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新型皮质类固醇戊酸二氟可龙乳膏、软膏和脂肪性软膏的多中心临床试验。第一部分:戊酸二氟可龙与氟可龙、己酸酯、新戊酸酯在双侧双盲局部应用设计中的对比研究(作者译)

[Multicentre-clinical trial of the novel corticosteroid diflucortolone valerate in the forms of cream, ointment and fatty ointment. Part I: Comparative study of diflucortolone valerate with fluocortolone, -capronate, -pivalate in a double-blind contralateral design with topical application (author's transl)].

作者信息

Reckers V R, Wendt H

出版信息

Arzneimittelforschung. 1976;26(7b):1499-504.

PMID:795433
Abstract

6alpha,9-Difluor-11beta-hydroxy-16alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione (diflucortolone valerate, Nerisona) 0.1% as a cream, ointment and fatty ointment was investigated in a double-blind contralateral design in 925 patients in comparison to fluocortolone (Ultralan), fluocortolone caproate and fluocortolone pivalate in three concurrently performed studies. The results of the contralateral study show Nerisona cream and ointment to be more effective (P less than 0.01) than Ultralan. The fatty ointment was also superior, but the difference was statistically significant (P less than 0.05) only in the indication psoriasis. No differences could be established in the less sensitive absolute assessment. The therapeutic success rate of 76-92% according to strict criteria-only complete healing and distinct improvement were counted as a success-clearly demonstrates the efficacy of the preparations. The local side effects recorded-mainly irritation and burning- were of a mild nature.

摘要

在三项同步进行的研究中,采用双盲对侧设计,对925例患者使用6α,9 - 二氟 - 11β - 羟基 - 16α - 甲基 - 21 - 戊酰氧基 - 1,4 - 孕二烯 - 3,20 - 二酮(戊酸二氟可龙,Nerisona)0.1%的乳膏、软膏和脂肪性软膏进行了研究,并与氟可龙(Ultralan)、己酸氟可龙和特戊酸氟可龙进行了比较。对侧研究结果显示,Nerisona乳膏和软膏比Ultralan更有效(P<0.01)。脂肪性软膏也更具优势,但仅在银屑病适应症中差异具有统计学意义(P<0.05)。在不太敏感的绝对评估中未发现差异。根据严格标准(仅将完全愈合和明显改善计为成功),治疗成功率为76% - 92%,清楚地证明了这些制剂的疗效。记录的局部副作用主要为刺激和烧灼感,性质较轻。

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