Significant efficacy of short-course, low-concentration betamethasone mouthwash therapy for severe erosive oral lichen planus: a randomized controlled trial,Clinical Oral Investigations

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Significant efficacy of short-course, low-concentration betamethasone mouthwash therapy for severe erosive oral lichen planus: a randomized controlled trial
Clinical Oral Investigations ( IF 3.1 ) Pub Date : 2023-06-06 , DOI: 10.1007/s00784-023-05051-w
Qingxiang Zeng ₁ , Yangfan Liu ₁ , Shimeng Wang ₁ , Houshang Wang ₁ , Shuang Yu ₁ , Fanglong Wu ₁ , Jin Yang ₁ , Hongmei Zhou ₁

Affiliation

Objectives

To evaluate the short-term efficacy of low-concentration betamethasone mouthwash for severe erosive oral lichen planus (EOLP).

Materials and method

In this randomized, investigator-blind, positive-controlled trial, OLP patients with erosive lesions received betamethasone mouthwash (0.137 mg/mL) or dexamethasone mouthwash (0.181 mg/mL) three times daily for 2 or 4 weeks and were followed up for 3 months to observe recurrence. The primary outcome was the week-2 reduction in erosive area.

Results

Fifty-seven participants were randomized to betamethasone (n = 29) and dexamethasone (n = 28). At week 2, participants using betamethasone (n = 28) experienced a greater reduction in erosive area than gargling with dexamethasone (n = 26). Similarly, secondary outcomes, including the healing proportion of erosions, reduced pain level, reduction in atrophic area, Thongprasom score, and recurrence interval, showed the superiority of betamethasone. At week 4, betamethasone (n = 7) was not superior to dexamethasone (n = 15) in further reducing lesional area and pain level. No serious adverse events were documented.

Conclusions

The 0.137 mg/mL compound betamethasone mouthwash exhibited significant efficacy in rapidly enhancing erosion healing within 2 weeks and extending the recurrence interval with a good safety profile.

Clinical relevance

This study proved the significant efficacy of short-course 0.137 mg/mL betamethasone mouthwash therapy for treating erosion and pain, providing a novel topical agent for patients with severe EOLP.

Trial registration

This study was prospectively registered at the International Clinical Trials Registry Platform (ChiCTR1800016507) on 5 June 2018.

中文翻译：

短疗程、低浓度倍他米松漱口水治疗重度糜烂性口腔扁平苔藓的显着疗效：一项随机对照试验

目标

评估低浓度倍他米松漱口水治疗严重糜烂性口腔扁平苔藓（EOLP）的短期疗效。

材料与方法

在这项随机、研究者盲法、阳性对照试验中，患有糜烂性病变的 OLP 患者每天接受倍他米松漱口水 (0.137 mg/mL) 或地塞米松漱口水 (0.181 mg/mL) 3 次，持续 2 或 4 周，并随访 3 周。个月观察复发情况。主要结果是第 2 周糜烂面积减少。

结果

57 名参与者被随机分配至倍他米松 ( n = 29) 和地塞米松 ( n = 28)。第 2 周时，使用倍他米松 ( n = 28) 的参与者比使用地塞米松漱口的参与者 ( n = 26)的糜烂面积减少幅度更大。同样，次要结果，包括糜烂的愈合比例、疼痛程度的减轻、萎缩面积的减少、Thongprasom 评分和复发间隔，显示了倍他米松的优越性。第 4 周时，倍他米松 ( n = 7)在进一步缩小皮损面积和疼痛程度方面并不优于地塞米松 ( n = 15)。没有记录到严重的不良事件。