口服特比萘芬联合外用联苯苄唑乳膏治疗足癣长期临床研究

目的 为足癣治疗提供较理想的方案.方法 盐酸特比萘芬250 mg,口服1次/d;1%联苯苄唑乳膏,外用1次/d.250例足癣患者随机入组.A组口服1周加外用1周,B组口服1周加外用2周,C组口服2周加外用1周,D组口服2周加外用2周,E组单独外用4周.在治疗结束时、治疗结束后4周、24周、40周、56周、72周时对各组的疗效、复发率进行评价.结果 在停药后第24周时,A、B、C、D组与E组疗效比较差异有统计学意义.在停药后第40周、56周、72周时,D组与A、B组疗效比较差异也出现统计学意义.在停药后24周、40周时,A、B、C、D组真菌学疗效与E组比较差异有统计学意义.在停药56周、72周时,D组与A、B组真菌学疗效比较差异也出现统计学意义.在停药40周时,A、B、C、D组与E组复发率比较差异有统计学意义.在停药56周、72周时,D组与A、B组复发率比较差异也出现统计学意义.结论 口服特比萘芬2周联合外用1%联苯苄唑乳膏2周治疗足癣的有效率和真菌学疗效最高,复发率最低.     

2%硝酸舍他康唑乳膏治疗体股癣和足癣疗效和安全性评价

目的 评价2％硝酸舍他康唑乳膏治疗足癣和体、股癣的疗效及安全性,并与2％硝酸咪康唑乳膏对照。方法 采用多中心随机双盲对照试验。试验组及对照组分别外用2％硝酸舍他康唑乳膏和2％硝酸咪康唑乳膏,每天2次,疗程4周。在治疗开始及治疗2周、4周、6周时进行观察。结果 足癣试验组61例,对照组58例;体、股癣试验组56例,对照组55例完成了观察。足癣在4周时,临床有效率试验组98．36％,对照组93．10％,在6周时分别为100％和98．28％;在4周和6周时真菌学清除率试验组均为95．1％,对照组均为100％;在4周时总有效率试验组98．36％,对照组93．10％,在6周时分别为100％和98．28％。体、股癣在4周时,临床有效率试验组98．21％,对照组92．73％,在6周时分别为100％和98．18％;在4周和6周时真菌学清除率试验组和对照组均为100％;在4周时总有效率试验组98．21％,对照组92．73％,在6周时分别为100％和98．18％。药物不良反应发生率试验组1．7％,对照组0．9％,表现为局部刺激。结果 显示2％硝酸舍他康唑乳膏治疗足癣和体、股癣的疗效及安全性与2％硝酸咪康唑乳膏相似（P〉0．05）。结论 2％硝酸舍他康唑乳膏治疗足癣和体、股癣有效、安全。     

特比萘芬短程口服加外用特比萘芬治疗中重度皮肤癣菌病的临床对照研究

目的为治疗中、重度皮肤癣菌病选择合适的方法。方法采用开放、随机对照的平行研究。将临床和真菌镜检确诊的中重度体、股癣和手、足癣患者随机分入A、B、C、D四组,A组口服特比萘芬片联合外用特比萘芬乳膏,疗程7d;B组常规口服特比萘芬片,疗程14d;C组常规外用特比萘芬乳膏,疗程14d;D组外用联苯苄唑乳膏,疗程4周。对各组的临床疗效、安全性、患者对治疗的满意度等进行分析。结果①真菌学疗效:停药后4周时A组手、足癣患者的真菌清除率最高为96.65%,与D组比较(65.00%)差异有显著性。②临床疗效:停药后2周和4周时A组手足癣患者的治愈率分别为93.33%和90.00%,与D组(68%、64%)比较差异有显著性。③患者满意度:在本研究的四组中,A组患者对疗效的满意度最高,与C组、D组比较差异有显著性;患者的综合满意度(包括对治疗费用、安全性等方面)A组最高,与C组、D组比较差异有显著性。D组患者对费用的接受程度最高,A组优于B组,有极显著的统计学差异。治疗结束后患者对安全性的接受程度四组间没有显著差异。结论特比萘芬口服加外用1周的“1 1”短程联合疗法治疗中、重度皮肤癣菌病的疗效高、疗程短、依从性好,患者满意度高。     

