Eslami Gohar, Ghorbani Anahita, Akbari Jafar, Farmoudeh Ali, Faghih Fereshteh, Moghimi Minoo
Cardiovascular Research Center, Mazandaran University of Medical Sciences, Sari, Iran.
Department of Clinical Pharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.
Front Dent. 2023 May 31;20:18. doi: 10.18502/fid.v20i18.12824. eCollection 2023.
This study aimed to assess the efficacy of oral mucoadhesive N-acetylcysteine (NAC) tablets for treatment of recurrent aphthous stomatitis (RAS). Forty-nine patients with RAS were randomized to receive mucoadhesive NAC tablets (n=25) or placebo (n=24). Tablets were prescribed three times a day for 7 days in each group. Pain intensity was evaluated with visual analog scale (VAS) three times a day from day 1 to day 7. Also, patients were clinically examined on days 0 (before entering the study), 3, 5, and 7 using a metal caliper to measure the diameter of the lesions. The data were statistically analyzed and P<0.05 was considered statistically significant. Regarding the VAS score, all participants in the treatment group showed complete recovery on day 7 (P<0.01). Also, the diameter of the lesions was significantly smaller in the treatment group than the placebo group at the end of the study (P<0.001). The results of this clinical trial showed for the first time that mucoadhesive NAC tablets can significantly decrease pain and the diameter of RAS lesions without any systemic complications.
本研究旨在评估口服黏膜黏附性N-乙酰半胱氨酸（NAC）片治疗复发性阿弗他口炎（RAS）的疗效。49例RAS患者被随机分为两组，分别接受黏膜黏附性NAC片（n = 25）或安慰剂（n = 24）治疗。每组均按每日3次给药，持续7天。从第1天到第7天，每天3次用视觉模拟量表（VAS）评估疼痛强度。此外，在第0天（进入研究前）、第3天、第5天和第7天对患者进行临床检查，使用金属卡尺测量病变直径。对数据进行统计学分析，P<0.05被认为具有统计学意义。关于VAS评分，治疗组所有参与者在第7天均显示完全恢复（P<0.01）。此外，在研究结束时，治疗组病变直径明显小于安慰剂组（P<0.001）。该临床试验结果首次表明，黏膜黏附性NAC片可显著减轻RAS病变的疼痛和直径，且无任何全身并发症。
