Xiaoyun He
This retrospective study evaluated clinical outcomes associated with Wandai Decoction (WDT) plus recombinant human interferon α-2b (rhIFN-α-2b) in patients with persistent high-risk human papillomavirus (HR-HPV) infection and a spleen-deficiency pattern, with particular attention to vaginal microecology and peripheral T-cell subsets. Clinical data from 125 patients treated between March 2024 and September 2025 were analyzed. According to the treatment regimen, 57 patients received oral WDT plus rhIFN-α-2b vaginal suppositories, whereas 68 patients received rhIFN-α-2b alone. Both groups received three consecutive treatment courses. After treatment, the observation group had a higher total effective rate than the control group (89.47% vs. 72.06%, p = 0.015) and a shorter time to first HPV conversion (P = 0.028), whereas the overall four-category HPV outcome distribution (P = 0.060) and HPV16/18-specific conversion rate (P = 0.138) did not differ significantly. More favorable vaginal microecological findings included lower pH, leukocyte esterase positivity, and amine test positivity, along with higher rates of normal hydrogen peroxide status, vaginal cleanliness grade I-II, and Lactobacillus predominance (P < 0.05). Fungal detection, bacterial vaginosis-related abnormalities, and mixed infection were also less frequent (P < 0.05). Post-treatment CD4+ T-cell percentage and the CD4+/CD8+ ratio were higher, whereas CD8+ T-cell percentage was lower, in the observation group (P < 0.05). The total traditional Chinese medicine syndrome score, abnormal cervical color, and contact bleeding also showed more favorable findings. The overall rate of recorded adverse events did not differ significantly between groups (P = 0.057). WDT plus rhIFN-α-2b was associated with more favorable HPV-related, vaginal microecological, peripheral T-cell subset, and symptom outcomes; however, the retrospective design and residual confounding preclude causal interpretation.