Lebwohl M, Elewski B, Eisen D, Savin R C
Mount Sinai Medical Center, 5 E 98th St, 12th Floor, Box 1048, New York, NY 10029, USA.
Cutis. 2001 Mar;67(3):261-6.
Two randomized, double-blind, vehicle-controlled, multicenter studies assessed the efficacy and safety of a new terbinafine 1% solution for the treatment of interdigital tinea pedis and tinea corporis or tinea cruris (tinea corporis/cruris). Patients with interdigital tinea pedis applied terbinafine 1% solution or vehicle twice daily for 1 week with 7 weeks of follow-up (N = 153), and patients with tinea corporis/cruris applied terbinafine 1% solution or vehicle once daily for 1 week with 3 weeks of follow-up (N = 66). Efficacy was assessed mycologically and clinically at the end of treatment and throughout follow-up. In the tinea pedis study, 66% of patients were effectively treated with terbinafine compared with 4% of the group treated by vehicle (P < .001; Mantel-Haenszel test). In the tinea corporis/cruris study, treatment was effective in 65% of the terbinafine group compared with 8% of the vehicle group (P < .001). There were no significant differences in the frequency of cutaneous adverse events between the 2 groups in either study. We conclude that one week of therapy with terbinafine 1% solution is highly effective, superior to vehicle, and safe for use in superficial fungal infections.
两项随机、双盲、赋形剂对照的多中心研究评估了一种新的1%特比萘芬溶液治疗足趾间足癣及体癣或股癣（体癣/股癣）的疗效和安全性。足趾间足癣患者应用1%特比萘芬溶液或赋形剂，每日两次，共1周，并随访7周（N = 153）；体癣/股癣患者应用1%特比萘芬溶液或赋形剂，每日一次，共1周，并随访3周（N = 66）。在治疗结束时及整个随访期间，从真菌学和临床方面评估疗效。在足癣研究中，特比萘芬有效治疗了66%的患者，而赋形剂治疗组为4%（P <.001；Mantel-Haenszel检验）。在体癣/股癣研究中，特比萘芬组65%的患者治疗有效，赋形剂组为8%（P <.001）。在两项研究中，两组间皮肤不良事件的发生率均无显著差异。我们得出结论，1%特比萘芬溶液治疗1周高效、优于赋形剂，且用于浅表真菌感染安全。
