Abstract: OBJECTIVE To investigate the efficacy of Jianpi Lishi Jiedu Formula combined with Compound Huangbai Liquid Topical Agent in treating cervical human papillomavirus (HPV) infection and its effect on immune function. METHODS Based on the random number table method, a total of 146 patients with cervical HPV infection who were diagnosed and treated at Cangzhou People's Hospital from Jan. 2023 to Dec. 2024 were enrolled and divided into a lotion group and a combination group (n=73 each). The lotion group was treated with Compound Huangbai Liquid Lotion, while the combination group was additionally treated with Jianpi Lishi Jiedu Formula. The two groups were compared in terms of TCM syndrome scores, therapeutic efficacy, immune function, inflammatory factor levels and adverse reactions. RESULTS In both groups, the TCM syndrome scores, CD₈⁺, high-sensitivity C-reactive protein (hs-CRP) and tumor necrosis factor-α (TNF-α) levels were lower after treatment than before treatment, and those in the combination group were lower than those in the lotion group after treatment (P<0.05). The total effective rate of the combination group was higher than that of the lotion group (97.26% vs. 86.30%, P=0.016). In both groups, the levels of immunoglobulin (Ig) A, IgG, IgM, CD₃⁺, CD₄⁺ and interleukin-12 (IL-12) were higher after treatment than before treatment, and those in the combination group were higher than those in the lotion group after treatment (P<0.05). No significant difference was found in the total incidence of adverse reactions between the combination group and the lotion group after treatment (8.22% vs. 5.48%，P=0.512). CONCLUSION The combination of Jianpi Lishi Jiedu Formula and Compound Huangbai Liquid Lotion shows good efficacy in treating cervical HPV infection, improves TCM syndromes, reduces inflammatory factor levels, enhances immune function, and has a favorable safety profile.