伊曲康唑用于治疗儿童皮肤真菌感染。

The use of itraconazole to treat cutaneous fungal infections in children.

作者信息

Gupta A K, Nolting S, de Prost Y, Delescluse J, Degreef H, Theissen U, Wallace R, Marynissen G, De Doncker P

机构信息

Division of Dermatology, Department of Medicine, Sunnybrook and Women's College Health Sciences Center (Sunnybrook site), and the University of Toronto, Toronto, Canada.

出版信息

Dermatology. 1999;199(3):248-52. doi: 10.1159/000018256.

DOI:10.1159/000018256

PMID:10592406

Abstract

BACKGROUND

Cutaneous mycoses such as tinea capitis, onychomycosis and some cases of tinea corporis/cruris, and tinea pedis/manus require oral antifungal therapy. There is relatively limited data regarding the use of the newer oral antifungal agents, e.g. itraconazole, in the treatment of these mycoses in children.

OBJECTIVE

We wished to determine the efficacy and safety of itraconazole continuous therapy in the management of cutaneous fungal infections in children.

METHODS

Children with cutaneous mycoses were treated with itraconazole in an open-label manner in 4 studies. For tinea capitis, the treatment regimens using itraconazole continuous therapy were: study 1, 3 mg/kg/day for 4 or 8 weeks; study 2, 5 mg/kg/day for 6 weeks, and study 3, 5 mg/kg/ day for 4 weeks. In a different trial, study 4, itraconazole continuous therapy 5 mg/kg/day was used to treat toenail onychomycosis (duration: 12 weeks), tinea corporis/ cruris (duration: 1 week) and tinea pedis/manus (duration: 2 weeks).

RESULTS

The efficacy rates at follow-up 12 weeks from the start of therapy in children with tinea capitis treated using the itraconazole continuous regimen were: clinical cure (CC) and mycological cure (MC) in study 1 (n = 10, Trichophyton violaceum all patients), CC 50%, MC 86%; in study 2 (n = 35, Microsporum canis 22 patients, Trichophyton sp. 12 patients), CC 82.8%, MC 80%, and in study 3 (n = 16, M. canis 11 patients, Trichophyton sp. 5 patients), (CC 66.7%, MC 78.5%. Itraconazole was also effective in the treatment of dermatomycoses in 24 children (study 4). The CC and MC rates at the follow-up 8 weeks from the start of therapy in children with dermatomycoses and 12 months in children treated for onychomycosis were: onychomycosis (n = 1, T. rubrum), CC 100%, MC 100%; tinea corporis (n = 12, M. canis 10 patients), CC 100%, MC 90%; tinea cruris (n = 3, Trichophyton sp. 2 patients), CC 100%, MC 100%; tinea manus (n = 1, T. rubrum), CC 100%, MC 100%, and tinea pedis (n = 7, T. rubrum), CC 100%, MC 100%). Adverse effects consisted of a cutaneous eruption in 1 (1.2%) of the 85 children, with mild, transient, asymptomatic elevation of liver function tests (less than twice the upper limit of normal) in 2 (3.4%) of 58 children in whom monitoring was performed.

CONCLUSIONS

Itraconazole is effective and safe in the treatment of tinea capitis and other cutaneous fungal infections in children.

摘要

背景

头癣、甲癣以及部分体癣/股癣和足癣/手癣等皮肤癣菌病需要口服抗真菌治疗。关于新型口服抗真菌药（如伊曲康唑）用于治疗儿童这些癣菌病的数据相对有限。

目的

我们希望确定伊曲康唑持续治疗儿童皮肤真菌感染的疗效和安全性。

方法

在4项研究中，对患有皮肤癣菌病的儿童采用开放标签方式给予伊曲康唑治疗。对于头癣，伊曲康唑持续治疗的方案为：研究1，3mg/kg/天，共4或8周；研究2，5mg/kg/天，共6周；研究3，5mg/kg/天，共4周。在另一项试验（研究4）中，采用伊曲康唑持续治疗5mg/kg/天治疗趾甲甲癣（疗程：12周）、体癣/股癣（疗程：1周）和足癣/手癣（疗程：2周）。

结果

采用伊曲康唑持续治疗方案治疗的头癣儿童，从治疗开始随访12周时的有效率为：研究1（n = 10，所有患者均为紫色毛癣菌）临床治愈率（CC）为50%，真菌学治愈率（MC）为86%；研究2（n = 35，犬小孢子菌22例，毛癣菌属12例），CC为82.8%，MC为80%；研究3（n = 16，犬小孢子菌11例，毛癣菌属5例），CC为66.7%，MC为78.5%。伊曲康唑对24例儿童皮肤癣菌病（研究4）也有效。皮肤癣菌病儿童从治疗开始随访8周以及甲癣治疗儿童随访12个月时的CC和MC率为：甲癣（n = 1，红色毛癣菌），CC为100%，MC为100%；体癣（n = 12，犬小孢子菌10例），CC为100%，MC为90%；股癣（n = 3，毛癣菌属2例），CC为100%，MC为100%；手癣（n = 1，红色毛癣菌），CC为100%，MC为100%；足癣（n = 7，红色毛癣菌），CC为100%，MC为100%。不良反应包括85例儿童中有1例（1.2%）出现皮疹，在接受监测的58例儿童中有2例（3.4%）出现肝功能轻度、短暂、无症状升高（低于正常上限的两倍）。