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。     

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。     

1％盐酸布替萘芬喷雾剂与1％联苯苄唑喷雾剂治疗体股癣、足癣的多中心随机双盲对照研究

目的观察和评价山东省医药工业研究所研制的1%盐酸布替萘芬喷雾剂治疗体股癣、足癣的临床疗效和安全性。方法采用多中心随机、双盲、平行对照法,对照药为1%联苯苄唑喷雾剂。在治疗开始、中间、结束和2周随访时记录症状、体征积分及真菌学检查结果,以评价疗效,并监测不良事件。结果体股癣共117例,试验组58例,对照组59例。足癣共119例,试验组59例,对照组60例。体股癣停药时试验组与对照组痊愈率分别为25.86%和40.68%,有效率为86.21%和91.53%;2周随访痊愈率为58.62%和74.58%,有效率为96.55%和96.61%。足癣停药时痊愈率分别为23.73%和25.00%,有效率为81.36%和78.33%;2周随访痊愈率为37.29%和41.57%,有效率为81.36%和90.00%。试验组有13例出现局部不良反应,发生率为10.16%;对照组有20例,发生率为16.67%。上述各项指标经统计学检验,与对照药物差异均无统计学意义。结论1%盐酸布替萘芬喷雾剂治疗体股癣、足癣安全有效。     

利拉萘酯软膏治疗体股癣的临床研究

目的探讨利拉萘酯软膏治疗体股癣的疗效和安全性。方法采用多中心、随机双盲、有效对照、平行分组法对144例体股癣患者进行了4周的临床研究。结果138例患者完成临床观察并纳入统计分析,其中试验组71例,对照组67例,试验组治愈率为46.48%,对照组为40.30%,两组有效率分别为83.10%和83.58%,真菌清除率分别为95.83%和95.65%;不良反应发生率分别为0.70%和0。两组之间的临床治愈率、有效率和真菌清除率及不良反应率差异均无显著性。结论2%利拉萘酯软膏治疗体股癣综合疗效和不良反应发生率与1%联苯苄唑软膏相似,具有较好的疗效和安全性。     

1%盐酸布替萘芬软膏治疗浅部真菌病随机单盲对照多中心临床试验

采用1%盐酸布替萘芬软膏与1%联苯苄唑乳膏治疗219例浅部真菌病,治疗结果表明,二类新药1%盐酸布替萘芬软膏对手足癣和体股癣临床疗效、真菌学疗效、不良反应发生率与对照药1%联苯苄唑乳膏相似。虽然停药后1周试验组手足癣和体股癣治愈率均高于对照组(P<0.05),但两组的有效率均差异无统计学意义(P=1.000)。     

1%盐酸布替萘芬治疗浅部真菌病临床疗效及安全性观察

选择110例体股癣和手足癣患者外用1%盐酸布替萘芬乳膏,2次/d,随访观察症状和体征积分变化情况。结果:盐酸布替萘芬乳膏治疗体、股癣和手、足癣有效率为97.27%,其疗效好,安全性高,值得临床选用。     

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。     

萘替芬酮康唑乳膏治疗体股癣疗效观察

目的评价萘替芬酮康唑乳膏(必亮乳膏)治疗体股癣的疗效。方法100例患者随机分为治疗组和对照组各50例,分别外用萘替芬酮康唑乳膏、硝酸咪康唑乳膏,均早晚各1次,疗程4周。在治疗的第2,4周和停药1周时观察记录患者皮损变化、不良反应及皮损处皮屑真菌镜检,并评价疗效。结果治疗的第4周和停药1周时,治疗组疗效明显优于对照组(P(0.05),治疗组和对照组局部不良反应发生率分别为6.00%,4.00%,症状较轻,均能坚持治疗。结论外用萘替芬酮康唑乳膏(必亮乳膏)治疗体股癣疗效较好,不良反应发生率低。     

1%盐酸布替萘芬乳膏治疗浅部真菌病临床观察

目的：评价1％盐酸布替萘芬乳膏治疗浅部真菌病的临床疗效及安全性，并与1％联苯苄唑凝胶进行比较。方法：对83例浅部真菌病患者进行治疗，其中治疗组43例，外用1％盐酸布替萘芬乳膏，每日1次；对照组40例，外用1％联苯苄唑凝胶，每日1次，体股癣疗程2周，手足癣4周。分别于停药及停药2周时观察记录患者的临床表现及治疗效果。结果：1％盐酸布替萘芬乳膏和1％联苯苄唑凝胶临床疗效相似，停药时临床总有效率分别为90．7％和90．0％，真菌总清除率为93．0％和90．0％；停药2周时临床总有效率分别为97．7％和92．5％，真菌总清除率为100．0％和92．5％。不良反应少。结论：1％盐酸布替萘芬乳膏治疗浅部真菌病疗效显著且安全。     

