Abstract: Objective To evaluate the efficacy and safety of Qinlingzi vaginal infusion and human interferon α2b vaginal effervescent tablets in treating high-risk human papillomavirus (HPV) infection, and to explore the potential advantages of Qinlingzi vaginal infusion in clinical applications. Method Patients with high-risk HPV infection from Suzhou Hospital of Traditional Chinese Medicine Affiliated to Nanjing University of Chinese Medicine between October 2022 and August 2023 were selected as research subjects. A total of 180 patients were included, with 90 patients in the control group receiving interferon α2b vaginal effervescent tablets and 90 patients in the study group received Qinlingzi vaginal infusion treatment. The HPV clearance rates, traditional Chinese medicine (TCM) syndrome scores, and adverse reactions were compared between the two groups after 3 and 6 menstrual cycles of treatment. Result The overall effective rate of HPV clearance in the control group was 20.00% at 3 months and 33.33% at 6 months, both significantly lower than that in the study group, which was 55.56% at 3 months and 71.11% at 6 months, with statistically significant differences (P<0.05). After treatment, the TCM syndrome score in the study group was significantly lower than that in the control group (P<0.05). The HPV clearance rates at 3 months and 6 months post-treatment were compared across different age groups in both groups. In the control group, the best efficacy was observed in the 19-30 age group, with rates of 88.89% at 3 months and 100.00% at 6 months. In the study group, the 19-30 age group also showed the best efficacy, with 100.00% clearance rates at both 3 and 6 months. When comparing the two groups, at 3 months, the efficacy in the 19-30, >31-40, and >40 age groups was better in the study group than in the control group, but significant differences were only found in the >31-40 and >40 age groups (P<0.05). At 6 months, the efficacy in the >31-40 and >40 age groups was better in the study group, with a significant difference only in the >31-40 age group (P<0.05). Regarding inflammatory factor levels, there were no significant differences in the levels of Transforming Growth Factor-β1 (TGF-β1) and Interleukin-6 (IL-6) between the two groups before treatment (P>0.05). After 3 and 6 months of treatment, TGF-β1 levels decreased and IL-6 levels increased in both groups. However, the study group had significantly lower TGF-β1 and higher IL-6 levels compared to the control group (P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups. Conclusion The therapeutic effect of Qinlingzi vaginal lavage solution on high-risk HPV is superior to that of interferon α2b vaginal effervescent tablets. It can significantly improve clinical symptoms and has good safety.

Key words: Qinlingzi, Human interferon alpha 2b vaginal effervescent tablets, High-risk human papillom avirus, Cervical lesions, Traditional Chinese Medicine syndrome integral