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一项开放性随机对照研究,旨在测试口服特比萘芬脉冲疗法单药治疗以及联合8%环吡酮胺外用制剂或5%盐酸阿莫罗芬外用制剂治疗甲真菌病的疗效和安全性。

An open randomized comparative study to test the efficacy and safety of oral terbinafine pulse as a monotherapy and in combination with topical ciclopirox olamine 8% or topical amorolfine hydrochloride 5% in the treatment of onychomycosis.

作者信息

Jaiswal Amit, Sharma R P, Garg A P

机构信息

Department of Dermatology and Venereology, L. L. R. M. Medical College, Meerut, Uttar Pradesh, India.

出版信息

Indian J Dermatol Venereol Leprol. 2007 Nov-Dec;73(6):393-6. doi: 10.4103/0378-6323.37056.

DOI:10.4103/0378-6323.37056
PMID:18032857
Abstract

BACKGROUND

Onychomycosis is a fungal infection of nails caused by dermatophytes, yeasts and molds.

AIMS

To study the efficacy and safety of oral terbinafine pulse as a monotherapy and in combination with topical ciclopirox olamine 8% or topical amorolfine hydrochloride 5% in onychomycosis.

METHODS

A clinical comparative study was undertaken on 96 Patients of onychomycosis during the period between August 2005 to July 2006. Forty-eight patients were randomly assigned in group A to receive oral terbinafine 250 mg, one tablet twice daily for seven days every month (pulse therapy); 24 patients in group B to receive oral terbinafine pulse therapy plus topical ciclopirox olamine 8% to be applied once daily at night on all affected nails; and 24 patients in group C to receive oral terbinafine pulse therapy plus topical amorolfine hydrochloride 5% to be applied once weekly at night on all the affected nails. The treatment was continued for four months. The patients were evaluated at four weekly intervals till sixteen weeks and then at 24 and 36 weeks.

RESULTS

We observed clinical cure in 71.73, 82.60 and 73.91% patients in groups A, B and C, respectively; Mycological cure rates against dematophytes were 88.9, 88.9 and 85.7 in groups A, B and C, respectively. The yeast mycological cure rates were 66.7, 100 and 50 in groups A, B and C, respectively. In the case of nondermatophytes, the overall response was poor: one out of two cases (50%) responded in group A, while one case each in group B and group C did not respond at all.

CONCLUSION

Terbinafine pulse therapy is effective and safe alternative in treatment of onychomycosis due to dermatophytes; and combination therapy with topical ciclopirox or amorolfine do not show any significant difference in efficacy in comparison to monotherapy with oral terbinafine.

摘要

背景

甲癣是由皮肤癣菌、酵母菌和霉菌引起的指甲真菌感染。

目的

研究口服特比萘芬脉冲疗法单药治疗以及联合8%环吡酮胺外用制剂或5%盐酸阿莫罗芬外用制剂治疗甲癣的疗效和安全性。

方法

2005年8月至2006年7月期间,对96例甲癣患者进行了一项临床对照研究。48例患者被随机分配到A组,接受口服特比萘芬250毫克,每月连续7天,每天2次,每次1片(脉冲疗法);24例患者被分配到B组,接受口服特比萘芬脉冲疗法加8%环吡酮胺外用制剂,每晚在所有患甲上涂抹1次;24例患者被分配到C组,接受口服特比萘芬脉冲疗法加5%盐酸阿莫罗芬外用制剂,每周在所有患甲上涂抹1次。治疗持续4个月。每4周对患者进行评估,直至16周,然后在24周和36周进行评估。

结果

我们观察到,A、B、C组的临床治愈率分别为71.73%、82.60%和73.91%;A、B、C组针对皮肤癣菌的真菌学治愈率分别为88.9%、88.9%和85.7%。A、B、C组酵母菌真菌学治愈率分别为66.7%、100%和50%。对于非皮肤癣菌,总体反应较差:A组2例中有1例(50%)有反应,而B组和C组各有1例无反应。

结论

特比萘芬脉冲疗法是治疗皮肤癣菌所致甲癣的一种有效且安全的替代方法;与口服特比萘芬单药治疗相比,联合外用环吡酮或阿莫罗芬治疗在疗效上没有显著差异。

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