HR-HPV16/18 infection with CINI/P16 negative CIN II
Conditions
Interventions
Sponsors
Beijing Tsinghua Changgeng Hospita
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1) HPV16 or HPV18 were positive by cobas4800 HPV test; (2) Colposcopic examination was satisfactory, and the histopathological results were CINI or CINII (p16 negative); (3) The menstrual cycle is regular, menstrual cycle >= 25 days and = 3 days and <= 7 days; (4) Age 18-50 years old (including the cut-off value), sexual life history, postmenopausal women; (5) During the trial and within 6 months after the end of the trial, there was no pregnancy plan. At the same time, they voluntarily complied with the requirement that only condoms (without sex hormones) should be used for contraception; (6) Voluntary participation in the study, and has signed the informed consent.
Exclusion criteria
Exclusion criteria: (1) Abnormal development of reproductive system (such as imperforate hymen, vaginal atresia, etc.), or previous total cervical resection; (2) Those who have received HPV vaccination in the past; (3) Vaginal intraepithelial neoplasia (VAIN) was found in the vaginal wall or fornix; (4) Patients with previous malignant tumors of reproductive system (such as cervical cancer or endometrial cancer, vaginal cancer, vulvar cancer, etc.); (5) Cervical histopathology showed CIN II(P16 positive) or CIN III or above; (6) Patients with severe upper and lower genital tract infection, or cervical gonococcal, mycoplasma or chlamydia infection; (7) The patients who were not satisfied with colposcopy and needed ECC; (8) They are complicated with serious primary diseases such as heart, brain, liver, kidney and hematopoietic system (such as malignant tumor), or known severe low immune function (such as AIDS, systemic lupus erythematosus and other serious diseases of immune system, malignant tumor after radiotherapy and chemotherapy, organ transplantation, etc.), or mental disease, or liver and kidney function damage (alt, AST >= upper limit of normal value x 1.5 times), The creatinine was higher than the upper limit of normal value; (9) Within 3 months before participating in the trial, those who had used physical therapy (such as cryotherapy, laser ablation, electrocautery and condensation) or surgical treatment (such as cold knife conization, LEEP, laser conization) for cervical HR-HPV combined with cervical intraepithelial lesions (CIN) or who were judged by researchers to need physical therapy (such as cryotherapy, laser ablation, electrocautery and condensation, etc.) or surgical treatment (such as cold knife conization, LEEP, laser conization, etc.); (10) Within 4 weeks before participating in the trial, they had used drugs (including traditional Chinese medicine, chemical drugs, biological products, etc.) or mechanical and Xiaozi products for the treatment of cervical HR-HPV with CIN; (11) Those who used oral contraceptives, glucocorticoids or immunosuppressants within three months before using the test drug; (12) In pregnancy, lactation; (13) Allergic to Baofukang suppository; (14) Those with a history of alcohol abuse, long-term smoking or drug abuse, or unable to stop drinking, smoking or drug abuse during the trial period; (15) Those who have participated in other clinical trials in recent 3 months; (16) According to the judgment of the researcher, it is not suitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reversal rate of LSIL (CINI/P16-negative CINII) in the 7th Menstrual Cycle;The negative rate of HR-HPV16/18 in Cervix at the 7th Menstrual Cycle; | — |
Countries
China
Contacts
Public ContactLiao Qinping
Outcome results
None listed