特比萘芬治疗趾甲甲真菌病：一种新的治疗方案。

Terbinafine in onychomycosis of the toenail: a novel treatment protocol.

作者信息

Watson A, Marley J, Ellis D, Williams T

机构信息

Royal Newcastle Hospital, New South Wales, Australia.

出版信息

J Am Acad Dermatol. 1995 Nov;33(5 Pt 1):775-9. doi: 10.1016/0190-9622(95)91815-9.

DOI:10.1016/0190-9622(95)91815-9

PMID:7593777

Abstract

BACKGROUND

Current treatment of onychomycosis of the toenail is poor and relapse is common.

OBJECTIVE

Our purpose was to assess the efficacy and safety of oral terbinafine and placebo in onychomycosis of the toenail with the use of a novel treatment protocol.

METHODS

This was a randomized, double-blind, 48-week study. Twelve weeks of terbinafine (250 mg daily) or placebo was followed by 12 weeks of observation. Responders received no further treatment and nonresponders were offered 12 weeks of terbinafine (250 mg daily) from week 28.

RESULTS

Of 111 evaluable patients, 88% (49 of 56) of the patients given terbinafine and 29% (16 of 55) of the patients given placebo had a negative mycologic culture at week 24 (p < 0.001), 57% (32 of 56) of the terbinafine group and 6% (3 of 55) of the placebo group were responders (p < 0.001). By week 48, after the terbinafine nonresponders were given a second 12-week course of terbinafine, the overall mycologic cure rate for the patients given terbinafine was 94%.

CONCLUSION

High mycologic cure rates in onychomycosis of the toenail can be achieved by terbinafine by this novel treatment regimen.

摘要

背景

目前对趾甲甲真菌病的治疗效果不佳，复发很常见。

目的

我们的目的是使用一种新的治疗方案评估口服特比萘芬和安慰剂治疗趾甲甲真菌病的疗效和安全性。

方法

这是一项随机、双盲、为期48周的研究。给予12周的特比萘芬（每日250毫克）或安慰剂治疗，随后观察12周。有反应者不再接受进一步治疗，无反应者从第28周开始接受12周的特比萘芬（每日250毫克）治疗。

结果

在111例可评估患者中，给予特比萘芬的患者中有88%（56例中的49例）和给予安慰剂的患者中有29%（55例中的16例）在第24周真菌培养呈阴性（p<0.001）；特比萘芬组有57%（56例中的32例）、安慰剂组有6%（55例中的3例）有反应（p<0.001）。到第48周，在特比萘芬无反应者接受第二个12周疗程的特比萘芬治疗后，给予特比萘芬的患者总体真菌治愈率为94%。