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补充锌和维生素D治疗有症状的口腔扁平苔藓:一项三臂随机临床试验。

Supplementary zinc and vitamin D in management of symptomatic oral lichen planus: a three-arm randomized clinical trial.

作者信息

Aboushousha Alaa, Kamal Yasmine, Ali Shereen

机构信息

Faculty of Dentistry, Cairo University, 11 El-Saraya Street, Manial, Cairo, 11553, Egypt.

出版信息

BMC Oral Health. 2025 Jun 2;25(1):872. doi: 10.1186/s12903-025-06173-1.

Abstract

BACKGROUND

Oral lichen planus (OLP) is a chronic inflammatory disease affecting the oral mucosa, with immune mediated pathogenesis. Both zinc and vitamin D are essential micronutrients implicated in OLP pathogenesis, with zinc influencing epithelial growth, wound healing, and oxidative stress mitigation, while vitamin D modulates immune cell function, cytokine activity, and keratinocyte behavior. The current trial was conducted to assess the effect of topical corticosteroid supplemented with zinc or vitamin D compared to topical corticosteroid in management of symptomatic oral lichen planus.

METHODS

Forty-two patients diagnosed with symptomatic oral lichen planus (atrophic, erosive, or bullous types) were included in the study, based on clinical examination and histopathological confirmation in accordance with the modified World Health Organization (WHO) criteria (2003). Participants were divided randomly into three parallel groups. Group I received topical corticosteroid; Group II received topical corticosteroid with systemic zinc; Group III received topical corticosteroid with systemic vitamin D. The outcome measures included pain intensity using Visual Analogue Scale and clinical improvement using Thongprasom et al. scoring system. Treatment lasted for 8 weeks; patients were clinically evaluated at baseline and on weekly basis.

RESULTS

Intergroup comparisons revealed that by Week 3, pain scores were significantly lower in Groups II and III compared to Group I. Intragroup analysis showed significant reductions in pain scores over time for all groups, with Group II showing the most pronounced decrease from baseline to Week 7. Thongprasom scores decreased significantly in all groups, with Group II showing the most significant reduction by Week 8.

CONCLUSIONS

Systemic zinc supplementation combined with topical corticosteroid can be used as an adjunct therapy for OLP management. Topical corticosteroid supplemented with vitamin D has comparable effect to topical corticosteroid alone on pain and clinical improvement in symptomatic OLP.

CLINICAL TRIAL REGISTRATION

NCT04765267 (full protocol can be accessed). Date of Initial Clinical Trial Registration: 4 February 2021.

摘要

背景

口腔扁平苔藓(OLP)是一种影响口腔黏膜的慢性炎症性疾病,其发病机制由免疫介导。锌和维生素D都是参与OLP发病机制的必需微量营养素,锌影响上皮生长、伤口愈合和减轻氧化应激,而维生素D调节免疫细胞功能、细胞因子活性和角质形成细胞行为。本试验旨在评估与局部使用皮质类固醇相比,局部使用皮质类固醇联合锌或维生素D治疗有症状口腔扁平苔藓的效果。

方法

根据临床检查和组织病理学确认,按照修改后的世界卫生组织(WHO)标准(2003年),将42例诊断为有症状口腔扁平苔藓(萎缩型、糜烂型或大疱型)的患者纳入研究。参与者被随机分为三个平行组。第一组接受局部使用皮质类固醇;第二组接受局部使用皮质类固醇并口服锌剂;第三组接受局部使用皮质类固醇并口服维生素D。观察指标包括使用视觉模拟量表评估疼痛强度,以及使用Thongprasom等人的评分系统评估临床改善情况。治疗持续8周;在基线时和每周对患者进行临床评估。

结果

组间比较显示,到第3周时,第二组和第三组的疼痛评分显著低于第一组。组内分析显示,所有组的疼痛评分随时间均显著降低,第二组从基线到第7周下降最为明显。所有组的Thongprasom评分均显著降低,第二组在第8周时下降最为显著。

结论

口服锌剂联合局部使用皮质类固醇可作为OLP治疗的辅助疗法。局部使用皮质类固醇联合维生素D在缓解有症状OLP的疼痛和临床改善方面与单独使用局部皮质类固醇效果相当。

临床试验注册

NCT04765267(可获取完整方案)。首次临床试验注册日期:2021年2月4日。

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