[Clinical study of Total Glucosides of Paeony Capsules for oral lichen planus with Yin-deficiency and internal-heat pattern: efficacy evaluation and analysis of tongue and pulse characteristics].

Oral lichen planus(OLP) is a chronic inflammatory oral mucosal disease with potential malignant transformation risk. Yin-deficiency and internal-heat is a common TCM subtype characterized by a red tongue with thin white coating and a thin and slippery pulse. Although western medical treatments, mainly glucocorticoids, can relieve symptoms to some extent, their efficacy is limited, and recurrence is frequent. This study aimed to investigate the clinical efficacy and safety of Total Glucosides of Paeony Capsules in treating OLP patients with the Yin-deficiency and internal-heat pattern, and to analyze their tongue and pulse characteristics, providing new clinical evidence for integrative medicine for OLP. A nonrandomized concurrent controlled design was adopted, including 44 patients with the Yin-deficiency and internal-heat pattern of OLP who attended Stomatology Department, Peking University Third Hospital, from July 2020 to March 2023. According to shared decision-making between physicians and patients, they were assigned to control group(treated with dexamethasone gargle) and treatment group(treated with oral Total Glucosides of Paeony Capsules), with 22 patients in each group. Therapeutic efficacy was evaluated using lesion scoring, visual analogue scale(VAS) scores, and overall effective rate, and follow-up was conducted at baseline, 2 weeks, and 6 months after treatment. The results showed that the VAS scores in the treatment group was significantly lower than that in the control group at the 6 months follow-up(P=0.004), and the overall effective rate of the treatment group(81.82%) was significantly higher than that of the control group(45.45%)(P=0.01). Tongue and pulse analysis indicated that red tongue with thin white coating(13.63%), red-tipped tongue with thin white coating(11.36%), thin and slippery pulse(59.10%) were typical manifestations of the Yin-deficiency and internal-heat pattern in OLP. In addition, no serious adverse reactions were observed during treatment, and Total Glucosides of Paeony Capsules showed good safety during long-term use. These results suggest that Total Glucosides of Paeony Capsules may provide clinical benefits for patients with OLP of the Yin-deficiency and internal-heat pattern, particularly in pain relief, with a sustained trend of improvement and a favorable safety profile over the 6 months follow-up.