萘替芬酮康唑乳膏每日1次治疗足癣疗效观察

目的观察萘替芬酮康唑乳膏1次/d治疗足癣的效果与安全性。方法将参与试验的足癣患者随机分组,试验组每晚1次外用萘替芬酮康唑乳膏,对照组早晚各1次外用萘替芬酮康唑乳膏。连续用药4周,于治疗前,用药2周、4周及停药2周后分别进行症状和体征评分。结果治疗结束和停药2周时,两组的临床疗效无显著差异(P>0.05)。治疗2周时试验组和对照组的真菌清除率分别为78.6%和90.3%,有显著差异(P<0.05);治疗结束和停药2周时试验组的真菌清除率分别为92.9%和97.6%,对照组分别为94.4%和98.6%,均无显著差异(P>0.05)。结论萘替芬酮康唑乳膏1次/d治疗足癣疗效好,简便易行,安全性高。     

Comparison of terbinafine and clotrimazole in treating tinea pedis.

OBJECTIVE--To compare the efficacy and safety of terbinafine 1% cream and clotrimazole 1% cream in the treatment of tinea pedis. DESIGN--Multicentre, double blind parallel group study. SETTING--32 general practices and one hospital. PATIENTS--256 patients with mycologically confirmed tinea pedis. Of the 211 patients evaluable, 107 were randomised to terbinafine (75 male, 32 female; mean (range) age 40 (12-81) years) and 104 to clotrimazole (79 male, 25 female; mean (range) age 36 (12-71) years). INTERVENTIONS--Terbinafine 1% cream applied twice daily for one week and inert cream applied twice daily for the next three weeks. Clotrimazole 1% cream applied twice daily for four weeks. MAIN OUTCOME MEASURES--Mycological cure (negative results on microscopy and culture) and effective treatment (mycological cure plus no or minimal signs and symptoms) measured at weeks 1, 2, 3, 4, and 6. RESULTS--At week four rates of mycological cure were 93.5% for terbinafine and 73.1% for clotrimazole (p = 0.0001); and at week six 97.2% for terbinafine and 83.7% for clotrimazole (p = 0.001). Rates of effective treatment at week 4 were 89.7% for terbinafine and 58.7% for clotrimazole (p = 0.0001); and 89.7% for terbinafine and 73.1% for clotrimazole (p = 0.002) at week 6. CONCLUSION--These results indicate that a one week course of terbinafine 1% cream is more effective in the treatment of tinea pedis than a four week course of clotrimazole 1% cream, both in terms of mycological cure and effective treatment.     

硝酸舍他康唑乳膏每日1次疗法治疗股癣疗效观察

目的 观察舍他康唑乳膏1次/d疗法治疗股癣的效果与安全性.方法 将参与试验的股癣患者随机分组,试验组每晚1次外用舍他康唑乳膏,对照组早晚各1次外用舍他康唑乳膏,连续用药4周,于治疗前、用药2周、4周及停药后2周分别进行症状和体征评分.结果 治疗结束和停药2周时,两组的临床疗效无显著差异(P＞0.05).治疗2周时试验组和对照组的真菌清除率分别为82.6％和92.5％,有显著差异(P＜0.05);治疗结束和停药2周时试验组的真菌清除率分别为95.9％和97.3％,对照组分别为96.4％和98.6％,均无显著差异(P＞0.05).结论 舍他康唑乳膏1次/d疗法治疗股癣疗效好,简便易行,安全性高.     

趾间型足癣患者细菌菌种分布特征

目的了解趾间型足癣患者趾间和健康志愿者趾间细菌菌种分布特征。方法对37例经临床和真菌镜检确诊的趾间型足癣患者的趾间进行细菌培养,然后给予1%联苯苄唑霜1次/d外用治疗4周,在治疗后的第1、2、4周分别对趾间再进行细菌培养。33例健康志愿者作为对照。结果健康志愿者趾间细菌培养葡萄球菌属占92.5%,其中表皮葡萄球菌占32.5%,未分离到金黄色葡萄球菌。趾间型足癣患者细菌培养葡萄球菌属占74.4%,其中金黄色葡萄球菌占27.9%,表皮葡萄球菌仅占2.3%,还分离到化脓性链球菌、粪肠球菌、屎肠球菌、奇异变形杆菌、铜绿假单胞菌等。经过4周的外用联苯苄唑霜治疗,金黄色葡萄球菌消失,表皮葡萄球菌又成为优势菌（37.5%）。结论趾间型足癣患者趾间金黄色葡萄球菌的分离率明显高,此乃足癣继发细菌感染的主要致病菌,因此积极治疗足癣对预防足癣合并症有非常重要的意义。     

