国产特比萘芬治疗甲真菌病40例疗效观察

目的:观察国产特比萘芬治疗甲真菌病的疗效;方法:将门诊确诊为甲真菌病的患者分为治疗组40例(口服特比萘芬)和对照组36例(口服伊曲康唑);结果:停药6个月后治疗组的指趾甲真菌病治愈率分别是84.1%和83.5%;有效率分别是98.4%和95.9%;对照组指趾甲真菌治愈率分别90.9%和88.3%,有效率分别为99.0%和97.9%,两组指趾甲真菌病治愈率比较差异无显著性(指甲2=2.19,趾甲2=1.67,均P>0.05);结论:国产特比萘芬治疗甲真菌病有较好疗效。     

伊曲康唑和特比萘芬序贯疗法治疗甲真菌病的临床观察

目的:探讨序贯疗法治疗甲真菌病的安全性、依从性和疗效.方法:甲真菌病患者先服伊曲康唑1周,停3周为1个疗程,接着服特比萘芬1周,停3周为1个疗程.指甲真菌病服2个疗程,趾甲真菌病服3个疗程.结果:指甲真菌病有效率100%,趾甲真菌病有效率90.91%.结论:伊曲康唑与特比萘序贯疗法治疗甲真菌病安全有效,依从性好.     

特比萘芬治疗甲真菌病临床疗效观察

目的观察特比萘芬治疗甲真菌病的临床疗效。方法所有患者第1周均给予特比萘芬0.25 g口服,1次/d,第2周开始,隔日1次,每次0.25g,指甲真菌病患者共服7周,总量7 g,趾甲真菌病患者及指、趾同患真菌病患者共服11周,总量10.5 g,两组患者分别于服药后的第12周和第16周复诊观察近期疗效;服药后第24周复诊观察远期疗效。结果指甲真菌病患者近期治愈率为52.4%,趾甲真菌病及指、趾同患真菌病患者为35.2%,远期治愈率分别为85.7%和75.9%。结论特比萘芬治疗甲真菌病效果良好。     

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

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。     

伊曲康唑和特比萘芬序贯法治疗甲真菌病疗效观察

目的观察伊曲康唑和特比萘芬序贯疗法治疗甲真菌病的临床疗效及安全性。方法对照组采用伊曲康唑冲击治疗(每日中晚餐各口服伊曲康唑200mg,连用1周,停用3周为一个疗程),指甲真菌病治疗2个疗程,趾甲真菌病治疗3个疗程。观察组指甲真菌病先用伊曲康唑冲击治疗1个疗程,随后应用盐酸特比萘芬冲击疗法(每日中晚餐各口服特比萘芬250mg,连用1周,停药3周),趾甲真菌病还需再重复伊曲康唑冲击治疗1个疗程。两组治疗结束后3、6月时各复诊一次,观察不良反应发生情况。结果观察组治疗3个月后的有效率显著高于对照组(P0.05),经6个月治疗后,2组有效率与治疗3个月后有效率相比均略有提高,但差异无统计学意义(P0.05),观察组有效率高于对照组,但无显著性差异(P0.05)。复发率观察显著低于对照组(P0.05)。结论伊曲康唑和特比萘芬序贯疗法治疗甲真菌病疗效确切,复发率与不良反应较少,值得临床推广应用。     

特比萘芬治疗糖尿病患者甲真菌病疗效和对血糖水平的影响

目的:评价特比萘芬连续疗法治疗糖尿病患者甲真菌病的有效性、安全性、耐受性和对患者血糖水平的影响。方法:90例糖尿病甲真菌病患者口服特比萘芬250mg,每日1次,指甲癣患者连续口服12周,趾甲癣患者连续口服16周;停药第24周观察最终疗效和血糖水平。结果:在第36周时,指甲真菌病的临床治愈率84.8%,有效率90.9%,真菌学治愈率93.9%;第40周时,趾甲真菌病的临床治愈率78.9%,有效率87.7%,真菌学治愈率89.5%;治疗前后空腹血糖和糖化血红蛋白水平无显著性差异。结论:特比萘芬治疗糖尿病患者甲真菌病有效、安全,耐受性良好;对患者血糖水平无明显影响。     

