1%硝酸异康唑乳膏治疗体股癣、足癣疗效和安全性评价

Evaluation of efficacy and safety of 1% isoconazole nitrate cream in the treatment of tinea pedis and tinea corporis & cruris

目的评价1%硝酸异康唑乳膏治疗足癣和体股癣的疗效及安全性,并与2%硝酸咪康唑霜对照。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1%硝酸异康唑乳膏和2%硝酸咪康唑霜,2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72例;体股癣试验组73例,对照组73例。足癣患者在4周时临床有效率试验组87.3%,对照组87.5%,在6周时分别为88.7%和91.7%;在4周时真菌学清除率试验组83.1%,对照组94.4%(P=0.0363),在6周时分别为84.5%和90.3%;在4周时总有效率试验组77.5%,对照组86.1%;在6周时分别为78.9%和86.1%。体股癣患者在2周时临床有效率试验组87.7%,对照组93.2%,在4周时分别为91.8%和94.5%;在2周时真菌学清除率试验组82.2%,对照组89.0%;在4周时分别为89.0%和93.2%;在2周时总有效率试验组78.1%,对照组86.3%,在4周时分别为87.7%和93.2%。与药物相关的不良反应发生率试验组为2.1%,对照组为1.4%,表现为用药局部刺激、瘙痒、灼痛感或红斑。结果显示1%硝酸异康唑乳膏治疗足癣和体股癣的疗效及安全性与2%硝酸咪康唑霜相似(P>0.05)。结论1%硝酸异康唑乳膏治疗足癣和体股癣有效、安全。

Objective To compare the efficacy and safety of isoconazole nitrate 1% cream and miconazole nitrate 2% cream in the treatment of tinea pedis and tinea corporis ＆ cruris. Methods A multi-center, double-blind, randomized controlled trial was conducted. Isoconazole nitrate 1% cream and miconazole nitrate 2% cream were applied in the lesions of the trial and control group respectively twice daily for 4 weeks to tinea pedis and for 2 weeks to tinea corporis ＆ cruris. Results Seventy-one cases in the trial group and 72 cases in control group were evaluated for tinea pedis; 73 cases in the trial group and 73 cases in the control group were evaluated for tinea corporis ＆ cruris. The clinical effective rate of tinea pedis in forth week was 87.3% in the trial group and 87.5% in control group; and 88.7% versus 91.7% in the sixth week respectively. Mycological cure rate of tinea pedis in forth week was 83.1% in the trial group and 94.4% in control group; and 84.5% versus 90.3% in the sixth week respectively. The total effective rate of tinea pedis in forth week was 77.5% in the trial group and 86.1% in control group; and 78.9% versus 86.1% at week 6 respectively. The clinical effective rate of tinea corporis ＆ cruris in the second week was 87.7% in the trial group and 93.2% in control group; and 91.8% versus 94.5% at week 4 respectively. Mycological cure rates for tinea corporis ＆ crnris at week 2 were 82.2% in the trial group and 89.0% in control group; and 89.0% versus 93.2% at week 4 respectively. The total effective rates of tinea corporis ＆ crnris in second week was 78. 1% in the trial group and 86.3% in control group; and 87.7% versus 93.2% at week 4 respectively. Treatment-related adverse events consisted of local irritation,itching, burn or erythema, occurred in 2.1% of patients in the trial group, in 1.4% of patients in the control group. The effcacy and safety of isoconazole nitrate 1% cream in the treatment of tinea pedis and tinea corporis ＆ crnris are similar to that of miconazole nitrate 2% cream （ P 〉 0.05 ）. Conclusion This study suggests that isoconazole nitrate 1% cream was effective and safe in the treatment of tinea pedis and tinea corporis ＆ crnris.