足癣义诊患者临床分析及特比萘芬联合疗法疗效观察

目的分析西京医院皮肤科近3a来每年足癣义诊患者基本情况,并对口服特比萘芬片结合外用特比萘芬乳膏治疗足癣进行疗效分析。方法回顾性分析3a来每年夏天足癣义诊活动中就诊于西京医院皮肤科足癣患者情况。其中2007年义诊患者随机分为3组。I为单纯特比萘芬乳膏治疗组,外用特比萘芬乳膏2次/d×2周;Ⅱ为单纯口服特比萘芬片组,给予口服特比萘芬片（兰美抒片）250mg/d×1周;Ⅲ组给予口服特比萘芬,250mg/d×1周,联合外用特比萘芬乳膏,2次/d×2周。3组分别在患者治疗1个月后电话随访。结果3a足癣义诊周患者平均真菌阳性率为75.76%;采用特比萘芬联合疗法治疗的患者,有效率高达85.26%,复发率不足6%。结论特比萘芬联合疗法治疗足癣疗效肯定。     

Tolnaftate (Tinactin), a New Topical Antifungal Agent

Using the double-blind technique, patients with tinea pedis, tinea cruris and tinea corporis were treated with either (a) 1% tolnaftate in a cream base or (b) the cream base.Twenty-four of 29 patients (82.7%) using 1% tolnaftate cream demonstrated clearing or great improvement of their lesions after three weeks of therapy, whereas only two of nine (22.2%) had similar results using the placebo.     

新型酮康唑喷膜对豚鼠体癣模型疗效的观察

目的 观察新型酮康唑喷膜对豚鼠体癣模型的疗效。方法 选择健康豚鼠20只,用穿刺法制备豚鼠体癣模型。将体癣模型随机分A组（新型酮康唑喷膜治疗组）,B组（喷膜基质治疗组）,C组（复方酮康唑霜治疗组）和D组（对照组）。根据豚鼠皮疹和真菌学检查进行疗效评估。结果 A组和C组的豚鼠治疗后局部红斑和水肿明显减轻,与治疗前比较有显著意义（P〈0．05）;停药2周时,A组和C组真菌镜检、培养阴性率均为100％,明显高于B和D组（P〈0．05）。结论 新型酮康唑喷膜对豚鼠体癣模型有良好的抗真菌活性。     

中国基层医疗机构手癣和足癣诊治现状调查

目的了解基层医生有关手癣、足癣的诊治现状,分析影响因素,制定有针对性的措施。方法通过网络平台对全国19个省市的基层医生进行问卷调查。结果共回收完整问卷729份。结果显示:①约20%的基层医生对手、足癣的发病因素方面存在认识不足,约50%的基层医生对受侵犯皮肤的组织定位存在误区。②基层医生对手、足癣鉴别诊断的重要性重视不够,真菌镜检设备使用率不足一半。③基层医生能正确选用外用抗真菌药,硝酸咪康唑乳膏使用率超过80%。④仍有10.70%的基层医生推荐使用外用糖皮质激素治疗手、足癣。结论基层医生在手、足癣的规范诊疗方面仍有待提高。     

特比萘芬治疗顽固性手、足癣的临床疗效及安全性评价

目的评价特比萘芬治疗顽固性手、足癣的临床疗效及安全性。方法将120例患者随机分为实验组和对照组,实验组口服特比萘芬250mg,1次/d,联合外用特比萘芬乳膏,2次/d,连续3周;对照组患者仅外用特比萘芬乳膏2次/d,连续3周。停药2周后评价最终疗效和不良反应,停药4周后观察复发率。结果停药2周后,实验组患者的临床有效率为95%,真菌学清除率为95%,不良反应发生率为5%（主要为胃肠道反应）;对照组患者的临床有效率为40%,真菌学清除率为75%。停药4周后,实验组患者未见复发,对照组患者复发率为20%。结论口服特比萘芬联合外用特比萘芬乳膏治疗顽固性手、足癣是安全、有效的。     

Topical treatment with eberconazole of the experimental guinea pig cutaneous candidosis.

