Kragballe K, Barnes L, Hamberg K J, Hutchinson P, Murphy F, Møller S, Ruzicka T, Van De Kerkhof P C
Department of Dermatology, Marselisborg Hospital, DK-800 Aarhus C, Denmark.
Br J Dermatol. 1998 Oct;139(4):649-54. doi: 10.1046/j.1365-2133.1998.02461.x.
The objectives of the study were to determine whether concurrent treatment with calcipotriol (50 microg/g) and either clobetasone 17-butyrate cream (0.5 mg/g) (moderate potency) or betamethasone 17-valerate cream (1 mg/g) (potent) or placebo (vehicle of calcipotriol) was more effective and/or caused less skin irritation than calcipotriol cream (50 microg/g) used twice daily. It was a multicentre, double-blind, parallel group study. Patients applied calcipotriol cream in the morning and either vehicle (n = 174), calcipotriol (n = 174), clobetasone (n = 175) or betamethasone creams (n = 176) in the evening for up to 8 weeks. Adverse events led to withdrawal in 20 patients (2.9%). The mean percentage change in PASI (psoriasis area and severity index) was -40.6 in the calcipotriol/vehicle group, -48.3 in the calcipotriol/calcipotriol group, -53.7 in the calcipotriol/clobetasone 17-butyrate group and -57.5 in the calcipotriol/betamethasone 17-valerate group. A statistically significant difference was seen between the four treatment groups (P = 0.006) with calcipotriol/vehicle being less effective than the other treatments. A statistically significant difference in favour of calcipotriol/betamethasone 17-valerate was seen between the calcipotriol/calcipotriol group and the calcipotriol/betamethasone 17-valerate group. The majority of adverse events were skin irritations, which were reported for 31.2% of patients treated with calcipotriol/vehicle, 34.3% of patients treated with calcipotriol twice daily and 23.8% vs. 17.1% of patients treated with calcipotriol/clobetasone 17-butyrate and calcipotriol/betamethasone 17-valerate, respectively. Skin irritation was seen statistically significantly less frequently in patients treated with calcipotriol/ clobetasone 17-butyrate or calcipotriol/betamethasone 17-valerate (P = 0.001), whereas no difference was seen between the other groups. In conclusion, calcipotriol applied twice daily was as effective as calcipotriol/clobetasone 17-butyrate, but slightly less effective than calcipotriol/betamethasone 17-valerate. The incidence of skin irritation was less for patients using concurrent corticosteroids, whereas treatment with calcipotriol/vehicle did not reduce the incidence of skin irritation when compared with calcipotriol twice daily.
该研究的目的是确定，与每日两次使用的卡泊三醇乳膏（50μg/g）相比，卡泊三醇（50μg/g）与丁酸氯倍他松乳膏（0.5mg/g，中效）或戊酸倍他米松乳膏（1mg/g，强效）或安慰剂（卡泊三醇赋形剂）联合治疗是否更有效和/或引起更少的皮肤刺激。这是一项多中心、双盲、平行组研究。患者在早晨涂抹卡泊三醇乳膏，晚上涂抹赋形剂（n = 174）、卡泊三醇（n = 174）、丁酸氯倍他松（n = 175）或戊酸倍他米松乳膏（n = 176），持续8周。不良事件导致20名患者（2.9%）退出。卡泊三醇/赋形剂组的银屑病面积和严重程度指数（PASI）平均变化百分比为-40.6，卡泊三醇/卡泊三醇组为-48.3，卡泊三醇/丁酸氯倍他松组为-53.7，卡泊三醇/戊酸倍他米松组为-57.5。四个治疗组之间存在统计学显著差异（P = 0.006），卡泊三醇/赋形剂组比其他治疗组效果差。卡泊三醇/卡泊三醇组和卡泊三醇/戊酸倍他米松组之间，观察到有利于卡泊三醇/戊酸倍他米松的统计学显著差异。大多数不良事件是皮肤刺激，接受卡泊三醇/赋形剂治疗的患者中有31.2%报告出现皮肤刺激，每日两次接受卡泊三醇治疗的患者中有34.3%，接受卡泊三醇/丁酸氯倍他松和卡泊三醇/戊酸倍他米松治疗的患者中分别有23.8%和17.1%。接受卡泊三醇/丁酸氯倍他松或卡泊三醇/戊酸倍他米松治疗的患者中，皮肤刺激的发生率在统计学上显著较低（P = 0.001），而其他组之间未观察到差异。总之，每日两次使用卡泊三醇与卡泊三醇/丁酸氯倍他松效果相同，但比卡泊三醇/戊酸倍他米松稍差。联合使用皮质类固醇的患者皮肤刺激发生率较低，而与每日两次使用卡泊三醇相比，使用卡泊三醇/赋形剂治疗并未降低皮肤刺激的发生率。
