A national multicenter, open randomized controlled study was conducted. It is planned to invite 30 multi-center units across the country to compete for enrollment, and each multi-center will enroll 140 patients meeting colposcopic indications (70 in the conventional group and 70 in the experimental group), totaling 4200 patients. Enrolled subjects were randomly divided into two groups. Methylation test + colposcopic biopsy was performed in the conventional group, and clinical follow-up was performed according to the methylation results; in the experimental group, methylation test + colposcopic biopsy +OITS was performed, and clinical follow-up was performed according to the methylation results and OITS results. To verify the effectiveness of methylation tests and OITS in screening for CIN2+, whether they can reduce missed diagnosis of CIN2+, whether they can flag excessive colposcopic procedures, and the value of clinical follow-up for cervical lesions.
Women between the ages of 18 and 65 who have already had sex life
HPV16, 18 positive or high-risk HPV infection with cytology ≧ASC-US
No history of cervical cancer and cervical physical therapy, a complete cervix
No menstrual period, no sexual activity and vaginal medication within 48 hours
Cervical dysplasia (congenital malformation or double uterus, etc.)
History of cervical treatment (coning, ablation, or photodynamic therapy)
There are definite immunosuppression conditions, such as HIV infection or organ transplantation
Patients with severe bleeding diseases such as coagulation abnormalities or photosensitive diseases (such as porphyria, lupus erythematosus, etc.)