Treatment of toenail onychomycosis with oral terbinafine plus aggressive debridement: IRON-CLAD, a large, randomized, open-label, multicenter trial

This study was conducted to investigate the efficacy of oral terbinafine with and without aggressive debridement for the treatment of toenail onychomycosis. Onychomycosis patients aged 18 to 75 years received 12 weeks of terbinafine, 250 mg/day, alone (n = 255) or with aggressive debridement (n = 249). Both groups showed marked improvement from baseline at all time points. At week 48, complete, mycologic, and clinical cure rates were higher in the terbinafine plus debridement group compared with the terbinafine alone group, although significance was reached only for clinical cure (59.8% versus 51.4%; P = .023). Although approximately 39% of the patients received at least one antidiabetic, antihypertensive, or cholesterol-lowering agent concomitantly, including statins, the incidence of treatment-emergent adverse events was low and the adverse events were generally mild to moderate in severity. No clinically significant changes in liver transaminase levels were observed 6 weeks after treatment or after 12 weeks in those tested. These results support the well-established safety and efficacy of terbinafine for treatment of onychomycosis.     

特比萘芬治疗老年糖尿病患者趾甲真菌病疗效观察

目的观察应用时间对特比萘芬治疗趾甲真菌病的疗效和安全性。方法将84例老年糖尿病趾甲真菌病患者随机分为两组,均口服特比萘芬250mg／d,观察组共治疗16周,对照组12周。停药后24周观察疗效。结果观察组治愈率68．2％,高于对照组40．0％（x^2=6．71,P〈0．01）;观察组显效率为86．4％,高于对照组的67．5％（X^2=4．26,P〈0．05）。真菌治愈率观察组为93．2％,对照组为77．4％,观察组优于对照组（x^2=4．21,P〈0．05）。在停药52周时,观察组30例中复发2例,对照组16例中复发6例,差异有统计学意义（x^2=4．93,P〈0．05）。结论应用时间影响特比萘芬治疗趾甲真菌病的效果。应用时间长,治愈率高,复发率低。     

特比奈芬治疗88例儿童甲真菌病临床观察

目的 观察特比奈芬治疗儿童甲真菌病的疗效及安全性。方法 应用特比奈芬治疗儿童指甲真菌病50例及趾甲真菌病38例，并作疗效、真菌清除率及安全性观察。结果 特比奈芬治疗儿童指甲真菌病的痊愈率及总有效率分别为92．1％和97-37％：趾甲真菌病则分别为86．36％和93．94％。真菌清除率均达到96．59％。在本临床研究中未发现特比奈芬有严重的毒副反应。结论 特比奈芬治疗儿童甲真菌病疗效显著、安全性高，是有效根治儿童甲真菌病的方法之一。     

Study of oral itraconazole and terbinafine pulse therapy in onychomycosis

In this open, randomized and comparative study, the safety and efficacy of systemic intermittent itraconazole and terbinafine was examined in 30 patients with onychomycosis. The patient with positive mycological culture and also the patients with positive microscopy and negative culture were investigated. Patients were randomly assigned: 15 patients in each group received either 200mg itraconazole or 250 mg terbinafine twice daily during the first week of a 4 weeks cycle. The treatment duration was 16 weeks and was followed-up for 36 weeks. Both the treatment regimen showed significant reduction in onychomycosis affected areas after 8 weeks and maximum reduction was observed at the end of 36 weeks. At the end point of the follow-up period, the clinical cure rates (no residual deformity or with some deformity) were 86.7% in the itraconazole group and 100% in the terbinafine group. The mycological cure rates were 86.7% and 100% respectively. However, no statistically significant differences between the treatment groups were seen in clinical, mycological (P= 0.864) and severity assessment (P= 0.220). Nausea, abdominal cramp, headache, back pain and flu like syndrome are the adverse effects more frequently reported. At least one adverse effect was reported by 17 patients, of them 12 belonged to itraconazole group and 5 to terbinafine group and the difference was statistically significant (P= 0.027). The overall therapeutic effectiveness, safety and cost affectivity were in favor of Terbinafine pulse therapy.     

