Syed T A, Ahmadpour O A, Ahmad S A, Shamsi S
Department of Dermatology, University of California, San Francisco 94143-0989, USA.
J Dermatol. 1998 Oct;25(10):648-52. doi: 10.1111/j.1346-8138.1998.tb02474.x.
Onychomycosis is an increasingly common and recalcitrant fungal nail infection world-wide. The purpose of this placebo-controlled, double-blind study was to determine the clinical efficacy, chemical avulsion, and tolerability of 2% butenafine hydrochloride and 20% urea incorporated in a cream to cure toenail onychomycosis in a preselected population. Sixty patients (38M, 22F), ranging between 18 and 60 years (mean 27.4), with more than 25% involvement of the big toenail were enrolled in the study. The diagnosis of onychomycosis was established by mycologic identification and reconfirmed by positive fungal culture. A precoded 25-g tube was randomly assigned to each patient (50 active and 10 placebo) with instructions to apply the trial medication to their infected toenail twice daily with an occlusive dressing for one week. The affected nail was removed with a nail clipper. No occlusive dressing was maintained after the initial one week regimen. To assess the chemical avulsion of the infected toenail, mycologic cure, clinical effectiveness of the treatment, and overall success, patients were examined twice a week for 16 weeks and thereafter on a weekly basis for a further 36 weeks. The treatment was well tolerated by all the patients throughout the study, with no dropouts. Marked improvement was seen in 73.3% patients after weeks 8, 16 and 24 with clinically and mycologically confirmed negative fungal culture. Code disclosure revealed that active butenafine and urea cream cured significantly more patients than placebo (88% versus 0%; p < 0.0001). Of the 60 patients 91.6% reported no drug-related adverse symptoms. Five patients reported non-objective mild inflammation without discontinuation of the treatment. During one year follow-up of the study phase, none of the cured patients had a relapse. In conclusion, the mycologic and overall assessment of this study demonstrate that 2% butenafine HCl and 20% urea incorporated in a cream for keratinolysis is safe to use and significantly more effective than placebo in curing big toenail onychomycosis.
甲癣是一种在全球范围内日益常见且难以治愈的真菌性指甲感染。这项安慰剂对照、双盲研究的目的是确定含2%盐酸布替萘芬和20%尿素的乳膏对预选人群中趾甲甲癣的临床疗效、化学剥脱作用和耐受性。60名患者（38名男性，22名女性），年龄在18至60岁之间（平均27.4岁），大脚趾甲受累超过25%，被纳入该研究。甲癣的诊断通过真菌学鉴定确定，并经真菌培养阳性再次确认。为每位患者随机分配一支预编码的25克装药膏（50支活性药膏和10支安慰剂），并指示患者每天两次将试验药物涂抹于感染的趾甲上，并用封闭敷料覆盖一周。用指甲刀去除患甲。在最初一周的治疗方案后不再使用封闭敷料。为评估感染趾甲的化学剥脱作用、真菌学治愈情况、治疗的临床效果和总体成功率，对患者进行为期16周的每周两次检查，之后再进行36周的每周一次检查。在整个研究过程中，所有患者对治疗的耐受性良好，无脱落病例。在第8周、16周和24周后，73.3%的患者有明显改善，真菌培养临床和真菌学确认呈阴性。编码披露显示，活性布替萘芬和尿素乳膏治愈的患者明显多于安慰剂（88%对0%；p<0.0001）。60名患者中，91.6%报告无药物相关不良症状。5名患者报告有非客观性轻度炎症，但未中断治疗。在研究阶段的一年随访中，所有治愈患者均未复发。总之，本研究的真菌学和总体评估表明，含2%盐酸布替萘芬和20%尿素用于角质溶解的乳膏使用安全，在治愈大脚趾甲甲癣方面比安慰剂显著更有效。
