1卢立康唑乳膏治疗足癣的疗效和安全性评价

摘要

Objective To compare the efficacy and safety of 1% luliconazole cream and 1% terbinafine hydrochloride cream in the treatment of tinea pedis.Methods A single-center,single-blind,randomized controlled trial was conducted.1% lulicon-azole cream was applied in the trial group once daily for 2 weeks and 1% terbinafine hydrochloride cream in control group was applied twice daily for 2 weeks.Patients were evaluated at 0 (baseline),2,4 weeks.Results Thirty cases in the trial group and 30 cases in control group were evaluated.The clinical effective rate at 2 weeks was 63.33% in the trial group and 76.67% in control group;and 93.33% versus 90.00% at 4 weeks respectively.Mycological cure rates at 2 weeks and 4 weeks were 46.67% and 86.67% in the trial group,and in control group they were 53.33% and 80.00% respectively.The total effec-tive rate at week 2 was 43.33% in the trial group and 60.00% in control group;and 86.67% versus 80.00% at 4 weeks,re-spectively.Treatment-related adverse events consisted of local irritation,occurred in 3.33% of patients both in the trial group and control group.The efficacy and safety of 1% luliconazole cream in the treatment of tinea pedis are similar to that of 1%terbinafine hydrochloride cream (P >0.05 ).Conclusion This study suggests that 1% luliconazole cream was effective and safe in the treatment of tinea pedis.%目的：评价1%卢立康唑乳膏治疗足癣的疗效及安全性,并与1%盐酸特比萘芬乳膏对照。方法采用单中心随机单盲对照试验。试验组外用1%卢立康唑乳膏,1次/d,疗程2周；对照组外用1%盐酸特比萘芬乳膏,2次/d,疗程2周。在治疗开始及治疗2周、停药2周时进行观察。结果试验组30例、对照组30例患者完成了观察。在治疗2周时,试验组临床有效率为63.33%,对照组为76.67%,停药2周时试验组和对照组临床有效率分别为93.33%和90.00%；治疗2周和停药2周时真菌学清除率试验组为46.67%和86.67%,对照组为53.33%和80.00%；治疗2周时试验组总有效率为43.33%,对照组为60.00%,停药2周时分别为86.67%和80.00%。试验组和对照组药物不良反应表现为局部刺激,发生率均为3.33%。结果显示1%卢立康唑乳膏治疗足癣的疗效及安全性与1%盐酸特比萘芬乳膏相似(P >0.05)。结论1%卢立康唑乳膏治疗足癣有效、安全。