特比奈芬治疗88例儿童甲真菌病临床观察

目的 观察特比奈芬治疗儿童甲真菌病的疗效及安全性.方法 应用特比奈芬治疗儿童指甲真菌病50例及趾甲真菌病38例,并作疗效、真菌清除率及安全性观察.结果 特比奈芬治疗儿童指甲真菌病的痊愈率及总有效率分别为9.1%和97.37%;趾甲真菌病则分别为86.36%和93.94%.真菌清除率均达到96.59%.在本临床研究中未发现特比奈芬有严重的毒副反应.结论 特比奈芬治疗儿童甲真菌病疗效显著、安全性高,是有效根治儿童甲真菌病的方法之一.     

特比萘芬联合半导体激光治疗甲癣102例疗效观察

目的 分析特比萘芬联合半导体激光治疗甲癣的临床疗效.方法 选取我科2011年3月至2015年3月门诊就诊的甲癣患者共102例.按照患者接受的治疗方案,分为联合组和对照组.对照组口服盐酸特比萘芬片0.25 g,1次/d,连服12周.联合组在对照组治疗方案基础上,加用半导体激光照射治疗,每周2次,疗程相同.停药24周后,对比两组患者的临床疗效.结果 与对照组比较,联合组治疗后病甲(指甲、趾甲)的指甲生长长度、甲分离、甲板增厚、甲板破坏程度和甲沟炎评分、甲真菌病临床评分指数差异有统计学意义(P＜0.05);联合组治疗后的总有效率、清除率高于对照组(100.00％ vs 90.19％,54.92％vs29.41％,P＜0.05).结论 特比萘芬联合半导体激光治疗甲癣具有较好的临床疗效.     

伊曲康唑冲击疗法治疗甲真菌病50例

目的： 评价伊曲康唑冲击疗法治疗由皮肤癣菌、酵母菌和霉菌引起的甲真菌病的有效性、安全性和耐受性。方法： 采用冲击疗法, 连续服用伊曲康唑（４００ ｍｇ／ｄ） １ 周后, 停药３周为１ 个疗程。指甲真菌病服药２ 个疗程; 趾甲真菌病服药３ 个疗程。观察疗程结束、停药３个月及停药６ 个月时指（ 趾） 甲真菌病的临床治愈率和真菌学治愈率。结果： 疗程结束时、停药后３ 个月及停药后６ 个月时指甲真菌病的临床治愈率分别为２５ ％ 、８５ ％ 和９０ ％ , 真菌学治愈率分别为６５ ％ 、９０ ％ 和９５ ％ ; 趾甲真菌病的临床治愈率分别为１６－６ ％ 、６３－３ ％ 和８６－７ ％ , 真菌学治愈率分别为５６－７ ％ 、８３－３ ％ 和９０ ％ 。疗程结束后, 随时间延长治愈率不断提高, 停药后６ 个月达最高。指甲真菌病的治愈率高于趾甲真菌病; 真菌学治愈率高于临床治愈率。未发现严重不良反应。停药后６ 个月时复发率为６ ％ 。结论： 伊曲康唑为广谱抗真菌药, 冲击疗法治疗甲真菌病具有疗效高、安全性好、耐受性高以及费用低廉的特点。     

Satisfaction with onychomycosis treatment. Pulse versus continuous dosing

The purpose of this study, which involved two dermatology clinics and two podiatric medical clinics, was to determine whether a difference exists in patient-reported satisfaction and compliance between continuous terbinafine therapy and pulse-dose itraconazole therapy for the treatment of toenail onychomycosis. Patients in this multicenter, open-label, cross-sectional study had previously completed treatment with either oral terbinafine or oral itraconazole for toenail onychomycosis. Patients were interviewed by telephone to assess clinical outcomes, compliance, and satisfaction with treatment; clinical data were collected by medical chart review. Patients reported significantly greater ease and convenience of treatment and higher overall satisfaction with continuous terbinafine therapy compared with pulse-dose itraconazole therapy.     

