一种作用起效迅速的新钙泊三醇/倍他米松制剂在寻常型银屑病治疗中优于倍他米松二丙酸酯或钙泊三醇单药治疗。
A new calcipotriol/betamethasone formulation with rapid onset of action was superior to monotherapy with betamethasone dipropionate or calcipotriol in psoriasis vulgaris.
作者信息
Douglas W S, Poulin Y, Decroix J, Ortonne J P, Mrowietz U, Gulliver W, Krogstad A L, Larsen F G, Iglesias L, Buckley C, Bibby A J
机构信息
Department of Dermatology, Monklands Hospital, Lanarkshire, Scotland, UK.
出版信息
Acta Derm Venereol. 2002;82(2):131-5. doi: 10.1080/00015550252948194.
In this study, we compared a new combination ointment containing both calcipotriol and betamethasone dipropionate with betamethasone dipropionate ointment (Diprosone) and calcipotriol ointment (Daivonex) in patients with psoriasis vulgaris; 1106 patients were randomized to twice daily double-blind treatment with combination, betamethasone dipropionate or calcipotriol for 4 weeks. Patients then received twice daily calcipotriol, unblinded, for a further 4 weeks. Mean percentage change in PASI at end of the double-blind phase was -74.4 (combination group), -61.3 (betamethasone group) and -55.3 (calcipotriol group). Mean difference (95% Cl) combination-betamethasone was -13.1 (-16.9 to -9.3, p < 0.001) and for combination-calcipotriol -19.0 (-22.8 to -15.2, p <0.001). The differences in PASI were also statistically significant after 1 week. In the double-blind phase, 8.1% of patients (combination) reported lesional/ perilesional adverse reactions compared to 4.7% (betamethasone) and 12.0% (calcipotriol). In the combination group, mean PASI at the end of the double-blind phase was 2.5, and at end of the unblinded phase 3.6, compared with 3.9 and 4.1 (betamethasone) and 4.4 and 3.7 (calcipotriol). Calcipotriol/betamethasone combination is more effective and has a more rapid onset of action than either active constituent used alone, and is well tolerated. It is safe to transfer patients from combination to calcipotriol, with maintenance of clinical effect.
在本研究中,我们将一种同时含有卡泊三醇和二丙酸倍他米松的新复方软膏与二丙酸倍他米松软膏(得肤宝)及卡泊三醇软膏(达力士)用于寻常型银屑病患者进行比较;1106例患者被随机分为三组,分别接受每日两次的复方软膏、二丙酸倍他米松或卡泊三醇双盲治疗,为期4周。之后患者继续接受每日两次的卡泊三醇治疗,为期4周,此阶段不再设盲。双盲阶段结束时,银屑病面积和严重程度指数(PASI)的平均变化百分比在复方组为-74.4,倍他米松组为-61.3,卡泊三醇组为-55.3。复方组与倍他米松组的平均差值(95%置信区间)为-13.1(-16.9至-9.3,p<0.001),复方组与卡泊三醇组为-19.0(-22.8至-15.2,p<0.001)。1周后PASI的差异也具有统计学意义。在双盲阶段,复方组有8.1%的患者报告有皮损/皮损周围不良反应,倍他米松组为4.7%,卡泊三醇组为12.0%。双盲阶段结束时,复方组的平均PASI为2.5,非盲阶段结束时为3.6,倍他米松组分别为3.9和4.1,卡泊三醇组分别为4.4和3.7。卡泊三醇/倍他米松复方制剂比单独使用任何一种活性成分更有效,起效更快,且耐受性良好。将患者从复方制剂转换为卡泊三醇治疗是安全的,且能维持临床疗效。