口服特比萘芬加外用益康唑短程联合疗法治疗足癣的临床对照研究

Short-tem Oral Administration of Terbinafine Combined with Topical Application of Econazole in Treatment of Tinea Pedis:A Randomized and Controlled Clinical Study

目的评价口服特比萘芬片加外用益康唑乳膏短程联合疗法治疗足癣的疗效和安全性。方法采用随机数字表法将124名患者分为两组:试验组予特比萘芬片250mg口服,1次/d,联合益康唑乳膏外用,2次/d,共7d;对照组予益康唑乳膏外用,2次/d,同时口服维生素C片0.1g,1次/d,共28d。于停药时和停药后4周时观察临床疗效和真菌学疗效,停药后4周时观察复发情况。结果共有113例患者完成临床观察,脱落7例(试验组1例,对照组6例),剔除4例(对照组4例)。停药时两组相比试验组治愈率明显低于对照组(χ2=23.03,P<0.01),有效率及真菌清除率差异无统计学意义(χ2=0.33,P>0.05;χ2=0.03,P>0.05);停药后4周时两组相比试验组治愈率、有效率及真菌清除率均显著高于对照组(χ2=17.21,P<0.01;χ2=14.56,P<0.01;χ2=23.03,P<0.01);停药后4周时两组相比试验组复发率明显低于对照组(χ2=14.04,P<0.01);两组不良反应发生率相比差异无统计学意义(χ2=3.27,P>0.05)。结论口服特比萘芬片加外用益康唑乳膏短程联合疗法治疗足癣依从性和安全性高、疗效好。

Objective To study the efficacy and safety of short - term oral administration of terbinafine combined with topical application of econazole in the treatment of tinea pedis. Methods An open-labelled, randomized, controlled and parallel clinical trial was carried out. A total of 124 patients with clinical and mycological diagnosis of tinea pedis were divided into two groups. The trial group was treated with oral terbinafine 250 mg daily, and 1% of econazole ointment twice daily, continuously for 7 days. The control group was treated with 1% of econazole ointment twice daily and oral vitamine C （as placebo） 0.1 g daily. Efficacy and safety were compared. Results At the end of treatment, the clinical cure rate of the trial group was significantly lower than that of the control group （ χ^2 = 23.03, P 〈 0.01 ）, and there were no significant differences in effective rate and mycological clearance rate between the two groups （ χ^2 = 0.33, P 〉 0.05 ; χ^2 = 0.03, P 〉 0.05 ）. Four weeks later after the end of treatment, the clinical cure rate, the effective rate and the mycological clearance rate of the trial group were significantly higher than that of the control group （χ^2= 17.21, P 〈 0.01 ; χ^2 = 14.56, P 〈 0.01 ;χ^2 = 23.03, P 〈 0.01 ）, and the recurrence rate was significantly lower than that of the control group （ χ^2 = 14.04, P 〈0.01 ）. The incidence of adverse events in the trial group was not significantly different from that in the control group. Conclusion Short-term oral administration of terbinafine combined with topical application of econazole is safe, well tolerated and effective in the treatment of tinea pedis.