ALA-PDT in Patients With CIN2 in p16-positivity and High-risk HPV Infection

Exclusion Criteria

• •Atypical glandular cells (AGS) or adenocarcinoma in situ (AIS) on cytology ,or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease
• •Invasive carcinoma possibility or lesions extending to the vaginal wall
• •Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination
• •Undiagnosed vaginal bleeding within the last 3 months
• •With allergic disease at present; known or suspected porphyria; known allergy to ALA or analogues
• •With serious cardiovascular, neurologic, psychiatric, endocrine, hematological disease; immunocompromised conditions or long-term glucocorticoid or immunosuppressants exposure; patients with malignant tumors within the last 5 years
• •Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase \> 3 upper limit of normal \[ULN\], or total bilirubin \> 1.5 ULN, or serum creatinine or blood urea nitrogen \> 1.5 ULN)
• •History of treatment with systemic antivirals (continued for ≥ 14 days) within the last 3 months
• •Pregnancy or nursing
• •Participation in any clinical studies within the last 30 days
• •Poor compliance or inability to complete the trial
• •Subjects that the investigators judged to be not suitable to participate the study besides above