Hengge U R, Krause W, Hofmann H, Stadler R, Gross G, Meurer M, Brinkmeier T, Frosch P, Moll I, Fritsch P, Müller K, Meykadeh N, Marini A, Ruzicka T, Gollnick H
Department of Andrology and Venereology, Philipps-University Marburg, Marburg, Germany.
Br J Dermatol. 2006 Nov;155(5):1021-8. doi: 10.1111/j.1365-2133.2006.07446.x.
Lichen sclerosus is a chronic inflammatory autoimmune disease causing significant sclerosis, atrophy and pruritus. Treatment remains unsatisfactory, with potent corticosteroids being the most effective therapy.
To conduct a multicentre, phase II trial to assess the safety and efficacy of tacrolimus ointment 0.1% for the treatment of lichen sclerosus with a follow-up period of 18 months at 10 university and teaching hospitals in Germany and Austria.
Eighty-four patients (49 women, 32 men and three girls) aged between 5 and 85 years with long-standing, active lichen sclerosus (79 with anogenital and five with extragenital localization) were treated with topical tacrolimus ointment 0.1% twice daily for 16 weeks. Computerized analysis of the lesional area was performed. The primary endpoint was clearance of active lichen sclerosus. Secondary endpoints were time to optimal response, reduction of sclerosis and duration of remission.
The primary endpoint (clearance of active lichen sclerosus) was reached by 43% of patients at 24 weeks of treatment. Partial resolution was reached in 34% of patients. Maximal effects occurred between week 10 and 24 of therapy. Treatment led to a significant reduction of the total lesional area (P < 0.01) and to a significant decline in the total symptom score (P < 0.005). Symptoms (e.g. itching) and findings (erythema, erosions and induration) showed significant improvement. No serious adverse events were observed. There were three (9%) recurrences during the follow-up period.
Topical tacrolimus ointment 0.1% was safe and effective for the treatment of long-standing active lichen sclerosus.
硬化性苔藓是一种慢性炎症性自身免疫性疾病，可导致明显的硬化、萎缩和瘙痒。治疗效果仍不尽人意，强效皮质类固醇是最有效的治疗方法。
在德国和奥地利的10所大学及教学医院进行一项多中心II期试验，以评估0.1%他克莫司软膏治疗硬化性苔藓的安全性和有效性，随访期为18个月。
84例年龄在5至85岁之间患有长期活动性硬化性苔藓的患者（49名女性、32名男性和3名女孩）（79例为肛门生殖器部位，5例为生殖器外部位）接受每日两次外用0.1%他克莫司软膏治疗，持续16周。对皮损面积进行计算机分析。主要终点是活动性硬化性苔藓的清除。次要终点是达到最佳反应的时间、硬化程度的减轻和缓解持续时间。
43%的患者在治疗24周时达到主要终点（活动性硬化性苔藓的清除）。34%的患者部分缓解。最大疗效出现在治疗的第10至24周之间。治疗导致皮损总面积显著减少（P < 0.01），总症状评分显著下降（P < 0.005）。症状（如瘙痒）和体征（红斑、糜烂和硬结）有显著改善。未观察到严重不良事件。随访期间有3例（9%）复发。
外用0.1%他克莫司软膏治疗长期活动性硬化性苔藓安全有效。
