摘要
目的评价2%利拉萘酯乳膏治疗足癣和体股癣的疗效及安全性,并与1%联苯苄唑霜对照。方法采用多中心随机双盲对照试验。试验组及对照组分别外用2%利拉萘酯乳膏和1%联苯苄唑霜,1次/d,疗程足癣4周,体股癣2周。结果足癣试验组71例,对照组70例;体股癣试验组70例,对照组69例进行评价。足癣患者在4周时临床有效率试验组97.2%,对照组92.9%,在6周时分别为100%和98.6%;在4周时真菌学清除率试验组93.0%,对照组94.3%,在6周时分别为94.4%和92.9%;在4周时总有效率试验组90.1%,对照组88.6%;在6周时分别为94.4%和92.9%。体、股癣患者在2周时临床有效率试验组97.1%,对照组95.7%,在4周时分别为97.1%和94.2%;在2周时真菌学清除率试验组94.3%,对照组95.7%;在4周时分别为97.1%和97.1%;在2周时总有效率试验组92.9%,对照组91.3%,在4周时分别为95.7%和94.2%。与药物相关的不良事件发生率对照组1.4%,表现为局部刺激。结果显示2%利拉萘酯乳膏治疗足癣和体股癣的疗效及安全性与1%联苯苄唑霜相似(P>0.05)。结论2%利拉萘酯乳膏治疗足癣和体、股癣有效、安全。
Objective To compare the efficacy and safety of liranaftate 2% cream and bifonazole 1% cream in the treatment of tinea pedis and tinea corporis ＆ cruris. Methods A multi-center, double-blind, randomized controlled trial was conducted. Liranaftate 2% cream and bifonazole 1% cream were applied in the trial and control group respectively once daily for 4 weeks to tinea pedis and for 2 weeks to tinea corporis ＆ cruris. Results Seventy-one cases in the trial group and 70 cases in control group were evaluated for tinea pedis; 70 cases in the trial group and 69 cases in the control group were evaluated for tinea corporis ＆ cruris. The clinical effective rates for tinea pedis at week 4 were 97.2% in the trial group and 92.9% in control group; and 100% versus 98.6% at week 6 respectively. Mycological cure rates for tinea pedis at week 4 were 93.0% in the trial group and 94.3% in control group; and 94.4% versus 92.9% at week 6 respectively. The total effective rates for tinea pedis at week 4 were 90.1% in the trial group and 88.6% in control group; and 94.4% versus 92.9% at week 6 respectively. The clinical effective rates for tinea corporis ＆ cruris at week 2 were 97.1% in the trial group and 95.7% in control group; and 97.1% versus 94.2% at week 4 respectively. Mycological cure rates for tinea corporis ＆ cruris at week 2 were 94.3% in the trial group and 95.7% in control group; and 97.1% versus 97.1% at week 4 respectively. The total effective rates for tinea corporis ＆ cruris at week 2 were 92.9% in the trial group and 91.3% in control group; and 95.7% versus 94.2% at week 4 respectively. Treatment-related adverse events consisted of local irritation, occurred in 1.4% of patients in the control group. The effcacy and safety of liranaftate 2% cream in the treatment of tinea pedis and tinea corporis ＆ cruris are similar to that of bifonazole 1% cream （ P 〉 0. 05）. Conclusion This study suggest that liranaftate 2% cream was effective and safe in the treatment of tinea pedis and tinea corporis ＆ cruris.
出处
《中国真菌学杂志》
2007年第2期107-110,共4页
Chinese Journal of Mycology
关键词
利拉萘酯
足癣
体癣
股癣
Liranaftate
tinea pedis
tinea corporis ＆ cruris
