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一项使用普拉康唑作为强效口服抗马拉色菌药物治疗脂溢性皮炎的试点研究。

A pilot study on seborrheic dermatitis using pramiconazole as a potent oral anti-Malassezia agent.

作者信息

Piérard Gérald E, Ausma Jannie, Henry Frédérique, Vroome Valérie, Wouters Luc, Borgers Marcel, Cauwenbergh Geert, Piérard-Franchimont Claudine

机构信息

Department of Dermatopathology, University Hospital of Liège, Liège, Belgium.

出版信息

Dermatology. 2007;214(2):162-9. doi: 10.1159/000098577.

DOI:10.1159/000098577
PMID:17341867
Abstract

BACKGROUND

Seborrheic dermatitis is considered to be a Malassezia-driven disease. Little objective information is available so far from biometrological quantitative assessments of this skin condition. Pramiconazole is a novel triazole with potent in vitro antifungal activity, especially against Malassezia spp.

OBJECTIVE

To study the sequential effects of pramiconazole on Malassezia, inflammation and epidermal changes.

METHOD

This study was performed in 2 groups of subjects suffering from seborrheic dermatitis. The first group (n = 17) remained untreated and was used as control. Clinical, mycological and biometrological assessments were performed at inclusion and during the following 2 weeks. The second group of subjects (n = 10) received a single 200-mg oral dose of pramiconazole at inclusion. Clinical, mycological and biometrological evaluations were performed before and during 1 month following the single antifungal intake. For both parts of the study, several parameters were assessed including yeast density, desquamation, erythema, itching and sebum excretion.

RESULTS

In the control group, no significant changes were observed in any of the parameters during the observation period. The findings were markedly different in the pramiconazole-treated subjects. The yeast density was significantly improved on days 3, 7 and 28. Desquamation, erythema, itching, and the global clinical evaluation as assessed by the patients and investigators became significantly improved on days 7 and 28. A trend in decrease of scaliness was noted. No effect on sebum excretion was evidenced. In conclusion, a single 200-mg dose of pramiconazole exhibitsin vivo efficacy in controlling some important clinical aspects of seborrheic dermatitis. Following a reduction in the number of yeasts on day 3, a decrease in the severity of clinical signs and symptoms occurred from day 7 onwards. Sebum excretion appeared uninvolved in the clearing process of seborrheic dermatitis.

CONCLUSION

A single 200-mg dose of pramiconazole appears to abate seborrheic dermatitis. The density in Malassezia present on lesional skin is first decreased, followed by clearing of the clinical signs.

摘要

背景

脂溢性皮炎被认为是一种由马拉色菌引发的疾病。到目前为止,关于这种皮肤状况的生物计量学定量评估几乎没有客观信息。普拉康唑是一种新型三唑类药物,具有强大的体外抗真菌活性,尤其是对马拉色菌属。

目的

研究普拉康唑对马拉色菌、炎症和表皮变化的连续影响。

方法

本研究在两组脂溢性皮炎患者中进行。第一组(n = 17)未接受治疗,用作对照。在纳入研究时以及随后的2周内进行临床、真菌学和生物计量学评估。第二组受试者(n = 10)在纳入研究时口服单次200毫克剂量的普拉康唑。在单次抗真菌药物摄入前及摄入后的1个月内进行临床、真菌学和生物计量学评估。对于研究的两个部分,评估了几个参数,包括酵母密度、脱屑、红斑、瘙痒和皮脂分泌。

结果

在对照组中,观察期内任何参数均未观察到显著变化。普拉康唑治疗的受试者的结果明显不同。酵母密度在第3天、第7天和第28天显著改善。脱屑、红斑、瘙痒以及患者和研究者评估的整体临床评价在第7天和第28天显著改善。观察到鳞屑有减少趋势。未发现对皮脂分泌有影响。总之,单次200毫克剂量的普拉康唑在控制脂溢性皮炎的一些重要临床方面具有体内疗效。在第3天酵母数量减少后,从第7天起临床体征和症状的严重程度有所降低。皮脂分泌似乎与脂溢性皮炎的清除过程无关。

结论

单次200毫克剂量的普拉康唑似乎可减轻脂溢性皮炎。皮损皮肤上存在的马拉色菌密度首先降低,随后临床体征消退。

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