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钙泊三醇/倍他米松二丙酸酯:治疗躯干、四肢和头皮寻常性银屑病的应用评价。

Calcipotriol/betamethasone dipropionate: a review of its use in the treatment of psoriasis vulgaris of the trunk, limbs and scalp.

机构信息

Adis, a Wolters Kluwer Business, Auckland, New Zealand.

出版信息

Drugs. 2011 Apr 16;71(6):709-30. doi: 10.2165/11207300-000000000-00000.

Abstract

Calcipotriol/betamethasone dipropionate (calcipotriol 50 μg/g and betamethasone 0.5 mg/g) is a fixed-dose combination of a vitamin D(3) analogue and a corticosteroid indicated for the once-daily, topical treatment of psoriasis vulgaris of the trunk, limbs and scalp in adults. Both the ointment (Daivobet®; Dovobet®) and gel (Xamiol®; Daivobet® Gel; Dovobet® Gel) formulations of calcipotriol/betamethasone dipropionate can be used to treat psoriasis vulgaris of the trunk and/or limbs, although the gel formulation was specifically developed for the treatment of scalp psoriasis. This article reviews the efficacy and tolerability of calcipotriol/betamethasone dipropionate in patients with psoriasis vulgaris, as well as summarizing its pharmacological properties. Calcipotriol/betamethasone dipropionate has low systemic absorption and displays local anti-inflammatory and immunoregulatory properties. It reduces the hyperproliferation of keratinocytes and helps normalize keratinocyte differentiation. In large, well designed clinical trials, calcipotriol/betamethasone dipropionate, either as the ointment or the gel formulation, applied once daily for 4-8 weeks, was more effective than placebo, calcipotriol and tacalcitol, as well as betamethasone dipropionate in most instances, for the topical, symptomatic treatment of psoriasis vulgaris of the trunk/limbs. Likewise, calcipotriol/betamethasone dipropionate gel applied once daily for 8 weeks was more effective than placebo or either component alone in the topical, symptomatic treatment of psoriasis vulgaris of the scalp. Long-term, once-daily, when required therapy with calcipotriol/betamethasone dipropionate for 52 weeks was more effective than calcipotriol alone for the treatment of scalp psoriasis, and was at least as effective as switching to calcipotriol for 48 weeks after 4 weeks of calcipotriol/betamethasone dipropionate or alternating between calcipotriol/betamethasone dipropionate and calcipotriol every 4 weeks for 52 weeks in the treatment of psoriasis vulgaris of the trunk/limbs. Calcipotriol/betamethasone dipropionate also improved health-related quality of life. Calcipotriol/betamethasone dipropionate was generally well tolerated, with most adverse drug reactions being lesional or perilesional effects of mild or moderate severity. Calcipotriol/betamethasone dipropionate was often associated with fewer lesional/perilesional adverse reactions than calcipotriol or tacalcitol and did not appear to be associated with a higher incidence of corticosteroid-related adverse events during long-term therapy. Pharmacoeconomic analyses predicted calcipotriol/betamethasone dipropionate to be more cost effective than other topical therapies. Thus, calcipotriol/betamethasone dipropionate is an important, effective, once-daily, topical therapy for the symptomatic treatment of psoriasis vulgaris of the trunk, limbs and scalp.

摘要

钙泊三醇/倍他米松二丙酸酯(钙泊三醇 50μg/g 和倍他米松 0.5mg/g)是一种维生素 D3 类似物和皮质类固醇的固定剂量组合,适用于治疗成人寻常型银屑病的躯干、四肢和头皮的每日一次局部治疗。钙泊三醇/倍他米松二丙酸酯的软膏(达力士®;都保®)和凝胶(Xamiol®;达力士®凝胶;都保®凝胶)制剂均可用于治疗躯干和/或四肢的寻常型银屑病,尽管凝胶制剂是专门为治疗头皮银屑病而开发的。本文回顾了钙泊三醇/倍他米松二丙酸酯治疗寻常型银屑病患者的疗效和耐受性,并总结了其药理学特性。钙泊三醇/倍他米松二丙酸酯全身吸收低,具有局部抗炎和免疫调节作用。它可减少角质形成细胞的过度增殖,并有助于使角质形成细胞分化正常化。在大型、设计良好的临床试验中,钙泊三醇/倍他米松二丙酸酯软膏或凝胶制剂,每日一次使用 4-8 周,在大多数情况下,比安慰剂、钙泊三醇和他卡西醇以及倍他米松二丙酸酯更有效,用于治疗躯干/四肢寻常型银屑病的症状。同样,钙泊三醇/倍他米松二丙酸酯凝胶每日一次使用 8 周,在治疗头皮银屑病的症状方面,比安慰剂或单独使用任何一种药物都更有效。长期、每日一次,当需要使用钙泊三醇/倍他米松二丙酸酯治疗 52 周时,治疗头皮银屑病的效果优于单独使用钙泊三醇,并且在治疗躯干/四肢寻常型银屑病时,与转换为钙泊三醇治疗 48 周或在使用钙泊三醇/倍他米松二丙酸酯治疗 4 周后交替使用钙泊三醇/倍他米松二丙酸酯或每 4 周交替使用钙泊三醇/倍他米松二丙酸酯和钙泊三醇 52 周的效果一样好。钙泊三醇/倍他米松二丙酸酯还改善了与健康相关的生活质量。钙泊三醇/倍他米松二丙酸酯一般耐受性良好,大多数药物不良反应为轻度或中度严重程度的皮损或皮损周围效应。与钙泊三醇或他卡西醇相比,钙泊三醇/倍他米松二丙酸酯通常与较少的皮损/皮损周围不良反应相关,并且在长期治疗期间似乎不会与更高的皮质类固醇相关不良反应发生率相关。药物经济学分析预测钙泊三醇/倍他米松二丙酸酯比其他局部治疗更具成本效益。因此,钙泊三醇/倍他米松二丙酸酯是一种重要的、有效的、每日一次的局部治疗方法,可用于治疗躯干、四肢和头皮的寻常型银屑病的症状。

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