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含有卡泊三醇/倍他米松二丙酸酯的复方软膏(他卡西醇/得肤宝/达力士软膏)的短期和长期安全性评估:寻常型银屑病患者的下丘脑-垂体-肾上腺轴功能

Short- and long-term safety assessment of a two-compound ointment containing calcipotriene/betamethasone dipropionate (Taclonex/Daivobet/Dovobet ointment): hypothalamic-pituitary-adrenal axis function in patients with psoriasis vulgaris.

作者信息

Fleming Colin, Ganslandt Cecilia, Leese Graham P

机构信息

Ninewells Hospital and Medical School, Dundee, United Kingdom.

出版信息

J Drugs Dermatol. 2010 Aug;9(8):969-74.

PMID:20684147
Abstract

The two-compound ointment (Taclonex/Daivobet/Dovobet ointment) combining calcipotriene 50 microg/g and betamethasone 0.5 mg/g (as dipropionate) is very effective in the treatment of psoriasis vulgaris. There is a possibility that hypothalamo-pituitary-axis (HPA) suppression may occur if the potent corticosteroid component is absorbed to a sufficient extent. The effect of the two-compound ointment on HPA axis function was assessed in two studies. Study 1 was a four-week, double-blind study which compared the effects of the two-compound ointment with betamethasone 0.5 mg/g (as dipropionate; Diprosone) ointment in 24 patients with extensive psoriasis (involving 15-30% of the body surface area). No patients receiving the two-compound ointment had HPA axis suppression. Study 2 assessed HPA axis function after four and 52 weeks in a subset of patients (n = 19) participating in a long-term safety study. Patients were treated with the two-compound ointment for the first four weeks followed by 48 weeks of treatment as needed with either 1) two-compound ointment; 2) two-compound ointment alternating with calcipotriene four-weekly or 3) calcipotriene. No patients using the two-compound ointment for all 52 weeks or alternating four-weekly with calcipotriene had HPA axis suppression.

摘要

将50微克/克卡泊三醇与0.5毫克/克倍他米松(以二丙酸酯形式)混合的复方软膏(Taclonex/Daivobet/Dovobet软膏)在寻常型银屑病的治疗中非常有效。如果强效皮质类固醇成分被充分吸收,有可能会发生下丘脑 - 垂体轴(HPA)抑制。在两项研究中评估了该复方软膏对HPA轴功能的影响。研究1是一项为期四周的双盲研究,比较了该复方软膏与0.5毫克/克倍他米松(以二丙酸酯形式;得宝松)软膏对24例广泛银屑病患者(累及体表面积15 - 30%)的影响。接受复方软膏治疗的患者中没有出现HPA轴抑制。研究2在参与一项长期安全性研究的部分患者(n = 19)中,在四周和52周后评估了HPA轴功能。患者在前四周接受复方软膏治疗,随后根据需要进行48周的治疗,治疗方式为:1)复方软膏;2)复方软膏与卡泊三醇每四周交替使用;或3)卡泊三醇。在全部52周均使用复方软膏或每四周与卡泊三醇交替使用的患者中,没有出现HPA轴抑制。

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