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。     

特比萘芬间歇疗法治疗趾甲真菌病疗效观察

目的：观察特比萘芬间歇疗法治疗趾甲真菌病的疗效及安全性。方法：52例患者随机分为两组,治疗组采用特比萘芬间歇疗法治疗,对照组采用特比萘芬连续疗法。结果：治疗组和对照组治疗结束时的治愈率分别为10.71%和16.67%,有效率分别为62.49%和66.67%,真菌学治愈率分别为60.71%和62.50%。第36周治愈率分别为78.57%和83.33%,有效率分别为89.29%和91.67%,真菌学治愈率分别为82.14%和83.33%。两组在治疗结束时和第36周治愈率、有效率和真菌学治愈率的差异均无统计学意义（P〉0.05）。结论：特比萘芬间歇疗法治疗趾甲真菌病与标准的特比萘芬连续疗法一样安全有效。     

特比萘芬口服治疗甲真菌病26例疗效观察

应用特比萘芬，商品名疗霉舒口服治疗甲真菌病26例，进行为期2年的临床疗效观察，结果显示临床治愈率及真菌学治愈率高，提示特比萘芬为治疗甲癣的首选药物。     

甲真菌病临床评分指数指导特比萘芬连续疗法治疗甲真菌病

目的 制定甲真菌病临床评分指数(SCIO),并观察其指导特比萘芬连续疗法治疗甲真菌病的疗效及安全性。方法 根据影响甲真菌病疗效的主要因素;甲真菌病的病情和甲的生长速度,制定SCIO。计算99例甲真菌病患者靶甲的SCIO积分,并予相应疗程的特比萘芬口服治疗。结果 94例患者,停药时(近期)临床痊愈率15.96％,有效率51.06％,真菌学治愈率72.34％;停药后3个月(中期)临床痊愈率79.79％,有效率91.49％,真菌学治愈率89.36％。不良反应发生率为16.16％。结论 SCIO具有一定的科学性和实用性,指导特比萘芬连续疗法治疗甲真菌病疗效良好。     

口服特比萘芬治疗甲真菌病83例疗效观察

目的了解特比萘芬治疗甲真菌病的疗效和安全性。方法将2005年5月～2008年10月就诊的159例甲真菌病随机分为两组,治疗组83例,口服特比萘芬250mg,1次/d,连续服药;对照组76例口服伊曲康唑200mg,2次/d,冲击治疗,连用1周,停药3周为1个疗程,共3～4个疗程。结果治疗组和对照组停药时痊愈率分别为63.86%和50.00%,有效率分别为83.13%和69.74%,真菌学痊愈率分别为79.52%和65.79%;停药后16周痊愈率分别为84.34%和75.00%,有效率分别为97.60%和94.74%,真菌学痊愈率分别为93.98%和88.16%。不良反应发生率分别为9.64%和9.2%。两组在停药时及停药后16周痊愈率、有效率和真菌学治愈率,差异均无显著意义(P均>0.05);不良反应发生率差异也无显著性意义(P>0.05)。结论特比萘芬治疗甲真菌病疗效好,安全性高。     

特比萘芬治疗甲真菌病57例临床观察

目的观察特比萘芬治疗甲真菌病的疗效及安全性。方法治疗组口服特比萘芬片250 mg,1次/d,单纯指甲受累者连用9周,单纯趾甲受累或伴有指甲受累者连用12周;对照组采用30%冰醋酸外涂,2次/d,连用3个月。分别于停药时、第6,9个月时进行临床和真菌学评价。结果治疗组停药时、第6,9个月时,治愈率分别为4 9.1 2%,80.70%和89.47%;有效率分别为80.70%,91.22%和89.47%;真菌学治愈率分别为43.86%,94.74%和94.74%。治疗后各阶段的临床治愈率、有效率及真菌学治愈率均明显高于同时段对照组(P<0.01)。治疗组有3例出现胃肠道不适,1例出现一过性ALT升高,不影响治疗。结论特比萘芬治疗甲真菌病近、远期疗效好,临床和真菌学治愈率高,不良反应少,安全性好。     

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。     

特比萘芬间歇疗法治疗老年人甲真菌病的疗效和安全性评价

目的探讨特比萘芬间歇疗法在治疗老年人甲真菌病中的疗效和安全性。方法采用随机双盲方法,将老年人甲真菌病患者分为2组。特比萘芬间歇疗法组:特比萘芬250mg,1次/d,连续4周,停药4周,再予连续4周;特比萘芬持续疗法组:特比萘芬250mg,次1/d,连续12周。在服药后第12周、24周、36周、48周、72周进行回访,观察疗效和不良反应。结果在72周时,特比萘芬间歇疗法组与持续疗法组的临床有效率为79.17%和81.82%;真菌清除率为83.33%和90.91%。在不同的观察时间,两组的临床有效率和真菌清除率相比较,差异均无统计学意义(P均>0.05)。结论在治疗老年人甲真菌病中,特比萘芬间歇疗法可以达到与特比萘芬持续疗法类似的疗效和安全性。     

