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白蕨提取物治疗特应性皮炎:一项随机、双盲、安慰剂对照、多中心试验。

Polypodium leucotomos extract in atopic dermatitis: a randomized, double-blind, placebo-controlled, multicenter trial.

作者信息

Ramírez-Bosca A, Zapater P, Betlloch I, Albero F, Martínez A, Díaz-Alperi J, Horga J F

机构信息

Servicio de Dermatología, Centro Dermatológico Estético de Alicante, Alicante, Spain.

出版信息

Actas Dermosifiliogr. 2012 Sep;103(7):599-607. doi: 10.1016/j.ad.2012.01.008. Epub 2012 May 3.

DOI:10.1016/j.ad.2012.01.008
PMID:22560125
Abstract

INTRODUCTION

Topical corticosteroids are used to treat inflammation and relieve itching in atopic dermatitis, but their use is limited by adverse reactions.

OBJECTIVES

The main aim of this study was to investigate whether daily treatment with Polypodium leucotomos extract would reduce the use of topical corticosteroids in children and adolescents with atopic dermatitis. We also analyzed oral antihistamine use and changes in disease severity.

PATIENTS AND METHODS

We performed a phase IV randomized, double-blind, placebo-controlled, multicenter trial involving 105 patients aged between 2 and 17 years who were receiving topical corticosteroids to treat moderate atopic dermatitis. The patients were randomized to receive, in addition to their standard treatment, Polypodium leucotomos extract or placebo (both in capsule form) for 6 months. The percentage of days on which topical corticosteroids and other atopic dermatitis treatments were used was calculated.

RESULTS

Use of Polypodium leucotomos extract did not significantly reduce the mean (SD) percentage of days on which topical corticosteroids were used (11% [12%] vs 12% [11%] for placebo). A significant reduction was, however, observed for oral histamine use (median percentage of days, 4.5% in the Polypodium leucotomos group and 13.6% in the placebo group [P= .038]). The percentage of patients who used oral antihistamines was also lower in the Polypodium leucotomos group.

CONCLUSION

Long-term treatment with Polypodium leucotomos extract has benefits for children and adolescents with atopic dermatitis who require pharmacologic treatment to reduce inflammation and relieve itching.

摘要

引言

外用皮质类固醇用于治疗特应性皮炎的炎症和缓解瘙痒,但它们的使用受到不良反应的限制。

目的

本研究的主要目的是调查每日使用白鬼笔提取物是否会减少特应性皮炎儿童和青少年外用皮质类固醇的使用。我们还分析了口服抗组胺药的使用情况以及疾病严重程度的变化。

患者和方法

我们进行了一项IV期随机、双盲、安慰剂对照、多中心试验,纳入了105名年龄在2至17岁之间、正在接受外用皮质类固醇治疗中度特应性皮炎的患者。患者被随机分配,除标准治疗外,接受白鬼笔提取物或安慰剂(均为胶囊形式)治疗6个月。计算使用外用皮质类固醇和其他特应性皮炎治疗的天数百分比。

结果

使用白鬼笔提取物并未显著降低外用皮质类固醇使用天数的平均(标准差)百分比(安慰剂组为12%[11%],白鬼笔提取物组为11%[12%])。然而,观察到口服组胺的使用有显著减少(天数中位数百分比,白鬼笔提取物组为4.5%,安慰剂组为13.6%[P = 0.038])。白鬼笔提取物组使用口服抗组胺药的患者百分比也较低。

结论

对于需要药物治疗以减轻炎症和缓解瘙痒的特应性皮炎儿童和青少年,长期使用白鬼笔提取物有益。

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