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比较外用椰子油乳膏和丙酸氯倍他索软膏治疗口腔扁平苔藓的疗效:一项双盲随机对照试验。

Comparative efficacy of topical coconut cream and clobetasol propionate ointment for the management of oral lichen planus: A double-blinded randomized control trial.

机构信息

Department of Oral Medicine and Radiology, KAHER's KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Belagavi, Karnataka, India.

出版信息

Indian J Pharmacol. 2022 Mar-Apr;54(2):84-89. doi: 10.4103/ijp.ijp_984_20.

Abstract

CONTEXT

Oral lichen planus (OLP) is a quite common chronic inflammatory mucocutaneous disorder affecting the oral cavity and skin. The current treatment relies on systemic or topical corticosteroids but is known to cause side effects thereby demanding a search for an alternative.

AIM

This study aims to assess and to compare the efficacy of topical Coconut (Cocos nucifera) 50% cream and Clobetasol propionate 0.05% ointment for the management of OLP.

SETTINGS AND DESIGN

An institution-based double-blinded randomized control trial.

MATERIALS AND METHODS

Sixty clinically diagnosed OLP patients were allotted to two groups (30 in each): Group I (Coconut cream-50%) and Group II (Clobetasol Propionate ointment-0.05%). Patients were examined every 15 days until two months for a change in the lesion size and reduction in the burning sensation. The measurement of lesion size and burning sensation was done using Adobe Photoshop software (version CS3) and Numeric Pain Rating scale (NPS), respectively.

STATISTICAL ANALYSIS USED

The recordings were subjected to the statistical analysis using Wilcoxon matched-pairs and Mann-Whitney U tests for intra-group and inter-group comparisons, respectively.

RESULTS

There was an 85% regression in the size of the lesion in Group I whereas Group II had it to be 95%, and a 100% reduction in the NPS score in Group I whereas Group II had it to be 95%.

CONCLUSION

The Coconut cream showed a significant decrease in the size of the lesion and the burning sensation with no side effects neither any signs of toxicity reported during the treatment or follow-up, thereby proving to be a safe and promising medication for OLP.

摘要

背景

口腔扁平苔藓(OLP)是一种常见的慢性炎症性黏膜疾病,影响口腔和皮肤。目前的治疗依赖于全身或局部皮质类固醇,但已知会引起副作用,因此需要寻找替代药物。

目的

本研究旨在评估和比较局部应用椰子(Cocos nucifera)50%乳膏和氯倍他索丙酸酯 0.05%软膏治疗 OLP 的疗效。

设置和设计

基于机构的双盲随机对照试验。

材料和方法

将 60 例临床诊断为 OLP 的患者分为两组(每组 30 例):I 组(椰子乳膏-50%)和 II 组(氯倍他索丙酸酯软膏-0.05%)。患者每 15 天检查一次,直到两个月,以观察病变大小的变化和烧灼感的减轻。使用 Adobe Photoshop 软件(CS3 版)和数字疼痛评分量表(NPS)分别测量病变大小和烧灼感。

统计分析

使用 Wilcoxon 配对和 Mann-Whitney U 检验分别对组内和组间的记录进行统计分析。

结果

I 组病变大小的消退率为 85%,而 II 组为 95%;I 组 NPS 评分的降低率为 100%,而 II 组为 95%。

结论

椰子乳膏能显著缩小病变面积,减轻烧灼感,且无副作用,治疗或随访期间无毒性迹象,因此被证明是治疗 OLP 的一种安全有效的药物。

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