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伊曲康唑与特比萘芬治疗甲癣的开放性随机对照研究

Open randomized comparison of itraconazole versus terbinafine in onychomycosis.

作者信息

Arenas R, Domínguez-Cherit J, Fernández L M

机构信息

Department of Dermatology, General Hospital Dr. Manuel Gea González, Tlalpan, Mexico.

出版信息

Int J Dermatol. 1995 Feb;34(2):138-43. doi: 10.1111/j.1365-4362.1995.tb03600.x.

DOI:10.1111/j.1365-4362.1995.tb03600.x
PMID:7737776
Abstract

BACKGROUND

Onychomycoses are among the most frequent nail diseases. The principal agents are dermatophytes. Itraconazole and terbinafine are two effective and systemic antimycotics. Previous trials have shown, that treatment schedules with effective concentrations for 3 months cause drug deposits in nail plates that persist 6 months after the end of the treatment.

METHODS

A comparative, open, prospective study was carried out with random assignment of patients. The first group included 27 patients under treatment with 200 mg of itraconazole once daily for 3 months. The second group included 26 patients treated with 250 mg of terbinafine for 3 months. Both series of patients were followed for 6 additional months.

RESULTS

Both groups were similar in age, sex, and history of onychomycosis. Trichophyton rubrum was the main isolated agent in all patients. The percentage of diseased nails was similar in both groups affecting predominantly the first toenail. Treatment was highly effective and differences between groups were not significant. The rate of adverse events was 21% in the itraconazole group and 47% in the terbinafine group.

CONCLUSIONS

Itraconazole and terbinafine are two drugs of choice in dermatophytic onychomycosis.

摘要

背景

甲癣是最常见的指甲疾病之一。主要病原体是皮肤癣菌。伊曲康唑和特比萘芬是两种有效的全身性抗真菌药。先前的试验表明,有效浓度治疗3个月的方案会导致甲板中出现药物沉积,在治疗结束后持续6个月。

方法

进行了一项比较、开放、前瞻性研究,对患者进行随机分组。第一组包括27例患者,接受每日一次200毫克伊曲康唑治疗3个月。第二组包括26例患者,接受250毫克特比萘芬治疗3个月。两组患者均随访6个月。

结果

两组患者在年龄、性别和甲癣病史方面相似。红色毛癣菌是所有患者中主要分离出的病原体。两组患病指甲的百分比相似,主要影响大脚趾趾甲。治疗非常有效,两组之间差异不显著。伊曲康唑组不良事件发生率为21%,特比萘芬组为47%。

结论

伊曲康唑和特比萘芬是皮肤癣菌性甲癣的两种首选药物。

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