中华皮肤科杂志 ›› 2005, Vol. 38 ›› Issue (8): 474-477.

• 论著 • 上一篇    下一篇

1%盐酸布替萘芬喷雾剂与1%联苯苄唑喷雾剂治疗体股癣足癣的多中心随机、双盲对照研究

李岷1, 顾军2, 毕志刚3, 沈永年1, 吕桂霞1, 王英2, 张美华3, 刘维达1   

  1. 1. 中国医学科学院、中国协和医科大学皮肤病研究所真菌科 南京 210042;
    2. 第二军医大学附属长海医院皮肤性病科;
    3. 南京医科大学附属第一医院皮肤性病科
  • 收稿日期:2005-04-10 发布日期:2005-08-15
  • 通讯作者: 刘维达,E-mail:liumyco@hotmail.com E-mail:liumyco@hotmail.com

A Randomized,Double-Blind,Multi-Center Clinical Trial with Butenafine Hydrochloride 1% Aerosol Versus Bifonazole 1% Aerosol for the Treatment of Tinea Pedis,Tinea Corporis or Tinea Cruris

LI Min1, GU Jun2, BI Zhi-gang3, SHEN Yong-nian1, LÜ Gui-xia1, WANG Ying2, ZHANG Mei-hua3, LIU Wei-da1   

  1. Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing 210042, China
  • Received:2005-04-10 Published:2005-08-15

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摘要： 目的 观察和评价山东省医药工业研究所研制的1%盐酸布替萘芬喷雾剂治疗体股癣、足癣的临床疗效和安全性.方法 采用多中心随机、双盲、平行对照法,对照药为1%联苯苄唑喷雾剂.在治疗开始、中间、结束和2周随访时记录症状、体征积分及真菌学检查结果,以评价疗效,并监测不良事件.结果 体股癣共117例,试验组58例,对照组59例.足癣共119例,试验组59例,对照组60例.体股癣停药时试验组与对照组痊愈率分别为25.86%和40.68%,有效率为86.21%和91.53%;2周随访痊愈率为58.62%和74.58%,有效率为96.55%和96.61%.足癣停药时痊愈率分别为23.73%和25.00%,有效率为81.36%和78.33%;2周随访痊愈率为37.29%和41.57%,有效率为81.36%和90.00%.试验组有13例出现局部不良反应,发生率为10.16%;对照组有20例,发生率为16.67%.上述各项指标经统计学检验,与对照药物差异均无统计学意义.结论 1%盐酸布替萘芬喷雾剂治疗体股癣、足癣安全有效.

关键词: 癣, 布替萘芬, 联苯苄唑

Abstract: Objective To investigate the efficacy and safety of butenafine hydrochloride 1% aerosol in the treatment of tinea pedis,tinea cruris or tinea corporis.Methods A randomized,double-blind,multicenter clinical trial was conducted.Efficacy was assessed in terms of mycological cure,total clinical sign and symptom scores,and clinical response,at baseline,mid-term,end of study,and 2 weeks after treatment.Results One hundred and seventeen patients with tinea cruris or tinea corporis were randomly allocated to individual groups treated with either butenafine 1% aerosol (n=58,male 53,female 5,age 29.45±11.80,course of disease 3.0±5.0 months) or bifonazole 1% aerosol (n=59,male 49,female 10,age 34.12±12.98,course of disease 3.0±11.0 months).One hundred and nineteen patients with tinea pedis were also allocated to two groups treated with either butenafine (n=59,male 59,age 22.97±3.97,course of disease 24.0±36.0 months) or bifonazole (n=60,male 60,age 23.77±4.12,course of disease 36.0±48.0 months).The cure rates and total response rates were 25.86% vs.40.68%,and 86.21% vs.91.53%,in the study group and the control group,respectively,at the end of study,and 58.62% vs.74.58%,and 96.55% vs.96.61% in 2 weeks following-up,for the patients with tinea cruris or tinea corporis.Also,the cure rates and total response rates were 23.73% vs.25.00%,81.36% vs.78.33%,in the study group and the control group,respectively,at the end of study,and 37.29% vs.41.57% and 81.36% vs.90.00% in 2 weeks following-up,for the patients with tinea pedis.Local adverse reactions were recorded in 13 of butenafine group,and 20 of bifonazole group.The differences of above data between two groups were not statistically significant.Conclusion Butenafine hydrochloride 1% aerosol is effective and well tolerated for the treatment of tinea pedis,tinea cruris or tinea corporis.

Key words: Tinea, Butenafine, Bifonazole