5%阿莫罗芬甲擦剂治疗甲真菌病的临床疗效观察

目的 评价5%阿莫罗芬甲擦剂与内服特比萘芬片治疗未累及甲母质的浅表型或远端侧位型甲真菌病的临床疗效.方法 将入选的324例患者随机分成A,B两组,A组给予5%阿莫罗芬甲擦剂外涂,1次/周,治疗6个月.B组给予特比萘芬片(兰美抒)0.25g/d口服,指甲真菌病患者服药12周,趾甲真菌病患者服药16周.分别于治疗后第10周及24周进行疗效评价.结果 治疗24周后,A组痊愈率 87.7%,有效率92.6%;B组分别为88.9%,95.1%.两组痊愈率、有效率差异均无显著性(P>0.05).结论 5%阿莫罗芬甲擦剂治疗未累及甲母质的浅表型或远端侧位型甲真菌病疗效好.     

特比萘芬治疗甲真菌病

丙烯胺类是一类新的抗真菌药物,其作用机理不同于唑类,其中特比萘芬(terbinafine,Lamisil)有杀真菌作用、口服有效。初步资料表明对治疗甲真菌感染也有效。本文是英国用特比萘芬治疗甲真菌病多中心观察的总结。治疗分2组:长程特比萘芬治疗组,剂量为250mg/d 趾甲感染用12月、指甲感染用6月,共103例,完成90例。结果:治疗结束时,真菌学治愈(镜检和培养均阴性),在趾甲感染中为80%,指甲感染为95%,副作用主要为上消化道不适,3例因此而停药;未见其它重要的副作用,尤其未     

特比萘芬治疗甲真菌病的疗效观察

为了评价特比萘芬6周疗法治疗指甲真菌病、8周疗法治疗趾甲真菌病的疗效,我科于1999年5月至2000年5月采用诺华制药公司生产的特比萘芬对65例甲真菌病进行了治疗和2年的随访,得到了较为满意的结果,现报道如下。     

CO2点阵激光联合萘替芬酮康唑乳膏治疗甲真菌病疗效评价

目的：评价CO₂点阵激光联合萘替芬酮康唑乳膏外用治疗甲真菌病的临床疗效。方法：对2017年1月至2018年8月我科门诊甲真菌病患者患甲进行CO₂点阵激光照射（2周1次）,每日外涂萘替芬酮康唑乳膏治疗,共治疗16周。观察临床疗效、真菌学检查结果及不良反应发生情况。结果：共治疗35例患者,35个靶甲,其中指甲5个,趾甲30个;白色浅表型8个,远端侧位甲下型18个,近端甲下型9个。在第4次治疗后有效率为54.29%,真菌清除率为74.29%;疗程结束3个月后有效率为82.89%,真菌清除率为88.57%。结论：CO₂点阵激光联合萘替芬酮康唑乳膏治疗甲真菌病安全有效。     

Evaluation of 6 weeks treatment of terbinafine in tinea unguium in a double-blind trial comparing 6 and 12 weeks therapy

