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采用黏附性霉酚酸酯米福汀贴片治疗口腔扁平苔藓:一项随机临床试验。

Treatment of oral lichen planus with mucoadhesive mycophenolate mofetil patch: A randomized clinical trial.

机构信息

Post Graduate Student of Oral and Maxillofacial Medicine, Oral and Maxillofacial Medicine Department, Mashhad Dental Faculty, Mashhad, Iran.

Department of Oral and Maxillofacial Medicine, School of Dentistry, Tabriz University of Medical Sciences, Tabriz, Iran.

出版信息

Clin Exp Dent Res. 2020 Oct;6(5):506-511. doi: 10.1002/cre2.302. Epub 2020 Jun 26.

Abstract

OBJECTIVES

Oral lichen planus (OLP) is a chronic inflammatory disease of unknown etiology which is known as a premalignant disease. A complete cure has not been found for this condition. Mycophenolate mofetil (MMF) is a new drug that seems to be effective in improving OLP lesions. But there are no studies on the efficacy of mucoadhesive form of MMF in ulcerative OLP. Therefore, this study was performed to determine the therapeutic effect of MMF mucoadhesive on OLP lesions.

MATERIAL AND METHODS

Twenty-seven patients with OLP, were enrolled in two groups. All the patients were instructed to place the MMF 2% mucoadhesive on the lesion twice daily for 4 weeks. Lesion size was measured by a sterile digital caulis (mm) and the severity of burning sensation and pain by visual analogue scale (VAS; cm) at baseline and weekly follow-ups.

RESULTS

There was no significant difference in burning sensation and lesion size at Weeks 1, 2, and 3 in both groups. In Group A, at Week 4, there was significant reduction in pain and burning sensation and lesion size on both sides (p = .048, .012). The difference in lesion size on control sides was not significant. In Group B, at Week 4, there was significant reduction in pain and burning sensation and lesion size (p = .004). No side effects were reported by the patients.

CONCLUSIONS

Based on the results, 2% MMF mucoadhesive was effective in decreasing burning sensation and pain severity and ulcer size of ulcerative OLP and the effect was time-dependent.

摘要

目的

口腔扁平苔藓(OLP)是一种病因不明的慢性炎症性疾病,已知其为癌前病变。目前尚未找到这种疾病的完全治愈方法。霉酚酸酯(MMF)是一种新药,似乎能有效改善 OLP 病变。但尚无关于 MMF 粘膜粘附剂型在溃疡性 OLP 中的疗效研究。因此,本研究旨在确定 MMF 粘膜粘附剂对 OLP 病变的治疗效果。

材料和方法

将 27 例 OLP 患者纳入两组。所有患者均被指示每天两次将 2%MMF 粘膜粘附剂涂于病变部位,持续 4 周。在基线和每周随访时,使用无菌数字棒(mm)测量病变大小,使用视觉模拟量表(VAS;cm)测量烧灼感和疼痛的严重程度。

结果

两组在第 1、2 和 3 周时的烧灼感和病变大小均无显著差异。在第 4 周时,A 组两侧的疼痛、烧灼感和病变大小均显著降低(p =.048,.012)。对照组两侧的病变大小差异无统计学意义。在第 4 周时,B 组的疼痛、烧灼感和病变大小均显著降低(p =.004)。患者未报告任何副作用。

结论

基于这些结果,2%MMF 粘膜粘附剂可有效减轻溃疡性 OLP 的烧灼感、疼痛严重程度和溃疡大小,且疗效具有时间依赖性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/06ac/7545225/5c4818958132/CRE2-6-506-g001.jpg

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