评估褪黑素对灼口综合征患者的影响:一项双盲、安慰剂对照的随机临床试验

IF 0.6 4区 医学 Q4 PHARMACOLOGY & PHARMACY
T. Nosratzehi, A. Payandeh, Kosar Arbab
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引用次数: 0

摘要

本研究旨在评价褪黑素和安慰剂在口腔灼烧(BMs)患者中的作用。这项双盲、安慰剂对照的随机临床试验研究对30例BMS患者进行了研究。在此期间,将患者分为2个研究组和对照组。研究组每天服用4种3毫克的褪黑素,对照组服用安慰剂。然后由医师测量烧灼感的严重程度,采用彼得堡问卷,采用VAS量表测量睡眠质量。数据在应用软件进入SPSS 20后再采用T检验或等效非参数分析,两组治疗前后平均睡眠评分和平均口腔刺激严重程度采用独立T检验进行评价。水平显著性为0.05。目前的研究结果表明,在BMS患者中使用褪黑激素和安慰剂可以降低感觉并改善他们的睡眠质量,尽管它可能不会完全降低感觉。研究组治疗后烧伤严重程度为4.93±2.56,对照组为6.93±2.12,差异有统计学意义(P =0.036)。两组患者睡眠质量评分差异无统计学意义(p值= 0.43)。使用褪黑素是一种可靠的治疗疼痛的方法,迄今为止还没有标准的治疗方法。尽管有证据表明睡眠障碍与BMS之间存在关联,但在本研究中,褪黑素在减少BMS引起的灼烧方面并不优于安慰剂。建议确定压力源和与之斗争的方法,以更大的样本和更高的口服剂量进行进一步的研究,延长随访期和控制心理因素,以及测量可能影响药代动力学的体重指数。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluation of the effect of melatonin in patients with Burning mouth syndrome: a double-blind, placebo-controlled randomized clinical trial
The present study was carried out to evaluate the effect of Melatonin and Placebo in the patient with the Burning mouth (BMs). This double-blind, placebo-controlled randomized clinical trial study was carried out on 30 patients who were suffering from BMS. During this period patients were divided into 2 study and control groups. The study group used four 3 mg Melatonin daily and the control group received a placebo. Then the severity of the burning sensation was measured by the physician Sleep quality was measured using the VAS scale using the Petersburg questionnaire. Data in the application Enter SPSS 20 and then using T test or equivalent Nonparametric was analyzed, mean sleep score and mean severity of oral irritation before and after treatment in two the group was evaluated using T-test Independent. Level significance was considered 0.05. The results of the present study show that the use of melatonin and a placebo in patients with BMS reduces sensation and improves their sleep quality, although it may not reduce it completely. In this study severity of burning was 4.93±2.56 after treatment in the study group and 6.93±2.12 in the control group, which was statistically significant (P =0.036). No significant difference was observed between the two groups in the sleep quality score (P-value = 0.43). Using Melatonin can be a reliable way to treat pain for which there is no standard treatment to date. Although evidence suggests an association between sleep disorders and BMS, melatonin was not superior to a placebo in reducing BMS-induced burning in the present study. Identification of stressors and the ways to struggle with them, further studies with larger samples and higher oral doses, extended follow-up periods and control of psychological factors, and measurement of body mass index that may affect pharmacokinetics are recommended.
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来源期刊
CiteScore
1.40
自引率
0.00%
发文量
165
审稿时长
7.5 months
期刊介绍: The Brazilian Journal of Pharmaceutical Sciences accepts for publication Original Papers applicable to the fields of Pharmaceutical Sciences; Reviews and Current Comment Articles, which are published under the Scientific Editor and Associate Editors invitation to recognized experts or when they are spontaneously submitted by the authors in the form of abstracts to have their importance evaluated. A critical view of the subject with insertions of results of previous works in the field in relation to the state of art must be included; Short Communications reporting new methods and previews of works on researches of outstanding importance in which originality justify a quick publication. A maximum of 2000 words excluding tables, figures and references is an acceptable limit. One table, one figure and ten references may be added, and Book Reviews of the latest editions of books, prepared by specialists invited by the Scientific Editor and Associate Editors. Thematic Supplements as well as those related to scientific meetings can be published under the Scientific Editor and/or Associate Editors agreement.
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