氨来呫诺口腔膜治疗轻型复发性口腔溃疡的临床研究

Clinical study on amlexanox oral pellicles for treatment of minor recurrent aphthous ulcer

目的研究氨来呫诺口腔膜治疗轻型复发性口腔溃疡的有效性和安全性。方法采用随机、双盲、平行对照的临床试验方法。试验组(17例)和对照组(15例)分别给予氨来呫诺口腔膜和安慰剂贴于患部,4次/d,连用5d。在治疗满3d和治疗满5d时观察溃疡面积大小和疼痛指数。结果用药后3d和5d,试验组和对照组溃疡面积愈合有效率分别为76.5%、31.3%和100.0%、73.3%;溃疡疼痛缓解有效率分别为82.4%、86.7%和94.1%、86.7%。结论氨来呫诺口腔膜可促进溃疡愈合,使用安全,但止痛效果不太明显。

Objective To study the effects and security of amlexanox oral pellicles for treatment of minor recurrent aphthous ulcer（MiAU）. Methods A randomized,double -blind trial method was carried on 32 patients with MiAU which were randomly devided into experimental group（17 patients） and control group（15 patients）, each group respectively administered with Amlexanox oral pellicles or placebo on the ulcer 4 times a day for 5days. Follow-up was conducted on day 3 and day 5 after the first visit of the patients,the area of the ulcer was observed and the pain controll effect was evaluated with pain index. Results On the 3th day,the effective rates of ulcer healing in the experimental group and control group were 76.5% and 31.3%, respectively （P〈0.05） ; the effective rates of pain relief were 82.4% ,86.7% ,respectively（P〉0. 005）. On the 5th day, the effective rates of ulcer healing in the experimental group and control group were 100.0 %, 73.3 %, respectively（P〈0.05） ;and the effective rates of pain relief were 94. 1 %,86.7%, respectively（P〉0.05）. Conclusion Amlexanox oral pellicles can obviously accelerate the healing of ulcer with security,but the effet of pain relief is not abvious.