A new calcipotriol/beta methasone formulation with rapid onset of action was superior to monotherapy with betamethasone dipropionate or calcipotriol in psoriasis vulgaris
A new calcipotriol/beta methasone formulation with rapid onset of action was superior to monotherapy with betamethasone dipropionate or calcipotriol in psoriasis vulgaris
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DOI：
10.1080/00015550252948194
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发表时间：
2002-01-01
影响因子：
3.6
通讯作者：
Bibby, AJ
中科院分区：
文献类型：
--
作者：
Douglas, WS;Poulin, Y;Bibby, AJ
在本研究中，我们比较了一种含有钙化三醇和二丙酸倍他米松的新型联合软膏与二丙酸倍他米松软膏（diproone (R)）和钙化三醇软膏（Daivonex(R)）在寻常型银屑病患者中的疗效；1106例患者随机分为双盲治疗组，每日2次，联合双丙酸倍他米松或钙化三醇治疗4周。然后患者每天接受两次钙化三醇，无盲治疗，持续4周。双盲期结束时PASI的平均百分比变化为-74.4（联合组），-61.3（倍他米松组）和-55.3（钙化三醇组）。联合倍他米松的平均差异（95% Cl）为-13.1(-16.9至-9.3,p < 0.001)，联合钙化三醇的平均差异为- 19.0（- 22.8至- 15.2,p < 0.001）。1周后PASI的差异也有统计学意义。在双盲期，8.1%的患者（联合）报告了病变/病灶周围不良反应，而倍他米松和钙化三醇分别为4.7%和12.0%。在联合组，双盲期结束时的平均PASI为2.5，非盲期结束时的平均PASI为3.6，而倍他米松组为3.9和4.1，钙化三醇组为4.4和3.7。钙化三醇/倍他米松联合使用比单独使用任何一种活性成分更有效，起效更快，耐受性良好。患者从联合用药转为钙化三醇用药是安全的，临床效果维持。
In this study, we compared a new combination ointment containing both calcipotriol and betamethasone dipropionate with betamethasone dipropionate ointment (Diprosone(R)) and calcipotriol ointment (Daivonex(R)) 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 I 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.