利拉萘酯乳膏治疗体股癣及足癣的多中心随机双盲对照观察

目的 探讨2%利拉萘酯乳膏治疗体股癣、足癣的临床疗效和安全性。方法 采用多中心随机双盲阳性药平行对照法，分别在3个中心进行，入选288例患者，2%利拉萘酯乳膏试验组144例，1% 联苯苄唑乳膏对照组144例；每组中体股癣患者各72例，足癣患者各72例。每日涂药1次，足癣疗程4周，每2周复诊1次；体股癣疗程2周，每周复诊1次；停药后2周均再复诊1次。结果 试验组体股癣患者中有１例脱落。停药时体股癣试验组的痊愈率和有效率分别为59.2%和94.4%，足癣试验组分别为41.7%和81.9%，与对照组比较，差异均无统计学意义（P ＞ 0.05）。在用药结束后2周时，体股癣试验组的痊愈率和有效率分别为67.6%和94.4%，足癣试验组分别为54.2%和81.9%，与对照组比较，差异无统计学意义（P ＞ 0.05）。在用药结束后2周，体股癣和足癣试验组符合方案分析集真菌学清除率分别为97.18%和90.28%，试验组和对照组差异均无统计学意义（P ＞ 0.05）。用药后发生的不良反应表现为用药部位红肿、疼痛，其中体股癣试验组不良反应发生率为2.78%。结论 2%利拉萘酯乳膏治疗体股癣、足癣有良好的疗效和安全性。     

Comparative study between terbinafine 1% emulsion-gel versus ketoconazole 2% cream in tinea cruris and tinea corporis

An open, prospective, comparative, randomised and parallel-group study of 65 patients was conducted to evaluate the efficacy and safety of topical 1 % emulsion-gel of terbinafine versus 2% ketoconazole cream in the treatment of tinea corporis and tinea cruris. Treatment for terbinafine emulsion-gel was applied once daily for 1 week, whereas ketoconazole cream was applied once daily for 2 weeks; patients were followed for 2 weeks. Thirty-three patients in the terbinafine group and 32 in the ketoconazole group were evaluated for efficacy and safety. At the end of the study, rates of mycological cure were 94% for terbinafine emulsion-gel and 69% for ketoconazole cream (p = 0.027). A clinical and mycological overall evaluation was obtained for 72% of patients receiving terbinafine emulsion gel and 31% of patients receiving ketoconazole cream (p = 0.002). A total of four patients (1 in the terbinafine group and 3 in the ketoconazole group) had contact dermatitis-like side effects. We conclude that a 1-week course of terbinafine 1% emulsion-gel is significantly more effective than ketoconazole 2% cream in the treatment of tinea corporis and tinea cruris as regards clinical and mycological cure and treatment safety.     

One-week therapy with oral terbinafine in cases of tinea cruris/corporis

The use of oral terbinafine in the treatment of superficial dermatophyte infections has been extensively studied, using different treatment regimens. To evaluate the efficacy of short-term therapy with oral terbinafine in cases of tinea cruris/corporis. 22 patients (21 male and one female) with mycologically proven tinea cruris/corporis, were included in the present study. Each patient received one tablet of terbinafine 250 mg daily for 1 week. Patients were followed-up for 6 weeks after completion of treatment. Clinical and mycological assessments were performed at the end of treatment, and at the end of the follow-up period. The mean sum of scores of signs and symptoms in all patients decreased significantly from 12-36 before treatment to 0 at the end of the follow-up period, and mycological investigations were negative in all patients at the end of the follow-up period. Our results show that 1-week therapy with oral terbinafine is highly effective in the treatment of tinea cruris/corporis.     

1%盐酸布替萘芬乳膏治疗体股癣、足癣疗效观察

目的：评价1％盐酸布替萘芬乳膏治疗体股癣、足癣的临床疗效和安全性。方法：采用多中心、随机、双盲、平行对照的方法．试验组外用1％盐酸布替萘芬乳膏,对照组外用1％联苯苄唑乳膏。结果：体股癣患者停药时试验组与对照组痊愈率分别为32．76％和38．98％。有效率分别为93．10％和94．92％;停药2周时,试验组与对照组痊愈率分别为62．07％和64．41％,有效率分别为93．10％和96．61％。足癣患者停药时．试验组与对照组痊愈率分别为29．31％和30．00％．有效率分别为89．66％和85．00％;停药2周时,试验组与对照组痊愈率分别为48．28％和43．33％．有效率分别为91．38％和86．67％。局部不良反应发生率,两试验组为5．13％;两对照组为4．17％。上述各项指标,两组比较差异无统计学意义。结论：1％盐酸布替萘芬乳膏治疗体股癣、足癣安全有效。     