0.9 ms 1064 nm Nd：YAG激光联合伊曲康唑治疗趾甲真菌病

目的探究0.9 ms 1064 nm Nd：YAG激光联合伊曲康唑治疗趾甲真菌病的临床疗效及安全性。方法对37例（178个甲） 趾甲真菌病患者随机分为甲乙两组,再按甲真菌病临床评分指数（SCIO）和甲真菌病严重度指数（OSI）分值高低各分为不同亚 组。所有患者均使用激光治疗（1次/周,共8次）。乙组第1周口服伊曲康唑0.2 g,2/日。比较治疗前后的疗效、临床评分、外观变 化以及不良反应,并进行患者满意度调查。结果随访12个月,临床有效率甲组31.33%、乙组35.79%;真菌清除率甲组30.00%、 乙组41.18%;两组临床有效率、真菌清除率差异均无统计学意义（P>0.05）。SCIO/OSI变化,甲组均无统计学意义（P>0.05）、乙 组均有统计学意义（P<0.05）;SCIO<12、OSI<16时,不同亚组之间临床有效率无明显差异（P>0.05）;SCIO≥12、OSI≥16时,不同 亚组之间临床有效率有差异性（P<0.05）。分别有33.71%、74.72%、70.79%的病甲在面积、形状、颜色方面得到改善。62.16%患 者对治疗效果满意。所有患者无明显不良反应。结论0.9 ms 1064 nm Nd：YAG激光1年内有效改善甲真菌病病甲的外观,对 于较为严重的甲真菌病,联合伊曲康唑治疗是个更好的选择。     

Treatment of dermatophyte toenail onychomycosis in the United States. A pharmacoeconomic analysis

This study attempted to determine the cost-effectiveness of therapies for dermatophyte toenail onychomycosis in the United States in 2001. The antimycotic agents evaluated were ciclopirox 8% nail lacquer and the oral agents terbinafine, itraconazole (pulse), itraconazole (continuous), fluconazole, and griseofulvin. A treatment algorithm for the management of onychomycosis was developed, and a meta-analysis was carried out to determine the average mycologic and clinical response rates for the various agents. The cost of the regimen was figured as the sum of the costs of drug acquisition, medical management, and management of adverse effects. The expected cost of management and disease-free days were determined, and a sensitivity analysis was conducted. It was concluded that ciclopirox 8% nail lacquer, which has recently become available in the larger size of 6.6 mL, is a cost-effective agent for the management of toenail onychomycosis.     

阿莫罗芬搽剂治疗70例甲真菌病的疗效观察

目的观察5%阿莫罗芬搽剂治疗甲真菌病的疗效。方法将130例患者随机分为5%阿莫罗芬搽剂组（治疗组）70例和特比萘芬组（对照组）60例。治疗组给予5%阿莫罗芬擦剂外涂,每周1次。对照组给予特比萘芬口服,0.25g/d。各组在治疗3月后进行SCIO评分,以疗效指数判定疗效。结果 5%阿莫罗芬擦剂治疗甲真菌病有效率为85.7%,特比萘芬有效率为83.3%,两组疗效差异无统计学意义（P〉0.05）。结论外用5%阿莫罗芬擦剂治疗未累及甲母质的甲真菌病疗效好。     

长脉宽1064 nm Nd：YAG激光治疗趾甲真菌病的疗效及安全性

目的：探讨长脉宽1064 nm Nd：YAG激光治疗趾甲真菌病的疗效及安全性。方法对确诊的104例（461个趾甲）趾甲真菌病患者,根据年龄段分为Ⅰ组（≥60岁）和Ⅱ组（<60岁）,按照SCIO评分及病甲位置的差异分为不同亚组;所有患者病甲均使用长脉宽1064 nm Nd：YAG激光进行每周1次、共10~12次的治疗,随访至初次治疗后的48周,观察疗效及不良反应。结果所有病人随访至48周,总体临床有效率为72.5%。Ⅱ组的临床有效率和真菌学治愈率均高于Ⅰ组,差异有统计学意义（P<0.05）。不同SCIO亚组之间的临床有效率无统计学差异（P>0.05）。第2~4趾甲亚组的临床有效率优于第1、第5趾甲亚组,差异有统计学意义（P<0.05）;所有患者无明显不良反应。结论长脉宽1064 nm Nd：YAG激光是一种安全微创有效的治疗甲真菌病的方法,可在临床推广使用。     

