特比萘芬短程口服加外用特比萘芬治疗中重度皮肤癣菌病的临床对照研究

目的为治疗中、重度皮肤癣菌病选择合适的方法。方法采用开放、随机对照的平行研究。将临床和真菌镜检确诊的中重度体、股癣和手、足癣患者随机分入A、B、C、D四组,A组口服特比萘芬片联合外用特比萘芬乳膏,疗程7d;B组常规口服特比萘芬片,疗程14d;C组常规外用特比萘芬乳膏,疗程14d;D组外用联苯苄唑乳膏,疗程4周。对各组的临床疗效、安全性、患者对治疗的满意度等进行分析。结果①真菌学疗效:停药后4周时A组手、足癣患者的真菌清除率最高为96.65%,与D组比较(65.00%)差异有显著性。②临床疗效:停药后2周和4周时A组手足癣患者的治愈率分别为93.33%和90.00%,与D组(68%、64%)比较差异有显著性。③患者满意度:在本研究的四组中,A组患者对疗效的满意度最高,与C组、D组比较差异有显著性;患者的综合满意度(包括对治疗费用、安全性等方面)A组最高,与C组、D组比较差异有显著性。D组患者对费用的接受程度最高,A组优于B组,有极显著的统计学差异。治疗结束后患者对安全性的接受程度四组间没有显著差异。结论特比萘芬口服加外用1周的“1 1”短程联合疗法治疗中、重度皮肤癣菌病的疗效高、疗程短、依从性好,患者满意度高。

Short-term oral combined with topical application of terbinnafine in treatment of moderate to severe dermatophytosis:a randomized, parallel and controlled clinical study

Objective To choose a better treatment of moderate to severe dermatophytosis.Methods An open-labelled,randomized,controlled and parallel clinical trial was carried out.Two hundred and forty patients with clinical and mycological diagnosis of moderate to severe tinea corporis,tinea cruris or tinea pedis were divided into four groups to receive oral terbinafine(Lamisil)combined with topical terbinafine(Lamisil)1% cream for 7 days(group A),or oral terbinafine(Lamisil)for 14 days(group B),or topical Lamisil 1% cream for 14 days(group C),or topical Bifonazole(MeiKe)cream for 4 weeks(group D).Efficacy,safety and patient's evaluation were compared.Results At week 4,the mycological cure rate in group A was significantly higher than in group D(96.65% vs 65.00%).At week 2 and week 4 the clinical cure rates of tinea pedis in group A were significantly higher than in group D(93.33% and 90.00% in group A vs.68% and 64% in group D).At the end point the patients in group A showed the highest satisfaction with efficacy compared with group C and D.The same result rose from global satisfaction(including efficacy,expense,and safety)among these 3 groups.Best patient's acceptability of expense was achieved from group D and the acceptability in group A is significantly better than in group B.There was no statistical difference in patient's acceptability of safety among these 4 groups.Conclusion One-week treatment of oral combined with topical application of terbinafine was much more effective,safe,well tolerated and patient's satisfaction in the treatment of moderate to severe dermatophytosis.