Markinson Bryan C, Caldwell Bryan D
a Icahn School of Medicine at Mount Sinai.
J Am Podiatr Med Assoc. 2015 Apr 13. doi: 10.7547/14-088.1.
We sought to evaluate the efficacy of efinaconazole topical solution, 10%, in patients with onychomycosis and coexisting tinea pedis.
We analyzed 1,655 patients, aged 18 to 70 years, randomized (3:1) to receive efinaconazole topical solution, 10%, or vehicle from two identical multicenter, double-blind, vehicle-controlled 48-week studies evaluating safety and efficacy. The primary end point was complete cure rate (0% clinical involvement of the target toenail and negative potassium hydroxide examination and fungal culture findings) at week 52. Three groups were compared: patients with onychomycosis and coexisting interdigital tinea pedis on-study (treated or left untreated) and those with no coexisting tinea pedis.
Treatment with efinaconazole topical solution, 10%, was significantly more effective than vehicle use irrespective of the coexistence of tinea pedis or its treatment. Overall, 352 patients with onychomycosis (21.3%) had coexisting interdigital tinea pedis at baseline, with 215 of these patients (61.1%) receiving investigator-approved topical antifungal agents for their tinea pedis in addition to their randomized onychomycosis treatment. At week 52, efinaconazole complete cure rates of 29.4% were reported in patients with onychomycosis when coexisting tinea pedis was treated compared with 16.1% when coexisting tinea pedis was not treated. Both cure rates were significant compared with vehicle (P = .003 and .045, respectively), and in the latter subgroup, no patients treated with vehicle achieved a complete cure.
Treatment of coexisting tinea pedis in patients with onychomycosis enhances the efficacy of once-daily topical treatment with efinaconazole topical solution, 10%.
我们旨在评估10%的艾氟康唑外用溶液治疗甲癣合并足癣患者的疗效。
我们分析了1655例年龄在18至70岁之间的患者，这些患者被随机分配（3:1）接受10%的艾氟康唑外用溶液或赋形剂，来自两项相同的多中心、双盲、赋形剂对照的48周研究以评估安全性和疗效。主要终点是第52周时的完全治愈率（目标趾甲临床受累为0%且氢氧化钾检查和真菌培养结果为阴性）。比较了三组：研究期间患有甲癣并合并指间足癣（已治疗或未治疗）的患者以及无合并足癣的患者。
无论足癣是否存在或其治疗情况如何，10%的艾氟康唑外用溶液治疗均比使用赋形剂显著更有效。总体而言，352例甲癣患者（21.3%）在基线时合并指间足癣,其中215例患者（61.1%）除了随机接受的甲癣治疗外，还因足癣接受了研究者批准的外用抗真菌药物治疗。在第52周时，合并足癣且接受治疗的甲癣患者中，艾氟康唑的完全治愈率报告为29.4%，而合并足癣未接受治疗的患者中这一比例为16.1%。与赋形剂相比，这两种治愈率均有统计学意义（分别为P = 0.003和0.045），并且在后一亚组中，接受赋形剂治疗的患者无一人实现完全治愈。
治疗甲癣患者合并的足癣可提高每日一次外用10%艾氟康唑外用溶液治疗的疗效。