Comparison of one week of oral terbinafine (250 mg/day) with four weeks of treatment with clotrimazole 1% cream in interdigital tinea pedis

Treatment of interdigital tinea pedis often involves long-term therapy with topically applied preparations. Effective oral preparations, such as the allylamine terbinafine (Lamisil), taken over a shorter period, could provide a useful therapeutic alternative. A total of 269 patients from five centres with clinically diagnosed interdigital tinea pedis were entered into this double-blind, randomized, double-dummy, parallel-group study comparing oral terbinafine 250 mg once daily for 1 week with 1% clotrimazole (Canesten) cream applied twice daily for 4 weeks. Of these, 137 patients were evaluable for efficacy (confirmed dermatophyte infection by microscopy and culture): 63 terbinafine and 74 clotrimazole. At week 4, the mycological cure rates (negative culture at week 1 and negative results on microscopy and culture at week 4 onwards) were very similar (71% for clotrimazole and 72% for terbinafine). There was a faster response rate in the terbinafine group with respect to signs and symptoms at week 1. Both treatments were equally well tolerated; adverse events occurred equally in the two groups. In conclusion, oral terbinafine in a single daily dose of 250 mg for 1 week is as effective and as well tolerated as 1% clotrimazole cream applied twice daily for 4 weeks in the treatment of interdigital tinea pedis.     

Itraconazole compared with griseofulvin in the treatment of tinea corporis/cruris and tinea pedis/manus: an interpretation of the clinical results of all completed double-blind studies with respect to the pharmacokinetic profile.

Itraconazole is an orally active triazole antifungal which has been compared to griseofulvin in a number of double-blind trials. In dermatophytosis with a non-fixed treatment regimen for a maximum of 3 months, itraconazole 100 mg o.d. has produced a 100% mycological cure rate as compared with a 67% rate with griseofulvin 500 mg o.d. (p less than 0.01). Based on the pharmacokinetic profile, 100 mg itraconazole daily was then compared with 500 mg ultramicronized griseofulvin daily using a fixed treatment schedule of 15 days in tinea corporis and/or cruris and 30 days in tinea pedis and/or manus. In all studies in tinea corporis/cruris (n = 277), the superiority of itraconazole was shown for the clinical outcome at the last follow-up visit 2 weeks post-therapy (88 vs. 69%, p less than 0.01) and in the mycological outcome at the last follow-up visit (81 vs. 65%, p less than 0.05). In tinea pedis/manus (n = 210), the clinical response was virtually the same for the two treatment groups, but the most important finding was the mycological outcome with a significantly better result in favor of itraconazole at the end of treatment (77 vs. 61%, p less than 0.05) even more pronounced at the follow-up visit (85 vs. 48%, p less than 0.01). We conclude that itraconazole 100 mg daily in the treatment of tinea corporis/cruris and in tinea pedis/manus is significantly more effective than 500 mg griseofulvin daily when fixed treatment regimens are used. Furthermore, the best results are obtained with itraconazole 2-3 weeks after the end of treatment.(ABSTRACT TRUNCATED AT 250 WORDS)     

美克治疗体股癣、手足癣、花斑癣和皮肤念珠菌病疗效观察

目的评价美克(1%联苯苄唑乳膏)治疗体股癣、手足癣、花斑癣和皮肤念珠菌病的临床疗效和安全性。方法采用多中心、随机、平行对照的方法,试验组外用美克,对照组外用欣欣(1%盐酸布替萘芬乳膏)。结果体股癣患者停药时试验组与对照组痊愈率分别为42.20%和39.45%,有效率分别为94.49%和91.74%;停药2w时,试验组与对照组痊愈率分别为85.32%和82.56%,有效率分别为97.24%和96.33%。手足癣停药时试验组与对照组痊愈率分别为39.87%和37.34%,有效率分别为85.54%和84.81%;停药2w时,试验组与对照组痊愈率分别为59.49%和58.22%,有效率分别为89.24%和86.70%。花斑癣患者停药时试验组与对照组痊愈率分别为50.72%和52.17%,有效率分别为79.71%和76.81%;停药2w时,试验组与对照组痊愈率分别为66.67%和63.76%,有效率分别为84.05%和81.16%。皮肤念珠菌病患者停药时试验组与对照组痊愈率分别为34.88%和39.53%,有效率分别为72.09%和76.74%;停药2w时,试验组与对照组痊愈率分别为65.11%和67.44%,有效率分别为88.37%和86.04%。局部不良反应发生率各试验组合计为5.27%;各对照组合计为5.54%。上述各项指标,各病种试验组与对照组比较差异均无统计学意义。结论美克治疗体股癣、手足癣、花斑癣和皮肤念珠菌病安全有效。     