Eberconazole is a new azole antifungal drug for topical treatment of superficial mycoses. The usefulness of this drug was evaluated in an experimental model of cutaneous candidosis in guinea pigs comparing with the classical clotrimazole in a single blind trial. Twenty-five animals were inoculated in two symmetrical areas of the back with Candida albicans developing skin infection. One group of 10 animals were treated once per day with clotrimazole 1% cream in one side and with excipient in the other. Other group of 10 guinea pigs received eberconazole 1% cream and excipient. Five animals did not receive any treatment and were used as controls. After five days of treatment most lesions cured or improved and cultures were negative when clotrimazole or eberconazole were applied. Seventy per cent of lesions treated with excipient were clinically improved and 10% cured, but 85% of cultures remained positive for C. albicans. The therapeutic efficacy of eberconazole 1% cream was similar to clotrimazole 1% cream in the guinea ping model of cutaneous candidosis. Tolerance of both drugs was excellent. These results suggest the usefulness of eberconazole in human cutaneous infections due to C. albicans.     

足癣患者治疗现状调查

目的了解中国足癣患者的治疗现状,加强临床医生对相关诊治指南推荐方案的认知和理解。方法中国医师协会皮肤科医师分会组织全国9家医院进行中国足癣患者治疗现状问卷调查。结果共收集到问卷690份,结果显示我国足癣患者大多数选择自行购买外用抗真菌药物治疗,最常选用的外用药物为咪唑类药物,往往以瘙痒和／或皮疹消失作为停止治疗的依据,治疗最长时间中位数为2周,在治疗足癣的疗程上显示出明显不足。足癣患者常合并甲真菌病等其他皮肤癣菌病,同时其家庭成员患病率也较高,在治疗足癣患者的同时,应积极治疗其合并的其他皮肤癣菌病,也应同时对患者家庭成员进行治疗。结论本研究对更加有针对性地制定合理足癣预防和治疗方案并加强患者宣教具有重要作用。     

Fungal infection of the feet in soccer players and non-athlete individuals

This study was conducted to evaluate the occurrence of mycoses affecting the feet of soccer players and to compare this results with those in non-athlete individuals of the same age and sex. Initial evaluation consisted of a dermatological examination of the foot in 22 Chinese athletes, 83 Brazilian athletes and 24 Brazilian non-athletes. Scales of plantar skin, interdigital and subungual areas of the foot were collected for mycological examination (direct and culture). Nail clippings were obtained for histopathologic analysis. Tinea pedis was diagnosed more frequently among the non-athlete individuals. None of the Chinese athletes had tinea pedis alone. However, in this group onychomycosis was frequently higher when compared to the other groups. The fungal microbiota comprised Trichophyton rubrum (40%), Trichophyton mentagrophytes (36.4%) and Candida spp (20%). Candida spp was isolated only from Brazilian athletes. Results obtained with KOH wet mounts agreed with the results obtained in culture and with histopathologic examinations (50.5% vs 40.9%). The frequency of tinea pedis among soccer players was lower than the other groups in this study, possibly due to health education and professional feet care.     

KP-103, a novel triazole derivative,is effective in preventing relapse and successfully treating experimental interdigital tinea pedis and tinea corporis in guinea pigs

The therapeutic efficacy of KP-103, a triazole derivative, for 10 guinea pigs with interdigital tinea pedis or tinea corporis was investigated. Topical KP-103 solution (0.25 to 1%) was dose-dependently effective in treating both dermatophytoses. A 1% KP-103-treatment rendered all infected skins culture-negative on day-2 posttreatment. A high negative-culture rate was obtained with 1% solutions of butenafine and lanoconazole but not with 1% neticonazole solution. The follow up study performed on day-30 and day-9 posttreatment demonstrated that the relapse rates for 1% KP-103-treated animals with tinea pedis and for those with tinea corporis were 20 and 30%, respectively, and that these values were the same as those for 1% butenafine-treated animals, but lower than those for 1% lanoconazole-treated animals (55 and 80%, respectively). When a single dose of 1% KP-103 was applied to the back skin 48 hr before fungal inoculation, 9 of the 10 animals were protected from the dermatophytosis, suggesting that active KP-103 is retained in skin tissue for at least 48 hr after dosing. Moreover, it was suggested that KP-103 retains a high activity in the horny layer because of its lower keratin-affinity. The effectiveness of KP-103 against dermatophytoses may be due to the favorable pharmacokinetic properties in the skin tissues, together with its potent antifungal activity.     

