伊曲康唑序贯联合特比萘芬脉冲疗法与特比萘芬脉冲疗法治疗趾甲甲真菌病的单盲、随机、前瞻性研究

Single-blind, randomized, prospective study of sequential itraconazole and terbinafine pulse compared with terbinafine pulse for the treatment of toenail onychomycosis.

作者信息

Gupta A K, Lynde C W, Konnikov N

机构信息

Department of Medicine, Sunnybrook and Women's College Health Sciences Center, Toronto, Ontario, Canada.

出版信息

J Am Acad Dermatol. 2001 Mar;44(3):485-91. doi: 10.1067/mjd.2001.110644.

DOI:10.1067/mjd.2001.110644

PMID:11209119

Abstract

OBJECTIVE

Efficacy and safety of sequential pulse therapy with itraconazole and terbinafine were compared with pulse terbinafine alone in the treatment of toenail onychomycosis.

METHODS

This was a 72-week prospective, single-blind, randomized, multicenter, comparative, parallel group, nonindustry-sponsored trial. A total of 190 patients were recruited from 3 outpatient dermatology offices in North America. Patients were at least 18 years old and had a clinical and mycologic diagnosis of dermatophyte toenail onychomycosis. Patients were randomly assigned to receive sequential pulse therapy (IIT) with 2 pulses of itraconazole followed by 1 or 2 pulses of terbinafine (itraconazole pulse is 200 mg twice daily for 1 week and terbinafine pulse is 250 mg twice daily for 1 week) versus 3 or 4 pulses of terbinafine (TTT). Main outcome measures at week 72 evaluated mycologic cure rate (negative light microscopy and culture), clinical cure (nail appears completely or totally normal), complete cure (clinical and mycologic cure), and effective therapy (mycologic cure and clinical response with at least 5 mm of new, uninvolved nail growth).

RESULTS

At week 72, in the IIT versus TTT groups, the mycologic cure rate was 54 of 75 (72.0%) versus 44 of 90 (48.9%), clinical cure rate was 42 of 75 (56.0%) versus 35 of 90 (38.9%), effective therapy 49 of 75 (65.3%) versus 41 of 90 (45.6%), and complete cure 39 of 75 (52.0%) versus 29 of 90 (32.2%), respectively. Both regimens were well tolerated with no new adverse effects being identified. The rate of permanent discontinuation of therapy because of adverse effects was 2 of 81 (2.5%) with IIT and 2 of 95 (2.1%) with TTT. Each of the adverse effects normalized over time. The number of patients who reported an adverse effect in the 2 groups was 12 of 81 (14.8%) versus 22 of 95 (23.2%), respectively. All these adverse effects were reversible and mild to moderate in severity.

CONCLUSION

Sequential pulse therapy with itraconazole and terbinafine is effective and safe for the treatment of dermatophyte toenail onychomycosis.

摘要

目的

比较伊曲康唑和特比萘芬序贯脉冲疗法与单用脉冲特比萘芬治疗趾甲甲真菌病的疗效和安全性。

方法

这是一项为期72周的前瞻性、单盲、随机、多中心、比较性、平行组、非行业资助的试验。共从北美3家皮肤科门诊招募了190例患者。患者年龄至少18岁，临床及真菌学诊断为皮肤癣菌趾甲甲真菌病。患者被随机分配接受伊曲康唑2个脉冲序贯脉冲疗法（IIT），随后是1个或2个脉冲的特比萘芬（伊曲康唑脉冲为每日2次，每次200mg，共1周，特比萘芬脉冲为每日2次，每次250mg，共1周），与3个或4个脉冲的特比萘芬（TTT）进行比较。第72周的主要结局指标评估真菌学治愈率（镜检和培养阴性）、临床治愈（指甲外观完全或基本正常）、完全治愈（临床和真菌学治愈）以及有效治疗（真菌学治愈且临床有反应，至少有5mm新的、未受累的指甲生长）。

结果

在第72周时，IIT组与TTT组相比，真菌学治愈率分别为75例中的54例（72.0%）和90例中的44例（48.9%），临床治愈率分别为75例中的42例（56.0%）和90例中的35例（38.9%），有效治疗分别为75例中的49例（65.3%）和90例中的41例（45.6%），完全治愈分别为75例中的39例（52.0%）和90例中的29例（32.2%）。两种治疗方案耐受性均良好，未发现新的不良反应。因不良反应导致永久停药的比例，IIT组为81例中的2例（2.5%），TTT组为95例中的2例（2.1%）。每种不良反应随时间推移均恢复正常。两组中报告有不良反应的患者数量分别为81例中的12例（14.8%）和95例中的22例（23.2%）。所有这些不良反应均可逆，严重程度为轻度至中度。