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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。第二部分:与几种市售制剂的对比研究(作者译)

[Multicentre-clinical trial of the novel corticosteroid diflucortolone valerate in the forms of cream, ointment and fatty ointment. Part II: Comparative study with several commercial preparations (author's transl)].

作者信息

Reckers V R, Wendt H

出版信息

Arzneimittelforschung. 1976;26(7b):1504-9.

PMID:795434
Abstract

6alpha,9-Difluoro-11beta-hydroxy-16alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione (diflucortolone valerate, Nerisona) in the forms of cream, ointment and fatty ointment was investigated against 5 commercial preparations with beta-methasone-17-valerate, fluocinonide, fluocinolone acetonide, flumetasone pivalate and desoximetasone in 15 simultaneously conducted and multicentre-clinical studies-all on double-blind contralateral studies-involving a total of 1923 patients. The Nerisona preparations proved to be highly effective-particularly in eczematous diseases- and comparable to the above-mentioned commercial preparations. Nerisona ointment was shown to be superior to flumetasone cream. The statistical reliability of such data is discussed.

摘要

以乳膏、软膏和脂肪性软膏形式存在的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),在15项同时开展的多中心临床研究(均为双盲对侧研究)中,与5种含17 - 戊酸倍他米松、氟轻松、醋酸氟轻松、匹伐氟米松和去氧米松的市售制剂进行了对比,共涉及1923例患者。结果表明,Nerisona制剂具有高效性,尤其在治疗湿疹类疾病方面,与上述市售制剂效果相当。Nerisona软膏表现优于匹伐氟米松乳膏。文中还讨论了此类数据的统计可靠性。

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