Ebert Anne K, Rösch Wolfgang H, Vogt Thomas
Department of Pediatric Urology, Klinik St. Hedwig, University of Regensburg, Steinmetzstrasse 1-3, Regensburg, Germany.
Eur Urol. 2008 Oct;54(4):932-7. doi: 10.1016/j.eururo.2008.03.013. Epub 2008 Mar 19.
Management of lichen sclerosus (LS) in boys is still controversial. Although in most cases only the prepuce is affected, meatal and urethral involvement may require major surgical reconstruction with substantial morbidity.
Because the frequency of such complicated courses is still unclear, an adjuvant postoperative treatment is highly desirable. Therefore, we addressed safety and tolerability of tacrolimus 0.1% ointment in the postoperative period.
DESIGN, SETTING, AND PARTICIPANTS: Among 222 penile surgeries, in 25 cases LS was confirmed histologically and 20 of those patients participated in the adjuvant treatment study. Moreover, 18 patients of the same cohort showed a lichenoid inflammatory reaction pattern suggestive of early but not fully established LS.
Subsequent to the operation and after explicit information about off-label use, parents applied tacrolimus 0.1% ointment twice daily to the glans and the meatus for 3 wk in cases of proven LS. The 18 patients with possible early LS were followed up only without any treatment. Clinical follow-up was performed up to 13 mo (median).
All 20 LS patients completed the topical treatment without any relevant side-effects. Two relapses occurred in the treatment group and were clinically cured with an additional 3-wk cycle of topical tacrolimus 0.1% ointment. None of the 18 early LS cases progressed to full-scale LS.
This is the first study showing that tacrolimus 0.1% ointment applied immediately after surgery of fully established LS is a tolerable and most probably safe adjuvant novel treatment option. Because the therapy led to disease control in all treated individuals for >1 yr (median), this study establishes the groundwork for future trials with expanded treatment and follow-up periods to verify the true clinical benefit of tacrolimus in patients after LS surgery. Lichenoid tissue reactions suggestive of early LS seem to require no adjuvant treatment.
男孩扁平苔藓（LS）的治疗仍存在争议。尽管在大多数情况下仅包皮受累，但尿道口和尿道受累可能需要进行大型手术重建，且会带来较高的发病率。
由于此类复杂病程的发生率仍不明确，术后辅助治疗非常必要。因此，我们探讨了术后使用0.1%他克莫司软膏的安全性和耐受性。
设计、地点和参与者：在222例阴茎手术中，25例经组织学确诊为LS，其中20例患者参与了辅助治疗研究。此外，同一队列中的18例患者表现出苔藓样炎症反应模式，提示早期但尚未完全确诊的LS。
手术之后，在明确告知药物标签外使用情况后，对于确诊为LS的病例，家长每天两次在龟头和尿道口涂抹0.1%他克莫司软膏，持续3周。18例可能为早期LS的患者仅进行随访，未接受任何治疗。临床随访长达13个月（中位数）。
所有20例LS患者均完成了局部治疗，未出现任何相关副作用。治疗组出现2例复发，再次使用0.1%他克莫司软膏进行3周的局部治疗后临床治愈。18例早期LS病例均未发展为完全型LS。
这是第一项表明在完全确诊的LS手术后立即使用0.1%他克莫司软膏是一种耐受性良好且很可能安全的新型辅助治疗选择的研究。由于该治疗使所有接受治疗的个体疾病得到控制超过1年（中位数），本研究为未来扩大治疗和随访期的试验奠定了基础，以验证他克莫司对LS手术后患者的真正临床益处。提示早期LS的苔藓样组织反应似乎无需辅助治疗。
