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硫酸锌黏膜粘附制剂治疗复发性阿弗他口炎的评价:一项随机、双盲、安慰剂对照临床试验。

Evaluation of zinc sulfate mucoadhesive formulation on recurrent aphthous stomatitis: a randomized double-blind, placebo-controlled clinical trial.

机构信息

Department of Oral and Maxillofacial Diseases, Faculty of Dentistry, Mazandaran University of Medical Sciences, Sari, Iran.

Department of Pharmaceutics, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.

出版信息

BMC Oral Health. 2020 Jul 28;20(1):212. doi: 10.1186/s12903-020-01194-4.

DOI:10.1186/s12903-020-01194-4
PMID:32723352
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7385976/
Abstract

BACKGROUND

Recurrent aphthous stomatitis (RAS) is a common lesion that affects the oral mucosa. There are several methods to treat RAS, including systemic and topical formulations. This study was conducted to evaluate the anti-inflammatory effect of topical zinc sulfate and its efficacy in the treatment of RAS.

METHODS

A double-blind randomized clinical trial was conducted on 46 patients with RAS. They were randomly assigned into two groups to receive a zinc sulfate mucoadhesive tablet or placebo for 7 days. The pain severity was measured at baseline and daily while the diameter of the lesion was measured at baseline and on days 3, 5, and 7. The obtained data were analyzed in SPSS V.16.

RESULTS

There was no significant difference in the mean diameter of lesions and pain at baseline between the two groups (P = 0.643 and P = 0.842, respectively). However, on the third, fifth, and seventh days of the study, the diameter of the lesion significantly reduced in the intervention group (P = 0.001) and the pain intensity became significantly different between groups from the fourth day of the study (P = 0.001).

CONCLUSION

Zinc sulfate mucoadhesive tablet was effective in recovery and reducing the pain and diameter of the aphthous lesion and could be considered for the treatment of RAS.

TRIAL REGISTRATION

Evaluation of the effectiveness of zinc sulfate mucoadhesive tablet in the improvement of recurrent aphthous stomatitis (RAS), IRCT20151109024975N9. Registered August 1, 2018, https://en.irct.ir/trial/32423 . This project was registered by the Iranian Registry of Clinical Trials ( http://www.irct.ir ). The IRCT ID was IRCT20151109024975N9.

摘要

背景

复发性阿弗他口炎(RAS)是一种常见的口腔黏膜病变。有几种方法可以治疗 RAS,包括全身和局部制剂。本研究旨在评估局部硫酸锌的抗炎作用及其治疗 RAS 的疗效。

方法

对 46 例 RAS 患者进行了一项双盲随机临床试验。他们被随机分为两组,分别接受硫酸锌粘膜粘附片或安慰剂治疗 7 天。在基线和每天测量疼痛严重程度,在基线和第 3、5 和 7 天测量病变直径。使用 SPSS V.16 分析获得的数据。

结果

两组患者的病变平均直径和疼痛基线无显著差异(P 值分别为 0.643 和 0.842)。然而,在研究的第 3、5 和 7 天,干预组的病变直径显著缩小(P 值均为 0.001),从研究的第 4 天起,两组之间的疼痛强度差异显著(P 值均为 0.001)。

结论

硫酸锌粘膜粘附片在促进 RAS 愈合、减轻疼痛和减少口疮病变方面具有显著疗效,可考虑用于治疗 RAS。

试验注册

评估硫酸锌粘膜粘附片在改善复发性阿弗他口炎(RAS)中的有效性(IRCT20151109024975N9)。于 2018 年 8 月 1 日注册于伊朗临床试验注册中心(http://www.irct.ir),注册号为 IRCT20151109024975N9。该项目由伊朗临床试验注册中心注册(http://www.irct.ir),注册号为 IRCT20151109024975N9。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/adac/7385976/044812d556cb/12903_2020_1194_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/adac/7385976/2b70d22a7c7b/12903_2020_1194_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/adac/7385976/27eb987edc5c/12903_2020_1194_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/adac/7385976/044812d556cb/12903_2020_1194_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/adac/7385976/2b70d22a7c7b/12903_2020_1194_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/adac/7385976/27eb987edc5c/12903_2020_1194_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/adac/7385976/044812d556cb/12903_2020_1194_Fig3_HTML.jpg

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