Long-term results in patients with onychomycosis treated with terbinafine or itraconazole

BACKGROUND: Previously, a double-blind, randomized, multicentre study (LION study) compared the efficacy of continuous terbinafine 250 mg daily for 3 or 4 months with itraconazole pulse therapy 400 mg daily for 3 or 4 months. At the end of the study at week 72 terbinafine proved to be more effective. OBJECTIVES: To perform a 4-year follow-up of the Finnish participants in this study. METHODS: Patients were re-examined clinically and mycologically. RESULTS: Complete clinical and mycological cure with terbinafine for 4 months was 78% compared with 35% with terbinafine for 3 months, 24% with itraconazole for 4 months and 28% with itraconazole for 3 months. CONCLUSIONS: These results suggest that the initial treatment for onychomycosis should be a 4-month continuous course of terbinafine.     

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

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.     

Pulse itraconazole vs. continuous terbinafine for the treatment of dermatophyte toenail onychomycosis in patients with diabetes mellitus

BACKGROUND: Oral terbinafine and oral itraconazole are two of the most common agents used for the treatment of toenail dermatophyte onychomycosis. Despite the fact that diabetic patients are more likely to have onychomycosis than normal individuals are, there is little research into the efficacy of standard oral regimens of terbinafine and itraconazole for onychomycosis in the diabetic population. STUDY DESIGN: We present a prospective, randomized, single-blind, parallel group, comparator-controlled, multi-centre study designed to assess the efficacy of the pulse itraconazole (200 mg twice daily, 1 week on, 3 weeks off, for 12 weeks) vs. continuous terbinafine (250 mg once daily for 12 weeks) oral therapies in the treatment of dermatophyte toenail distal and lateral subungual onychomycosis (DLSO) in the diabetic population. EFFICACY PARAMETERS: Primary efficacy measures included mycological cure rate (negative KOH and culture) and effective cure (mycological cure plus nail plate involvement of 10% or less) at Week 48. RESULTS: At Week 48, mycological cure was attained by 88.2% (30 of 34) and 79.3% (23 of 29) of patients in the itraconazole and terbinafine groups, respectively (P not significant). Effective cure (mycological cure with 相似文献   

Single-blind, randomized, prospective study on terbinafine and itraconazole for treatment of dermatophyte toenail onychomycosis in the elderly

BACKGROUND: The 2 most common agents used to treat dermatophyte onychomycosis of the toe are terbinafine (continuous) and itraconazole (pulse). Although comparative studies have been performed evaluating the efficacy of these 2 agents in adults, no such studies have been reported specifically in the elderly subset. OBJECTIVE: This prospective, randomized, single-blind, non--industry-sponsored, comparative study evaluated the efficacy and safety of terbinafine (continuous) and itraconazole (pulse) therapies in the treatment of dermatophyte onychomycosis of the toe in the elderly population. METHODS: Elderly patients (> or =60 years old) with dermatophyte onychomycosis of at least 1 great toe were randomly assigned to receive either terbinafine 250 mg/day for 12 weeks or itraconazole (pulse) 200 mg twice a day for 1 week, given for 3 pulses. At month 6 from the start of therapy, if there was less than 50% reduction in the affected nail plate area compared with baseline, or if there was less than 3 mm outgrowth of unaffected nail plate as measured in midline, then patients who had been administered terbinafine (continuous) therapy were given an extra 4 weeks of the drug (total of 16 weeks of therapy), and those who had received itraconazole (pulse) therapy were given an extra pulse (fourth pulse). Patients were evaluated at 1.5, 3, 6, 12, and 18 months from the start of therapy. The efficacy measures included mycologic cure rate and clinical efficacy (mycologic cure plus clinical cure or clinical improvement so that 10% or less of nail plate was clinically involved). RESULTS: There were 101 elderly patients enrolled in the study with 50 and 51 patients receiving terbinafine and itraconazole, respectively. The terbinafine group consisted of 28 men and 22 women, age (mean +/- standard error [SE]) 68.0 +/- 0.9 years, duration of onychomycosis (mean +/- SE) 18.2 +/- 1.4 years, number of nails involved (mean +/- SE) 5.5 +/- 0.5, and percent baseline nail plate area involved (mean +/- SE) 67.5% +/- 4.2%. The corresponding figures for the itraconazole (pulse) group were 24 men and 27 women, age (mean +/- SE) 68.8 +/- 0.8 years, duration of onychomycosis (mean +/- SE) 16.1 +/- 1.7 years, number of nails involved (mean +/- SE) 6.0 +/- 0.7, and percent baseline nail plate area involved (mean +/- SE) 74.9% +/- 3.8%, respectively, with no significant difference between the groups. At month 6, the number of patients that required an extra 4 weeks of terbinafine in the allylamine group or an extra itraconazole pulse in the triazole group was 13 of 50 and 23 of 51, respectively. The mycologic cure rate and clinical efficacy at 18 months from the start of therapy for the terbinafine group were 64.0% and 62.0%, respectively. The corresponding figures for the itraconazole (pulse) group were 62.7% and 60.8%, respectively, with no significant difference between the 2 groups. There were no dropouts during therapy. For both groups the drug appeared safe with no significant adverse events (AEs) or clinically significant laboratory abnormalities. All the AEs were mild and transient. There was high compliance with both regimens. CONCLUSIONS: In the elderly, for the treatment of dermatophyte toe onychomycosis, both terbinafine (continuous) and itraconazole (pulse) therapies are effective, safe, and associated with high compliance.     

