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卤米松乳膏的国际临床试验概述。

An overview of international clinical trials with halometasone cream.

作者信息

Yawalkar S J, Macarol V, Montanari C

出版信息

J Int Med Res. 1983;11 Suppl 1:1-7.

PMID:6339286
Abstract

In international multicentre comparative clinical trials carried out by dermatologists in 717 patients with non-infected acute eczematous dermatoses at 28 trial centres in Austria, Germany, Holland, Switzerland and Yugoslavia, halometasone cream exhibited a very satisfactory therapeutic effect in acute contact dermatitis, atopic dermatitis, nummular dermatitis and seborrhoeic dermatitis. It yielded 'good' to 'very good' results in 89.7% of the 333 patients treated with halometasone cream. Halometasone cream was significantly more effective than Diproderm, Diprosone and Ultralan creams with respect to the overall success rate, the percentage of patients with 'very good' results and early cures. It proved marginally superior to Halciderm cream in therapeutic efficacy. The onset of therapeutic effect was more rapid in patients treated with halometasone cream than in those on treatment with comparative preparations. Halometasone cream was well tolerated and neither skin atrophy nor any systemic effect due to the transcutaneous systemic absorption of the corticoid was observed. In view of the rapid onset of action, very good efficacy and tolerability, halometasone cream, with agreeable cosmetic and applicatory properties, may be considered as a suitable corticosteroid topical for the treatment of acute eczematous and other corticosteroid-responsive dermatoses.

摘要

在奥地利、德国、荷兰、瑞士和南斯拉夫的28个试验中心,皮肤科医生对717例非感染性急性湿疹性皮炎患者进行了国际多中心对比临床试验。卤米松乳膏在急性接触性皮炎、特应性皮炎、钱币状皮炎和脂溢性皮炎中显示出非常令人满意的治疗效果。在333例接受卤米松乳膏治疗的患者中,89.7%的患者取得了“良好”至“非常好”的疗效。在总体成功率、“非常好”疗效患者的百分比和早期治愈率方面,卤米松乳膏显著优于双醋二氟松乳膏、二丙酸倍他米松乳膏和优力肤乳膏。在治疗效果上,它略优于氯氟舒松乳膏。使用卤米松乳膏治疗的患者比使用对照制剂治疗的患者起效更快。卤米松乳膏耐受性良好,未观察到因皮质类固醇经皮全身吸收导致的皮肤萎缩或任何全身效应。鉴于起效迅速、疗效极佳且耐受性良好,卤米松乳膏具有良好的美容和使用特性,可被视为治疗急性湿疹性及其他对皮质类固醇有反应的皮肤病的合适外用皮质类固醇。

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