卡泊三醇倍他米松二丙酸酯头皮制剂用于头皮银屑病长期治疗的安全性和有效性研究。
A study of the safety and efficacy of calcipotriol and betamethasone dipropionate scalp formulation in the long-term management of scalp psoriasis.
作者信息
Luger T A, Cambazard F, Larsen F G, Bourcier M, Gupta G, Clonier F, Kidson P, Shear N H
机构信息
Department of Dermatology, University Clinic Münster, Münster, Germany.
出版信息
Dermatology. 2008;217(4):321-8. doi: 10.1159/000155642. Epub 2008 Sep 12.
BACKGROUND
Effective and safe products are needed for long-term management of scalp psoriasis. This study investigated the long-term safety and efficacy of a two-compound formulation (calcipotriol 50 microg/g plus betamethasone dipropionate 0.5 mg/g) for scalp psoriasis.
METHODS
In this 52-week, international, double-blind study, 869 patients with moderate-to-severe scalp psoriasis were randomized to either a two-compound scalp formulation (n = 429) or calcipotriol (n = 440).
RESULTS
Adverse drug reactions were less frequent in the two-compound group compared with the calcipotriol group (17.2 vs. 29.5%; p < 0.001). Incidences of adverse events possibly associated with long-term corticosteroid use were low in both the two-compound (2.6%) and the calcipotriol (3.0%) groups. Disease was satisfactorily controlled in 92.3% of visits in the two-compound group versus 80.0% in the calcipotriol group (p < 0.001).
CONCLUSION
The two-compound scalp formulation demonstrated a high level of safety and efficacy in long-term management of scalp psoriasis.
背景
头皮银屑病的长期管理需要有效且安全的产品。本研究调查了一种复方制剂（卡泊三醇50微克/克加二丙酸倍他米松0.5毫克/克）用于头皮银屑病的长期安全性和有效性。
方法
在这项为期52周的国际双盲研究中，869例中度至重度头皮银屑病患者被随机分为复方头皮制剂组（n = 429）或卡泊三醇组（n = 440）。
结果
与卡泊三醇组相比，复方组的药物不良反应发生率更低（17.2%对29.5%；p < 0.001）。复方组（2.6%）和卡泊三醇组（3.0%）中可能与长期使用皮质类固醇有关的不良事件发生率均较低。复方组92.3%的访视中疾病得到满意控制，而卡泊三醇组为80.0%（p < 0.001）。
结论
复方头皮制剂在头皮银屑病的长期管理中显示出高度的安全性和有效性。
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