CAJ | 학술논문

目的观察和评价不同疗程1％卢立康唑乳膏治疗足癣的疗效和安全性.方法采用多中心、随机、双盲、阳性药物对照研究,将入选患者按照试验中心分层随机分成3组,包括卢立康唑短疗程组(外用1％卢立康唑乳膏,每日1次,共2周,后2周使用安慰剂)、卢立康唑长疗程组(外用1％卢立康唑乳膏,每日1次,共4周)、联苯苄唑对照组(外用1％联苯苄唑乳膏,每日1次,共4周).开始用药后第2、3、4、6周评价临床和真菌学疗效.结果 420例真菌镜检阳性的患者随机分成3组,每组140例,398例患者进入疗效分析.用药2周时,对照组、短疗程组、长疗程组临床有效率分别为29.29％、31.43％和35.00％(P＞ 0.05),真菌清除率分别为49.29％、58.57％和57.86％(P＞ 0.05);用药3周时,临床有效率分别为73.57％、78.57％和70.00％(P＞0.05);用药4周时,临床有效率分别为89.29％、91.43％和89.29％(P＞ 0.05),真菌清除率分别为80.00％、87.86％和85.00％(P＞ 0.05).停药后2周,对照组、短疗程组、长疗程组的临床有效率分别是92.14％、92.86％和92.14％(P＞ 0.05),真菌清除率分别为80.71％、90.00％和89.29％(P＜ 0.05).对照组局部不良反应发生率为0.71％,短疗程组为0,长疗程组为2.14％.结论 1％卢立康唑乳膏外用治疗足癣安全有效,每日1次治疗2周与治疗4周的疗效相当.
목적 관찰화평개불동료정1％로립강서유고치료족선적료효화안전성.방법 채용다중심、수궤、쌍맹、양성약물대조연구,장입선환자안조시험중심분층수궤분성3조,포괄로립강서단료정조(외용1％로립강서유고,매일1차,공2주,후2주사용안위제)、로립강서장료정조(외용1％로립강서유고,매일1차,공4주)、련분변서대조조(외용1％련분변서유고,매일1차,공4주).개시용약후제2、3、4、6주평개림상화진균학료효.결과 420례진균경검양성적환자수궤분성3조,매조140례,398례환자진입료효분석.용약2주시,대조조、단료정조、장료정조림상유효솔분별위29.29％、31.43％화35.00％(P＞ 0.05),진균청제솔분별위49.29％、58.57％화57.86％(P＞ 0.05);용약3주시,림상유효솔분별위73.57％、78.57％화70.00％(P＞0.05);용약4주시,림상유효솔분별위89.29％、91.43％화89.29％(P＞ 0.05),진균청제솔분별위80.00％、87.86％화85.00％(P＞ 0.05).정약후2주,대조조、단료정조、장료정조적림상유효솔분별시92.14％、92.86％화92.14％(P＞ 0.05),진균청제솔분별위80.71％、90.00％화89.29％(P＜ 0.05).대조조국부불량반응발생솔위0.71％,단료정조위0,장료정조위2.14％.결론 1％로립강서유고외용치료족선안전유효,매일1차치료2주여치료4주적료효상당.
Objective To evaluate the efficacy and safety of different courses of luliconazole 1％ cream in the treatment of tinea pedis.Methods A randomized,double-blind,multicenter controlled trial was conducted.According to a stratified randomization protocol,420 patients positive for fungal elements on direct microscopy were equally and randomly divided into 3 groups:short-term group applying luliconazole 1％ cream once daily for 2 weeks followed by placebo once daily for the next 2 weeks,long-term group applying luliconazole 1％ cream once daily for 4 weeks,bifonazole group applying bifonazole 1％ cream once daily for 4 weeks.Efficacy was assessed in terms of mycological clearance and clinical response rates on week 2,3,4 and 6 after initiation of treatment.Statistical analysis was carried out by paired t test,analysis of variance,chi-square test and a nonparametric test.Results Finally,398 patients were eligible for the efficacy analysis.The clinical response rate in the bifonazole group,shortterm group and long-term group was 29.29％,31.43％ and 35.00％ respectively on week 2 after initiation of treatment (P ＞ 0.05),73.57％,78.57％ and 70.00％ respectively on week 3 (P ＞ 0.05),89.29％,91.43％ and 89.29％ respectively on week 4 (P ＞ 0.05),with the mycological clearance rate being 49.29％,58.57％ and 57.86％ respectively on week 2 (P ＞ 0.05),80.00％,87.86％ and 85.00％ respectively on week 4 (P ＞ 0.05).Significant differences were observed on week 2 after the end of treatment in mycological clearance rate (80.71％ in the bifonazole group vs.90.00％ in the short-term group vs.89.29％ in the long-term group,P ＜ 0.05),but not in clinical response rate (92.14％ in the bifonazole group vs.92.86％ in the short-term group vs.92.14％ in the longterm group,P ＞ 0.05).The incidence rate of local adverse reactions was 0.71％ in the bifonazole group,0 in the short-term group and 2.14％ in the long-term group.Conclusion Luliconazole 1％ cream is effective and well tolerated in the treatment of tinea pedis,with the efficacy of 2-week once-daily regimen equivalent to that of 4-week once-daily regimen.