Rhodus N L, Bereuter J
Division of Oral Medicine, University of Minnesota, School of Dentistry, Minneapolis 55455, USA.
Quintessence Int. 1998 Dec;29(12):769-73.
Recurrent aphthous stomatitis is a very common condition, currently treated with anti-inflammatory agents, which palliate the symptoms. The purpose of this clinical trial was to compare a medication commonly used to treat recurrent aphthous stomatitis, Kenalog-in-Orabase, and a newer agent, Debacterol.
Sixty patients diagnosed with recurrent aphthous stomatitis were enrolled in the study. Twenty patients were assigned to each of the two treatment groups, and 20 age- and sex-matched patients were assigned to the control group, which received no treatment. After the diagnosis was made, clinical examinations and ulcer measurements were performed, and a subjective evaluation of symptoms (100-mm visual analog scale) was completed by each subject. The subjects did not use any other medications. Both agents were applied topically (the frequency varied depending on the group of subjects) at specified intervals. Ulcer measurements and subjective evaluations were made at days 0, 3, 6, and 10 for all subjects.
In both treatment groups, by day 10, 100% of the ulcers had clinically healed and were no longer causing pain. Patients in the Debacterol group reported a significantly greater decrease in pain at 3 days (> 70%) than did subjects in the other groups (< 20%), although the size of the ulcer did not differ significantly in any of the groups. After day 6, 80% of the ulcers in the Debacterol group had clinically disappeared and no longer caused symptoms, as compared to about 30% in the other groups.
Patients subjectively reported significantly greater relief from symptoms with Debacterol than with Kenalog-in-Orabase or no treatment. The relief of symptoms associated with recurrent aphthous stomatitis may or may not correspond to clinical improvement, and these two topical medications may affect signs and symptoms of the lesions differently.
复发性阿弗他口炎是一种非常常见的病症，目前使用抗炎药物进行治疗，这些药物可缓解症状。本临床试验的目的是比较一种常用于治疗复发性阿弗他口炎的药物——口腔用曲安奈德（Kenalog-in-Orabase）和一种新型药物——德拜克托（Debacterol）。
60名被诊断为复发性阿弗他口炎的患者参与了该研究。两个治疗组各分配20名患者，20名年龄和性别匹配的患者被分配到未接受治疗的对照组。确诊后，进行了临床检查和溃疡测量，每位受试者完成了症状的主观评估（100毫米视觉模拟量表）。受试者未使用任何其他药物。两种药物均按指定间隔局部应用（频率因受试者组而异）。所有受试者在第0、3、6和10天进行溃疡测量和主观评估。
在两个治疗组中，到第10天，100%的溃疡在临床上已愈合且不再引起疼痛。德拜克托组的患者在第3天报告疼痛明显减轻（>70%），而其他组的受试者疼痛减轻程度（<20%），尽管溃疡大小在任何组中均无显著差异。第6天后，德拜克托组80%的溃疡在临床上消失且不再引起症状，而其他组约为30%。
患者主观报告称，与口腔用曲安奈德或不治疗相比，德拜克托能显著缓解症状。与复发性阿弗他口炎相关的症状缓解可能与临床改善相符，也可能不相符，这两种局部用药可能对病变的体征和症状有不同影响。
