口腔疾病防治 ›› 2020, Vol. 28 ›› Issue (1): 36-40.DOI: 10.12016/j.issn.2096-1456.2020.01.006

• 临床研究 • 上一篇    下一篇

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

邵彦雄,周海文()   

  1. 上海交通大学医学院附属第九人民医院·口腔医学院口腔黏膜科,上海市口腔医学重点实验室,上海市口腔医学研究所,上海(200001)
  • 收稿日期:2018-11-05 修回日期:2019-07-13 出版日期:2020-01-20 发布日期:2020-01-17
  • 通讯作者: 周海文
  • 作者简介:邵彦雄,医师,硕士,Email:sdwhsyx@163.com
  • 基金资助:
    国家重点研发计划项目(2017YFC0840100);国家重点研发计划项目(2017YFC0840110)

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

SHAO Yanxiong,ZHOU Haiwen()   

  1. Department of Oral Mucosal Diseases, Shanghai Ninth People′s Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology, Shanghai 200001, China
  • Received:2018-11-05 Revised:2019-07-13 Online:2020-01-20 Published:2020-01-17
  • Contact: Haiwen ZHOU

摘要:

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。

关键词: 复发性阿弗他溃疡, 壳聚糖, 聚乙烯醇, 贴膜, 随机对照临床研究, 溃疡愈合

Abstract:

Objective To study the efficacy and safety of oral mucoadhesive containing chitosan for the treatment of recurrent aphothous stomatitis (RAS).Methods 72 subjects, who were diagnosed with RAS, were involved in the study. The subjects were randomly allocated to the test or control group and shown how to use the films. The film containing chitosan was provided to the participants in the test group and the polyvinyl alcohol film was provided to the control group. Baseline, pain score (visual analog scale), ulcer size and adverse effects were recorded.Results The reduction 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 groups in the pain score, ulcer size, or reduction in the pain score (P > 0.05). No obvious adverse effects were observed. Conclusion The oral mucoadhesive film containing chitosan promotes healing of RAS.

Key words: recurrent aphthous stomatitis, chitosan, polyvinyl alcohol, film, clinical controlled study, ulcer healing

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