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1%特比萘芬乳膏每日两次、为期1周的治疗方案治疗足趾间足癣的疗效。安慰剂对照、双盲、多中心试验结果

Efficacy of a 1-week, twice-daily regimen of terbinafine 1% cream in the treatment of interdigital tinea pedis. Results of placebo-controlled, double-blind, multicenter trials.

作者信息

Berman B, Ellis C, Leyden J, Lowe N, Savin R, Shupack J, Stiller M, Tschen E, Zaias N, Birnbaum J E

机构信息

University of California, Davis.

出版信息

J Am Acad Dermatol. 1992 Jun;26(6):956-60. doi: 10.1016/0190-9622(92)70141-2.

Abstract

BACKGROUND

Patients with tinea pedis often discontinue treatment before eradication of the fungus when their symptoms improve. The result is an incomplete cure/recurrence.

OBJECTIVE

Terbinafine, a topical fungicidal agent, was evaluated in double-blind, placebo-controlled trials (159 patients) for its ability to achieve cure and relief of symptoms in the same time frame, that is, before compliance wanes.

METHODS

Mycologic characteristics (with potassium hydroxide examination and culture) and clinical signs and symptoms were assessed at baseline, at the end of a 1-week, twice-daily treatment and at 1, 3, and 5 weeks after the completion of therapy.

RESULTS

Both terbinafine and vehicle provided early relief of symptoms. However, only terbinafine gave progressive mycologic improvement such that at 5 weeks after treatment, 88% of the patients receiving terbinafine had converted from positive to negative mycology compared with 23% of the patients treated with vehicle.

CONCLUSION

The rapid and potent fungicidal action of terbinafine results in a high cure rate in interdigital tinea pedis with 1 week of treatment and may avoid failures caused by non-compliance.

摘要

背景

足癣患者在症状改善后,往往在真菌根除之前就停止治疗。结果是治疗不彻底/复发。

目的

在双盲、安慰剂对照试验(159例患者)中评估外用杀菌剂特比萘芬在相同时间框架内实现治愈和缓解症状的能力,即在依从性降低之前。

方法

在基线、每日两次为期1周的治疗结束时以及治疗完成后的1、3和5周,评估真菌学特征(通过氢氧化钾检查和培养)以及临床体征和症状。

结果

特比萘芬和赋形剂均能早期缓解症状。然而,只有特比萘芬能使真菌学状况持续改善,以至于在治疗5周后,接受特比萘芬治疗的患者中有88%真菌学检查结果从阳性转为阴性,而接受赋形剂治疗的患者这一比例为23%。

结论

特比萘芬快速且强效的杀菌作用导致在治疗1周后指间型足癣的治愈率很高,并可能避免因不依从导致的治疗失败。

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