Cervical low-grade squamous intraepithelial lesion (CIN1) with high-risk human papillomavirus infection
Conditions
Interventions
Experimental group:ALA-PDT
Sponsors
Department of Gynecology and Obstetrics, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Eligibility
Sex/Gender
Female
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Female aged 30-65 years; 2. Being histopathologically verified cervical low-grade squamous intraepithelial lesion with high-risk human papillomavirus infection within 3 months; 3. Additional criteria for inclusion included: (1) The pregnancy test was negative; (2) There was no pregnancy plan within 24 months from the end of the last menstruation to the beginning of the trial. (3) No sexual activity or consent to contraception by condom 24 months from the end of the last menstruation to the beginning of the trial; (4) Participating voluntarily and signing the informed consent.
Exclusion criteria
Exclusion criteria: 1. Being found ASC-H (atypical squamous cells that could not exclude high-grade intraepithelial lesions), HSIL (high-grade intraepithelial lesions), AGC (atypical gland cells), AIS (adenocarcinoma in situ) by cytological examination, or being observed malignant cells by cytology and histology, or being suspected of having malignant lesions or cancer infiltration. 2. Patients who cannot be excluded from invasive cancers or lesions extending to the vaginal wall. 3. Severe pelvic inflammation, cervical inflammation or other severe gynecological inflammation were found in clinical examination. 4. Having undiagnosed vaginal bleeding; 5. Currently suffering from allergic diseases; suspected or known to have porphyria or known to have a history of allergy to experimental drugs and chemically similar drugs; 6. Patients with serious cardiovascular, cerebrovascular, neurological, spiritual, endocrine, hepatic and hematopoietic diseases; severe immunodeficiency or long-term use of glucocorticoids and immunosuppressants; patients with malignant tumors; 7. Pregnant and lactating women; 8. Those who have taken physiotherapy for LSIL (CIN1) after pathological diagnosis; 9. Those who received interferon and antiviral drugs within 3 months; 10. Persons without or with limited capacity for civil conduct; 11. Patients who are judged by the researchers not suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clearance of cervical lesions; | — |
Secondary
| Measure | Time frame |
|---|---|
| High-risk HPV clearance rate;Clearance of cervical lesions;Safety of photodynamic therapy; | — |
Countries
China
Contacts
Public ContactDi Wen, Qiu Lihua
Department of Gynecology and Obstetrics, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Outcome results
None listed