Institut für Pilzkrankheiten, Berlin, Germany.
Mycoses. 2013 Jul;56(4):414-21. doi: 10.1111/myc.12037. Epub 2013 Apr 16.
Onychomycosis is a common fungal infection most often affecting the toenails. If untreated, it can cause discomfort sufficient to reduce quality of life. To evaluate efficacy and safety of bifonazole cream vs. placebo in onychomycosis treatment after non-surgical nail ablation with urea paste. Fifty-one study centres randomized 692 subjects with mild-to-moderate onychomycosis to receive bifonazole 1% cream or placebo for 4 weeks following non-surgical nail ablation with urea 40% paste over 2-4 weeks. Efficacy of the two phase treatment was evaluated by overall cure of the target nail comprising clinical and mycological cure 2 weeks, 3 and 6 months after end of treatment. At 2 weeks (primary endpoint), overall cure rate was superior in bifonazole-treated group (54.8% vs. 42.2% for placebo; P = 0.0024). The clinical cure rate was high in both treatment groups (86.6% bifonazole vs. 82.8% placebo), but proportion with mycological cure was higher with bifonazole treatment (64.5%) vs. placebo treatment 49.0%, (P = 0.0001). We observed higher early overall cure rate with 4 weeks topical bifonazole compared with placebo after removal of infected nail parts with urea. This two stage treatment was well tolerated and offers an additional option in topical onychomycosis therapy.
甲真菌病是一种常见的真菌感染，最常影响趾甲。如果不治疗，它会引起足够的不适，降低生活质量。评估尿素膏非手术性指甲消融术后使用联苯苄唑乳膏与安慰剂治疗甲真菌病的疗效和安全性。51 个研究中心将 692 例轻度至中度甲真菌病患者随机分为两组，分别接受联苯苄唑 1%乳膏或安慰剂治疗，在 2-4 周内用 40%尿素膏进行非手术性指甲消融后，各治疗 4 周。采用综合临床和真菌学治愈 2 周、3 个月和 6 个月后评估两阶段治疗的疗效。在 2 周（主要终点）时，联苯苄唑治疗组的总治愈率（54.8% vs. 42.2%安慰剂；P = 0.0024）优于安慰剂治疗组。两组治疗的临床治愈率均较高（联苯苄唑 86.6%，安慰剂 82.8%），但联苯苄唑治疗组的真菌学治愈率较高（64.5% vs. 安慰剂 49.0%；P = 0.0001）。我们观察到，在使用尿素去除感染指甲部分后，与安慰剂相比，外用 4 周联苯苄唑可更早获得总治愈率。这种两阶段治疗方法耐受性良好，为甲真菌病的局部治疗提供了另一种选择。
