Department of Dermatology, Teikyo University Mizonokuchi Hospital, 5-1-1 Futako, Takatsu, Kawasaki, Kanagawa, 213-8507, Japan.
Medical Mycology Unit, Graduate School of Medicine, Teikyo University, Tokyo, Japan.
Mycopathologia. 2021 May;186(2):259-267. doi: 10.1007/s11046-021-00540-6. Epub 2021 Mar 22.
Fosravuconazole L-lysine ethanolate (F-RVCZ), a ravuconazole prodrug, is a newly available agent with high expectations for efficacy in the treatment of onychomycosis. However, clinical data regarding the efficacy of F-RVCZ are limited because the drug was launched only in Japan in 2018. Therefore, we analyzed the outcome of F-RVCZ therapy in the treatment of onychomycosis at outpatient dermatology clinics in Japan. We examined data for 109 patients (68 male, 41 female) with varying clinical type, including total dystrophic onychomycosis and dermatophytoma, and a wide range of age groups, including the elderly. The complete cure rate at 12 weeks was 6.4% (7/109) and 67.9% (74/109) at the last visit (mean time to last visit: 32 ± 14.2 weeks). Mean rate of improvement in the affected nail area was 49.1 ± 23.3% at 12 weeks and 86.8 ± 22.4% at the last visit. Efficacy at 12 weeks and the last visit, respectively, was as follows: none, 4 cases and 1 case; slight, 35 cases and 4 cases; moderate, 51 cases and 21 cases; significant, 12 cases and 9 cases; complete cure, 7 cases and 74 cases. There were no serious adverse events. This retrospective survey was the first large-scale analysis of actual clinical practice outcomes and had minimal exclusions. Compared to previous reports, our results demonstrated excellent efficacy of F-RVCZ therapy in a variety of patients. Considering our results and the ease of oral administration (1 capsule/day for 12 weeks) and few adverse events, F-RVCZ therapy appears to be a useful option for the treatment of onychomycosis.
福沙那韦赖氨酸乙酯(F-RVCZ),一种新型的泊沙康唑前体药物,在治疗甲真菌病方面具有较高的疗效预期。然而,由于该药物于 2018 年才在日本上市,因此关于 F-RVCZ 疗效的临床数据有限。因此,我们分析了日本皮肤科门诊使用 F-RVCZ 治疗甲真菌病的疗效。我们检查了 109 例不同临床类型(包括全营养不良性甲真菌病和甲真菌瘤)和广泛年龄组(包括老年人)的患者数据。12 周时的完全治愈率为 6.4%(7/109),末次随访时为 67.9%(74/109)(末次随访平均时间:32±14.2 周)。12 周时受累指甲面积的改善率平均为 49.1±23.3%,末次随访时为 86.8±22.4%。12 周和末次随访时的疗效分别为:无效 4 例和 1 例,轻度 35 例和 4 例,中度 51 例和 21 例,显著 12 例和 9 例,完全治愈 7 例和 74 例。无严重不良事件。本回顾性研究是首次对实际临床实践结果进行的大规模分析,排除病例较少。与之前的报告相比,我们的结果表明 F-RVCZ 治疗在各种患者中具有优异的疗效。考虑到我们的结果以及口服给药的便利性(12 周 1 粒/天)和较少的不良反应,F-RVCZ 治疗似乎是治疗甲真菌病的一种有效选择。