Long-term follow up of patients with toenail onychomycosis after treatment with terbinafine

The long-term outcome of 111 patients treated with oral terbinafine for toenail onychomycosis with a novel treatment protocol was assessed a median of 138 weeks alter entry into the trial. All but three patients had either one or two 12 week courses of terbinafine 250 mg daily. 01 the 77 evaluable patients, 72.7% were still classified as responders (i.e. negative mycological culture and at least 3 mm olnew unaffected nail growth) on reassessment. The present study shows that a favourable long-term outcome can be achieved in patients who have been treated with at least one 12 week course of terbinafine.     

An open randomized comparative study of oral itraconazole pulse and terbinafine pulse in the treatment of onychomycosis

BACKGROUND: Onychomycosis is a recalcitrant disease of the nails caused by dermatophytes, yeasts, and molds. AIMS: To compare the clinical efficacy of oral itraconazole pulse therapy and oral terbinafine pulse therapy in onychomycosis. METHODS: A randomized single-blind clinical comparative study was undertaken on 120 patients of onychomycosis during the period March 1999-February 2002. Sixty patients were randomly assigned to receive oral itraconazole 100 mg, two capsules twice daily for seven days a month and the other group of sixty patients received oral terbinafine 250 mg, one tablet twice daily for seven days every month. Four such monthly pulses were administered for each drug. The patients were evaluated at 4-weekly intervals till sixteen weeks and then at 24, 36 and 48 weeks. RESULTS: We observed a clinical cure rate of 82% and mycological cure rate of 90% in the group of patients treated with itraconazole while the group with terbinafine showed clinical and mycological cure rates of 79% and 87% respectively. This difference was not statistically significant. CONCLUSIONS: Both oral itraconazole and terbinafine are effective in the treatment of onychomycosis when administered in the pulse dosage form. Terbinafine is more cost effective while itraconazole has a broader spectrum of antimycotic activity.     

A meta-analysis comparing long-term recurrences of toenail onychomycosis after successful treatment with terbinafine versus itraconazole

Abstract As the most frequently used systemic antifungal agents for onychomycosis, terbinafine and itraconazole have both proved to have the conditions of recurrence in various degrees during follow-up period after end of therapy; very little is known about their comparative recurrences after long-term follow-up. We conducted a meta-analysis of available trials to compare the long-term recurrences of toenail onychomycosis after successful treatment with terbinafine versus itraconazole. Meta-analysis was performed by the Review Manager version 5.0.25. Risk ratio and 95% confidence intervals were calculated by the fixed effect model. Five trials and total 251 eligible patients were included in this meta-analysis. The combined risk ratio of the meta-analysis comparing terbinafine with itraconazole for mycological recurrence rate was 0.44 (95% CI 0.29-0.66), which suggests that itraconazole therapy is more likely to produce mycological recurrence compared with terbinafine therapy.     

