硝酸舍他康唑霜与咪康唑霜治疗足癣、体股癣的多中心随机双盲对照临床研究

目的评价2％硝酸舍他康唑霜治疗足癣和体股癣的疗效及安全性,并与2％咪康唑霜对照。方法用多中心随机双盲对照试验。试验组及对照组分别外用2％硝酸舍他康唑霜及2％咪康唑霜,每天2次,疗程4周。在治疗开始及治疗2,4,6周时进行观察。结果 足癣试验组66例,对照组61例;体股癣试验组62例,对照组64例完成了观察。足癣:试验组治疗4周时,临床有效率90.9％(对照组91.8％),真菌学清除率89.2％(对照组91.8％)。6周时,分别为100％(对照组98.4％)和95.5％(对照组93.4％)。总有效率93.9％(对照组90.2％)。体股癣:试验组治疗4周时,临床有效率96.8％(对照组100％),真菌学清除率100％(对照组98.4％)。6周时,分别为98.4％(对照组98.4％)和100％(对照组98.4％)。总有效率98.4％(对照组96.9％)。试验组药物不良反应发生率3.1％(对照组2.4％),表现为局部轻度刺激。结论2％硝酸舍他康唑霜治疗足癣和体股癣均安全有效。

Multicenter, double-blind, randomized controlled sdudy on sertaconazole 2% cream and miconazole 2% cream in the treatment of tinea pedis and tinea corporis and cruris

Objective To compare the efficacy and safety of sertaconazole 2% cream and miconazole 2%cream in the treatment of tinea pedis and tinea corporis and cruris. Methods A multicenter, double-blind, randomized controlled trial was conducted. Sertaconazole 2% cream and miconazole 2%cream were applied in the trial and control group respectively twice daily for 4 weeks. Patients were evaluated at 0 (baseline), weeks 2,4, 6. Results Sixty six cases in the trial group and 61 cases in control group were evaluated for tinea pedis; 62 cases in the trial group and 64 cases in the control group were evaluable for tinea corporis and cruris. The clinical effective rates for tinea pedis at week 4 were 90.9% in the trial group and 91.8% in control group; and 100% versus 98.4% at week 6, respectively. Mycological cure rates for tinea pedis at week 4 were 89.2% in the trial group and 91.8% in the control group; and 95.5% versus 93.4% at week 6, respectively. The total effective rates for tinea pedis were 93.9% versus 90.2%, respectively. The clinical effective rates for tinea corporis and cruris at week 4 were 96.8% in the trial gr.oup and 100% in the control group; and 98.4% versus 98.4% at week 6, respectively. Mycological cure rates for tinea corporis and cruris at week 4 were 100% in the trial group and 98.4% in the control group; and 100% versus 98.4% at week 6, respectively. The total effective rates were 98.4% versus 96.9%, respectively. Treatment-related adverse events consisted of mild local irritation, occurred in 3.1% of patients in the trial group, 2.4% in the control group. Conclusion This study suggest that sertaconazole 2% cream were safe and effective in the treatment of tinea pedis and tinea corporis and cruris.