First randomized trial on clobetasol propionate and mometasone furoate in the treatment of vulvar lichen sclerosus: results of efficacy and tolerability
First randomized trial on clobetasol propionate and mometasone furoate in the treatment of vulvar lichen sclerosus: results of efficacy and tolerability
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DOI：
10.1111/bjd.12910
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发表时间：
2014-08-01
影响因子：
10.3
通讯作者：
Corazza, M.
中科院分区：
文献类型：
--
作者：
Virgili, A.;Borghi, A.;Corazza, M.
背景 丙酸氯倍他索 (CP) 局部应用 3 个月是外阴硬化性苔藓 (VLS) 的推荐和公认的一线治疗方法；然而，迄今为止，还没有随机对照试验比较 CP 与其他外用皮质类固醇的疗效和安全性。目的 比较两种不同的外用皮质类固醇（0.05% CP 软膏和 0.1% 糠酸莫米松 (MMF) 软膏）治疗 VLS 的有效性和耐受性。 方法 54 例 VLS 患者入组，进入为期 12 周的积极治疗阶段 (ATP)，并在逐渐减量的方案中随机使用 CP 或 MMF。主要疗效参数是缓解率、主观和客观评分较基线改善>= 75%的患者比例以及整个治疗过程中主观和客观评分的平均下降。 结果 到 12 周 ATP 结束时，CP 患者中 24 名 (89%) 患者被认为是缓解者，MMF 患者中 24 名 (89%) 患者被认为是缓解者； CP 组中 59% 和 37% 的患者以及 MMF 组中 67% 和 48% 的患者的主观和客观评分分别提高了至少 75%。与基线相比，两种治疗的平均症状和体征评分均显着下降。 CP 和 MMF 之间的任何评估疗效终点均未发现显着差异。两种治疗方法均具有良好的耐受性。 结论 丙酸氯倍他索和 MMF 对于 VLS 的治疗似乎同样有效且耐受性良好，两者都可能代表该疾病的一线治疗方法。
Background A 3-month topical application of clobetasol propionate (CP) represents the recommended and accepted first-line treatment for vulvar lichen sclerosus (VLS); however, to date, no randomized controlled trials have compared the efficacy and safety of CP with other topical corticosteroids. Objective To compare the effectiveness and tolerability of two different topical corticosteroids, CP 0.05% ointment and mometasone furoate (MMF) 0.1% ointment, in the treatment of VLS.Methods Fifty-four patients with VLS were enrolled in a 12-week active treatment phase (ATP) and randomized to apply either CP or MMF in a tapering regimen. The main efficacy parameters were the response rate, the rate of patients achieving an improvement from baseline of >= 75% in the subjective and objective scores, and the mean reduction in subjective and objective scores throughout the treatment.Results By the end of the 12-week ATP, 24 (89%) patients were considered to be responders among the CP patients and 24 (89%) among the MMF patients; 59% and 37% of patients in the CP group and 67% and 48% in the MMF group achieved an improvement of at least 75% in subjective and objective scores, respectively. The decrease in mean symptom and sign scores was significant compared with baseline with both treatments. No significant differences were found in any of the assessed efficacy endpoints between CP and MMF. Both treatments were well tolerated.Conclusions Clobetasol propionate and MMF appeared similarly efficacious and well tolerated for the treatment of VLS and both may represent the first-line treatment for the disease.