甲癣,表面真菌感染,当皮肤癣菌感染指甲板和床时发展。福劳康唑l-赖氨酸乙醇化物(F-RVCZ),第四代唑类抗真菌剂,具有有效的抗真菌活性和很少的药物相互作用,在临床试验中非常有效,治疗开始后48周的完全治愈率为59.4%。然而,一些患者没有完全治愈。为了实现更高的完全治愈率,额外的治疗需要检查。我们旨在检查(i)对甲癣的初始F-RVCZ治疗反应不足的患者的额外F-RVCZ治疗的标准;(ii)额外治疗的时机;和(iii)额外治疗的效果。这是一个多中心,开放标签,三臂随机临床试验。甲癣患者口服批准剂量的F-RVCZ12周,并在第24周评估其疗效。在第24周表现出指甲受累率降低≥55%的患者被纳入X组并进行随访。降低<55%的患者被随机分配到随访组(A组)或其他治疗组(B组)。X组72周完全治愈率为73.3%。A组和B组,完全治愈率分别为29.6%和46.7%,分别,差异有统计学意义(P=0.0414,比值比2.08)。在研究期间,318例患者中59例(18.6%)发生药物不良反应63例,不能排除与F-RVCZ的因果关系。B组,75名患者中有3名(4.0%)出现3次药物不良反应,所有在额外治疗期间观察到;没有一个是严重的。在第24周,当指甲受累减少≥55%时,无需额外的F-RVCZ治疗,即可获得较高的完全治愈率;然而,当在第24周减少<55%时,应考虑额外的F-RVCZ治疗以提高治愈率。
Onychomycosis, a superficial fungal infection, develops when dermatophytes infect nail plate and beds. Fosravuconazole l-lysine ethanolate (F-RVCZ), a fourth-generation azole antifungal agent with potent antifungal activity and few drug interactions, was highly effective in a clinical
trial, with a complete cure rate of 59.4% at 48 weeks after treatment initiation. However, some patients were not completely cured. To achieve a higher complete cure rate, additional therapy needs to be examined. We aimed to examine (i) the criteria for additional F-RVCZ therapy in patients with an inadequate response to initial F-RVCZ treatment for onychomycosis; (ii) the timing of additional therapy; and (iii) the effects of additional treatment. This was a multicenter, open-label, three-arm randomized clinical
trial. Patients with onychomycosis were orally administered an approved dose of F-RVCZ for 12 weeks, and its efficacy was assessed at week 24. Patients who demonstrated ≥55% reduction in nail involvement ratio at week 24 were included in Group X and followed up. Patients with <55% reduction were randomly assigned to follow-up (Group A) or additional treatment (Group B) groups. The complete cure rate at week 72 in Group X was 73.3%. In Groups A and B, the complete cure rates were 29.6% and 46.7%, respectively, and were significantly different (P = 0.0414, odds ratio 2.08). During the
study, 63 adverse drug reactions were recorded in 59 of the 318 patients (18.6%), for which a causal relationship with F-RVCZ could not be ruled out. In Group B, three of 75 patients (4.0%) experienced three adverse drug reactions, all observed during additional treatment; none were serious. A high complete cure rate is possible without additional F-RVCZ treatment when nail involvement decreases by ≥55% at week 24; however, when the reduction is <55% at week 24, additional F-RVCZ treatment should be considered to improve the cure rate.