Monshi Babak, Ellersdorfer Christina, Edelmayer Michael, Dvorak Gabriella, Ganger Clemens, Ulm Christian, Rappersberger Klemens, Vujic Igor
Department of Dermatology and Venereology, Klinik Landstraße, Juchgasse 25, 1030 Vienna, Austria.
Clinical Division of Oral Surgery, University Clinic of Dentistry, Medical University of Vienna, Sensengasse 2a, 1090 Vienna, Austria.
J Clin Med. 2021 Nov 22;10(22):5454. doi: 10.3390/jcm10225454.
Topical cyclosporine (CSA) has been reported as an alternative treatment in steroid-refractory oral lichen planus (OLP), but evidence is limited and conflicting. An N-of-1 trial setting could be appropriate to evaluate interindividual differences in treatment response. We studied a series of 21 open-label, biphasic single-patient observations. Patients (15 women, 6 men) with OLP recalcitrant to topical steroids received four weeks of CSA mouth rinse (200 mg/twice daily) followed by four weeks of drug withdrawal. Pain (visual analogue scale (VAS) score), disease extent (physicians' global assessment (PGA) score) and quality of life (Dermatology Life Quality Index (DLQI) score,) were assessed at baseline (T0), after four weeks of treatment (T1) and after another four weeks without treatment (T2). Median age was 58 years (interquartile range/IQR = 52-67) and median disease duration was 18 months (IQR = 12-44). Median baseline VAS score decreased significantly at T1 ( = 0.0003) and increased at T2 ( = 0.032) (T0 = 5 (IQR = 3-6.5); T1 = 2 (IQR = 0.5-3.4); T2 = 3 (IQR = 2-4.8)). Similarly, median baseline PGA score decreased significantly at T1 ( = 0.001) and increased at T2 ( = 0.007) (T0 = 2 (IQR = 1.3-2.5); T1 = 1 (IQR = 1-2); T2 = 2 (IQR = 1-2)). Median baseline DLQI score also decreased significantly at T1 ( =.027) but did not change at T2 ( = 0.5) (T0 = 2.5 (IQR = 1-5.8); T1 = 1 (IQR = 0-3); T2 = 1 (IQR = 1-4)). CSA responders ( = 16) had significantly higher median baseline VAS scores (5.2 (IQR = 5-6.5)) than nonresponders ( =5) (2 (IQR = 2-3.5) ( = 0.02). In our study, pain, disease extent and quality of life of patients with OLP improved significantly during therapy with low-dose CSA mouth rinse and exacerbated after drug withdrawal. Remarkably, patients with high initial VAS scores seemed to profit most.
局部用环孢素（CSA）已被报道可作为类固醇难治性口腔扁平苔藓（OLP）的替代治疗方法，但证据有限且相互矛盾。N-of-1试验设置可能适合评估个体间治疗反应的差异。我们研究了一系列21例开放标签、双相单患者观察病例。对局部类固醇治疗无效的OLP患者（15名女性，6名男性）接受了四周的CSA漱口水治疗（200毫克/每日两次），随后停药四周。在基线（T0）、治疗四周后（T1）和停药四周后（T2）评估疼痛（视觉模拟量表（VAS）评分）、疾病范围（医生整体评估（PGA）评分）和生活质量（皮肤病生活质量指数（DLQI）评分）。中位年龄为58岁（四分位间距/IQR = 52 - 67），中位病程为18个月（IQR = 12 - 44）。中位基线VAS评分在T1时显著降低（ = 0.0003），在T2时升高（ = 0.032）（T0 = 5（IQR = 3 - 6.5）；T1 = 2（IQR = 0.5 - 3.4）；T2 = 3（IQR = 2 - 4.8））。同样，中位基线PGA评分在T1时显著降低（ = 0.001），在T2时升高（ = 0.007）（T0 = 2（IQR = 1.3 - 2.5）；T1 = 1（IQR = 1 - 2）；T2 = 2（IQR = 1 - 2））。中位基线DLQI评分在T1时也显著降低（ =.027），但在T2时未改变（ = 0.5）（T0 = 2.5（IQR = 1 - 5.8）；T1 = 1（IQR = 0 - 3）；T2 = 1（IQR = 1 - 4））。CSA反应者（ = 16）的中位基线VAS评分（5.2（IQR = 5 - 6.5））显著高于无反应者（ =5）（2（IQR = 2 - 3.5）（ = 0.02）。在我们的研究中，OLP患者的疼痛、疾病范围和生活质量在低剂量CSA漱口水治疗期间显著改善，停药后加重。值得注意的是，初始VAS评分高的患者似乎获益最大。
