Reinel D
Department of Dermatology, Bundeswehrkrankenhaus, Hamburg, FRG.
Dermatology. 1992;184 Suppl 1:21-4. doi: 10.1159/000247612.
456 patients with onychomycosis were treated once or twice weekly for up to 6 months with amorolfine 5% nail lacquer in an open, randomized study. The patients were examined at monthly intervals during treatment and followed-up 1 and 3 months after completion of treatment. Slightly better cure rates were achieved with twice weekly use than with once weekly use (overall cure rates 54.2 vs. 46.0%, p = 0.4). An overall cure or improvement was achieved in 74 and 68% of patients receiving twice- and once-weekly treatment, respectively. The mycological cure rate was 76.1% for twice-weekly treatment and 70.6% for once-weekly treatment. The nail lacquer was extremely well tolerated; 4 out of 456 patients reported mild local irritation. Plasma levels of amorolfine were determined in 19 patients and found to be below the detection limit of 0.5 ng/ml in all cases.
在一项开放性随机研究中，456例甲癣患者接受5%阿莫罗芬搽剂治疗，每周用药1次或2次，最长治疗6个月。治疗期间每月对患者进行检查，并在治疗结束后1个月和3个月进行随访。每周使用2次的治愈率略高于每周使用1次（总体治愈率分别为54.2%和46.0%，p = 0.4）。接受每周2次和每周1次治疗的患者中，分别有74%和68%实现了总体治愈或病情改善。每周2次治疗的真菌学治愈率为76.1%，每周1次治疗为70.6%。该搽剂耐受性极佳；456例患者中有4例报告有轻度局部刺激。对19例患者测定了血浆阿莫罗芬水平，发现所有病例均低于0.5 ng/ml的检测限。
