Recombinant Human Interferon a-2b Gel for HPV-16 and/ or HPV-18 Gynecological Infections

Randomized, Double-blind, Parallel, Controlled Clinical Study to Evaluated the Efficacy and Safety of Recombinant Human Interferon Alpha-2b Gel (Yallaferon®) in HPV-16 and/or HPV-18 Infection

to assess the efficacy and safety of recombinant human interferon α-2b gel (Yallaferon®) for the treatment of patients with cervical HPV-16 and/or HPV-18 infections; to analyze the HPV type infections and clinical negative conversion.

100 patients with positive HPV-16 and HPV-18 infection are randomized into interferon gel group and control group at ratio of 1:1 (50 patients in treatment group and 50 patients in control group). The patients in treatment group received 1g recombinant human α-2b interferon gel every other day for consecutive 6-10 courses of treatment, whereas no treatment was conducted in control group.

Inclusion Criteria:

• Age 25 to 65 years of age with the sex life of female patients;
• HPV DNA typing test for HPV-16 and/ or HPV-18 positive in 1 month.

Exclusion Criteria:

• Patients with cervical intraepithelial neoplasia Ⅱ / Ⅲ, cervical cancer;
• Associated with fungal vaginitis, trichomonas vaginitis, HIV positive patients;
• Associated with acute, severe bacterial or viral infection;
• Autoimmune diseases;
• Within 3 months before screening patients used corticosteroids, immunosuppressants or other antiviral drugs;
• Allergies or allergy to the drug known ingredients;
• History of suffering CNS diseases, epilepsy and/or psychological disorder;
• Pregnant and lactating women;
• The researchers do not consider it appropriate clinical trials.