Review of the clinical efficacy of flutrimazole gel in the treatment of dandruff and/or seborrheic dermatitis.

The purpose of this article is to review the phase II and phase III clinical trials with the new pharmaceutical gel form of flutrimazole. The aim of the phase II study was to determine the efficacy and tolerance of flutrimazole 1%, 2% and 4% gel when compared to placebo in the treatment of 80 patients with dandruff or seborrheic dermatitis at a dose of three applications per week during one month. Flutrimazole 1% gel had a similar efficacy compared to the other studied concentrations and a superior efficacy when compared to placebo (p < 0.05). All treatments studied had an excellent tolerance. In the phase III study, the efficacy and tolerance of flutrimazole 1% gel was compared to ketoconazole 2% gel in 192 patients with dandruff or seborrheic dermatitis. Flutrimazole gel had a similar efficacy to ketoconazole gel at a dose of three applications per week for 28 days. Both products were well tolerated and no adverse effects were recorded.     

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.     

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。     

盐酸布替萘芬乳膏治疗体、股癣,手、足癣60例疗效观察

目的观察1%盐酸布替萘芬乳膏治疗60例浅部真菌病疗效。方法进行治疗前、后临床疗效和真菌疗效评价。结果临床疗效评价和真菌疗效评价,总有效率分别为96.67%和96.7%。结论1%盐酸布替萘芬乳膏治疗浅表真菌病疗效良好。     

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。     

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.     

Short term treatment of dermatophyte onychomycosis with terbinafine.

OBJECTIVE--To evaluate the effect of short term treatment with terbinafine on dermatophytosis. DESIGN--Multicentre, randomised, double blind placebo controlled trial of 250 mg/day terbinafine for 12 weeks in dermatophyte onychomycosis. SETTING--Eight dermatology centres in the United Kingdom. PATIENTS--112 patients (mean age 44, range 19-78), 99 with mycologically proved toenail infections and 13 with fingernail infections, of whom eight were subsequently excluded and 19 failed to complete the study. INTERVENTION--Terbinafine 250 mg daily or placebo for 12 weeks. Follow up for 36 weeks after stopping treatment. MAIN OUTCOME MEASURES--Mycological cure (negative results on microscopy and culture) and clinical cure at the end of follow up, adverse events, and biochemical and haematological variables at monthly intervals during treatment. RESULTS--After follow up 82% (37/45) (95% confidence interval 68% to 92%) mycological cure and 69% clinical cure were recorded for evaluable patients treated with terbinafine for toenail infection and 71% (5/7) (30% to 96%) mycological cure and clinical cure for those treated for fingernail infection. The corresponding values for those treated with placebo were 12% (3% to 31%) mycological cure and no clinical cure for toenail infections and 33% (1% to 91%) mycological cure and no clinical cure for fingernail infections. On an intention to treat basis for toenail infections the figures were 73% (38/52) (58% to 85%) mycological cure for terbinafine compared with 6% (0% to 30%) for placebo (p less than 0.007). Two withdrawals were related to adverse events with terbinafine, and there were no significant abnormal laboratory test results. CONCLUSION--12 weeks'' terbinafine is effective and safe treatment for nail dermatophytosis.     

念珠菌性包皮龟头炎56例临床分析

目的 了解念珠菌性包皮龟头炎的临床特点、诱发因素、菌种分布及治疗.方法 对本院性病门诊中确诊的56例念珠菌性包皮龟头炎患者的临床和实验室资料进行回顾性分析,总结临床特征、诱发因素、菌种分布及治疗经验.结果 56例念珠菌性包皮龟头炎发病平均年龄(34.11±9.92)岁,25～ 40岁青年人占67.9％ (38/56);包皮过长者87.5％ (49/56),有糖尿病史14.29％ (8/56).56例患者念珠菌培养阳性48人(85.71％),共分离到49株念珠菌,其中白念珠菌44株(91.84％),近平滑念珠菌4例(8.16％).所有患者予舍他康唑乳膏外用,5例症状严重患者联合伊曲康唑口服,76.79％(43/56)的患者获得临床和真菌学治愈,1个月后随访无复发.结论 念珠菌性包皮龟头炎好发于青年人,白念珠菌仍是其最常见的病原菌,外用舍他康唑乳膏临床获得较好的疗效,为提高治愈率和避免再感染,治疗期间应避免性行为.     

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。     

Photodynamic Therapy in the Treatment of Superficial Mycoses: An Evidence-based Evaluation

Photodynamic therapy (PDT) is effective in the destruction of fungi. In order to evaluate the efficacy and safety of PDT for superficial mycoses, we performed an evidence-based review of published literature. Database of MEDLINE, EMBASE, and Cochrane Library was searched until March 2010. English-language articles evaluating the efficacy and safety of PDT for superficial mycoses were included. No randomized clinical trials were found. Seven reports described the antifungal effect of PDT against 63 superficial mycoses patients. Eight of 10 (80%) tinea cruris patients and 6 of 10 (60%) tinea pedis were led to mycological cure after 1–3 treatments. Unfortunately, only 4 (40%) tinea cruris patients and 3 (30%) tinea pedis had a persist healing at the 8-week follow-up. Six of the 9 (66.7%) foot-interdigital mycoses patients recovered clinically and microbiologically after 1 or 4 treatments. Only 2 patients (22.2%) had a persist healing at the 8-week follow-up. Eleven of 30 (36.6%) onychomycosis patients were cure for 18 months after treatment, and 3 onychomycosis patients were all cure in other 2 reports. The therapeutic effect of PDT for one pityriasis versicolor patients was well. Overall tolerability of PDT was good. Therefore, it is unclear what PDT’s place for superficial mycoses will be. Further clinical trials are needed to evaluate the efficacy of PDT to treat superficial mycoses. It is also important to optimize treatment protocols in order to cope with recurrence.     

