Abstract
OBJECTIVE: To evaluate the clinical efficacy and inflammatory modulation potential of Kangfuxin Liquid (KFXY; a traditional Chinese medicine recovery solution) in combination with metronidazole (MTZ) for the treatment of recurrent oral ulcers (ROU). METHODS: A retrospective cohort study was conducted using clinical data from 117 ROU patients admitted between January 2021 and January 2023. Patients were categorized into two groups: a control group (n=58) treated with MTZ oral adhesive patches alone, and an observation group (n=59) receiving KFXY plus MTZ. Primary outcomes included clinical response rates, symptom resolution time (ulcer healing, pain relief, and eating ability), systemic inflammatory biomarkers (C-reactive protein [CRP], tumor necrosis factor-alpha [TNF-α], interleukin-6 [IL-6]), oral microbial flora composition (Veillonella, Streptococcus), and adverse event incidence. RESULTS: Clinical Efficacy: The observation group demonstrated a significantly higher total response rate (94.92% vs 79.31%; P<0.05). Symptom Resolution: The KFXY-MTZ combination accelerated ulcer healing (P<0.05), reduced pain intensity (P<0.05), and improved oral intake (P<0.05) compared to MTZ alone. Inflammatory Modulation: Pre-treatment CRP, TNF-α, and IL-6 levels were comparable (P>0.05); post-treatment, these biomarkers were significantly lower in the observation group (P<0.05). Microbial Flora: Post-treatment levels of Veillonella and Streptococcus were significantly elevated in the observation group (P<0.05), indicating potential probiotic effects. Safety: Adverse event rates were similar between groups (control: 5.17%; observation: 6.78%; P>0.05). CONCLUSION: The KFXY-MTZ combination therapy exhibits robust anti-inflammatory and probiotic activities, accelerating ROU healing without compromising safety. These findings support its clinical utility as an integrative treatment strategy for ROU.