Butenafine: an update of its use in superficial mycoses

Butenafine is a synthetic benzylamine antifungal agent that may be fungicidal against susceptible organisms, e.g., dermatophytes. Butenafine may be effective and safe in the treatment of interdigital tinea pedis (apply twice daily for 1 week or once daily for 4 weeks), tinea corporis/tinea cruris (apply twice daily for 2 weeks), and pityriasis versicolor (apply once daily for 2 weeks). The effectiveness of the drug persists for at least 4 weeks following the discontinuation of therapy suggesting that there is some retention of the drug in the skin following termination of active therapy.     

复方联苯苄唑液治疗浅部真菌病双盲对照研究

目的 为了研究复方联苯苄唑液对浅部真菌病的疗效。方法 采用双盲对照的方法。试验组为复方联苯苄唑液,对照组为克霉唑癣药水。均每日涂患部1次,疗程体股癣为2周,手足癣为4周,停药后随访2周,主要观察红斑、丘疹、水疱、鳞屑、角化和瘙痒,评价治疗后每周的皮损情况。每例患者于疗前、疗中及疗后,停药后2周作真菌学检查。结果 观察434例患者,复方联苯苄唑液临床治愈率体股癣为82.25%,手足癣为68.75%,总有效率体股癣为95.85%,手足癣为92.5%;对照组治疗体股癣痊愈率为58.6%,手足癣为44.7%,有效率体股癣为83.0%,手足癣为87.2%。临床350株常见致病菌,复方联苯苄唑液的MIC为1.6~12.5mg/L,克霉唑药水的MIC为3.125~25mg/L。结论 复方联苯苄唑液是高效、广谱的抗真菌药物。本药能溶解、松解角质,渗透性好,可长期应用。     

Short-duration therapy with terbinafine 1% cream in dermatophyte skin infections

Summary In a multicentre, double-blind, parallel-group study, the efficacy and safety of a single application of terbinafine 1% cream was compared with 3, 5 and 7 days' once-daily therapy in the treatment of tinea pedis and tinea corporis/cruris.
Seventy-eight patients with tinea pedis (58 male, 20 female; mean age 36, range 19–80) and 21 patients with tinea corporis or tinea cruris (16 male, 5 female; mean age 37, range 22–72), presenting in general practice, were entered into the study. Of these, 65 patients with tinea pedis and 14 with tinea corporis or cruris completed the study and were evaluable.
Twenty-eight days after commencing therapy 78, 83, 82 and 83% of patients with tinea pedis in the 1-, 3-, 5-, and 7-day treatment groups, respectively, were mycologically cured, and 61, 78, 71 and 67%, respectively, were 'effectively treated'. There was no statistically significant difference between treatment groups. Similarly high cure rates were seen in patients with tinea corporis and tinea cruris. Three months after commencing therapy there was little evidence of relapse.
The study shows that there is a significant potential for short-duration therapy with terbinafine 1% cream in tinea infections of the skin, emphasized here by the high cure rates obtained following a single application.     

盐酸特比萘芬乳膏1周与咪康唑乳膏1周、4周治疗趾间型足癣的多中心随机双盲研究

目的 探讨1％特比萘芬乳膏1周、2％硝酸咪康唑乳膏1周、4周治疗趾间型足癣的疗效、安全性及复发情况。方法 采用多中心、随机、双盲、平行对照法,入选患者分层随机分为3组,包括特比萘芬1周组(特比萘芬外用每日2次连续1周后再使用3周安慰剂)、咪康唑1周组(咪康唑每日2次连用1周+3周安慰剂)和咪康唑4周组(咪康唑每日2次连用4周),用药后第1、3、4、6、9、12周随访进行临床、真菌学评估。结果 152例真菌培养阳性的患者进入疗效分析。4周随访时,特比萘芬1周组,咪康唑4周组和咪康唑1周组的真菌治愈率分别为94.7％、87.8％和82.6％;3组综合疗效有效率分别89.5％、81.6％和63.0％;第12周随访时,3组真菌复发率分别为12.96％、13.95％和21.05％;不良反应发生率3组分别为2.38％、2.38％和3.57％。结论 外用1％特比萘芬乳膏1周治疗趾间型足癣与外用咪康唑乳膏4周疗效和复发率相近。     