Terbinafine (Lamisil) has been registered throughout the world for the treatment of finger and toenail onychomycosis. The recommended duration of treatment of toenail onychomycosis based on phase III studies is 12 weeks. This study was designed to determine: (i) if patients in whom the proximal part of the toenails was not affected respond as well after 6 weeks treatment as after 12 weeks treatment; (ii) to identify factors which may allow selection of patients for shorter treatment duration; and (iii) confirm that 6 weeks therapy is sufficient in fingernail mycosis. One hundred and forty-eight patients received 250 mg terbinafine daily for either 6 or 12 weeks in a double- blinded manner, and were followed until 48 weeks after start of therapy. Cure of the nail infection was defined as negative mycological tests (mycological cure) and progressive growth of normal nail (clinical cure). Mycological cure was recorded in 43 of 72 (59.7%) in the 6-week group and 55 of 76 (72.4%) in the 12-week group. In those who completed the study per protocol in the 6-week group. 34 of 61 (55.7%) were cured mycologically corresponding to 46 of 56 (82.1%) in the 12-week group. The overall clinical and mycological cure rates for the two groups were 28 of 61 (45.9%) and 33 of 56 (58.9%), respectively. In the small number of patients with associated fingernail infection, all were improved and six of eight (75.0%) were cured after a duration of treatment of 6 weeks. A priori risk factors for failure of cure could not be identified in either group. However, shorter duration of disease prior to treatment and no involvement of the big toenail was associated with a trend toward better responses in both groups. It can be concluded from this study that, in toenail mycosis without visible matrix involvement, 6 weeks treatment of terbinafine is generally not sufficient, whereas fingernail infections respond well to this short therapy.     

Terbinafine (Lamisil) treatment of toenail onychomycosis in patients with insulin-dependent and non-insulin-dependent diabetes mellitus: a multicentre trial

BACKGROUND: Diabetes mellitus (DM) affects an estimated 175 million people world-wide. Approximately one-third of patients with DM have toenail onychomycosis. OBJECTIVES: To determine the efficacy and safety of terbinafine treatment of toenail onychomycosis in patients with DM receiving insulin and/or oral antidiabetic agents. Special interest was focused on potential drug interactions with oral hypoglycaemic substances. METHODS: In a multicentre trial, patients suffering from insulin-dependent DM (IDDM) or non- insulin-dependent DM (NIDDM) with toenail onychomycosis were treated for 12 weeks with oral terbinafine 250 mg daily and followed up to 48 weeks. In addition to clinical, mycological and laboratory investigations, blood glucose levels were monitored. RESULTS: At the end of the trial (week 48), a mycological cure rate of 73% was achieved. The rates of clinical cure and complete cure (mycological cure plus clinical cure) were 57% and 48%, respectively. There was no statistically significant difference between the NIDDM and IDDM groups with respect to the cure rates (P > 0.05). No hypoglycaemic episode was reported and none of the patients had hypoglycaemia during the treatment phase. CONCLUSIONS: With excellent cure rates and a good tolerability profile, terbinafine should continue to be a drug of choice for the treatment of toenail onychomycosis in the rising number of NIDDM patients receiving multiple medication.     

伊曲康唑间隙冲击疗法治疗甲真菌病200例

目的 :观察伊曲康唑冲击疗法治疗甲真菌病的临床疗效。方法 :2 0 0例甲真菌病患者每天口服伊曲康唑胶囊 2次 ,每次 2 0 0mg× 7天 ,停药 2 1天为 1个疗程。指甲真菌病用药 2个疗程 ,趾甲真菌病及指趾甲真菌病用药 3个疗程。结果 82例指甲真菌病临床痊愈率 91 4 6 % ,118例趾甲真菌病及指趾甲同患真菌病临床痊愈率 81 36 % ,二者伴发皮肤真菌感染者真菌清除率分别为 98 5 %和 97%。结论 :伊曲康唑短期冲击疗法治疗甲真菌病疗程短、疗效高、副作用小、安全性高、复发率低。     

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   

A double-blind, randomized study to compare the efficacy and safety of terbinafine (Lamisil) with fluconazole (Diflucan) in the treatment of onychomycosis

In a randomized, double-blind, double-placebo, multicentre study, terbinafine 250 mg daily for 12 weeks was compared with fluconazole 150 mg once weekly for 12 or 24 weeks in the treatment of onychomycosis. A total of 137 patients with culture-confirmed onychomycosis was divided into three groups: group A received terbinafine for 12 weeks, group B received fluconazole for 12 weeks, while group C received fluconazole for 24 weeks. At completion of the study (week 60), the mycological cure rate was higher in the terbinafine group than in the fluconazole groups: 89% vs. 51% and 49%, respectively (P < 0.001). The length of unaffected nail increased until week 24 in group B and until week 36 in group C, but was still increasing in group A at the final visit (week 60). Complete clinical cure of the target nail at week 60 was 67% in the terbinafine group, compared with 21% and 32% in the fluconazole groups, respectively. The incidence of adverse events was low for both study agents. We conclude that terbinafine 250 mg daily for 12 weeks is significantly more effective in the treatment of onychomycosis than fluconazole 150 mg once weekly for either 12 or 24 weeks.     

