Liu Zijian, Guo Xiang, Li Shufang, Lu Mingxing, Guo Qianyun, Liu Xingyun, Wang Yutian, Han Ying, Liu Hongwei
Department of Oral Medicine, Peking University School and Hospital of Stomatology and National Center of Stomatology and National Clinical Research Center for Oral Diseases and National Engineering Laboratory for Digital and Material Technology of Stomatology and Beijing Key Laboratory of Digital Stomatology and Research Center of Engineering and Technology for Computerized Dentistry Ministry of Health and NMPA Key Laboratory for Dental Materials, Beijing, China.
Stomatological Hospital of Xiamen Medical College and Xiamen Key Laboratory of Stomatological Disease Diagnosis and Treatment, Xiamen, China.
Front Pharmacol. 2023 Aug 4;14:1209075. doi: 10.3389/fphar.2023.1209075. eCollection 2023.
There has been a lack of treatments available to lower the frequency of recurrent aphthous ulcers (RAUs) until now. Total glucosides of paeony (TGP) is a botanical drug extracted from the dried roots of Pall. [Ranunculaceae; Paeoniae Radix Alba]. This study aims to evaluate the efficacy and safety of TGP in the treatment of RAU. This study was registered with the Chinese Clinical Trial Registry (ChiCTR1900025623). Patients were randomly assigned to the TGP or placebo group and treated with 1.8 g/day for 24 weeks. Participants were observed for a total of 36 weeks and were asked to record ulcer severity, medication, and adverse reactions in the form of diaries or apps every day. The primary outcome was the monthly ulcer-free interval. A total of 79 individuals were enrolled, with 40 assigned to the TGP group and 39 to the placebo group. The dropout rate was 18.18%. In the TGP group, the monthly ulcer-free interval was significantly longer than baseline (median, 9.6 days) since weeks 13-24 (median, 18.5 days) ( < 0.05), and after discontinuation, it was further prolonged (median, 24.7 days) than in weeks 13-24 ( < 0.05). In addition, the monthly ulcer-free interval was longer in the TGP group than in the placebo group (median, 15.9 days) at weeks 25-36 ( < 0.001). There were better improvements in the monthly number of ulcers and monthly area of ulcers, and visual analog scoring in the TGP group at weeks 25-36 ( < 0.001). TGP had a good long-term therapeutic effect on RAU with frequent occurrence. www.chictr.org.cn, identifier ChiCTR1900025623.
直到现在，一直缺乏可用于降低复发性阿弗他溃疡（RAU）发作频率的治疗方法。白芍总苷（TGP）是一种从芍药科芍药属植物芍药（毛茛科；白芍）干燥根中提取的植物药。本研究旨在评估TGP治疗RAU的疗效和安全性。本研究已在中国临床试验注册中心注册（ChiCTR1900025623）。患者被随机分配至TGP组或安慰剂组，接受每日1.8 g的治疗，持续24周。参与者共观察36周，并被要求每天以日记或应用程序的形式记录溃疡严重程度、用药情况及不良反应。主要结局为每月无溃疡间隔时间。共纳入79例个体，40例被分配至TGP组，39例被分配至安慰剂组。脱落率为18.18%。在TGP组中，自第13 - 24周起，每月无溃疡间隔时间显著长于基线水平（中位数，9.6天）（中位数，18.5天）（P<0.05），停药后，其进一步延长（中位数，24.7天），长于第13 - 24周（P<0.05）。此外，在第25 - 36周时，TGP组的每月无溃疡间隔时间长于安慰剂组（中位数，15.9天）（P<0.001）。在第25 - 36周时，TGP组的每月溃疡数量、每月溃疡面积及视觉模拟评分均有更好的改善（P<0.001）。TGP对频繁发作的RAU具有良好的长期治疗效果。www.chictr.org.cn，标识符ChiCTR1900025623。