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。     

特比萘芬治疗糖尿病伴念珠菌性间擦疹33例疗效观察

目的:探讨口服和外用特比萘芬治疗糖尿病伴念珠菌性间擦疹临床疗效观察,以及口服特比萘芬后对糖尿病患者血糖的影响。方法:选择Ⅱ型糖尿病伴念珠菌性间擦疹患者66例,随机分成A组和B组各33例。A组口服特比萘芬250 mg,每日1次,连服14天;A、B两组同时均外用特比萘芬软膏,每日2次,连用14天后评判疗效。A组患者服药前、停药时查空腹血糖以及餐后2小时血糖并作记录。结果:停药时A组有效率81.8%,B组69.7%;停药4周后有效率A组84.8%,B组69.7%。两组有效率比较差异均无统计学意义。口服特比萘芬前后A组患者血糖变化差异无统计学意义。结论:口服和外用特比萘芬治疗糖尿病伴念珠菌性间擦疹治愈率高,疗效确切,安全性好。     

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.     

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   

伊曲康唑间歇冲击治疗趾甲真菌病疗效和血清及甲中药物水平临床研究

目的:研究伊曲康唑间歇冲击疗法治疗趾甲真菌病(甲母质未受累)的疗效和在血清及甲中药物水平的变化。方法:41例趾甲真菌病患者应用伊曲康唑连续3个冲击治疗,第52周进行最终疗效评价;采用高压液相色谱仪(HPLC)法对其中15例趾甲真菌病患者进行了血清及甲中药物测定。结果:每次冲击后4周,血清中均未测得伊曲康唑;甲组织中伊曲康唑水平较高,在8或12周时达到高峰,停药后,伊曲康唑仍能以较高的水平在甲中储留36周;同一时间点,指甲和趾甲中的药物水平相似(P>0.05)。在第52周时,趾甲真菌病的临床治愈率为66.7％,临床有效率为79.5％,真菌学清除率为64.1％。结论:伊曲康唑口服吸收后从血液迅速向甲组织分布,停药后仍以较高水平储留在甲组织中并持续存在36周以上。     

Terbinafine in the treatment of onychomycosis: a review of its efficacy in high-risk populations and in patients with nondermatophyte infections

BACKGROUND: The prevalence of onychomycosis is higher in certain high-risk populations, such as the immunocompromised, diabetics and human immunodeficiency virus (HIV)-positive patients. These patients can also develop onychomycosis due to nondermatophyte fungi. Although the efficacy of terbinafine is well demonstrated in the treatment of conventional dermatophyte nail infection, there are few data on the efficacy of terbinafine in high-risk patient groups or in nondermatophyte fungi, which can be difficult to treat. OBJECTIVES: To review previously published data regarding the safety and efficacy of terbinafine in special patient populations, such as those with diabetes mellitus or HIV infection, those receiving immunosuppressive therapy, and patients with onychomycosis due to nondermatophyte fungi. METHODS: A Medline literature search up to October 2002 was performed in order to identify relevant studies. Pertinent abstracts presented at international meetings were also included. Cure rates (per-protocol and intention-to-treat) were extracted or calculated. All available safety data were also collated. RESULTS: Terbinafine was highly effective and well tolerated in patients with diabetes mellitus. Mycological cure rates of 62-78% were achieved in three studies, which is comparable with the efficacy in nondiabetic populations. Mycological cure rates of 64-91% were achieved in subsets of diabetic patients with Candida-positive nail cultures. The efficacy of terbinafine in patients receiving immunosuppressive therapy was also similar to that reported in immunocompetent patients. Levels of ciclosporin in the blood clearly decreased, with little clinical consequence; however, consideration should be given to the monitoring of ciclosporin levels in patients concomitantly receiving immunosuppressive therapy and terbinafine. Two small studies reported that terbinafine was also effective in treating onychomycosis in HIV-positive patients. Terbinafine was also effective and well tolerated in the treatment of nondermatophyte onychomycosis. CONCLUSIONS: This review suggests that terbinafine is a safe and effective treatment for onychomycosis in high-risk populations. However, the majority of these studies only included small numbers of patients and larger clinical trials are needed, especially in patients with HIV infection.     

特比萘芬合用地巴唑治疗甲真菌病的随机双盲对照研究

目的 观察特比萘芬与地巴唑联合治疗甲真菌病的疗效。方法 甲真菌病患者随机分组,治疗组口服特比萘芬250mg每日1次,同时口服地巴唑10mg每日3次;对照组口服特比萘芬250mg每日1次,同时口服安慰剂。治疗组指甲真菌病疗程为6周,趾甲疗程为8周;对照组指甲真菌病疗程为8周,趾甲疗程为10周。观察2种方法的疗效。结果 治疗后第24周随访,治疗组54例痊愈率为70.4%(38/54例),有效率为83.3%(45/54例);对照组51例痊愈率为66.7%(34/51例),有效率为80.4%(41/51例),两组比较差异均无显著性(P>0.05)。结论 特比萘芬与血管扩张剂联合治疗甲真80.4%(41/51例),两组比较差异均无显著菌病能缩短疗程,且无明显不良反应。     

