Efficacy and safety of fosravuconazole L-lysine ethanolate, a novel oral triazole antifungal agent, for the treatment of onychomycosis: A multicenter, double-blind, randomized phase III study.
Efficacy and safety of fosravuconazole L-lysine ethanolate, a novel oral triazole antifungal agent, for the treatment of onychomycosis: A multicenter, double-blind, randomized phase III study.
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fosravuconazole L-赖氨酸乙醇酸乙醇（一种新型口服三唑抗真菌剂）的功效和安全性治疗甲司霉病：多中心，双盲，随机的III期研究。
DOI：
10.1111/1346-8138.14607
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发表时间：
2018-10
期刊：
影响因子：
--
通讯作者：
Okubo A
中科院分区：
文献类型：
--
作者：
Watanabe S;Tsubouchi I;Okubo A
福斯拉康唑 L-赖氨酸乙醇盐 (F-RVCZ) 是雷夫康唑的前药，是一种新型三唑类抗真菌药物，具有广泛而有效的抗真菌活性。与安慰剂相比，F-RVCZ 的疗效和安全性在一项多中心、双盲、随机研究中进行了研究，研究对象为目标趾甲临床受累率达到或超过 25% 的日本甲癣患者。受试者 (n = 153) 被随机分配接受 F-RVCZ (100 mg RVCZ, n = 101) 或安慰剂 (n = 52) 口服治疗。每天一次，持续 12 周。主要终点是第 48 周（治疗后 36 周访视）时的完全治愈率（临床治愈 [0% 目标脚趾甲临床受累] 加真菌学治愈 [氢氧化钾检查阴性]）。次要终点是 F-RVCZ 的功效和真菌学效应随时间的变化。还评估了安全性。在完整分析集中，第 48 周时 F-RVCZ 组的完全治愈率 (59.4%, 60/101) 显着高于安慰剂组 (5.8%, 3/52) (P < 0.001)。第 48 周时，F-RVCZ 组的真菌学治愈率 (82.0%, 73/89) 也显着高于安慰剂组 (20.0%, 10/50, P < 0.001)。关于安全性，F-RVCZ 和安慰剂受试者的不良事件发生率分别为 83.2% (84/101) 和 80.8% (42/52)，药物不良反应 (ADR) 分别为 23.8% (24/101) 和 3.8% (2/52)。 ADR 的严重程度为轻度至中度，没有严重的。 F-RVCZ（相当于 100 mg 雷夫康唑）每日一次，持续 12 周，比安慰剂更有效，并且对于甲癣患者来说具有耐受性，表明它是一种有前途的治疗甲癣的药物。
Fosravuconazole L‐lysine ethanolate (F‐RVCZ) is a prodrug of ravuconazole, a novel triazole antifungal agent, exerting broad and potent antifungal activity. The efficacy and safety of F‐RVCZ, compared with a placebo, were investigated in a multicenter, double‐blind, randomized study of Japanese onychomycosis patients with 25% or more clinical involvement of the target toenail. Subjects (n = 153) were randomly assigned to receive F‐RVCZ (100 mg RVCZ, n = 101) or placebo (n = 52) p.o. once daily for 12 weeks. The primary end‐point was the rate of complete cure (clinical cure [0% clinical involvement of the target toenail] plus mycological cure [negative potassium hydroxide examination]) at week 48 (36‐week post‐treatment visit). Secondary end‐points were changes over time in the efficacy and mycological effect of F‐RVCZ. Safety was also evaluated. The complete cure rate at week 48 was significantly higher with F‐RVCZ (59.4%, 60/101) than the placebo (5.8%, 3/52) in the full analysis set (P < 0.001). The mycological cure rate at week 48 was also significantly higher with F‐RVCZ (82.0%, 73/89) than the placebo (20.0%, 10/50, P < 0.001). Regarding safety, adverse events were observed in 83.2% (84/101) and 80.8% (42/52), and adverse drug reactions (ADR) in 23.8% (24/101) and 3.8% (2/52) of F‐RVCZ and placebo subjects, respectively. ADR were mild to moderate in severity, with none being serious. F‐RVCZ (equivalent to 100 mg ravuconazole) administrated once daily for 12 weeks was more effective than placebo and tolerable in patients with onychomycosis, suggesting it to be a promising drug for onychomycosis treatment.
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影响因子：
4.9
作者：
Cuenca-Estrella, M;Gomez-Lopez, A;Rodriguez-Tudela, JL
通讯作者：
Rodriguez-Tudela, JL
影响因子：
9.4
作者：
Pfaller, MA;Diekema, DJ;Messer, SA
通讯作者：
Messer, SA
影响因子：
3.1
作者：
Watanabe, Shinichi;Kishida, Hiroshi;Okubo, Akihiro
通讯作者：
Okubo, Akihiro
影响因子：
4.9
作者：
Pfaller, MA;Messer, SA;Diekema, DJ
通讯作者：
Diekema, DJ
影响因子：
13.8
作者：
Elewski, Boni E.;Rich, Phoebe;Olin, Jason T.
通讯作者：
Olin, Jason T.