Zaias Nardo, Rebell Gerbert
Greater Miami Skin and Laser Center and Mount Sinai Medical Center, Miami Beach, FL 33140, USA.
Arch Dermatol. 2004 Jun;140(6):691-5. doi: 10.1001/archderm.140.6.691.
The standard treatment of Trichophyton rubrum nail bed onychomycosis (or distal subungual onychomycosis [DSO]) with daily terbinafine for 12 weeks involves treating for a fixed period shorter than the time required for complete replacement of the nail bed and overlying nail plate by normal growth. The same total amount of terbinafine pulse-dosed for approximately 12 months would treat the patient until normal replacement of the mycotic nail bed has occurred.
To determine the effectiveness of intermittent administration of oral terbinafine (250 mg/d for 7 consecutive days every 2-4 months) to cure DSO and to determine the maximum effective treatment interval.
A prospective, nonrandomized, open study of sequential groups of office patients.
A private dermatology practice.
A sequence of 4 groups of office patients with DSO (n = 10-20 each) were treated with pulse-dosed terbinafine for 7 consecutive days at intervals of 2, 3, and 4 months, respectively. In each group, treatment was continued until the distally advancing new nail bed and nail had completely removed the mycotic defect or failure of fungistasis was detected.
Results were determined by monthly evaluation. Cure was noted as complete replacement of the mycotic nail bed and overlying nail plate (ascertained by monthly metric measurements of the mycosis-free nail bed and overlying nail place distal to the proximal nail fold). Treatment failure was noted when the mycosis-free proximal portion of the nail bed failed to increase in correspondence with the distally directed movement of the nail bed and overlying nail.
Thirty-nine (93%) of the 42 patients in the first 3 groups were cured (95% binomial confidence interval, 67%-100%) with no evidence of decrease in efficacy. However, the group of patients who received the 7-day pulse treatment every 4 months experienced significantly more failures (P<.01), and cures dropped to 10 of 17 cases.
Terbinafine is an effective treatment for DSO when pulse-dosed for 7 days every 3 months but not every 4 months.
采用特比萘芬每日给药治疗红色毛癣菌甲床甲真菌病（或远端甲下甲真菌病[DSO]）12周，治疗时间固定，短于甲床和覆盖甲板通过正常生长完全替换所需时间。相同总量的特比萘芬脉冲给药约12个月可治疗患者直至真菌性甲床正常替换。
确定口服特比萘芬（250mg/d，每2 - 4个月连续给药7天）间歇给药治疗DSO的有效性，并确定最大有效治疗间隔。
对门诊患者连续分组进行的前瞻性、非随机、开放性研究。
一家私人皮肤科诊所。
4组门诊DSO患者（每组n = 10 - 20），分别每2、3、4个月连续7天接受脉冲给药特比萘芬治疗。每组持续治疗直至向远端推进的新甲床和指甲完全消除真菌缺陷或检测到抗真菌治疗失败。
每月评估确定结果。治愈定义为真菌性甲床和覆盖甲板完全替换（通过每月测量近端甲襞远端无真菌的甲床和覆盖甲板确定）。当甲床无真菌的近端部分未随甲床和覆盖甲板向远端移动而增加时，记录为治疗失败。
前三组42例患者中有39例（93%）治愈（95%二项式置信区间，67% - 100%），无疗效降低迹象。然而，每4个月接受7天脉冲治疗的患者组失败明显更多（P <.01），治愈率降至17例中的10例。
特比萘芬每3个月脉冲给药7天是治疗DSO的有效方法，但每4个月给药则不然。
