Kragballe K, Gjertsen B T, De Hoop D, Karlsmark T, van de Kerkhof P C, Larkö O, Nieboer C, Roed-Petersen J, Strand A, Tikjøb G
Department of Dermatology, Marselisborg Hospital, Aarhus, Denmark.
Lancet. 1991 Jan 26;337(8735):193-6. doi: 10.1016/0140-6736(91)92157-w.
The therapeutic efficacy and tolerability of calcipotriol ointment and betamethasone valerate ointment in psoriasis were compared in a multicentre, prospective, randomised, double-blind, right/left trial. 345 inpatients and outpatients with psoriasis vulgaris of symmetrical distribution were treated twice daily for 6 weeks with calcipotriol ointment 50 micrograms/g and betamethasone ointment 0.1% randomly assigned to opposite sides of the body. The main outcome measures--the psoriasis area and severity index (PASI), the investigators' assessments of erythema, thickness, and scaling, and the patients' own assessments of the overall response to treatment--were sought at weeks 2, 4, and 6. Both treatments significantly reduced the PASI scores and the investigator's assessment scores, but at each visit the PASI score was significantly (p less than 0.001) lower with calcipotriol than with betamethasone. At 6 weeks the mean PASI reduction was 68.8% with calcipotriol and 61.4% with betamethasone (95% confidence interval for difference 5.1-9.8, p less than 0.001). The scores for erythema, thickness, and scaling were significantly (p less than 0.001) lower with calcipotriol than with betamethasone at the end of treatment. The patients considered that 82.1% of calcipotriol-treated sides and 69.3% of betamethasone-treated sides had improved greatly or cleared up by the end of treatment (p less than 0.001). 57 adverse events were reported by 52 patients (15.1%). The most common adverse event, lesional/perilesional skin irritation, was slightly but not significantly (p = 0.12) more common with calcipotriol treatment. 15 (4.3%) patients were withdrawn from the study, 3 because of local adverse events. There were no changes in serum calcium during the study. Thus, calcipotriol ointment was superior to betamethasone valerate ointment in psoriasis vulgaris. Though long-term results are not yet available, calcipotriol holds great promise as an antipsoriatic agent.
在一项多中心、前瞻性、随机、双盲、左右对照试验中，比较了卡泊三醇软膏和倍他米松戊酸酯软膏治疗银屑病的疗效和耐受性。345例寻常型银屑病患者（包括住院患者和门诊患者），其皮损呈对称分布，随机将卡泊三醇软膏（50微克/克）和0.1%倍他米松软膏分别涂抹于身体的对侧，每日两次，治疗6周。在第2、4和6周时，评估主要结局指标——银屑病面积和严重程度指数（PASI）、研究者对红斑、厚度和鳞屑的评估以及患者对治疗总体反应的自我评估。两种治疗方法均显著降低了PASI评分和研究者的评估评分，但每次访视时，卡泊三醇治疗组的PASI评分均显著低于倍他米松治疗组（p<0.001）。在6周时，卡泊三醇组的PASI平均降低68.8%，倍他米松组为61.4%（差异的95%置信区间为5.1 - 9.8，p<0.001）。治疗结束时，卡泊三醇组的红斑、厚度和鳞屑评分显著低于倍他米松组（p<0.001）。患者认为，治疗结束时，82.1%使用卡泊三醇治疗的部位和69.3%使用倍他米松治疗的部位有显著改善或已消退（p<0.001）。52例患者（15.1%）报告了57例不良事件。最常见的不良事件是皮损/皮损周围皮肤刺激，卡泊三醇治疗组的发生率略高，但无显著差异（p = 0.12）。15例（4.3%）患者退出研究，3例因局部不良事件退出。研究期间血清钙水平无变化。因此，在寻常型银屑病的治疗中，卡泊三醇软膏优于倍他米松戊酸酯软膏。虽然尚未获得长期结果，但卡泊三醇作为一种抗银屑病药物具有很大的前景。
