目的 探讨白芍总苷胶囊联合复方氯己定治疗复发性口腔溃疡的临床疗效。方法 纳入2024年2月—2026年1月安徽医科大学第五附属医院收治的136例复发性口腔溃疡患者，按照随机数字表法为对照组和治疗组，每组各68例。对照组含漱复方氯己定含漱液，15 mL/次，3次/d。在对照组基础上，治疗组饭后口服白芍总苷胶囊，0.6 g/次，3次/d。两组患者疗程均为14 d。观察两组临床疗效，比较治疗前后局部评价指标（疼痛指数、平均溃疡期、溃疡面积）、症状体征积分、28项一般健康问卷（GHQ-28）和14项口腔健康影响程度量表（OHIP-14）评分，以及全身免疫炎症指数（SⅡ）、C反应蛋白与白蛋白比值（CAR）、外周血CD4⁺/CD8⁺和血清转化生长因子-β1（TGF-β1）水平，并统计两组不良反应发生率及复发率（随访3个月）。结果 治疗后，治疗组总有效率为97.06%，明显高于对照组的88.24%，两组总有效率比较差异具有统计学意义（P＜0.05）。治疗后，两组疼痛指数、平均溃疡期、溃疡面积均显著降低（P＜0.05），且治疗组患者局部评价指标均低于对照组（P＜0.05）。治疗后，两组症状体征积分和GHQ-28、OHIP-14评分均显著降低（P＜0.05），且治疗组评分均明显低于对照组（P＜0.05）。治疗后，两组SⅡ、CAR水平均显著下降，而外周血CD4⁺/CD8⁺和血清TGF-β1水平均明显升高（P＜0.05），且治疗组这些指标水平均明显优于对照组（P＜0.05）。结论 白芍总苷胶囊联合复方氯己定治疗复发性口腔溃疡可兼顾局部抗炎与全身免疫调控，疗效确切、安全性良好，能有效缓解患者症状、加速溃疡愈合，改善心理状态及生活质量，降低复发率。

Objective To explore the clinical efficacy of Total Glucosides of Paeony Capsules combined with compound chlorhexidine in the treatment of recurrent oral ulcer. Methods A total of 136 patients with recurrent oral ulcer admitted to the Fifth Affiliated Hospital of Anhui Medical University from February 2024 to January 2026 were enrolled and divided into control and treatment groups according to random number table method, with 68 cases in each group. The control group received gargling with Compound Chlorhexidine Gargle at 15 mL each time, three times daily. On the basis of the control group, the treatment group was given oral Total Glucosides of Paeony Capsules after meals at 0.6 g each time, three times daily. Both groups were treated for 14 days. The clinical efficacy was observed. Local evaluation indicators (pain index, average ulcer duration and ulcer area), symptom and sign scores, General Health Questionnaire-28 (GHQ-28) and Oral Health Impact Profile-14 (OHIP-14) scores, systemic immune-inflammation index (SⅡ), C-reactive protein to albumin ratio (CAR), peripheral blood CD4⁺/CD8⁺ ratio and serum transforming growth factor-β1 (TGF-β1) level were compared before and after treatment. The incidence of adverse reactions and recurrence rate during the 3-month follow-up were also recorded. Results After treatment, the total effective rate of the treatment group was 97.06%, which was significantly higher than 88.24% of the control group (P < 0.05). The pain index, average ulcer duration and ulcer area were significantly decreased in both groups after treatment (P < 0.05), and these local indicators were lower in the treatment group (P < 0.05). Additionally, the scores of symptoms and signs, GHQ-28 and OHIP-14 were markedly reduced in both groups (P < 0.05), with lower scores observed in the treatment group (P < 0.05). Moreover, SⅡ and CAR levels declined obviously, while peripheral blood CD4⁺/CD8⁺ ratio and serum TGF-β1 level increased significantly in the two groups (P < 0.05), and the treatment group achieved better improvements in all the above indicators (P < 0.05). Conclusion The combined therapy of Total Glucosides of Paeony Capsules and compound chlorhexidine exerts both local anti-inflammatory effects and systemic immune regulation for recurrent oral ulcer. It has definite curative effect and favorable safety, which can effectively relieve clinical symptoms, accelerate ulcer healing, improve mental status and quality of life, and reduce the recurrence rate.

R988.2

安徽省教育厅高等学校科研计划项目（2024AH050689）