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用圣约翰草乳膏局部治疗特应性皮炎——一项随机、安慰剂对照、双盲半侧比较研究。

Topical treatment of atopic dermatitis with St. John's wort cream--a randomized, placebo controlled, double blind half-side comparison.

作者信息

Schempp Christoph M, Windeck Timo, Hezel Svea, Simon Jan C

机构信息

Freiburg University Clinic, Department of Dermatology, Freiburg, Germany.

出版信息

Phytomedicine. 2003;10 Suppl 4:31-7. doi: 10.1078/1433-187x-00306.

DOI:10.1078/1433-187x-00306
PMID:12807340
Abstract

BACKGROUND

Recent investigations suggest an anti-inflammatory and antibacterial effect of hyperforin, which is a major constituent of Hypericum perforatum L. (Saint John's wort).

OBJECTIVE

In the present half-side comparison study we assessed the efficacy of a cream containing Hypericum: extract standardised to 1.5% hyperforin (verum) in comparison to the corresponding vehicle (placebo) for the treatment of subacute Atopic Dermatitis. The study design was a prospective randomised placebo-controlled double-blind monocentric study.

METHODS

In twenty one patients suffering from mild to moderate Atopic Dermatitis (mean SCORAD 44.5) the treatment with verum or placebo was randomly allocated to the left or right site of the body, respectively. The patients were treated twice daily over a period of four weeks. Eighteen patients completed the study. The severity of the skin lesions on the left and right site was determined by means of a modified SCORAD-index (primary endpoint).

RESULTS

The intensity of the eczematous lesions improved on both sites of treatment. However, the hypericum-cream was significantly superior to the vehicle at all clinical visits (days 7, 14, 28) (p < 0.05). Skin colonisation with Staphylococcus aureus was reduced by both verum and placebo, showing a trend to better antibacterial activity of the hypericum-cream (p = 0.064). Skin tolerance and cosmetic acceptability was good or excellent with both the hypericum-cream and the vehicle (secondary endpoints).

CONCLUSION

Taken together, the present study shows a significant superiority of the hypericum-cream compared to the vehicle in the topical treatment of mild to moderate Atopic Dermatitis. The therapeutic efficacy of the hypericum-cream, however, has to be evaluated in further studies with larger patient cohorts, in comparison to therapeutic standards (i.e. glucocorticoids).

摘要

背景

近期研究表明贯叶连翘素具有抗炎和抗菌作用,贯叶连翘素是贯叶金丝桃(圣约翰草)的主要成分。

目的

在本次半侧对照研究中,我们评估了一种含贯叶金丝桃提取物(贯叶连翘素标准化含量为1.5%)的乳膏(试验组)与相应赋形剂(安慰剂)相比,治疗亚急性特应性皮炎的疗效。该研究设计为前瞻性随机安慰剂对照双盲单中心研究。

方法

21例轻至中度特应性皮炎患者(平均SCORAD评分为44.5),试验组或安慰剂分别随机分配至身体左侧或右侧进行治疗。患者每日治疗两次,为期四周。18例患者完成了研究。通过改良的SCORAD指数确定左右两侧皮肤病变的严重程度(主要终点)。

结果

治疗的两侧湿疹性病变强度均有所改善。然而,在所有临床访视(第7天、14天、28天)时,贯叶金丝桃乳膏均显著优于赋形剂(p<0.05)。试验组和安慰剂均降低了金黄色葡萄球菌的皮肤定植,贯叶金丝桃乳膏显示出更好的抗菌活性趋势(p = 0.064)。贯叶金丝桃乳膏和赋形剂的皮肤耐受性和美容可接受性均良好或极佳(次要终点)。

结论

综上所述,本研究表明在轻至中度特应性皮炎的局部治疗中,贯叶金丝桃乳膏显著优于赋形剂。然而,与治疗标准(即糖皮质激素)相比,贯叶金丝桃乳膏的治疗效果还需在更大患者队列的进一步研究中进行评估。

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