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乳香口腔崩解片治疗复发性口腔溃疡的疗效:一项随机、双盲、安慰剂对照临床试验。

The effectiveness of olibanum orally disintegrating tablet in the treatment of oral aphthous ulcers: A randomized, double-blind, placebo-controlled clinical trial.

作者信息

Soltani Rasool, Saberi Zahra, Ghanadian Syed Mustafa, Taheri Azade, Entezarhojjat Amir

机构信息

Department of Clinical Pharmacy and Pharmacy Practice, School of Pharmacy and Pharmaceutical Sciences, Isfahan University of Medical Sciences, Isfahan, Iran.

Infectious Diseases and Tropical Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.

出版信息

J Res Med Sci. 2022 Jan 29;27:8. doi: 10.4103/jrms.jrms_247_21. eCollection 2022.

Abstract

BACKGROUND

oleo-gum-resin (frankincense; olibanum) has anti-inflammatory, analgesic, and antimicrobial effects. This study aimed to evaluate the clinical effectiveness of frankincense extract in the treatment of oral aphthous ulcers.

MATERIALS AND METHODS

In a randomized, double-blind, placebo-controlled clinical trial, patients with aphthous ulcers were randomly assigned to either experimental (Frankincense extract) or placebo groups to use orally disintegrating tablets (ODT) of frankincense and placebo, respectively, four times a day for 3 days. The size of aphthous ulcers and the pain severity by visual analogue scale were recorded at days 0, 2, and 4 and compared between the groups.

RESULTS

Twenty-five patients in each group completed the study. Olibanum extract ODT significantly reduced the ulcer size on the second ( < 0.001) and fourth ( < 0.001) days as well as the pain score on the second ( = 0.002) and fourth ( < 0.001) days of the intervention compared to placebo. Furthermore, at the end of the intervention, the number of patients with complete ulcer healing and pain relief in the experimental group was significantly more than the placebo group (5 vs. 0, = 0.02; and 11 vs. 0, < 0.001, respectively).

CONCLUSION

Taking olibanum extract ODTs reduces the ulcer size and pain severity and accelerates the healing process in the oral aphthous lesions.

摘要

背景

油胶树脂(乳香)具有抗炎、止痛和抗菌作用。本研究旨在评估乳香提取物治疗复发性口腔溃疡的临床疗效。

材料与方法

在一项随机、双盲、安慰剂对照临床试验中,将复发性口腔溃疡患者随机分为试验组(乳香提取物)和安慰剂组,分别口服乳香和安慰剂的口腔崩解片,每日4次,共3天。在第0、2和4天记录复发性口腔溃疡的大小和视觉模拟量表的疼痛严重程度,并在两组之间进行比较。

结果

每组25例患者完成研究。与安慰剂相比,乳香提取物口腔崩解片在干预的第2天(<0.001)和第4天(<0.001)显著减小溃疡大小,在第2天(=0.002)和第4天(<0.001)显著降低疼痛评分。此外,在干预结束时,试验组溃疡完全愈合和疼痛缓解的患者数量显著多于安慰剂组(分别为5例对0例,=0.02;11例对0例,<0.001)。

结论

服用乳香提取物口腔崩解片可减小溃疡大小,降低疼痛严重程度,并加速复发性口腔黏膜损伤的愈合过程。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7761/8943586/ceaecb0bd3c5/JRMS-27-8-g001.jpg

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