特比萘芬治疗老年人甲真菌病多中心临床疗效和安全性评价  

The safety and efficacy of terbinafine in the treatment of elderly patients with onychomycosis:a multicenter trial

作　　者：高广程[1] 姚志远[2] 葛蒙梁[3] 刘永生[1] 尤力平[2] 潘德海[2] 

机构地区：[1]首都医科大学附属北京友谊医院皮肤科,北京100050 [2]中日友好医院皮肤科,北京100029 [3]卫生部北京医院皮肤科,北京100730

出　　处：《临床皮肤科杂志》2007年第12期795-797,共3页Journal of Clinical Dermatology

摘　　要：目的:观察特比萘芬连续疗法治疗60岁以上甲真菌病患者的疗效、安全性和耐受性。方法:120例老年甲真菌病患者口服特比萘芬250mg,每日1次,指甲真菌病患者连续口服12周,趾甲真菌病患者连续口服16周;指甲真菌病患者在服药后第36周、趾甲真菌病患者在服药后第52周评价最终疗效和不良反应;同时检查血、尿常规,肝、肾功能。结果:在停药时及第36周时,指甲真菌病患者的临床有效率分别为68.8%和96.9%,真菌学治愈率分别为87.5%和96.9%;在停药时及第52周时,趾甲真菌病患者的临床有效率分别为44.2%和87.2%,真菌学治愈率分别为62.8%和96.5%。不良反应发生率为8.3%,主要为胃肠道反应。未发现特比萘芬与其他药物间的相互作用。结论:特比萘芬治疗老年人甲真菌病有效,且安全、耐受性良好。Objective： To study the efficacy, safety and tolerability of continuous terbinafine in the treatment of onychomycosis in patients over the age of 60 years. Methods： One hundred and twenty cases of onychomycosis over the age of 60 years were treated with oral terbinafine 250 mg daily continuously for 12 weeks and 16 weeks for the patients with finger nail onychomycosis and toenail onychomycosis respectively. The global efficacy, the incidence of adverse events, the blood and urine routine tests, liver and kidney function were evaluated after 36 weeks and 52 weeks for the patients with fingernail and toenail onychomycosis respectively. Results： After stopping the treatment and at the 36th week for fingernail onychomycosis, the total clinical response rates were 68.8% and 96.9% respectively, the mycology clearance rates were 87.5% and 96.9% respectively. After stopping the treatment and at the 52nd week for toenail onychomycosis, the total clinical response rates were 44.2% and 87.2% respectively, the mycology clearance rates were 62.8% and 96.5% respectively. The incidence of adverse events was 8.3%, the majority were gastrointestinal disorders. No drug interactions were recorded. Conclusion： Terbinafine is a safe, effective and well tolerated drug for the treatment of onychomycosis in the elderly.

关 键 词：甲真菌病 老年人 特比萘芬 安全性 临床试验 

分 类 号：R756.4[医药卫生—皮肤病学与性病学]