Avner Shemer, Nir Nathansohn, Baruch Kaplan, Henri Trau
Department of Dermatology, C. Sheba Medical Center, Tel Hashomer, Israel.
J Dermatolog Treat. 2006;17(2):117-20. doi: 10.1080/09546630600621953.
Itraconazole given in pulse therapy has become popular for onychomycosis treatment since it results in less plasma exposure to the drug while maintaining an effective drug concentration in the nail plate and also increasing patient compliance.
The current study aims to evaluate two different regimens of itraconazole for toenail onychomycosis, looking at both the immediate post-therapy cure rate and the relapse rate after 2 years.
Two groups of 52 patients each were given either 'standard' oral itraconazole pulse therapy for 3 months (200 mg x 2/day for 1 week/month) followed by an additional single course (200 mg/day for 7 days) after 3 months (regimen A) or 'modified' (6-week interval) itraconazole pulse therapy x3 followed by an additional single course (200 mg x 2/day for 7 days) after 3 months. All patients were followed-up for 24 months from the beginning of treatment.
Regimen A: 37 patients were available for examination after 24 months, of whom 22 patients (59.5%) had total cure and two patients (5.5%) had marked improvement. Regimen B: 38 patients were available for examination after 24 months, of whom 29 patients (76.3%) had total cure and three patients (7.9%) had marked improvement. There were no statistical differences in cure rates between the two groups at the end of treatment, after 12 months and after 24 months. None of the patients (in both treatment groups) who had total cure at the end of the treatment period had onychomycosis recurrence after 12 or 24 months.
The results at the end of the 24-month period are encouraging, where 64.9% (regimen A) and 84.2% (regimen B) of the patients had total cure or marked improvement in their toenail condition. Therefore, those two regimens are acceptable alternatives to the current treatment regimen.
伊曲康唑脉冲疗法因在维持甲板有效药物浓度的同时减少血浆药物暴露量且提高患者依从性，已广泛用于甲真菌病治疗。
本研究旨在评估两种不同伊曲康唑治疗方案对趾甲真菌病的疗效，观察治疗后即时治愈率和2年后复发率。
两组各52例患者，一组接受“标准”口服伊曲康唑脉冲疗法3个月（200毫克×2/天，每月1周），3个月后再接受一个疗程（200毫克/天，共7天）（方案A）；另一组接受“改良”（间隔6周）伊曲康唑脉冲疗法，共3个疗程，3个月后再接受一个疗程（200毫克×2/天，共7天）。所有患者从治疗开始随访24个月。
方案A组：24个月后37例患者可供检查，其中22例（59.5%）完全治愈，2例（5.5%）显著改善。方案B组：24个月后38例患者可供检查，其中29例（76.3%）完全治愈，3例（7.9%）显著改善。治疗结束时、12个月和24个月后两组治愈率无统计学差异。治疗期结束时完全治愈的患者（两组均有）在12个月或24个月后均无甲真菌病复发。
24个月时的结果令人鼓舞，方案A组64.9%、方案B组84.2%的患者趾甲状况完全治愈或显著改善。因此，这两种方案是现有治疗方案的可接受替代方案。
