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1%奥昔康唑乳膏和洗剂每日一次局部给药治疗皮肤癣菌病的临床疗效和安全性评估:一项开放标签、非对照的多中心研究。

Evaluation of clinical efficacy and safety of once daily topical administration of 1% oxiconazole cream and lotion in dermatophytosis : an open label, non comparative multicentre study.

作者信息

Jerajani H R, Amladi S T, Bongale R, Adepu V, Tendolkar U M, Sentamilselvi G, Janaki V R, Janaki C, Vidhya S, Marfatia Y S, Patel K, Sharma N, Cooverji N D

机构信息

LTM Medical College & LTM General Hospital, Sion, Mumbai, Madras Medical College & Government General Hospital, Madras, SSG Medical College and General Hospital, Baroda, Glaxo & Wellcome India, India.

出版信息

Indian J Dermatol Venereol Leprol. 2000 Jul-Aug;66(4):188-92.

PMID:20877072
Abstract

The clinical efficacy and safety of once daily topical administration of 1% oxiconazole cream and lotion was assessed in an open label, non comparative trial in tinea cruris, tinea corporis and tinea pedis patients. In treated patients, severity scores of erythema, pruritus, scaling, vesicles, papules and burning showed a progressive fall over a period of 4 weeks at all the study centres. With lotion, mean percentage improvement of symptoms varied from 35% (week 1) to 87.6 - 98.7% (week 4). With cream, it varied from 35% (week 1) to 82.5 - 99.5% (week 4). Overall global evaluation response showed clear, excellent and good response in 60%, 21% and 17% of the patients treated with lotion respectively. With cream, excellent and good response was observed in 71%, 10% and 16% of the patients respectively. In T. pedis patients, clear, excellent and good response was observed in 4/8, 2/8 and 1/8 patients respectively with lotion. Cream showed clear (8/15), excellent (4/15) and good (1/15) in these patients. None of the patients out of 178 enrolled, reported any side effect during the trial.

摘要

在一项针对股癣、体癣和足癣患者的开放标签、非对照试验中,评估了每日一次局部使用1%奥昔康唑乳膏和洗剂的临床疗效和安全性。在接受治疗的患者中,所有研究中心的红斑、瘙痒、脱屑、水疱、丘疹和烧灼感的严重程度评分在4周内逐渐下降。使用洗剂时,症状的平均改善百分比从第1周的35%到第4周的87.6 - 98.7%不等。使用乳膏时,其变化范围从第1周的35%到第4周的82.5 - 99.5%。总体综合评估反应显示,使用洗剂治疗的患者中,分别有60%、21%和17%的患者有明显、极佳和良好的反应。使用乳膏时,分别有71%、10%和16%的患者观察到极佳和良好的反应。在足癣患者中,使用洗剂的患者分别有4/8、2/8和1/8的患者有明显、极佳和良好的反应。在这些患者中,乳膏显示出明显(8/15)、极佳(4/15)和良好(1/15)的反应。在178名入组患者中,没有患者在试验期间报告任何副作用。

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