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

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。

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

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.