Baudraz-Rosselet F, Rakosi T, Wili P B, Kenzelmann R
Department of Dermatology, University Hospital of Lausanne, Switzerland.
Br J Dermatol. 1992 Feb;126 Suppl 39:40-6. doi: 10.1111/j.1365-2133.1992.tb00009.x.
An open multicentre trial was conducted by 40 dermatologists in Switzerland involving 188 patients with onychomycosis of either the toenails or fingernails. Of these patients, 145 who had positive microscopy and culture of dermatophyte infection were evaluable: of the dermatophytes identified at the initial visit, 80% were Trichophyton rubrum and 12.4% were T. mentagrophytes. Only the most affected nail was evaluated during the observation period. Daily dosage was 250 mg of terbinafine (Lamisil) orally for up to 6 months. The cure rate (negative microscopy and culture) at the end of treatment was 77% for toenails and 100% for fingernails. A follow-up investigation was made 6 months after the end of treatment: of the 88 patients examined with onychomycosis of the toenail and the 14 with fingernail onychomycosis, 90.9% and 85.7%, respectively, remained free of recurrence. Of the 26 patients who had shown improvement, but not cure, by the end of the treatment period, 15 were clinically and mycologically cured at the time of the follow-up investigation. Terbinafine was generally well tolerated; the most frequent drug-related adverse events were mild-to-moderate gastrointestinal disturbances. Changes in liver or renal biochemical tests were not considered clinically relevant.
瑞士40位皮肤科医生开展了一项开放性多中心试验,涉及188例患有趾甲或指甲甲癣的患者。其中,145例显微镜检查和皮肤癣菌感染培养呈阳性的患者可纳入评估:初诊时鉴定出的皮肤癣菌中,80%为红色毛癣菌,12.4%为须癣毛癣菌。观察期内仅评估受影响最严重的指甲。每日口服特比萘芬(兰美抒)剂量为250毫克,疗程最长6个月。治疗结束时,趾甲的治愈率(显微镜检查和培养均为阴性)为77%,指甲为100%。治疗结束6个月后进行了随访调查:在接受检查的88例趾甲甲癣患者和14例指甲甲癣患者中,分别有90.9%和85.7%未复发。在治疗期结束时显示病情改善但未治愈的26例患者中,15例在随访调查时临床和真菌学上已治愈。特比萘芬总体耐受性良好;最常见的药物相关不良事件为轻度至中度胃肠道不适。肝脏或肾脏生化检查的变化在临床上不被视为相关情况。