Tosti A, Piraccini B M, Cameli N, Kokely F, Plozzer C, Cannata G E, Benelli C
Department of Dermatology, University of Bologna, Via Massarenti 1, 40138 Bologna, Italy.
Br J Dermatol. 1998 Oct;139(4):655-9. doi: 10.1046/j.1365-2133.1998.02462.x.
This double-blind randomized study was designed to compare the efficacy and safety of calcipotriol ointment (50 microg/g) with betamethasone dipropionate (64 mg/g) and salicylic acid (0.03 g/g) ointment in the treatment of nail bed psoriasis. Fifty-eight patients applied the given drug to the affected nails twice a day for 3-5 months, depending on clinical response. Efficacy was assessed monthly on the basis of nail thickness, measured in millimetres. Photographs of the treated nails were taken at baseline, and after 3 and 5 months. Tolerability was assessed at 3 and 5 months. In patients with fingernail psoriasis, after 3 months of treatment subungual hyperkeratosis was reduced from 2.3 +/- 0.1 mm (mean +/- SEM) to 1.5 +/- 0.1 mm (-26.5%) in the calcipotriol group and from 2.3 +/- 0.1 mm to 1.6 +/- 0.1 mm (-30.4%) in the betamethasone dipropionate and salicylic acid group [not significant (NS) between treatments, analysis of variance (ANOVA)]. After 5 months, responders showed a 49.2% reduction in hyperkeratosis in the calcipotriol group (from 2.8 +/- 0.1 mm to 1.4 +/- 0.2 mm) and 51.7% (from 2.1 +/- 0.1 mm to 1.0 +/- 0.1 mm) in the betamethasone dipropionate and salicylic acid group (P < 0.001 from baseline, NS between treatments, ANOVA). In patients with toenail psoriasis, after 3 months of treatment there was an overall reduction in hyperkeratosis from 2.6 +/- 0.1 mm to 2.1 +/- 0.1 mm (-20.1%) in the calcipotriol group and from 3.0 +/- 0.1 mm to 2.3 +/- 0.1 mm (-22. 9%) in the betamethasone dipropionate and salicylic acid group (P < 0.001 from baseline, NS between treatments, ANOVA). By the end of the fifth month there was a 40.7% reduction in hyperkeratosis in the calcipotriol group (from 2.1 +/- 0.1 mm to 1.2 +/- 0.1 mm) and 51.9% in the betamethasone dipropionate and salicylic acid group (from 2.7 +/- 0.1 mm to 1.3 +/- 0.1 mm; P < 0.0001 from baseline, NS between treatments, ANOVA). The results of the study show that calcipotriol is as effective as a combination of a topical steroid with salicylic acid in the treatment of nail psoriasis and represents a safe alternative in the topical treatment of nail psoriasis.
本双盲随机研究旨在比较卡泊三醇软膏（50μg/g）与倍他米松二丙酸酯（64mg/g）和水杨酸（0.03g/g）软膏治疗甲床银屑病的疗效和安全性。58例患者根据临床反应，每天两次将指定药物涂抹于患甲，持续3 - 5个月。每月根据以毫米为单位测量的指甲厚度评估疗效。在基线时、3个月和5个月后拍摄治疗指甲的照片。在3个月和5个月时评估耐受性。对于手指甲银屑病患者，治疗3个月后，卡泊三醇组的甲下角化过度从2.3±0.1mm（均值±标准误）降至1.5±0.1mm（-26.5%），倍他米松二丙酸酯和水杨酸组从2.3±0.1mm降至1.6±0.1mm（-30.4%）[治疗组间差异无统计学意义（NS），方差分析（ANOVA）]。5个月后，有反应者在卡泊三醇组的角化过度降低了49.2%（从2.8±0.1mm降至1.4±0.2mm），在倍他米松二丙酸酯和水杨酸组降低了51.7%（从2.1±0.1mm降至1.0±0.1mm）（与基线相比P<0.001，治疗组间差异无统计学意义，ANOVA）。对于脚趾甲银屑病患者，治疗3个月后，卡泊三醇组的角化过度总体从2.6±0.1mm降至2.1±0.1mm（-20.1%），倍他米松二丙酸酯和水杨酸组从3.0±0.1mm降至2.3±0.1mm（-22.9%）（与基线相比P<0.001，治疗组间差异无统计学意义，ANOVA）。到第5个月末，卡泊三醇组的角化过度降低了40.7%（从2.1±0.1mm降至1.2±0.1mm），倍他米松二丙酸酯和水杨酸组降低了51.9%（从2.7±0.1mm降至1.3±0.1mm；与基线相比P<0.0001，治疗组间差异无统计学意义，ANOVA）。研究结果表明，卡泊三醇在治疗甲银屑病方面与外用类固醇和水杨酸联合使用一样有效，是甲银屑病局部治疗的一种安全替代方法。
