2%硝酸舍他康唑乳膏治疗体股癣和足癣疗效和安全性评价

Evaluation of efficacy and safety of 2 Sertaconazole nitrate cream in the treatment of tinea corporis & cruris and tinea pedis

目的评价2%硝酸舍他康唑乳膏治疗足癣和体、股癣的疗效及安全性,并与2%硝酸咪康唑乳膏对照。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%硝酸舍他康唑乳膏和2%硝酸咪康唑乳膏,每天2次,疗程4周。在治疗开始及治疗2周、4周、6周时进行观察。结果足癣试验组61例,对照组58例;体、股癣试验组56例,对照组55例完成了观察。足癣在4周时,临床有效率试验组98.36%,对照组93.10%,在6周时分别为100%和98.28%;在4周和6周时真菌学清除率试验组均为95.1%,对照组均为100%;在4周时总有效率试验组98.36%,对照组93.10%,在6周时分别为100%和98.28%。体、股癣在4周时,临床有效率试验组98.21%,对照组92.73%,在6周时分别为100%和98.18%;在4周和6周时真菌学清除率试验组和对照组均为100%;在4周时总有效率试验组98.21%,对照组92.73%,在6周时分别为100%和98.18%。药物不良反应发生率试验组1.7%,对照组0.9%,表现为局部刺激。结果显示2%硝酸舍他康唑乳膏治疗足癣和体、股癣的疗效及安全性与2%硝酸咪康唑乳膏相似(P>0.05)。结论2%硝酸舍他康唑乳膏治疗足癣和体、股癣有效、安全。

Objective To compare the efficacy and safety of Sertaconazole nitrate 2% 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. Sertaconazole nitrate 2% cream and miconazole nitrate 2% cream were applied in the trial and control group respectively twice daily for 4 weeks. Patients were evaluated at 0（baseline） ,2,4,6 weeks. Results Sixty-one cases in the trial group and 58 cases in control group were evaluated for tinea pedis; 56 cases in the trial group and 55 cases in the control group evaluated for tinea corporis ＆ cruris. The clinical effective rates for tinea pedis at week 4 were 98.36% in the trial group and 93.10% in control group; and 100% versus 98.28% at week 6 respectively. Mycological cure rates for tinea pedis at week 4 and week 6 were both 95.1% in the trial group and both 100% in the control group. The total effective rates for tinea pedis at week 4 were 98.36% in the trial group and 93.10% in control group ; and 100% versus 98.28% at week 6, respectively. The clinical effective rate for tinea corporis ＆ cruris at week 4 was 98.21% in the trial group and 92.73% in control group; and 100% versus 98.18% at week 6 respectively. Mycological cure rates for tinea corporis ＆ cruris at week 4 and week 6 were all 100% in the trial group and in the control group. The total effective rates for tinea corporis ＆ cruris at week 4 were 98.21% in the trial group and 92.73% in control group ; and 100% versus 98.18% at week 6, respectively. Treatment-related adverse events consisted of local irritation, occurred in 1.7% of patients in the trial group, 0.9% in the control group. The effcacy and safety of sertaconazole nitrate 2% cream in the treatment of tinea pedis and tinea corporis ＆ cruris are similar to that of 2% miconazole nitrate cream（ P 〉 0.05 ）. Conclusion This study suggests that Sertaconazole nitrate 2% cream was effective and safe in the treatment of tinea pedis and tinea corporis ＆ cruris.