1%氟曲马唑乳膏治疗足癣疗效和安全性评价

中国真菌学杂志　 2016, Vol. 11 　Issue (1): 28-32.

1%氟曲马唑乳膏治疗足癣疗效和安全性评价

王爱平¹, 万喆¹, 顾军², 徐金华³, 李明⁴, 席丽艳⁵, 郝飞⁶, 张建中⁷, 赵广⁸, 姚晨⁹, 王蕊¹⁰, 刘博¹⁰, 王玉梅¹⁰, 李若瑜¹

1. 北京大学第一医院皮肤性病科, 皮肤病分子诊断北京市重点实验室, 北京 100034;
2. 上海长海医院皮肤科, 上海 200433;
3. 复旦大学附属华山医院皮肤科, 上海 200040;
4. 复旦大学附属中山医院皮肤科, 上海 200032;
5. 中山大学孙逸仙纪念医院皮肤科, 广州 510120;
6. 中国人民解放军第三军医大学第一附属医院皮肤科, 重庆 400038;
7. 北京大学人民医院皮肤科, 北京 100044;
8. 中国人民解放军空军总医院皮肤科, 北京 100036;
9. 北京大学第一医院医学统计室, 北京 100034;
1
0. 江苏恩华药业股份有限公司, 徐州 221009

收稿日期:2015-06-30 出版日期:2016-02-28 发布日期:2016-02-28
通讯作者: 李若瑜,E-mail:lry0660@gmail.com E-mail:lry0660@gmail.com
作者简介:王爱平,女(汉族),学士,主任医师.E-mail:wangap@medmail.com.cn

Evaluation of efficacy and safety of flutrimazole cream 1% in the treatment of tinea pedis

WANG Ai-ping¹, WAN Zhe¹, GU Jun², XUN Jin-hua³, LI Min⁴, XI Li-yan⁵, HAO Fei⁶, ZHANG Jian-zhong⁷, ZHAO Guang⁸, YAO Cheng⁹, WANG Rui¹⁰, LIU Bo¹⁰, WANG Yu-mei¹⁰, LI Ruo-yu¹

1. Department of Dermatology & venereology, Peking University First Hospital, Beijing Key Laboratory of Molecular Diagnosis of Dermatoses, Beijing 100034;
2. Department of Dermatology, Changhai Hospital of Shanghai, Shanghai 200433;
3. Department of Dermatology, Huashan Hospital, Fudan University, Shanghai 200040;
4. Department of Dermatology & venereology, Zhongshan Hospital, Fudan University, Shanghai 200032;
5. Department of Dermatology, the Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou 510120;
6. Department of Dermatology and Venereology, Southwest Hospital, Third Military Medical University, Chongqing 400038;
7. Department of Dermatology, Peking University People's Hospital, Beijing 100044;
8. Department of Dermatology, Air Force General Hospital of PLA, Beijing 100036;
9. Medical Statistics Room, Peking University First Hospital, Beijing 100034;
1
0. Jiangsu Nhwa Pharmaceutical Co., LTD, Xuzhou 221009

Received:2015-06-30 Online:2016-02-28 Published:2016-02-28

摘要/Abstract

摘要：

目的评价1%氟曲马唑乳膏治疗足癣的疗效及安全性。方法采用多中心、随机、双盲、非劣效临床试验,每天1次外用,疗程4周。结果主要疗效4周时的总有效率氟曲马唑组为71.43%,联苯苄唑组为64.81%(P=0.190)。在6周时(停药后2周),总有效率分别为82.61%和71.60%(P=0.018);真菌清除率分别为86.16%和77.50%(P=0.045);临床有效率分别为93.43%和91.58%(P=0.504)。与研究药物相关的不良反应发生率氟曲马唑组2.44%,联苯苄唑组2.46%(P=1.000),主要表现为用药局部皮肤刺激。结论1%氟曲马唑乳膏治疗足癣有效安全,4周时总疗效非劣效于1%联苯苄唑乳膏,但在6周时总疗效优于1%联苯苄唑乳膏,主要体现在真菌学疗效方面。

关键词: 氟曲马唑, 联苯苄唑, 足癣, 疗效, 安全性

Abstract:

Objective To evaluation of efficacy and safety of flutrimazole cream 1% in the treatment of tinea pedis.Methods A multicentre,double-blind,randomised,non-inferiority study were conducted.Flutrimazole cream 1% or bifonazole cream 1% were applied once daily for 4 weeks to tinea pedis.Results The primary index of drug efficacy were determined by the total effective rates at week 4,71.43% in the flutrimazole group and 64.81% in bifonazole group(P=0.190).At week 6(week 2 after end of treatment),the total effective rates were 82.61% versus 71.60%(P=0.018),respectively;mycological cure rates were 86.16% versus 77.50%(P=0.045),respectively;the clinical effective rates were 93.50% versus 91.75%(P=0.504),respectively.Treatment-related adverse events consisted of local skin irritation,occurred in 2.44% versus 2.46%(P=1.000),respectively.Conclusion This study suggest that flutrimazole cream 1% was effective and safety in the treatment of tinea pedis.Flutrimazole cream 1% was found to be equally effective and non-inferior to bifonazole cream 1%.But the total effective rates of flutrimazole cream 1% at week 6 were superior to bifonazole cream 1%,mainly being reflected in the aspect of mycology curative effect.

Key words: flutrimazole, bifonazole, tinea pedis, efficacy, safety

中图分类号:

R756.3

王爱平, 万喆, 顾军, 徐金华, 李明, 席丽艳, 郝飞, 张建中, 赵广, 姚晨, 王蕊, 刘博, 王玉梅, 李若瑜. 1%氟曲马唑乳膏治疗足癣疗效和安全性评价[J]. 中国真菌学杂志, 2016, 11(1): 28-32.

WANG Ai-ping, WAN Zhe, GU Jun, XUN Jin-hua, LI Min, XI Li-yan, HAO Fei, ZHANG Jian-zhong, ZHAO Guang, YAO Cheng, WANG Rui, LIU Bo, WANG Yu-mei, LI Ruo-yu. Evaluation of efficacy and safety of flutrimazole cream 1% in the treatment of tinea pedis[J]. Chinese Journal of Mycology, 2016, 11(1): 28-32.

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