Rich Phoebe
J Drugs Dermatol. 2015 Jan;14(1):58-62.
To evaluate efficacy of efinaconazole topical solution, 10% in onychomycosis patients with early and long-standing disease.
An analysis of 1655 patients, aged 18-70 years, randomized 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 target toenail, and both negative potassium hydroxide examination and fungal culture) at Week 52. Three groups were compared: those with early disease (<1year), patients with a baseline disease of 1-5 years, and those with long-standing onychomycosis (>5years).
The majority of patients had long-standing disease; were older, male and white. While nail involvement of the target toenail did not differ noticeably amongst the three groups, the number of nails involved did increase progressively with disease duration. Differences were seen in terms of infecting pathogens in early disease that might have important treatment implications. Efinaconazole was more effective in treating early disease, however more than 40% of patients with long-standing disease were considered treatment successes.
A period of 52 weeks may be too brief to evaluate a clinical cure in onychomycosis.
Treatment of onychomycosis early to avoid disease progression to other toenails is important. Once daily efinaconazole topical solution, 10% is particularly effective in these patients.
评估10%的艾氟康唑外用溶液治疗早期及病程较长的甲癣患者的疗效。
对1655例年龄在18至70岁之间的患者进行分析，这些患者被随机分配接受10%的艾氟康唑外用溶液或赋形剂，来自两项评估安全性和疗效的相同的多中心、双盲、赋形剂对照的48周研究。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%，氢氧化钾检查和真菌培养均为阴性）。比较了三组：早期疾病（<1年）患者、基线疾病为1至5年的患者以及病程较长的甲癣患者（>5年）。
大多数患者病程较长；年龄较大，为男性且为白人。虽然三组中目标趾甲的甲受累情况无明显差异，但受累趾甲数量确实随病程延长而逐渐增加。在早期疾病的感染病原体方面存在差异，这可能对治疗有重要影响。艾氟康唑治疗早期疾病更有效，然而超过40%的病程较长的患者被认为治疗成功。
52周的时间可能太短，无法评估甲癣的临床治愈情况。
早期治疗甲癣以避免疾病进展至其他趾甲很重要。每日一次的10%艾氟康唑外用溶液对这些患者特别有效。
