直是国家肿瘤防治工作的重点。本文旨在研究在我国农村地区,在当地现实条件下由基层技术人员操作的醋酸碘染色肉眼观察、细胞学以及careHPV DNA检测的可行性。本研究中把当地参加项目的女性随机分为3组,分别采用醋酸碘染色肉眼观察、细胞学以及careHPV DNA进行宫颈癌及癌前病变的初筛。初筛阳性的女性转诊进行阴道镜及活检。所有的检测都是有当地工作人员完成。最终诊断以中国医学科学院肿瘤医院病理专家的结果为准。同时通过问卷调查收集筛查对象及乡医村医有关HPV及筛查项目的认知和态度。最终有894名女性完成careHPV DNA检测,552名女性完成醋酸碘染肉眼观察,547名女性完成巴氏涂片。careHPV检测、醋酸碘染肉眼观察和巴氏涂片的阳性率分别为10.6%,18.1%和4.9%,差异具有统计学意义(χ~2=48.647,P<0.001)。总人群的CIN2+病变检出率为0.5%,尽管careHPV组的CIN2+病变检出率高于其他两组,但差异未发现统计学意义。通过以上研究,显示基层卫生工作人员对HPV相关知识的了解不足,但对于在国家筛查项目中引入HPV检测持积极的态度。在基层条件下由经过简单培训的实验员进行careHPV检测是可行的,应在基层卫生工作者中开展HPV及其检测相关的教育和培训。

To compare the performance of visual inspection with acetic acid and with Lugol＇s iodine（ VIA/VILI）,cytology and care HPV DNA assay in rural China performed by local health providers. Eligible women living in rural areas in Xinmi County,Henan Province were invited to participate in cervical cancer screening program. Enrolled women were randomized into 3 intervention arms,screened by VIA/VILI,pap smears,and care HPV assay respectively. Women had positive primary screening results were referred to colposcopy and/or biopsy. All the clinical and lab work was performed by local health providers. The final diagnoses of histopathology were based on the diagnosing of a senior histopathology expert from Cancer Hospital,Chinese Academy of Medical Sciences. Questionnaires about the knowledge and attitudes towards the HPV and the screening program of thehealth providers at village clinics were collected. Finally,894 women had careHPV DNA test,552 underwent VIA/VILI and 547 had Pap smears. The positive rates forcare HPV assay,VIA/VILI and Pap smears were 10. 6%,18. 1%,and 4. 9% respectively（ χ^2= 48. 647,P〈0.001）. The overall CIN2 ＋ detection rate was 0. 5%,the CIN2 ＋ detection rate for the three arms were not significantly different even that of care HPV was higher than the other arms（ 0. 7% for care HPV assay,0. 5% for VIA/VILI,0. 2% for pap smear,χ^2= 1. 648,P = 0. 439）. The knowledge of the health providers about HPV,HPV assay in screening was unsatisfactory. However,their attitudes about implementing HPV assay into the national program were positive. Implementing care HPV assay in low resource settings and performed by simply trained lab personnel is possible. Education for implementing HPV assay in local health providers is needed.