James Ian G, Loria-Kanza Yolanda, Jones Thomas C
Spring House Surgery, Bolton, United Kingdom.
J Dermatolog Treat. 2007;18(3):163-8. doi: 10.1080/09546630701247971.
In the treatment of tinea pedis, current terbinafine formulations are applied once or twice daily for 7 days. A terbinafine emulsion gel formulation has been developed to provide a 5-day treatment course for tinea pedis.
To determine the lowest effective concentration of terbinafine (1% or 3%) emulsion gel applied once daily for 5 days for the treatment of tinea pedis.
This double-blind, placebo-controlled study evaluated the efficacy of 1% and 3% terbinafine gel for 5 days in 84 outpatients with tinea pedis. The primary efficacy endpoint was the percentage of patients with effective treatment (negative microscopy and culture with only mild erythema/desquamation/pruritus [total score<or=2]) at study endpoint (last post-baseline observation up to and including week 6).
Efficacy rates with terbinafine 1% and 3% emulsion gel were significantly higher than with placebo (86% and 68% vs 11%, respectively; p<0.001). Similarly, mycological cure rates were significantly greater with terbinafine 1% and 3% gel (97% and 89%, respectively) than with placebo (22%; p<0.001).
Terbinafine 1% emulsion gel used once daily for 5 days was the lowest effective concentration, and was significantly superior to placebo. Both concentrations were effective and safe, providing convenient, short-duration treatment of tinea pedis.
在足癣治疗中，目前的特比萘芬制剂每日应用1次或2次，疗程为7天。已研发出一种特比萘芬乳胶凝胶制剂，用于足癣的5天治疗疗程。
确定每日应用1次、疗程为5天的特比萘芬（1%或3%）乳胶凝胶治疗足癣的最低有效浓度。
这项双盲、安慰剂对照研究评估了84例足癣门诊患者使用1%和3%特比萘芬凝胶5天的疗效。主要疗效终点是在研究终点（基线后最后一次观察直至并包括第6周）时治疗有效的患者百分比（显微镜检查和培养阴性，仅有轻度红斑/脱屑/瘙痒[总分≤２分]）。
1%和3%特比萘芬乳胶凝胶的有效率显著高于安慰剂（分别为86%和68% 对11%；p<0.001）。同样，1%和3%特比萘芬凝胶的真菌学治愈率（分别为97%和89%）显著高于安慰剂（22%；p<0.001）。
每日应用1次、疗程为5天的1%特比萘芬乳胶凝胶是最低有效浓度，且显著优于安慰剂。两种浓度均有效且安全，为足癣提供了方便的短疗程治疗。