Clinical trial: the safety of terbinafine in patients over the age of 60 years: a multicenter trial in onychomycosis of the feet

Thirty patients completed this open-label, multicenter prospective study performed to evaluate the efficacy and safety of terbinafine treatment of onychomycosis of the feet in elderly patients. Inclusion criteria included an age of 60 years or older, a diagnosis of onychomycosis confirmed by positive potassium hydroxide (KOH) preparation at baseline, and toenails capable of regrowth. Patients were excluded from the study if they had received any systemic antifungal therapy within the previous 3 months or topical antifungal therapy within 1 week prior to the start of the study; had psoriasis; had toenail abnormalities interfering with normal toenail appearance; were immunosuppressed or immunodeficient; or had serum hepatic enzyme (serum glutamic-oxaloacetic transaminase, SGOT; serum glutamic-pyruvic transaminase, SGPT) values greater than 1.5 times the upper limit of normal at baseline. Following baseline evaluations, eligible patients received a 12-week supply of oral terbinafine (250 mg/day) for self-administration. Compliance was assessed by tablet counts at each visit and defined as the use of at least 80% of the medication prescribed at the first two visits. Follow-up evaluations were conducted for the next 60 weeks, for a total study period of 72 weeks. These visits occurred at weeks 6, 12, 24, 36, 48, and 72. All follow-up visits included: (i) the reporting of adverse effects; (ii) assessment of efficacy by KOH preparation, mycologic culture, and investigator evaluation; and (iii) physician and patient global assessments of various quality of life parameters (except for the visit at week 36). Safety and tolerance were assessed by physical examination at baseline and week 12, by laboratory evaluations (hematology, blood chemistry, and urinalysis) at baseline, week 6 and week 12, and by reporting and evaluation of adverse events throughout the entire study. Investigators assessed the extent of involvement of the target toenail and recorded global assessments of therapeutic efficacy at all visits. Mycologic evaluation was conducted by KOH preparation and a mycologic culture of the target toenail. Because of discrepancies in KOH results between the investigator sites and the central laboratory in early analyses, we chose to use the mycologic culture results to evaluate efficacy. Because all 30 subjects were treated with terbinafine, the entire group was considered for safety evaluation.     

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%).     

Long-term effectiveness of treatment with terbinafine vs itraconazole in onychomycosis: a 5-year blinded prospective follow-up study

OBJECTIVE: To examine long-term cure and relapse rates after treatment with continuous terbinafine and intermittent itraconazole in onychomycosis. DESIGN: Long-term prospective follow-up study. SETTING: Three centers in Iceland. SUBJECTS: The study population comprised 151 patients aged 18 to 75 years with a clinical and mycological diagnosis of dermatophyte toenail onychomycosis. INTERVENTIONS: In a double-blind, double-dummy study, patients were randomized to receive either terbinafine (250 mg/d) for 12 or 16 weeks or itraconazole (400 mg/d) for 1 week in every 4 for 12 or 16 weeks (first intervention). Patients who did not achieve clinical cure at month 18 or experienced relapse or reinfection were offered an additional course of terbinafine (second intervention). MAIN OUTCOME MEASURES: The primary efficacy criterion was mycological cure, defined as negative results on microscopy and culture at the end of follow-up and no requirement of second intervention treatment. Secondary efficacy criteria included clinical cure without second intervention treatment and mycological and clinical relapse rates. RESULTS: Median duration of follow-up was 54 months. At the end of the study, mycological cure without second intervention treatment was found in 34 (46%) of the 74 terbinafine-treated subjects and 10 (13%) of the 77 itraconazole-treated subjects (P<.001). Mycological and clinical relapse rates were significantly higher in itraconazole vs terbinafine-treated patients (53% vs 23% and 48% vs 21%, respectively). Of the 72 patients who received subsequent terbinafine treatment, 63 (88%) achieved mycological cure and 55 (76%) achieved clinical cure. CONCLUSION: In the treatment of onychomycosis, continuous terbinafine provided superior long-term mycological and clinical efficacy and lower rates of mycological and clinical relapse compared with intermittent itraconazole.     

糖尿病患者趾甲真菌病的患病率及易感因素

目的 探讨糖尿病患者甲真菌病的患病率及易感因素.方法 研究我院糖尿病门诊和住院的糖尿病患者趾甲真菌病的发病情况,并与非糖尿病组比较.结果 糖尿病组与对照组趾甲真菌病的患病率分别为20.8%和9.4%,两组差异有显著性(P<0.001).两组均发现趾甲真菌病的患病率和年龄、性别显著相关(P<0.001).糖尿病组皮肤癣菌和酵母菌分离率接近,分别为47.4%和40.0%,对照组则为66.6%和27.3%.单因素分析表明趾甲真菌病的易感因素包括:糖尿病病程、周围血循环障碍、末梢神经炎、视网膜病变及口服免疫抑制剂.结论 糖尿病人群合并趾甲真菌病的风险是对照组的2.2倍.易感因素包括老龄、男性、病程长、周围血循环障碍、末梢神经炎、视网膜病变及口服免疫抑制剂.     

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.