Hospital Universitário Pedro Ernesto, Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brazil.
Mycoses. 2013 May;56(3):327-32. doi: 10.1111/myc.12032. Epub 2013 Jan 8.
Onychomycosis constitutes up to 50% of all nail disorders. Toenails are generally affected, mostly due to dermatophytes. Terbinafine is the most potent antifungal agent in vitro against dermatophytes. There are few randomised controlled trials using a non-continuous dose of terbinafine. The aim of this open-label pilot study was to reduce the total drug amount, the collateral effects and, specially, the costs; albeit maintaining the same efficacy of the standard regimens. Compare the outcomes of two different intermittent regimens with the same total amount of the medication (42 tablets in 6 months). Forty-one patients were divided into the following groups: terbinafine 250 mg day(-1) , for 7 days, monthly or terbinafine 500 mg day(-1) , once daily, for 7 days, every 2 months, both plus nail abrasion during 6 months. The efficacy was evaluated at months 6, 12 and 18 using the disease free nail criteria. Total cure = group I: eight patients (44.4%) and group II: eight patients (44.4%). Partial cure = group I: five patients (27.8%) and group II: four patients (22.2%). Treatment failure = group I: five patients (27.8%) and group II: three patients (16.7%). Recurrence = group I: zero patients (0.0%) and group II: three patients (16.7%). Two intermittent dosing regimens of terbinafine plus nail abrasion proved to be an alternative statistically effective, safe and with reduced drug costs for dermatophytes toenail onychomycosis.
甲真菌病构成所有指甲疾病的 50%。通常受影响的是趾甲,主要是由于皮肤癣菌。特比萘芬是体外对抗皮肤癣菌最有效的抗真菌药物。很少有随机对照试验使用非连续剂量的特比萘芬。本开放性标签试点研究的目的是减少总药物剂量、副作用,特别是降低成本;尽管保持与标准方案相同的疗效。比较两种不同的间歇性方案与相同的总药物剂量(6 个月内 42 片)的结果。将 41 名患者分为以下两组:特比萘芬 250mg/d,连续 7 天,每月一次或特比萘芬 500mg/d,每天一次,连续 7 天,每 2 个月一次,两组均在 6 个月内进行指甲锉磨。在第 6、12 和 18 个月使用无病指甲标准评估疗效。总治愈率=组 I:8 名患者(44.4%)和组 II:8 名患者(44.4%)。部分治愈率=组 I:5 名患者(27.8%)和组 II:4 名患者(22.2%)。治疗失败率=组 I:5 名患者(27.8%)和组 II:3 名患者(16.7%)。复发率=组 I:0 名患者(0.0%)和组 II:3 名患者(16.7%)。两种间歇性特比萘芬联合指甲锉磨治疗方案被证明是一种替代方案,在统计学上有效、安全且药物成本降低,适用于皮肤癣菌引起的趾甲甲真菌病。