Clinical application of modified Yihuang Decoction for the treatment of cervical high-risk HPV persistent infection.

BACKGROUND: Persistent high-risk HPV (HR-HPV) infection is a major cause of cervical cancer. While vaccines exist, treatment options for those already infected are limited. This study aims to evaluate the effectiveness and immune response of combining human interferon α2b (hIFN) with modified Yihuang Decoction (YHD) for HR-HPV infection. METHODS: This trial was conducted with 108 patients diagnosed with persistent HR-HPV infection. Participants received either hIFN monotherapy or a combination of hIFN and YHD (hIFN-YHD) for 3 months, followed by a 6-month follow-up. The primary outcomes included clinical efficacy, HR-HPV clearance rates, and changes in immune markers, such as IFN-γ, IL-4, and FPR3, in cervical biopsy tissues and vaginal lavage fluid. RESULTS: Treatment with hIFN-YHD resulted in significantly higher recovery (46.8%) and overall response rates (85.1%) compared with hIFN monotherapy (28.9% and 60.0%, respectively; p < 0.05). The negative conversion rate for HR-HPV was also significantly higher in the hIFN-YHD group, especially in patients with single and multiple infections (p < 0.001). Immunological analysis revealed increased FPR3 and IFN-γ expression and reduced IL-4 levels in the hIFN-YHD group. Additionally, hIFN-YHD treatment significantly increased IFN-γ levels and decreased IL-4 levels in vaginal lavage fluid (p < 0.001). CONCLUSION: The combination of hIFN and YHD significantly improves clinical outcomes and enhances immune responses in patients with persistent HR-HPV infection.