口服纳米姜黄素与口服泼尼松龙治疗口腔扁平苔藓的比较：一项随机双盲临床试验。
Comparison of oral Nano-Curcumin with oral prednisolone on oral lichen planus: a randomized double-blinded clinical trial.
作者信息
Kia Seyed Javad, Basirat Maryam, Mortezaie Tahereh, Moosavi Mahdieh-Sadat
机构信息
Dental sciences research center, Department of Oral and Maxillofacial Medicine, School of Dentistry, Guilan University of Medical Sciences, Rasht, Iran.
Dental Research Center, Dentistry Research Institute, Department of Oral and Maxillofacial Medicine, Faculty of Dentistry, Tehran University of Medical Sciences, Tehran, Iran.
出版信息
BMC Complement Med Ther. 2020 Oct 31;20(1):328. doi: 10.1186/s12906-020-03128-7.
BACKGROUND
Oral lichen planus (OLP) is a mucocutaneous autoimmune disease with T-cell mediation. Corticosteroids are considered as a first choice in OLP and should be used for a long period with a subsequent increase in dose since the disease has a chronic and recalcitrant nature. There have been efforts to use alternative therapies due to the Corticosteroid's side effects. Curcumin is a non-toxic natural product with different effects on various oral diseases. It demonstrates antioxidant, anti-inflammatory, antimicrobial, and anticarcinogenic activities. It seems that Curcumin can be used as a proper alternative for Corticosteroid treatments. To overcome limitations in the bioavailability of Curcumin, the therapeutic effect of oral Nano-Curcumin was evaluated for the first time.
METHODS
Sixty OLP patients were included in this double-blinded randomized clinical trial. The patients were randomly divided into two groups and received either 'Nano-Curcumin 80 mg' or 'Prednisolone 10 mg' treatments for 1 month. The patients should take one capsule after having their breakfast. The VAS scale was used to analyze pain severity and burning sensation. To assess lesion size the Thongprasom scale was employed. Repeated measures and independent t-tests, as well as LSD paired-test, were used to analyze the data.
RESULTS
Data from 57 patients were analyzed. The level of pain, burning sensation, and OLP lesions decreased in both groups of Curcumin and Prednisolone and no statistically significant difference was observed between the two groups.
CONCLUSION
Despite many studies conducted to find an effective approach for managing OLP, the results have often been unsatisfactory. In comparison with previous studies, current results clarify the importance of Nano-Curcumin bioavailability in therapeutic effects. Pain VAS and lesion size were decreased with oral Curcumin. The results have shown that oral Curcumin can be used as an alternative therapy for OLP in patients with the contraindicated Corticosteroids or should be used with caution. Oral Curcumin can be used in preventing the recurrence of OLP lesions after the treatment and initial control. Moreover, the amount of Curcumin dose is more important than its use duration in improving OLP.
TRIAL REGISTRATION
IRCT, IRCT20100101002950N5. Registered 9 February 2019, https://www.irct.ir/trial/36704 .
背景
口腔扁平苔藓（OLP）是一种由T细胞介导的黏膜皮肤自身免疫性疾病。皮质类固醇被认为是OLP的首选治疗药物，由于该疾病具有慢性和顽固性，应长期使用并随后增加剂量。由于皮质类固醇的副作用，人们一直在努力寻找替代疗法。姜黄素是一种无毒的天然产物，对各种口腔疾病有不同的作用。它具有抗氧化、抗炎、抗菌和抗癌活性。似乎姜黄素可以作为皮质类固醇治疗的合适替代品。为了克服姜黄素生物利用度的局限性，首次评估了口服纳米姜黄素的治疗效果。
方法
60例OLP患者纳入这项双盲随机临床试验。患者被随机分为两组，分别接受“80毫克纳米姜黄素”或“10毫克泼尼松龙”治疗1个月。患者应在早餐后服用一粒胶囊。采用视觉模拟评分（VAS）量表分析疼痛严重程度和烧灼感。采用通普拉松量表评估病损大小。使用重复测量和独立样本t检验以及LSD配对检验分析数据。
结果
分析了57例患者的数据。姜黄素组和泼尼松龙组的疼痛、烧灼感和OLP病损程度均有所降低，两组之间未观察到统计学显著差异。
结论
尽管进行了许多研究以寻找治疗OLP的有效方法，但结果往往不尽人意。与以往研究相比，目前的结果阐明了纳米姜黄素生物利用度在治疗效果中的重要性。口服姜黄素可降低疼痛VAS评分和病损大小。结果表明，口服姜黄素可作为皮质类固醇禁忌患者OLP的替代疗法，或应谨慎使用。口服姜黄素可用于预防OLP病损在治疗和初步控制后的复发。此外,在改善OLP方面，姜黄素的剂量比使用时间更重要。
试验注册
伊朗临床试验注册中心，IRCT20100101002950N5。2019年2月9日注册，https://www.irct.ir/trial/36704 。
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