Aly Raza, Fisher George, Katz Irving, Levine Norman, Lookingbill Donald P, Lowe Nicholas, Menter Alan, Morman Manuel, Pariser David M, Roth Harry L, Savin Ronald C, Shavin Joel S, Stewart Daniel, Taylor J Richard, Tucker Stephen, Wortzman Mitchell
Department of Dermatology, University of California San Francisco, USA.
Int J Dermatol. 2003 Sep;42 Suppl 1:29-35. doi: 10.1046/j.1365-4362.42.s1.6.x.
BACKGROUND Tinea pedis (athlete's foot) is the most common fungal infection in the general population. Ciclopirox, a broad-spectrum hydroxypyridone antifungal, has proven efficacy against the organisms commonly implicated in tinea pedis; Trichophyton rubrum, T.mentagrophytes and Epidermophyton floccosum.
Two multicenter, double-blind, clinical studies compared the efficacy and safety of ciclopirox gel with that of its vehicle base in subjects with moderate interdigital tinea pedis with or without plantar involvement.
Three hundred and seventy-four subjects were enrolled and randomized to one of two treatment groups: ciclopirox gel 0.77%, or ciclopirox gel vehicle, applied twice daily for 28 days, with a final visit up to day 50. The primary efficacy variable was Treatment Success defined as combined mycological cure and clinical improvement >/= 75%. Secondary measures of effectiveness were Global Clinical Response, Sign and Symptom Severity Scores, Mycological Evaluation (KOH examination and final culture result), Mycological Cure (negative KOH and negative final culture results) and Treatment Cure (combined clinical and mycological cure).
At endpoint (final post-baseline visit), 60% of the ciclopirox subjects achieved treatment success compared to 6% of the vehicle subjects. At the same time point, 66% of ciclopirox subjects compared with 19% of vehicle subjects were either cleared or had excellent improvement. Pooled data showed that 85% of ciclopirox subjects were mycologically cured, compared to only 16% of vehicle subjects at day 43, 2 weeks post-treatment.
Ciclopirox gel 0.77% applied twice daily for 4 weeks is an effective treatment of moderate interdigital tinea pedis due to T. rubrum, T. mentagrophytes and E. floccosum and is associated with a low incidence of minor adverse effects.
背景 足癣（运动员脚癣）是普通人群中最常见的真菌感染。环吡酮，一种广谱羟基吡啶酮类抗真菌药，已被证明对通常引起足癣的病原体有效；红色毛癣菌、须癣毛癣菌和絮状表皮癣菌。
两项多中心、双盲临床研究比较了环吡酮凝胶与其赋形剂基质在有或无足底受累的中度指间足癣患者中的疗效和安全性。
招募了374名受试者并随机分为两个治疗组之一：0.77%环吡酮凝胶或环吡酮凝胶赋形剂，每天涂抹两次，共28天，最后一次随访至第50天。主要疗效变量为治疗成功，定义为真菌学治愈和临床改善≥75%。有效性的次要指标包括总体临床反应、体征和症状严重程度评分、真菌学评估（氢氧化钾检查和最终培养结果）、真菌学治愈（氢氧化钾阴性和最终培养结果阴性）和治疗治愈（临床和真菌学联合治愈）。
在终点（基线后最后一次随访）时，60%的环吡酮治疗受试者取得了治疗成功，而赋形剂治疗受试者的这一比例为6%。在同一时间点，66%的环吡酮治疗受试者与19%的赋形剂治疗受试者被清除或有显著改善。汇总数据显示，在治疗后2周的第43天，85%的环吡酮治疗受试者真菌学治愈，而赋形剂治疗受试者的这一比例仅为16%。
每天两次涂抹0.77%环吡酮凝胶，持续4周，是治疗由红色毛癣菌、须癣毛癣菌和絮状表皮癣菌引起的中度指间足癣的有效方法，且轻微不良反应发生率较低。
