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1%布替萘芬乳膏治疗股癣:一项多中心、赋形剂对照、双盲试验

Butenafine 1% cream in the treatment of tinea cruris: a multicenter, vehicle-controlled, double-blind trial.

作者信息

Lesher J L, Babel D E, Stewart D M, Jones T M, Kaminester L, Goldman M, Weintraub J S

机构信息

Department of Medicine, Medical College of Georgia, Augusta 30912-3190, USA.

出版信息

J Am Acad Dermatol. 1997 Feb;36(2 Pt 1):S20-4. doi: 10.1016/s0190-9622(97)70318-9.

DOI:10.1016/s0190-9622(97)70318-9
PMID:9039201
Abstract

BACKGROUND

Butenafine hydrochloride, a potent antifungal agent related to the allylamines, has been used in Japan for treating various cutaneous mycoses including tinea cruris.

OBJECTIVE

We compared the safety and efficacy of butenafine hydrochloride and its vehicle when used once daily for 2 weeks to treat tinea cruris.

METHODS

Patients (n = 93) with tinea cruris and a positive potassium hydroxide examination and mycologic culture were enrolled. Of the 76 patients assessed for efficacy, 37 applied butenafine and 39 applied vehicle once daily for 2 weeks. Assessments were made at the end of the 2-week treatment period and 4 weeks after the end of treatment.

RESULTS

Patients in the butenafine group had a higher mycologic cure rate by day 7 (66% vs 13%, p < 0.0001), with marked improvement 4 weeks after the end of treatment (81% vs 13%, p < 0.0001). They also had a higher rate of effective treatment at day 7 (29% vs 5%, p < 0.01) and at 4 weeks after treatment (73% vs 5%, p < 0.0001). Adverse events definitely related to butenafine treatment were limited to one case of burning sensation after application.

CONCLUSION

Butenafine applied once daily for 2 weeks is effective in treating tinea cruris. The proportion of patients cured increased between the end of treatment and 4 weeks after treatment.

摘要

背景

盐酸布替萘芬是一种与烯丙胺类有关的强效抗真菌剂,在日本已用于治疗包括股癣在内的各种皮肤真菌病。

目的

我们比较了盐酸布替萘芬及其赋形剂每日一次使用2周治疗股癣的安全性和有效性。

方法

纳入氢氧化钾检查和真菌培养阳性的股癣患者(n = 93)。在评估疗效的76例患者中,37例应用布替萘芬,39例应用赋形剂,每日一次,共2周。在2周治疗期结束时和治疗结束后4周进行评估。

结果

布替萘芬组患者在第7天时真菌治愈率更高(66%对13%,p < 0.0001),治疗结束后4周有明显改善(81%对13%,p < 0.0001)。他们在第7天和治疗后4周的有效治疗率也更高(29%对5%,p < 0.01;73%对5%,p < 0.0001)。与布替萘芬治疗明确相关的不良事件仅限于1例用药后烧灼感。

结论

每日一次应用布替萘芬2周治疗股癣有效。治疗结束至治疗后4周期间治愈患者的比例增加。

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J Am Acad Dermatol. 1997 Feb;36(2 Pt 1):S20-4. doi: 10.1016/s0190-9622(97)70318-9.
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A comparative study to evaluate efficacy, safety and cost-effectiveness between Whitfield's ointment + oral fluconazole versus topical 1% butenafine in tinea infections of skin.一项比较研究,以评估惠菲尔德软膏+口服氟康唑与外用1%布替萘芬在皮肤癣菌感染中的疗效、安全性和成本效益。
Indian J Pharmacol. 2013 Nov-Dec;45(6):622-4. doi: 10.4103/0253-7613.121378.
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A comparative randomized open label study to evaluate efficacy, safety and cost effectiveness between topical 2% sertaconazole and topical 1% butenafine in tinea infections of skin.一项比较随机开放标签研究,以评估2%硝酸舍他康唑乳膏与1%布替萘芬乳膏治疗皮肤癣菌感染的疗效、安全性和成本效益。
Indian J Dermatol. 2013 Nov;58(6):451-6. doi: 10.4103/0019-5154.119955.
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Experimental and conformational analyses of interactions between butenafine and lipids.布替萘芬与脂质相互作用的实验及构象分析
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