Department of Medical Sciences, Section of Dermatology and Infectious Diseases, University of Ferrara, Ferrara, Italy.
Research Innovation Office, S. Anna University Hospital of Ferrara, Ferrara, Italy.
Dermatol Ther. 2021 Jul;34(4):e14955. doi: 10.1111/dth.14955. Epub 2021 May 4.
A complete clearance of vulvar lichen sclerosus (VLS) is achieved in a minority of patients treated with a standard 12-week duration corticosteroid treatment. The aim of this pragmatic, retrospective, open label, comparative trial was to assess the effectiveness, in terms of complete clearance, of a 24-week treatment with mometasone furoate 0.1% ointment (MMF) and to compare it with a 12-week therapy. We included VLS patients treated with MMF administered for five consecutive days/week for 24 weeks (group A). The following were assessed: (a) clearance in Global Subjective Score (GSS), Global Objective Score (GOS) or both, (b) changes of these parameters and dyspareunia at treatment completion compared to baseline, (c) safety profile. All these assessments were compared with the same outcomes recorded among VLS patients who had previously undergone a 12-week MMF treatment (group B). Twenty-nine patients were included in group A and 32 in group B. The rates of patients who achieved the clearance of GSS, GOS or both parameters did not significantly differ between groups A and B. The groups did not differ in any of the effectiveness outcomes assessed. A 24-week duration corticosteroid treatment does not seem to provide significant therapeutic benefits in comparison with standard 12-week courses, especially considering the occurrence of complete clearance.
外阴硬化性苔藓(VLS)患者经标准 12 周皮质类固醇治疗后,仅有少数患者可完全清除病变。本研究采用实用、回顾性、开放标签、对照试验的方法,旨在评估莫米松糠酸酯 0.1%软膏(MMF)24 周治疗的有效性(以完全清除为标准),并与 12 周治疗进行比较。我们纳入了接受 MMF 治疗的 VLS 患者,治疗方案为每周连续 5 天用药,共 24 周(A 组)。评估内容包括:(a)GSS 和/或 GOS 评分完全清除率;(b)与基线相比,治疗结束时这些参数和性交困难的变化;(c)安全性特征。将这些评估与 VLS 患者之前接受的 12 周 MMF 治疗(B 组)的相同结果进行比较。A 组有 29 例患者,B 组有 32 例患者。A 组和 B 组在 GSS、GOS 或两者均完全清除的患者比例方面无显著差异。两组在评估的任何有效性结果方面均无差异。与标准的 12 周疗程相比,24 周皮质类固醇治疗似乎并不能提供显著的治疗益处,尤其是考虑到完全清除的发生。