Iontophoretic delivery of terbinafine in onychomycosis: a preliminary study

Background  Onychomycosis is a common disease; topical treatment is usually poorly effective, while systemic treatment is more effective but may be associated with side-effects. Iontophoretic drug delivery may improve drug penetration through the nail and lead to better therapeutic results.
Objectives  To evaluate the efficacy, safety and tolerability of topical treatments with terbinafine HCl delivered with or without an iontophoretic patch in patients with onychomycosis of the toenails.
Methods  Patients enrolled into the study were divided randomly into two groups. Group A was treated with terbinafine and an iontophoretic patch (at a constant current density of 100 μA cm⁻²). Group B was treated with terbinafine without iontophoresis. Treatment was overnight wear, every day, 5 days per week, for 4 weeks. Follow-up period was 8 weeks from the end of treatment.
Results  A significant clinical response was recorded in patients of group A (active group). The percentage of patients having healthy toenail growth of more than 1·5 mm at the end of treatment was 40% compared with 11% in patients treated with terbinafine without current (passive group). The percentage of patients having fungal elements (KOH) in nail specimens decreased significantly at 8 weeks following the completion of treatment: 16% in the active group vs. 53% in the passive group. Patients in the active group reported a tingling sensation that is expected when using an iontophoretic drug delivery treatment.
Conclusions  The delivery of terbinafine under an electrical current of 100 μA cm⁻² appears to be efficacious and safe and is well tolerated for the treatment of nail onychomycosis.     

特比萘芬短程疗法治疗手指甲癣

用特比萘芬（Ｔｅｒｂｉｎａｆｉｎｅ）治疗手指甲癣病人２０例，剂量为２５０ｍｇ，每天１次，１周后隔日１次，共５周，总量为５２５０ｍｇ。４月后判断疗效。结果痊愈１８例，好转２例，有效率为１００％，痊愈率为９０％。服药期间未发现有明显副作用。证明特比萘芬短程疗法治疗手指甲癣是一个疗效高、安全可靠、简单易行的好方法。     

Combination of pulse therapy with terbinafine tablets and topical terbinafine cream for the treatment of dermatophyte onychomycosis: a pilot study

We performed a pilot study to assess the safety and efficacy of pulse therapy with terbinafine tablets in 66 patients with dermatophyte onychomycosis. One pulse consisted of oral terbinafine tablets (500 mg/day) given for 1 week followed by a 3-week interval. Topical 1% terbinafine cream was applied daily. The number of pulses was determined by the extent of improvement in the affected nails and by the patient's requests, up to a maximum of six pulses. Efficacy was assessed based on both clinical and mycological examinations 1 year after treatment initiation. We observed a complete cure in 51 patients (77.3%), marked improvement in five patients (7.6%), improvement in five patients (7.6%) and slight improvement in one patient (1.5%). Four patients (6.0%) showed no change. In the patients who were completely cured, the average number of pulses used was 3.7 +/- 1.4 pulses and the treatment duration was 3.3 +/- 1.6 months. Nine patients experienced adverse effects, consisting of gastrointestinal disturbance (eight patients) and drug-induced eruption (one patient). There were no abnormal findings in the laboratory tests, including liver function tests. In summary, terbinafine pulse therapy in combination with topical application of terbinafine cream appeared safe and effective in this pilot study.     

Multiple onychocryptosis following treatment of onychomycosis with oral terbinafine

The authors report an unusual case of multiple onychocryptosis, which developed following treatment of onychomycosis with oral terbinafine. With new growth of the healthy nail plate, the distal aspect of multiple toenails became ingrown with periungual inflammation. This required several minor surgical procedures to alleviate the onychocryptosis. The authors present this case report as a potential complication of oral antifungal therapy.     

Toenail onychomycosis in patients with acquired immune deficiency syndrome: treatment with terbinafine

Skin infections caused by dermatophytes are one of the most frequent dermatological complications in patients with acquired immunodeficiency syndrome (AIDS) resulting from infection with human immunodeficiency virus (HIV). Tinea unguium associated with AIDS is characterized by being clinically more aggressive and therapeutically more difficult to treat than in the general population. Terbinafine is considered to be a first-choice option for the treatment of dermatophyte onychomycosis in immunocompetent individuals. This drug has been used in a series of 21 HIV-positive patients diagnosed with tinea unguium for 1 year in the University Hospital La Paz, Madrid. All patients underwent a subsequent clinical follow-up for 6 months. The results showed a high percentage of clinical and mycological cures, as well as maintenance of the response after follow-up; no drug interactions or significant adverse effects related to the drug under study were recorded.