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氟可丁酯与氟氢可的松及醋酸氢化可的松双盲对侧比较的临床试验(作者译)

[Clinical trial of fluocortin butylester in a double-blind contralateral comparison versus fluocortolone and hydrocortisone acetate (author's transl)].

作者信息

Reckers R

出版信息

Arzneimittelforschung. 1977;27(11a):2240-4.

PMID:341901
Abstract

Butyl 6alpha-fluoro-11beta-hydroxy-3,20-dioxo-16alpha-methyl-1,4-pregnadien-21-oate (fluocortin butylester, Vaspit) is a recently developed corticosteroid, its distinguishing properties being that it is non-embryotoxic and has practially no systemic effects. In the course of 6 multicentre studies fluocortin butylester was tested in the forms of cream, ointment and fatty ointment in a comparison with corresponding formulations containing fluocortolone (Ultralan) caproate or pivalate, or hydrocortisone acetate. The total study population comprised 1705 patients with various dermal disorders. The results of these double-blind contralateral studies permit the conclusion that the efficacy of the Vaspit preparations ranges between those of fluocortolone and hydrocortisone acetate. Considering the risks involved with local corticosteroid therapy in children the development of a local corticosteroid with the properties of fluocortin butylester must be acknowledged as an advance.

摘要

6α-氟-11β-羟基-3,20-二氧代-16α-甲基-1,4-孕二烯-21-酸丁酯(氟可丁酯,Vaspit)是一种最近研发的皮质类固醇,其显著特性是无胚胎毒性且几乎无全身作用。在6项多中心研究中,对氟可丁酯的乳膏、软膏和脂肪性软膏剂型进行了测试,并与含己酸氟氢可的松(优乐散)或特戊酸酯,或醋酸氢化可的松的相应制剂进行比较。研究总人群包括1705例患有各种皮肤疾病的患者。这些双盲对侧研究的结果表明,Vaspit制剂的疗效介于氟氢可的松和醋酸氢化可的松之间。鉴于儿童局部使用皮质类固醇治疗存在风险,研发具有氟可丁酯特性的局部皮质类固醇必须被视为一项进步。

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