Olivier Valérie, Lacour Jean-Philippe, Mousnier Aline, Garraffo Rodolphe, Monteil Roger A, Ortonne Jean-Paul
Department of Dermatology, Hôpital Archet-2, BP 3079, 06202 Nice CEDEX, France.
Arch Dermatol. 2002 Oct;138(10):1335-8. doi: 10.1001/archderm.138.10.1335.
Chronic erosive oral lichen planus (EOLP) is a severe form of lichen of the buccal mucosa that is often resistant to systemic or topical therapies.
To evaluate the efficacy and safety of topical tacrolimus, 0.1 mg per 100 mL of water, in treating EOLP.
Open-label, prospective, noncomparative study, with 6 months of treatment and 6 months of follow-up.
Dermatology department at a university hospital in Nice, France.
Ten patients with histologically proved EOLP that was refractory to treatment. Two patients were withdrawn because of noncompliance; findings in 8 were available for evaluation.
Mouthwashes with tacrolimus, 0.1 mg per 100 mL of distilled water, 4 times daily for 6 months.
Efficacy was assessed using a calculated score that combined the intensity of spontaneous and meal-triggered pain and the surface area of erosions. Safety assessment included the monitoring of adverse effects, clinical laboratory values, and blood concentrations of tacrolimus.
Among the 8 patients evaluated, 1 had no improvement and 7 were improved. The mean score decreased from 7.00 at baseline to 5.43 (a 22.43% decrease) at 1 month, 4.14 (a 40.86% decrease) at 2 months, 3.00 (a 57.14% decrease) at 3 months, 2.43 (a 65.29% decrease) at 4 months, 2.57 (a 63.29% decrease) at 5 months, and 3.43 (a 51.00% decrease) at 6 months. A decrease of symptoms was reported by the 7 responding patients as soon as the first month of treatment. No severe adverse effects were observed. All patients had whole-blood concentrations of tacrolimus below the detection limit of the assay (1.5 ng/mL) at all intervals. At 9 months, 6 patients had had a relapse within a mean of 38.6 days. At 12 months, all patients had had a relapse and required treatment with topical corticosteroids or systemic hydroxychloroquine sulfate.
Results of our study suggest a rapid and important palliating effect of low concentration of topical tacrolimus in distilled water in patients with EOLP.
慢性糜烂性口腔扁平苔藓（EOLP）是口腔黏膜扁平苔藓的一种严重形式，通常对全身或局部治疗有抵抗性。
评估每100毫升水中含0.1毫克他克莫司的局部用药治疗EOLP的疗效和安全性。
开放标签、前瞻性、非对照研究，为期6个月的治疗和6个月的随访。
法国尼斯一家大学医院的皮肤科。
10例经组织学证实为治疗抵抗性的EOLP患者。2例因不依从退出研究；8例患者的结果可供评估。
用每100毫升蒸馏水中含0.1毫克他克莫司的漱口水，每天4次，共6个月。
疗效通过综合自发痛和进餐诱发痛的强度以及糜烂表面积计算得出的评分进行评估。安全性评估包括监测不良反应、临床实验室值和他克莫司的血药浓度。
在评估的8例患者中，1例无改善，7例有改善。平均评分从基线时的7.00降至1个月时的5.43（下降22.43%），2个月时为4.14（下降40.86%），3个月时为3.00（下降57.14%），4个月时为2.43（下降65.29%），5个月时为2.57（下降63.29%），6个月时为3.43（下降51.00%）。7例有反应的患者在治疗的第一个月就报告症状减轻。未观察到严重不良反应。所有患者在所有时间点的他克莫司全血浓度均低于检测限（1.5纳克/毫升）。9个月时，6例患者平均在38.6天内复发。12个月时，所有患者均复发，需要局部使用糖皮质激素或全身性硫酸羟氯喹治疗。
我们的研究结果表明，低浓度的他克莫司蒸馏水局部用药对EOLP患者有快速且显著的缓解作用。