伊曲康唑间隙冲击疗法治疗甲真菌病

观察伊曲康唑间隙冲击疗法治疗甲真菌病的临床疗效。182例甲真菌病患者每天口服伊曲康唑胶囊2次,每次200mg×7天,停药21天为1疗程。指甲真菌病用药2个疗程,趾甲真菌病及指趾甲真菌病用药3个疗程。结果55例指甲真菌病临床痊愈率90.9%,127例趾甲真菌病及指趾甲同患真菌病临床痊愈率80.3%,二者伴发皮肤真菌感染者真菌清除率分别为98%和96.5%。     

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.     

Randomized double-blind comparison of short-term itraconazole and terbinafine therapy for toenail onychomycosis.

Previous studies evaluating short-term itraconazole and terbinafine therapy for onychomycosis have varied in protocol and size; this double-blind study enabled a large-scale, standardized, direct comparison. Patients with toenail onychomycosis were randomized to itraconazole 200 mg daily (n = 146) or terbinafine 250 mg daily (n = 146) for 12 weeks, with a 36-week follow-up. Mycological cure rates at the follow-up end-point were significantly equivalent (61% with itraconazole vs. 67% with terbinafine). A similar proportion of patients in each group experienced adverse events during treatment (itraconazole, 22%; terbinafine, 23%). More patients receiving terbinafine stopped treatment permanently because of treatment-related adverse events (8% vs. 1%).     

A randomized trial of amorolfine 5% solution nail lacquer combined with oral terbinafine compared with terbinafine alone in the treatment of dermatophytic toenail onychomycoses affecting the matrix region

In view of recent advances in the development of antifungal agents, this study examined the possible synergy of two new antifungal agents, terbinafine and amorolfine. The study compared two different courses of terbinafine treatment combined with amorolfine 5% solution nail lacquer. Terbinafine was given orally for 6 (AT6 group) or 12 weeks (AT12 group) and amorolfine nail lacquer applied weekly for 15 months. A control group received terbinafine alone for 12 weeks. This was a randomized, prospective, open study of severe dermatophyte toenail onychomycosis with matrix region involvement. Nail samples were taken before the start of the study, at inclusion and at the visits at 6 weeks, 3, 9, 15 and 18 months. To assess the value of such combined therapy we chose an early parameter as the principal outcome variable, which was the result of mycological examination, including direct microscopy and culture, at 3 months (allowing a margin of 15 days). The secondary parameters of success were the mycological results at the later visits, clinical evaluation and a combined mycological-clinical response. Safety and tolerance were also assessed. Adverse events were recorded and liver function tests were performed monthly during the terbinafine treatment. Of the 147 patients included in the trial, 121 attended the 3-month visit, within a time limit of 15 days of 3 months after the beginning of treatment: 40 in the AT6 group, 40 in the AT12 group and 41 in the control group. In all, 32 of 121 patients (26. 4%) had negative mycological results on direct microscopy and culture: 14 of 40 (35.0%) in the AT6 group, 11 of 40 (27.5%) in the AT12 group and seven of 41 (17.1%) in the control group. The cure rate for the global (mycological and clinical cure) response measured at 18 months in 145 patients was 44.0% (22 patients) in the AT6 group, 72.3% (34 patients) in the AT12 group and 37.5% (18 patients) in the terbinafine group. These results suggest that the combination of amorolfine and terbinafine may be of value in the treatment of severe onychomycosis. At the same time a pilot pharmacoeconomic analysis was performed demonstrating a better cost per cure ratio for the patients receiving combination treatment.