利拉萘酯乳膏治疗手足癣和体股癣40例疗效观察

目的：评价2％利拉萘酯乳膏手足癣与体股癣的临床疗效及安全性，并与l％联苯苄唑乳膏进行比较。方法：对74例浅部真菌病患者进行治疗，其中治疗组40例，外用2％利拉萘酯乳膏，每日1次；对照组34例，外用1％联苯苄唑乳膏，每日1次。手足癣疗程4周，体股癣疗程2周。分别于停药及停药后2周观察患者的临床表现及治疗效果。结果：2％利拉萘酯乳膏和1％联苯苄唑乳膏临床疗效相似，停药时临床总有效率分别为87．50％和85．29％；停药后2周临床总有效率分别为97．50％和91．17％，两组总有效率比较差异均无统计学意义（P均〉0．05），无不良反应。结论：2％利拉萘酯乳膏治疗手足癣和体股癣使用方便，依从性好，安全，有效，是值得推广的一种新型外用抗真菌药。     

Comparative efficacy of topical 1% butenafine and 1% clotrimazole in tinea cruris and tinea corporis: a randomized, double-blind trial

Localized tinea cruris and tinea corporis can be treated by topical imidazoles (clotrimazole) or newer topical agents like butenafine, a benzylamine derivative with fungicidal activity. The therapeutic efficacy of these two agents was compared in this study. Eighty patients, diagnosed clinically to have tinea cruris or localized tinea corporis and confirmed on KOH examination, were randomly assigned to one of the two treatment groups in a double-blind manner; butenafine once daily for 2 weeks or clotrimazole twice daily for 4 weeks. Follow-up was done at 1, 2, 4 and 8 weeks. Clinical assessment score and KOH examination were performed at each visit. Butenafine recipients exhibited higher clinical cure as compared with clotrimazole recipients at the end of 1 week (26.5% vs 2.9%) as well as higher mycological cure (61.7% vs 17.6%). However, this difference was not statistically significant at 4 and 8 weeks of treatment.     

1%环吡酮胺软膏治疗浅部真菌病的疗效观察

目的 :评价环吡酮胺软膏治疗皮肤浅部真菌病的疗效和安全性。方法 :1 3 0例浅部真菌病分成二组 ,治疗组外用环吡酮胺软膏 ,对照组外用特比萘芬乳霜 ,体股癣疗程 2周 ,手足癣疗程 4周。结果 :治疗组 66例中治愈 42例 ,显效 1 8例 ,临床总有效率 90 91 % ,真菌清除率 89 3 9% ;对照组总有效率为 92 1 9% ,真菌清除率为 90 63 % ,两组疗效差异无显著性 (P >0 0 5 )。结论 :环吡酮胺软膏治疗皮肤浅部真菌病疗效显著且安全     

Topical treatment of interdigital tinea pedis: terbinafine compared with clotrimazole

A multicentre, prospective, randomized, double-blind, parallel group study was undertaken to compare the efficacy and tolerability of topical terbinafine with topical clotrimazole in the treatment of interdigital tinea pedis. Patients were randomized to receive either terbinafine 1% cream twice daily for 1 week, followed by a similar placebo cream for 5 weeks, or clotrimazole 1% cream twice daily for 4 weeks. Outcome measures were: (i) mycological cure (negative culture); (ii) effective treatment (negative culture plus a symptom score of 2 or less out of a maximum score of 18); and (iii) complete cure (negative culture and a symptom score of 0); measured at 1, 4, 8 and 12 weeks after the commencement of the study. One hundred and four of the 217 patients randomized had a culture-confirmed dermatophyte infection at baseline. In these patients, 84.6% in the terbinafine group were culture negative after 1 week, compared with only 55.8% in the clotrimazole group. Both agents were well tolerated. The study showed that terbinafine achieves mycological cure more rapidly than clotrimazole. This may result in improved compliance and better control over transmission of infection.     

Efficacy of a 1-week, twice-daily regimen of terbinafine 1 % cream in the treatment of interdigital tinea pedis: Results of placebo-controlled, double-blind, multicenter trials

BACKGROUND: Patients with tinea pedis often discontinue treatment before eradication of the fungus when their symptoms improve. The result is an incomplete cure/recurrence. OBJECTIVE: Terbinafine, a topical fungicidal agent, was evaluated in double-blind, placebo-controlled trials (159 patients) for its ability to achieve cure and relief of symptoms in the same time frame, that is, before compliance wanes. METHODS: Mycologic characteristics (with potassium hydroxide examination and culture) and clinical signs and symptoms were assessed at baseline, at the end of a 1-week, twice-daily treatment and at 1, 3, and 5 weeks after the completion of therapy. RESULTS: Both terbinafine and vehicle provided early relief of symptoms. However, only terbinafine gave progressive mycologic improvement such that at 5 weeks after treatment, 88% of the patients receiving terbinafine had converted from positive to negative mycology compared with 23% of the patients treated with vehicle. CONCLUSION: The rapid and potent fungicidal action of terbinafine results in a high cure rate in interdigital tinea pedis with 1 week of treatment and may avoid failures caused by non-compliance.     

