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一项关于足癣患者使用1周特比萘芬乳膏与4周咪康唑乳膏疗效对比的双盲研究。

Double-blind study of the efficacy of 1 week topical terbinafine cream compared to 4 weeks miconazole cream in patients with tinea pedis.

作者信息

Leenutaphong V, Niumpradit N, Tangwiwat S, Sritaveesuwan R, Muanprasat C

机构信息

Department of Dermatology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand.

出版信息

J Med Assoc Thai. 1999 Oct;82(10):1006-10.

Abstract

OBJECTIVE

To compare the efficacy of terbinafine cream for 1 week with the efficacy of miconazole cream for 4 weeks in the treatment of tinea pedis.

METHOD

Patients who visited our clinic for tinea pedis and who had positive KOH preparation and positive culture for dermatophyte were treated with terbinafine cream for 1 week and placebo for 3 weeks, or with miconazole cream for 4 weeks. Evaluation was done 1, 2, 3, 4 and 10 weeks after the start of the treatment. Mycological cure was defined as presence of a positive KOH preparation and a positive culture before treatment, and negative results for both after treatment. Clinical efficacy was defined as mycological cure and presence of at most a total signs and symptoms score of two.

RESULT

Forty-eight patients were studied. Half of them were treated with terbinafine and placebo and the other half with miconazole. Both groups had an equal distribution as to age, sex, race, duration and seriousness of the fungal infection and previous treatment. Mycological cure and clinical efficacy throughout the evaluation were similar in both treatment groups. After 10 weeks, mycological cure was seen in about 52.6 per cent and 55 per cent, and clinical efficacy in about 47 per cent, 45 per cent in terbinafine and miconazole treatment group respectively.

CONCLUSION

In the treatment of tinea pedis local application of terbinafine cream for 1 week is as good as treatment with miconazole cream for 4 weeks.

摘要

目的

比较特比萘芬乳膏治疗1周与咪康唑乳膏治疗4周对足癣的疗效。

方法

到本诊所就诊的足癣患者,若其KOH涂片及皮肤癣菌培养呈阳性,则给予特比萘芬乳膏治疗1周,安慰剂治疗3周,或给予咪康唑乳膏治疗4周。在治疗开始后的1、2、3、4和10周进行评估。真菌学治愈定义为治疗前KOH涂片及培养均为阳性,治疗后两者均为阴性。临床疗效定义为真菌学治愈且总体征和症状评分至多为2分。

结果

共研究了48例患者。其中一半接受特比萘芬和安慰剂治疗,另一半接受咪康唑治疗。两组在年龄、性别、种族、真菌感染的持续时间和严重程度以及既往治疗方面分布均衡。两个治疗组在整个评估过程中的真菌学治愈情况和临床疗效相似。10周后,特比萘芬治疗组和咪康唑治疗组的真菌学治愈率分别约为52.6%和55%,临床有效率分别约为47%和45%。

结论

在足癣治疗中,局部应用特比萘芬乳膏1周与应用咪康唑乳膏4周的效果相当。

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