三种常见抗真菌药口服治疗甲真菌病疗效观察

目的了解伊曲康唑、特比萘芬和氟康唑口服治疗甲真菌病的疗效。方法63例患者根据治疗药物的不同分为三组,伊曲康唑组41例,特比萘芬组13例,氟康唑组9例。分别在疗程结束后3个月和6个月时,进行真菌学检查和临床症状观察。结果伊曲康唑、特比萘芬和氟康唑治疗结束3个月和6个月的临床有效率分别为87．80％和92．68％、84．62％和92．31％、88．89％和88．89％;治疗结束3个月和6个月真菌学治愈率一致,分别为100％、92．31％和100％％。结论伊曲康唑与特比萘芬和氟康唑治疗甲真菌病均能取得较好的疗效。美扶因价格相对便宜,抗菌谱更广,具有更高的效价比。     

斯皮仁诺短程冲击间歇治疗老年甲真菌病

目的：观察斯皮仁诺短程冲击治疗老年人甲真菌病的临床疗效。方法：70例患者口服斯皮仁诺胶囊200 mg,2次/d,与餐同服-连用1周,停药3周为1个疗程。指甲真菌病患者用药2个疗程,趾甲真菌病及指趾甲真菌病患者用药3个疗程。结果：40例指甲真菌病患者痊愈率87.5%,显效率7.5%,总有效率95.0%;54例趾甲真菌病患者痊愈率77.8%,显效率11.1%,总有效率88.9%。结论：斯皮仁诺短程冲击治疗老年人甲真菌病疗程短、疗效高、副作用小、安全可行。     

伐尼克兰联合24周心理行为干预对烟草依赖的疗效和安全性

目的 评估伐尼克兰联合心理咨询行为干预对烟草依赖的疗效和安全性,并对中国烟草依赖者短期、长期戒烟率和安全性进行随访.方法 采用前瞻性、开放临床试验.对入选烟草依赖者给予口服12周伐尼克兰,联合戒烟建议随访,共随访到24周,观察戒烟者呼出气一氧化碳证实的戒烟率、不良反应及戒断症状.结果 入选病例27例,12周和24周持续戒烟率分别为78%和74%.不良反应主要为恶心（37%）、失眠（19%）、头痛（11%）、疲乏（7%）、异常梦境（7%）等,程度轻微,多为一过性.治疗阶段12周体质量平均增加（1.0±1.3）kg.戒断症状轻微,12周评分为1.9±2.3.结论 伐尼克兰联合心理咨询行为干预短期和长期戒烟率高,伐尼克兰安全、耐受性好,对中国烟草依赖者具有适用性.     

Evaluating costs for onychomycosis treatments: a practitioner's perspective

Onychomycosis is a common problem. The desired outcome of treatment for patients and clinicians is complete cure (negative culture and negative potassium hydroxide examination results plus a completely normal nail). This cost analysis sought to determine the cost-effectiveness of treatments for onychomycosis using complete cure as a unit of effectiveness. A simplified cost-effectiveness analysis was conducted using complete cure rates from randomized, blinded clinical trials involving at least 50 participants. Trials were identified by searching the literature, manually searching for review articles, and reviewing medication package inserts. For each trial that met the entry criteria, three levels of cost were used to calculate medication cost per complete cure: commercial price, average wholesale price, and Veterans Affairs pharmacy price. In addition, a computerized economic model was used to determine total cost per complete cure, including all medical costs. The most cost-effective treatments were those that involved terbinafine: pulse, continuous, or in combination with other agents. Itraconazole, griseofulvin, and fluconazole were less cost-effective. Ciclopirox nail lacquer was at least three times more expensive than all other agents when evaluating total costs per complete cure. Overall, the lowest cost per complete cure resulted from terbinafine treatment, with most evidence supporting 3 months of continuous therapy.     

