Kragballe K, Noerrelund K L, Lui H, Ortonne J P, Wozel G, Uurasmaa T, Fleming C, Estebaranz J L López, Hanssen L I, Persson L-M
Marselisborg Centret, Aarhus, Denmark.
Br J Dermatol. 2004 Jun;150(6):1167-73. doi: 10.1111/j.1365-2133.2004.05986.x.
A two-compound ointment containing calcipotriol 50 micro g g-1 and betamethasone dipropionate 0.5 mg g-1 has recently been shown to be an effective treatment for psoriasis.
This study was designed to investigate efficacy and safety of different treatment regimens with the two-compound product (Daivobet/Dovobet; LEO Pharma, Ballerup, Denmark) and calcipotriol 50 micro g g-1 ointment (Daivonex/Dovonex; LEO Pharma).
In total, 972 patients with psoriasis vulgaris were randomized to one of three treatment regimens: group 1, the two-compound product once daily for 8 weeks followed by calcipotriol ointment once daily for 4 weeks; group 2, the two-compound product once daily for 4 weeks followed by 8 weeks of treatment with calcipotriol ointment once daily on weekdays and the two-compound product once daily at weekends; and group 3, calcipotriol ointment twice daily for 12 weeks. The efficacy was evaluated by Psoriasis Area and Severity Index (PASI) and investigators' global assessments of disease severity. The primary response criteria were percentage reduction in PASI and proportion of patients with absent/very mild disease according to the investigators' global assessments after 8 weeks of treatment.
The mean reduction in PASI from baseline to the end of 8 weeks of treatment was 73.3% for group 1, 68.2% for group 2 and 64.1% for group 3. The proportion of patients with absent/very mild disease at the end of 8 weeks of treatment was 55.3% for group 1, 47.7% for group 2 and 40.7% for group 3. For both primary response criteria, group 1 was statistically superior to group 3 (P < 0.001), whereas group 2 did not differ significantly from group 3. The difference between group 1 and group 2 was statistically significant with regard to PASI but not regarding the proportion of patients with absent/very mild disease. Patients receiving initial therapy with the two-compound product achieved the fastest treatment response, and the maximum treatment effect for these patients was seen after 5 weeks. This effect was maintained with continued treatment with the two-compound product for up to 8 weeks. After 12 weeks of treatment, no significant differences were seen between the three groups with regard to reduction in PASI, whereas the proportion of patients with absent/very mild disease in group 2 was superior to that in group 3. Patients receiving therapy with the two-compound product experienced fewer lesional/perilesional adverse drug reactions than the calcipotriol-treated patients (P < 0.001): 10.9% in group 1, 11.5% in group 2 and 22.3% in group 3.
Two different short-term treatment regimens employing a recently developed two-compound product (calcipotriol/betamethasone dipropionate) provided rapid and marked clinical efficacy and were shown to be safe therapies for psoriasis vulgaris.
一种含有50μg/g卡泊三醇和0.5mg/g二丙酸倍他米松的复方软膏最近已被证明是治疗银屑病的有效方法。
本研究旨在调查使用该复方产品（得肤宝/达力士；丹麦利奥制药公司，巴勒鲁普）和50μg/g卡泊三醇软膏（达可普明/达力士；丹麦利奥制药公司）的不同治疗方案的疗效和安全性。
总共972例寻常型银屑病患者被随机分为三种治疗方案之一：第1组，复方产品每日一次，持续8周，然后卡泊三醇软膏每日一次，持续4周；第2组，复方产品每日一次，持续4周，然后在工作日使用卡泊三醇软膏每日一次治疗8周，周末使用复方产品每日一次；第3组，卡泊三醇软膏每日两次，持续12周。通过银屑病面积和严重程度指数（PASI）以及研究者对疾病严重程度的整体评估来评估疗效。主要反应标准为治疗8周后PASI的降低百分比以及根据研究者的整体评估无/非常轻度疾病的患者比例。
从基线到治疗8周结束时，第1组PASI的平均降低率为73.3%，第2组为68.2%，第3组为64.1%。治疗8周结束时无/非常轻度疾病的患者比例，第1组为55.3%，第2组为47.7%，第3组为40.7%。对于两个主要反应标准，第1组在统计学上优于第3组（P<0.001），而第2组与第3组无显著差异。第1组和第2组在PASI方面差异有统计学意义，但在无/非常轻度疾病患者比例方面无差异。接受复方产品初始治疗的患者实现了最快的治疗反应，这些患者在5周后出现最大治疗效果。用复方产品持续治疗长达8周可维持这一效果。治疗12周后，三组在PASI降低方面无显著差异，而第2组无/非常轻度疾病的患者比例优于第3组。接受复方产品治疗的患者比接受卡泊三醇治疗的患者出现皮损/皮损周围药物不良反应的情况更少（P<0.001）：第1组为10.9%，第2组为11.5%，第3组为22.3%。
采用最近开发的复方产品（卡泊三醇/二丙酸倍他米松）的两种不同短期治疗方案提供了快速且显著的临床疗效，并且被证明是治疗寻常型银屑病的安全疗法。
