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1%特比萘芬乳-凝胶与2%酮康唑乳膏治疗股癣和体癣的对比研究

Comparative study between terbinafine 1% emulsion-gel versus ketoconazole 2% cream in tinea cruris and tinea corporis.

作者信息

Bonifaz A, Saúl A

机构信息

Dermatology Service and Mycology Department, General Hospital of Mexico, Zempoalo 60-101, Navarte, Mexico D.F., C.P. 03020, Mexico.

出版信息

Eur J Dermatol. 2000 Mar;10(2):107-9.

Abstract

An open, prospective, comparative, randomised and parallel-group study of 65 patients was conducted to evaluate the efficacy and safety of topical 1 % emulsion-gel of terbinafine versus 2% ketoconazole cream in the treatment of tinea corporis and tinea cruris. Treatment for terbinafine emulsion-gel was applied once daily for 1 week, whereas ketoconazole cream was applied once daily for 2 weeks; patients were followed for 2 weeks. Thirty-three patients in the terbinafine group and 32 in the ketoconazole group were evaluated for efficacy and safety. At the end of the study, rates of mycological cure were 94% for terbinafine emulsion-gel and 69% for ketoconazole cream (p = 0.027). A clinical and mycological overall evaluation was obtained for 72% of patients receiving terbinafine emulsion gel and 31% of patients receiving ketoconazole cream (p = 0.002). A total of four patients (1 in the terbinafine group and 3 in the ketoconazole group) had contact dermatitis-like side effects. We conclude that a 1-week course of terbinafine 1% emulsion-gel is significantly more effective than ketoconazole 2% cream in the treatment of tinea corporis and tinea cruris as regards clinical and mycological cure and treatment safety.

摘要

对65例患者进行了一项开放性、前瞻性、比较性、随机平行组研究,以评估外用1%特比萘芬乳剂凝胶与2%酮康唑乳膏治疗体癣和股癣的疗效及安全性。特比萘芬乳剂凝胶治疗为每日给药1次,共1周,而酮康唑乳膏治疗为每日给药1次,共2周;对患者随访2周。对特比萘芬组的33例患者和酮康唑组的32例患者进行了疗效和安全性评估。研究结束时,特比萘芬乳剂凝胶的真菌学治愈率为94%,酮康唑乳膏为69%(p = 0.027)。接受特比萘芬乳剂凝胶治疗的患者中有72%获得了临床和真菌学综合评估,接受酮康唑乳膏治疗的患者中有31%获得了该评估(p = 0.002)。共有4例患者(特比萘芬组1例,酮康唑组3例)出现了接触性皮炎样副作用。我们得出结论,就临床和真菌学治愈以及治疗安全性而言,1%特比萘芬乳剂凝胶1周疗程在治疗体癣和股癣方面明显比2%酮康唑乳膏更有效。

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