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短期外用锦葵乳膏治疗儿童特应性皮炎的疗效:一项随机双盲安慰剂对照临床试验

Efficacy of Short Term Topical Malva Sylvestris L. Cream in Pediatric Patients with Atopic Dermatitis: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

作者信息

Meysami Mahshid, Hashempur Mohammad H, Kamalinejad Mohammad, Emtiazy Majid

机构信息

Department of Persian Medicine, School of Persian Medicine, Shahid Sadoughi University of Medical Sciences, Ardakan, Yazd, Iran.

Noncommunicable Diseases Research Center, Fasa University of Medical Sciences, Fasa, Iran.

出版信息

Endocr Metab Immune Disord Drug Targets. 2021;21(9):1673-1678. doi: 10.2174/1871530320666201023125411.

DOI:10.2174/1871530320666201023125411
PMID:33100212
Abstract

BACKGROUND

Atopic dermatitis (AD) is a chronic inflammatory pruritic dermatologic disease in children. Malva sylvestris L. (M. sylvestris) is a medicinal plant, which is used as a remedy for eczema in traditional Persian medicine. Previous studies have shown the anti-ulcerogenic and anti-inflammatory activity of this plant.

OBJECTIVE

We designed a clinical trial to evaluate the efficacy of topical cream of the M. sylvestris extract in the management of children with AD.

METHODS

Fifty-one children with AD were randomly enrolled in two arms of a randomized, double- blind, controlled clinical trial. They were treated by topical cream of the M. sylvestris extract or placebo for a palm-sized surface (single fingertip unit, twice daily) for 4 weeks. The SCORing Atopic Dermatitis (SCORAD) score was set as the primary outcome measure.

RESULTS

There was a significant improvement in the severity of participants' dermatitis regarding skin thickening score, redness score, and total SCORAD score of the M. sylvestris group as compared with the placebo group (P= 0.009, P=0.01, and P=0.03; respectively).

CONCLUSION

According to the results of this clinical trial, it could be concluded that the topical use of M. sylvestris extract cream was effective in the reduction of AD symptoms in children.

TRIAL REGISTRATION

This study is registered by the Iranian Registry of Clinical Trials with the code: IRCT20170107031814N2.

摘要

背景

特应性皮炎(AD)是一种儿童慢性炎症性瘙痒性皮肤病。锦葵是一种药用植物,在传统波斯医学中用作治疗湿疹的药物。先前的研究已表明该植物具有抗溃疡和抗炎活性。

目的

我们设计了一项临床试验,以评估锦葵提取物外用乳膏治疗儿童AD的疗效。

方法

51名AD患儿被随机纳入一项随机、双盲、对照临床试验的两个组。他们分别使用锦葵提取物外用乳膏或安慰剂治疗手掌大小的皮肤表面(单指尖单位,每日两次),持续4周。将特应性皮炎评分(SCORAD)设定为主要结局指标。

结果

与安慰剂组相比,锦葵组在皮肤增厚评分、发红评分和总SCORAD评分方面,参与者的皮炎严重程度有显著改善(分别为P = 0.009、P = 0.01和P = 0.03)。

结论

根据该临床试验结果,可以得出结论,外用锦葵提取物乳膏可有效减轻儿童AD症状。

试验注册

本研究已在伊朗临床试验注册中心注册,注册号为:IRCT20170107031814N2。

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