First Department of Dermatology-Venereology, Aristotle University Medical School, Thessaloniki, Greece.
J Urol. 2010 Apr;183(4):1395-9. doi: 10.1016/j.juro.2009.12.057. Epub 2010 Feb 19.
Genital lichen sclerosus is a chronic inflammatory and fibrosclerotic disease associated with substantial morbidity. Acitretin has been reported to be of benefit in many dermatological indications including lichen sclerosus. We evaluated the efficacy and tolerability of acitretin for biopsy confirmed, severe lichen sclerosus of the male genitalia.
A randomized, double-blind, placebo controlled study was performed in which 52 male patients with severe, long-standing lichen sclerosus were randomized in a 2:1 ratio to receive daily acitretin (35 mg) or placebo for 20 consecutive weeks. Followup lasted for 36 weeks from baseline. The primary end point was complete response of active lichen sclerosus as well as improvement of patient quality of life. Secondary end points were partial response and recurrence rates after treatment discontinuation.
A total of 49 patients completed the study and were eligible for statistical analysis. Complete response was achieved by 36.4% (12 of 33) of the acitretin group vs 6.3% (1 of 16) of the controls, while 36.4% (12 of 33) vs 12.5% (2 of 16) achieved partial resolution, respectively. Mean total clinical score of the acitretin group was significantly lower than that of the controls at week 20 [t (47) = -4.146, p = 0.00 < 0.5], which was also accompanied by a significant improvement in mean Dermatology Life Quality Index score [t (32) = 6,441, p = 0.000 < 0.05]. Acitretin was well tolerated and only minimal transient side effects were recorded.
Acitretin is safe and effective for the management of severe, long-standing lichen sclerosus of the male genitalia. Study limitations included bias during clinical evaluation considering the expected side effects of acitretin.
生殖器硬化性苔藓是一种与大量发病率相关的慢性炎症性和纤维化疾病。阿维 A 酯已被报道对多种皮肤科适应症有益，包括硬化性苔藓。我们评估了阿维 A 酯治疗男性生殖器活检证实的严重硬化性苔藓的疗效和耐受性。
进行了一项随机、双盲、安慰剂对照研究，将 52 名患有严重、长期硬化性苔藓的男性患者随机分为 2:1 比例，每天接受阿维 A 酯（35mg）或安慰剂治疗 20 周。随访时间从基线开始持续 36 周。主要终点是活动性硬化性苔藓的完全缓解以及患者生活质量的改善。次要终点是治疗停止后的部分缓解和复发率。
共有 49 名患者完成了研究并符合统计学分析要求。阿维 A 酯组完全缓解率为 36.4%（12/33），对照组为 6.3%（1/16），部分缓解率分别为 36.4%（12/33）和 12.5%（2/16）。阿维 A 酯组的平均总临床评分在第 20 周明显低于对照组[t（47）=-4.146，p=0.00<0.5]，同时平均皮肤病生活质量指数评分也显著改善[t（32）=6，441，p=0.000<0.05]。阿维 A 酯耐受性良好，仅记录到轻微的短暂副作用。
阿维 A 酯治疗男性生殖器严重、长期硬化性苔藓安全有效。研究局限性包括考虑到阿维 A 酯的预期副作用，在临床评估中存在偏倚。
