壳聚糖口腔贴膜治疗轻型复发性阿弗他溃疡随机对照临床研究

Treating recurrent aphthous stomatitis with oral mucoadhesive films containing chitosan:a clinical randomized controlled study

目的通过壳聚糖口腔贴膜对轻型复发性阿弗他溃疡的临床疗效观察,探讨其有效性和安全性。方法本研究共纳入72例患有轻型复发性阿弗他溃疡的受试者。在6日的试验期间,随机分配受试者至试验组或对照组并告知贴膜使用方法,试验组材料为壳聚糖口腔贴膜,对照组材料为聚乙烯醇膜;比较2组受试者溃疡疼痛值、溃疡面积及不良反应。结果在第4天至第6天,试验组溃疡面积缩小(2.91±3.66)mm^2,对照组溃疡面积缩小(1.10±2.26)mm^2,2组差异具有统计学意义(P<0.05),试验期间初诊及每次复查时,组间溃疡面积、溃疡疼痛值、溃疡疼痛缩小值比较差异均没有统计学意义(P>0.05)。试验过程中无不良反应发生。结论壳聚糖口腔贴膜具有一定的促进轻型复发性阿弗他溃疡愈合的作用。

ObjectiveTo study the efficacy and safety of oral mucoadhesive containing chitosan for the treatmentof recurrent aphothous stomatitis(RAS).Methods72 subjects,who were diagnosed with RAS,were involved in thestudy.The subjects were randomly allocated to the test or control group and shown how to use the films.The film con-taining chitosan was provided to the participants in the test group and the polyvinyl alcohol film was provided to the con-trol group.Baseline,pain score(visual analog scale),ulcer size and adverse effects were recorded.ResultsThe reduc-tion in ulcer size was significantly greater(P < 0.05) in the treatment group(2.91 ± 3.66)mm^2 than in the control group(1.10 ± 2.26) mm^2 between days 4 and 6.There was no significant difference between the treatment and control groupsin the pain score,ulcer size,or reduction in the pain score(P > 0.05).No obvious adverse effects were observed.ConclusionThe oral mucoadhesive film containing chitosan promotes healing of RAS.