犬小孢子菌致体癣1例

报道1例由犬小孢子菌引起的体癣。患者,女,27岁,因前额、颈部多发环状红斑2周就诊。经真菌培养确诊为犬小孢子菌感染所致的体癣。予特比萘芬、灰黄霉素搽剂（商品名“止霉舒搽剂”）外用1周后痊愈。     

Mycosis of the Plantar Surface of Foot Owing to Nondermatophyte Mold Nodulisporium griseobrunneum Mimicking a Tinea Pedis

Nondermatophyte molds (NDM) and dematiaceous molds are less frequently implicated as the etiological agents of tinea-like infections of the foot. Among the etiological agents, Hendersonula toruloidea (now, Nattrassia mangiferae), Scytalidium hyalinum, Alternaria species (spp.), and Fusarium spp. are infrequently associated with foot mycoses. Nodulisporium (N.) spp. is a mitosporic NDM, which has been implicated in human infections like cerebral phaeohyphomycosis and allergic fungal sinusitis. Here, we report N. griseobrunneum in a 9-year-old female with mycosis of the plantar surface of foot mimicking a tinea pedis. Potassium hydroxide mount of skin specimen demonstrated dichotomous branching septate hyphae. Fungal culture and molecular sequencing established N. griseobrunneum as the etiological agent. Antifungal susceptibility testing revealed lower MICs to all seven drugs tested including itraconazole (ITR). The patient was treated with ITR and topical terbinafine. To the best of our knowledge, this is the first communication depicting molecular confirmation of the etiologic agent and antifungal susceptibility data of the mycosis of the plantar surface of foot owing to N. griseobrunneum from India.

     

萘替芬酮康唑乳膏治疗股癣疗效观察

目的观察萘替芬酮康唑乳膏治疗股癣疗效和安全性。方法将160例患者随机分为治疗组和对照组,治疗组外用萘替芬酮康唑乳膏;对照组外用硝酸咪康唑乳膏,均早晚各涂一次。用药2周及停药3周后分别进行临床疗效和真菌学疗效评价。结果治疗2周时治疗组有效率为92.50%,而对照组有效率为76.25%,两组间差异有统计学意义(P<0.05)。治疗2周时真菌清除率治疗组97.50%,对照组87.50%,两组间差异有统计学意义(P<0.05)。停药3周时治疗组有效率为96.25%,对照组有效率为75.00%,两组间差异有统计学意义(P<0.05)。停药3周时真菌学清除率治疗组97.50%,对照组85.00%,两组间差异有统计学意义(P<0.05)。无明显不良反应发生。结论萘替芬酮康唑乳膏治疗股癣安全有效。     

In vivo fungicidal effect of KP-103 in a guinea pig model of interdigital tinea pedis determined by using a new method for removing the antimycotic carryover effect

We developed a new technique for culture study that successfully recovers fungi from drug-treated skin tissues, in which tissue specimens were homogenized, dialyzed against water, digested with trypsin, and then washed with PBS, to eliminate the drug that remaining in the skin tissue specimens. With this modified culture method, we reevaluated the efficacy of KP-103, neticonazole, and lanoconazole in a guinea pig interdigital tinea pedis model. Guinea pigs with tinea pedis were topically treated with a 1% solution of KP-103 or a reference drug once a day for 10 consecutive days. Five days after the last treatment, left and right feet were subjected to culture study by the conventional and modified recovery culture methods, respectively. One hundred percent (20/20) of lanoconazole-treated feet were judged as culture-negative by the conventional culture method, but 85% (17/20) of the feet were shown to be culture-positive when the modified recovery culture method was used. On the other hand, KP-103 achieved high rates of culture-negative rates, 95% (19/20) and 85% (17/20), in both conventional and modified culture methods, respectively. Furthermore, on day-30 posttreatment, KP-103 sterilized 14 of the 20 infected feet, whereas neticonazole and lanoconazole were not effective even in reducing fungal burden. KP-103 proved to be highly effective in achieving mycological cure and preventing relapse against tinea pedis presumably because of its good bioavailability in the skin based on its low keratin-affinity, along with its potent antifungal activity.