CIN2 CIN2-3
Conditions
Interventions
control group:placebo
Sponsors
Tongji Hospital, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Each subject must meet all of the following criteria to be enrolled in this study: 1) The patient must voluntarily joined the study, signed informed consent, good compliance, and cooperated with the follow-up; 2) Female patients with age >= 18 years old (calculated on the day of signing informed consent) and history of sexual life; 3) Satisfactory colposcopy included: a) The cervical transformation area, including the squamous columnar junction, was completely visible; b) The upper limit of acetic acid white epithelium or the edge of suspected CIN lesions were intact. 4) The diagnosis was confirmed by pathological experts in our hospital, and the result of histological biopsy was HSIL (CIN II, CIN II ~ III); 5) Before biopsy, the lesion area was greater than or equal to 15% of the cervical area and less than 75% of the cervical area; 6) After biopsy, there were still visible lesions under colposcopy before treatment; 7) HPV test confirmed HPV16 positive; 8) The subjects with fertility potential voluntarily performed strict contraception from signing informed consent to the end of the study.
Exclusion criteria
Exclusion criteria: 1. Cervical infiltrating carcinoma; 2. Adenocarcinoma in situ of the cervix, or other glandular epithelial lesions; 3. The lesion extends into the cervical canal (according to the clinical situation, the investigator will determine whether cervical curettage is necessary); 4. The lesion extends to the vaginal vault; 5. Colposcopy or clinical examination reveals severe pelvic inflammation, severe cervicitis, or other serious gynecological infectious diseases; 6. The investigator identified patients who were likely to experience vaginal bleeding at any time; 7. Those who had given birth or miscarriage within 6 weeks before enrollment; 8. Pregnant and lactating women; 9. Patients with a recurrence of HSIL due to incomplete cervix after previous surgical treatment; Or patients who have received other treatments since the current diagnosis of HSIL; 10. People with previous severe systemic allergic reactions; 11. A history of toxic shock syndrome; 12. Participated in or is participating in clinical trials of other drugs within 30 days prior to the trial; 13. Patients with cardiac insufficiency; Patients with liver function and renal insufficiency; 14. Concomitant diseases that, in the Investigator's judgment, seriously endanger patient safety or affect patient completion of the study; 15. Those who are unable or unwilling to sign the informed consent; 16. Those who are unable or unwilling to comply with research requirements; 17. The investigator himself, the research assistant, the research pharmacist, the clinical research assistant, or other personnel participating in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HPV16 infection;Histopathology; | — |
Secondary
| Measure | Time frame |
|---|---|
| HPV16 integration; | — |
Countries
China
Contacts
Public ContactMa Ding
Tongji Hospital, Huazhong University of Science and Technology
Outcome results
None listed