复方甘草酸苷片联合窄谱UVB治疗掌跖脓疱病疗效观察

目的 探讨复方甘草酸苷片（美能）联合窄谱中波紫外线（NB-UVB）治疗掌跖脓疱病的临床疗效.方法 将66例患者随机分成3组,各22例,治疗组：口服复方甘草酸苷片联合窄谱UVB照射;对照1组：仅口服复方甘草酸苷片;对照2组：窄谱UVB照射,3组均4周为1个疗程,分别于治疗前及治疗后第4周和第8周后观察疗效.结果 治疗组、对照1组和对照2组第4周末的治愈率分别为40.91%、18.18%、13.64%,有效率分别为72.73%、40.91%、36.36%,第8周末的治愈率分别为72.73%、31.82%、22.73%,有效率分别为90.91%、63.64%、54.55%,治疗组分别与对照1组和对照2组比较,治疗后4和8周末的疗效和有效率差异均有统计学意义.结论 复方甘草酸苷片联合窄谱UVB治疗掌跖脓疱病安全、有效.     

医用臭氧联合局部封闭治疗梨状肌综合征的临床应用

目的:观察医用臭氧联合局部封闭治疗梨状肌综合征的临床应用。方法:将59例诊断为梨状肌综合征的患者随机分为两组。对照组30例采用局部注射,压痛点消毒穿刺,注入甲基泼尼松龙25 mg和2%利多卡因2 ml、0.9%NaCl溶液5 ml、维生素B120.5 mg;观察组29例为臭氧联合局部封闭组,压痛点消毒穿刺,用浓度30μg/ml医用臭氧20 ml及甲基泼尼松龙25 mg和2%利多卡因2ml、0.9%NaCl溶液5 ml、维生素B120.5mg分别注入;于1周、4周后对两组药物的临床疗效进行评比。结果:治疗后1周两组比较差异无统计学意义(P>0.05);治疗4周对照组治愈率50.0%,总有效率70.0%,观察组治愈率79.3%总有效率96.5%,两组比较差异有统计学意义(P<0.05)。结论:医用臭氧联合局部封闭注射治疗梨状肌综合征效果良好,可成为一种优化的微创手术推广。     

特比萘芬软膏与复方酮康唑乳膏治疗浅部真菌病疗效比较

目的特比萘芬与复方酮康唑外用治疗皮肤浅部真菌病的疗效比较。方法浅部真菌病患者60例,随机分为特比萘芬组30例(应用特比萘芬软膏外涂患处,Bid×2周)和复方酮康唑组30例(外用复方酮康唑乳膏,Bid×2周);在停药时及停药2周后观察疗效。结果治疗结束时,特比萘芬组总有效率为73%(22/30),明显高于复方酮康唑组为57%(17/30)(P<0.05);停药2周后,特比萘芬组总有效率为97%(29/30),明显高于复方酮康唑组为47%(14/30)(P<0.05)。治疗结束时,特比萘芬组真菌清除率为83%,明显高于复方酮康唑组为53%(P<0.05),停药2周后,特比萘芬组真菌清除率为97%,明显高于复方酮康唑组为37%(P<0.01)。2组均未见明显不良反应。结论特比萘芬治疗浅部真菌病疗效优于复方酮康唑。     

伊曲康唑联合甲床修整术治疗重症甲真菌病的疗效观察

目的观察口服伊曲康唑联合甲床修整术治疗重症甲真菌病的临床疗效。方法将140例甲真菌病患者随机分为两组,治疗组68例采用甲床修整术联合口服伊曲康唑治疗;对照组72例单纯口服伊曲康唑治疗。结果治疗组痊愈率及总有效率分别为70.6%及88.2%,对照组分别为45.8%及65.2%,两组患者痊愈率及总有效率差异均有显著统计学意义（P〈0.01）。结论伊曲康唑口服联合甲床修整术治疗重症甲真菌病疗效高,能显著改善新甲的生长速度及外观。