特比萘芬与伊曲康唑： toenails趾甲真菌病的对照临床比较。（注：这里原文toenails表述不太准确，应该是toenail，结合语境推测是“趾甲真菌病”，翻译时做了适当修正）

Terbinafine versus itraconazole: a controlled clinical comparison in onychomycosis of the toenails.

作者信息

Bräutigam M

机构信息

Department of Clinical Research, Novartis Pharma GmbH, Nuremberg, Germany.

出版信息

J Am Acad Dermatol. 1998 May;38(5 Pt 3):S53-6. doi: 10.1016/s0190-9622(98)70485-2.

DOI:10.1016/s0190-9622(98)70485-2

PMID:9594938

Abstract

BACKGROUND

Because of the relative clinical inefficacy of antifungal therapy in the past, onychomycosis has largely been viewed as an incurable condition. The availability of two new oral antifungal agents suggests the possibility of revising this clinical precept.

OBJECTIVE

This study compared the efficacy and tolerability of terbinafine and itraconazole in the treatment of onychomycosis of the toenails.

METHODS

This investigation was a multicenter, double-blind, parallel group study. The primary therapeutic endpoints measured were mycologic cure and clinical improvement.

RESULTS

Mycologic cure rates (negative culture and microscopy) at the end of the study were 81% for terbinafine versus 63% for itraconazole (2p < 0.01). A total of 92% of terbinafine-treated patients had negative cultures at the end of the study, compared with 67% of itraconazole-treated patients (2p < 0.0001). Terbinafine was more effective than itraconazole in increasing the length of the unaffected area of the target nail: 9.44 mm versus 7.85 mm (2p < 0.05).

CONCLUSION

Terbinafine is more effective than itraconazole in the treatment of toenail onychomycosis.

摘要

背景

由于过去抗真菌治疗在临床上相对无效，甲癣在很大程度上被视为一种无法治愈的疾病。两种新型口服抗真菌药物的出现提示了修正这一临床观念的可能性。

目的

本研究比较了特比萘芬和伊曲康唑治疗趾甲癣的疗效和耐受性。

方法

本研究为多中心、双盲、平行组研究。测量的主要治疗终点为真菌学治愈和临床改善。

结果

研究结束时，特比萘芬的真菌学治愈率（培养和显微镜检查阴性）为81%，而伊曲康唑为63%（P<0.01）。研究结束时，共有92%接受特比萘芬治疗的患者培养结果为阴性，而接受伊曲康唑治疗的患者为67%（P<0.0001）。在增加目标趾甲未感染区域的长度方面，特比萘芬比伊曲康唑更有效：分别为9.44毫米和7.85毫米（P<0.05）。