A multicentre (double-blind) comparative study to assess the safety and efficacy of fluconazole and griseofulvin in the treatment of tinea corporis and tinea cruris

In a double-blind, parallel group study we compared fluconazole 150mg once weekly with griseofulvin 500 mg once daily for 4–6 weeks in the treatment of tinea corporis or tinea cruris. Eighty-four of 114 patients (74%) (39% after 3 weeks) were clinically cured in the fluconazole group compared with 72 of 116 (62%) (39% after 3 weeks) in tbe griseofulvin group (P = 0·06). In tbe fluconazole group 78% were mycological cured compared with 80% in the griseofulvin group. In the fluconazole group nine patients (7·5%) had treatment related adverse events and in tbe griseofulvin group 15 patients (12·5%) had adverse events. Fluconazole 150 mg once weekly for 6 weeks is botb clinically and mycologically effective in the treatment of tinea corporis and tinea cruris and few side-effects were reported.     

特比萘芬软膏与疗霉舒软膏随机对照治疗浅部真菌病多中心临床研究

目的　比较研究山东齐鲁制药厂生产的１ ％ 特比萘芬软膏和诺华公司生产的１ ％ 疗霉舒软膏治疗浅部真菌病的有效性和安全性。方法　随机、多中心临床研究。两种药物的用药剂量和疗程相同，外涂患处，每日２ 次，体股癣、花斑癣疗程１ 周，手足癣和皮肤念珠菌病疗程２ 周。结果　１ ％ 特比萘芬软膏治疗浅部真菌病，临床治愈率为７０ ．８ ％ ，总有效率９６ ．２ ％ ，真菌清除率为９０ ．６ ％ ，不良反应发生率０ ．９ ％ ；对照组疗霉舒临床治愈率为７４ ．５ ％ ，总有效率９７ ．１ ％ ，真菌清除率为９３ ．１ ％ ，不良反应发生率为２ ．０ ％ 。两种药物治疗浅部真菌病的临床疗效和安全性在统计学上差异均无显著性意义。结论１ ％ 特比萘芬软膏治疗浅部真菌病疗效好、安全性高，与１ ％ 疗霉舒软膏比较疗效相似。     

Ciclopirox for the treatment of superficial fungal infections: a review

Ciclopirox is a broad-spectrum antifungal agent that also exhibits anti-inflammatory and antibacterial activity. The lotion and cream formulations of ciclopirox are effective in many types of infection, including tinea corporis/cruris, tinea pedis, cutaneous candidiasis, pityriasis (tinea) versicolor, and seborrheic dermatitis. The new ciclopirox gel 0.77% formulation is also indicated for the treatment of seborrheic dermatitis of the scalp, interdigital tinea pedis and tinea corporis.     

Itraconazole in the treatment of tinea corporis and tinea cruris

Forty-five patients with tinea corporis or tinea cruris were treated with oral itraconazole 100 mg daily for 15 days. At the end of the 15-day treatment, 80% of the patients were healed or had markedly improved. At the first follow-up visit, 2 weeks after stopping therapy, 80% of patients were considered responders. An additional follow-up visit another month later (i. e. 6 weeks post-treatment) showed that 32 of 41 patients had responded (78%). Overall, the mycological cure rate (culture and microscopy negative) was somewhat lower than the clinical response rate. Only three patients reported minor side effects (7%). Nausea was reported by two patients and an urticarial reaction was seen in one patient after 8 days treatment. This latter patient discontinued therapy because of the adverse experience. It is concluded that itraconazole, given at a daily dose of 100 mg for 15 days, is effective in the treatment of tinea corporis and tinea cruris. Response rates at the last visit (6 weeks post-therapy) remained at the same satisfactory levels as at the first follow-up visit (2 weeks post-therapy), even though treatment was stopped after 2 weeks. Itraconazole appears to be well tolerated by patients. These results, both in terms of efficacy and side effects, are in line with results reported by other investigators. The fact that the mycological cure rates were somewhat lower than the clinical response rates had apparently no influence on the relapse rate at 6 weeks follow-up post-therapy.