Drinnan A J, Fischman S L
J Oral Pathol. 1978;7(6):414-7. doi: 10.1111/j.1600-0714.1978.tb01611.x.
A randomized double-blind study was designed to evaluate the safety and efficacy of levamisole in the treatment of recurrent aphthous stomatitis (RAS). Thirty patients, aged 9-65 years, were selected, based on a documented history of three or more episodes of RAS. Patients were instructed to take 150 mg of levamisole (or placebo) daily for 3 days at the onset of the first prodromal symptoms of an ulcer. The regimen was to be repeated for each new episode, but not more than once per week. At each episode patients were examined and evaluated as to number and duration of ulcers, interval between episodes, pain associated with ulcers, and side effects. Data on 24 patients were suitable for analysis. Of those patients receiving levamisole, six showed slight improvement and five were unchanged. Of those patients receiving the placebo, one showed a marked improvement, four slight improvement, six were unchanged, and two deteriorated. There was neither a clinical nor a statistically significant difference between the groups. It is concluded that levamisole, in this study protocol, had no effect on the incidence or severity of aphthous ulcers.
设计了一项随机双盲研究，以评估左旋咪唑治疗复发性阿弗他口炎（RAS）的安全性和有效性。根据有记录的三次或更多次RAS发作病史，选择了30名年龄在9至65岁之间的患者。在溃疡首次前驱症状出现时，指示患者每天服用150毫克左旋咪唑（或安慰剂），持续3天。每出现新的发作都重复该方案，但每周不超过一次。在每次发作时，对患者进行检查和评估，包括溃疡的数量和持续时间、发作间隔、与溃疡相关的疼痛以及副作用。24名患者的数据适合分析。在接受左旋咪唑治疗的患者中，6名略有改善，5名无变化。在接受安慰剂治疗的患者中，1名显著改善，4名略有改善，6名无变化，2名病情恶化。两组之间在临床和统计学上均无显著差异。结论是，在本研究方案中，左旋咪唑对阿弗他溃疡的发生率或严重程度没有影响。