利拉萘酯乳膏治疗股癣的疗效观察

2007年2—6月，我科采用2％利拉萘酯乳膏（山东鲁抗辰欣药业有限公司生产）外用治疗股癣，取得显著疗效，现报道如下。     

Efficacy and safety of terbinafine 1% solution in the treatment of interdigital tinea pedis and tinea corporis or tinea cruris

Two randomized, double-blind, vehicle-controlled, multicenter studies assessed the efficacy and safety of a new terbinafine 1% solution for the treatment of interdigital tinea pedis and tinea corporis or tinea cruris (tinea corporis/cruris). Patients with interdigital tinea pedis applied terbinafine 1% solution or vehicle twice daily for 1 week with 7 weeks of follow-up (N = 153), and patients with tinea corporis/cruris applied terbinafine 1% solution or vehicle once daily for 1 week with 3 weeks of follow-up (N = 66). Efficacy was assessed mycologically and clinically at the end of treatment and throughout follow-up. In the tinea pedis study, 66% of patients were effectively treated with terbinafine compared with 4% of the group treated by vehicle (P < .001; Mantel-Haenszel test). In the tinea corporis/cruris study, treatment was effective in 65% of the terbinafine group compared with 8% of the vehicle group (P < .001). There were no significant differences in the frequency of cutaneous adverse events between the 2 groups in either study. We conclude that one week of therapy with terbinafine 1% solution is highly effective, superior to vehicle, and safe for use in superficial fungal infections.     

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.     

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.     

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。     

Sulconazole nitrate 1.0 percent cream: a comparison with miconazole in the treatment of tinea pedis and tinea cruris/corporis

Sulconazole nitrate 1.0 percent cream was compared to miconazole nitrate 2.0 percent cream in a double-blind, parallel study involving ninety-six patients with cutaneous dermatophytosis. Both agents were highly effective, with no statistically significant differences in the parameters studied. Among tinea pedis patients, all of seven treated with sulconazole and six of nine treated with miconazole were mycologically cured (negative culture and potassium hydroxide test) at the end of four weeks of twice a day treatment, and there were no relapses by week 9. Among tinea cruris/corporis patients, the rates of mycological cure after three weeks of twice a day treatment with sulconazole or miconazole were, respectively, twenty-nine of thirty-two (91 percent) and 100 percent of thirty one (accompanied in all cases by complete or significant clearing of signs and symptoms); the respective relapse rates were four of twenty-five (16 percent) and eight of twenty-three (35 percent). Miconazole resulted in two cases of severe irritant dermatitis requiring discontinuation of treatment, whereas sulconazole produced no severe irritant reactions.     

SCH 370 (clotrimazole-betamethasone dipropionate) cream in patients with tinea cruris or tinea corporis

The safety and efficacy of SCH 370 (1 percent clotrimazole/0.05 percent betamethasone dipropionate) cream was compared with each of its individual components in 331 patients with tinea cruris or tinea corporis. The study was a multicentered, randomized, double-blind, parallel-groups design. The patients received one of three treatments applied twice a day for two weeks and returned for a follow-up visit two weeks after the last application. Total signs and symptoms scores of infections were evaluated at baseline, once between days three to five, and after weeks one, two, and four. Culture and potassium hydroxide preparations were done at baseline and weeks two and four. SCH 370 cream demonstrated more rapid therapeutic activity than the antifungal agent alone, resulting in significantly better clinical results in early treatment and in midtreatment. As expected with a steroid, betamethasone dipropionate achieved relief of inflammatory signs and symptoms early in the course of treatment, but SCH 370 was superior from one week on in the patients with tinea cruris and at post-treatment in the patients with tinea corporis. Mycologically, SCH 370 cream and clotrimazole were comparable at the end of the study and results were significantly better than those for betamethasone dipropionate. All three treatments were safe with no reports of unexpected or serious adverse experiences.