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局部用他克莫司与氯倍他索治疗有症状口腔扁平苔藓的比较:斯里兰卡的一项双盲随机临床试验。

Comparison of topical tacrolimus and clobetasol in the management of symptomatic oral lichen planus: A double-blinded, randomized clinical trial in Sri Lanka.

作者信息

Hettiarachchi Pilana Vithanage Kalani Shihanika, Hettiarachchi Ruvini Manjula, Jayasinghe Ruwan Duminda, Sitheeque Mohaideen

机构信息

Department of Oral Medicine and Periodontology, Faculty of Dental Sciences, University of Peradeniya, Peradeniya, Sri Lanka.

Center for Applied Health Economics, Menzies Health Institute, School of Medicine, Griffith University, Brisbane, QLD, Australia.

出版信息

J Investig Clin Dent. 2017 Nov;8(4). doi: 10.1111/jicd.12237. Epub 2016 Sep 15.

DOI:10.1111/jicd.12237
PMID:27633647
Abstract

AIM

Oral lichen planus (OLP) is a common, chronic inflammatory disease of the oral mucosa. Although several studies have shown the efficacy of different treatment modalities, a definitive cure has not yet been established. The present trial compares the effectiveness of topically-applied clobetasol and tacrolimus in the symptomatic management of OLP.

METHODS

A randomized, comparative, double-blind study with 68 patients (43 females, 25 males; mean age: 46.76 years) was undertaken. Patients were randomly divided into two groups of 34 patients each to receive topical tacrolimus 0.1% cream or clobetasol propionate 0.05% cream for 3 weeks.

RESULTS

After 3 weeks of treatment, the mean pain score dropped by 1.59 (right) and 1.53 (left) in the tacrolimus group, while in clobetasol group these values were 0.94 and 0.85, respectively. The mean scores for clinical appearance reduced by 1.18 (right) and 1.0 (left) in the tacrolimus group compared with a reduction of 0.5 and 0.26, respectively, in the clobetasol group. These reductions were statistically significant (P < .05).

CONCLUSION

The results suggest that tacrolimus 0.1% cream is an effective alternative to topical steroid and can be considered a first-line therapy in OLP. However, further studies are needed to confirm the effectiveness of this treatment before it is recommended for use in clinical practice.

摘要

目的

口腔扁平苔藓(OLP)是一种常见的口腔黏膜慢性炎症性疾病。尽管多项研究已表明不同治疗方式的疗效,但尚未确立根治方法。本试验比较局部应用氯倍他索和他克莫司对OLP进行症状管理的有效性。

方法

对68例患者(43例女性,25例男性;平均年龄:46.76岁)进行了一项随机、对照、双盲研究。患者被随机分为两组,每组34例,分别接受0.1%他克莫司乳膏或0.05%丙酸氯倍他索乳膏治疗3周。

结果

治疗3周后,他克莫司组的平均疼痛评分右侧下降1.59,左侧下降1.53,而氯倍他索组的这些值分别为0.94和0. Eight-five。他克莫司组的临床外观平均评分右侧下降1.18,左侧下降1.0,而氯倍他索组分别下降0.5和0.26。这些下降具有统计学意义(P < 0.05)。

结论

结果表明,0.1%他克莫司乳膏是局部应用类固醇的有效替代药物,可被视为OLP的一线治疗药物。然而,在推荐用于临床实践之前,还需要进一步研究来证实这种治疗方法的有效性。

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