美浮特皮肤抗菌液治疗足癣开放多中心临床观察

目的观察美浮特皮肤抗菌液在治疗足癣的临床疗效及安全性。方法采用开放、多中心方法。5家中心共计入组126例足癣患者。64例趾间糜烂型足癣患者一次性使用美浮特皮肤抗菌液浸足2h;62例鳞屑角化型患者使用2次,每次2h,使用间隔7d。分别于基线（V0）,1周（V1）,2周（V2）,3周（V3）记录症状和体征总积分（TotalSymptomScore,TSS）变化率以及真菌镜检、培养转阴情况来评价综合疗效、临床疗效和真菌学疗效。结果V3时,总真菌学清除率为92．86％。4个访视点总TSS评分分别为10．12±3．25,4．95±2．72,2．63±1．99和1．24±1．53,呈逐步下降趋势,治疗前后TSS差异有统计学意义（t=30．87,P〈0．005）。痊愈51例（40．48％）,显效64例（50．79％）,进步11例（8．73％）,总体有效率为91．27％。共发生疼痛20例次,瘙痒5例次,水肿2例次,烧灼感1例次,未经任何处理,以上不良反应均可自行缓解。结论美浮特皮肤抗菌液治疗足癣有效,安全性好。     

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。     

Protective effect of an oral natural phytonutrient in recurrent vulvovaginal candidiasis: a 12-month study

The aim of the present study is to assess the clinical efficacy of a phytocompound with antimicotic properties (K-712, with the following 100 mg composition: 10 mg of oleoresin from Pseudowintera colorata at 30 percent concentration in Polygodial together with trace amounts of Olea europea) in recurrent vulvo-vaginal candidiasis (RVVC) as compared to an azole drug during a 12-month period: 6 months of treatment followed by 6 months of observation. This prospective randomized study involved 82 women (19-61 years) with complaints of abnormal vaginal discharge and with a history of at least four proven episodes of RVVC in the previous 12 months. Patients were divided into two groups of treatment of 41 patients each and were given: A) Itraconazole 200 mg orally daily for 4 days, then 200 mg once weekly for 6 months or B) 1 tablet twice a day of a K-712 for 4 weeks and then for the first 2 weeks of each month for a total of 6 months. Both groups were then followed-up for further 6 months. Each treatment schedule was well tolerated with only 4 patients in the azole group complaining of transient mild symptoms (nausea, abdominal discomfort, unpleasant taste). Itraconazole reached an earlier symptomatic relief during the first two weeks of observation as compared with K-712 (p<0.05) but both treatments enabled a comparable benefit during the entire treatment study period, afterwards with comparable symptom/sign score (itraconazole vs K-712: 9 vs 11). At 6-month observation, mycological cure was reached by 83 percent in the itraconazole group and in 78 percent of the K-712-treated patients. During the further 6-month observation period without treatment, the itraconazole group showed significantly more relapses (65.7 vs 34.2 in K-712, p<0.05) and at the end of the whole 12-month study period the mycological cure was significantly higher in the K-712-treated patients (65.8 vs 34.3 percent, p<0.05). There was a non- significant trend increase of less drug-susceptible species in the itraconazole group. From these preliminary data it would appear that a natural antifungal phytocompound proves to be as good as itraconazole in the maintenance treatment of RVVC. Moreover, this approach seems to maintain a higher mycological success rate afterwards by reducing the number of relapses and probably of the growth of azole-resistant species.     

The Efficacy and Safety of Sertaconazole Cream (2 %) in Diaper Dermatitis Candidiasis

Aim

Diaper dermatitis (DD) is an inflammatory irritating condition that is common in infants. Most cases are associated with the yeast colonization of Candida or diaper dermatitis candidiasis (DDC), and therefore, the signs and symptoms improve with antimycotic treatment. Sertaconazole is a broad-spectrum third-generation imidazole derivative that is effective and safe for the treatment for superficial mycoses, such as tineas, candidiasis, and pityriasis versicolor. Our goal was to assess the efficacy and safety of sertaconazole cream (2 %) in DDC.

Materials and methods

Twenty-seven patients with clinical and mycological diagnosis of DDC were enrolled and treated with 2 daily applications for 14 days and were followed-up for 2 further weeks.

Results

Three etiologic agents were isolated: Candida albicans in 88.8 %, Candida parapsilosis in 7.3 %, and Candida glabrata in 3.2 %. There was an average symptom reduction from 7.1 to 3.2 in the middle of treatment and to 1.2 and 0.4 units at the end of treatment and follow-up, respectively. The treatment evaluation at the end of the follow-up period showed a total clinical and mycological cure in 88.8 %, improvement in 3.7 %, and failure in 7.4 %. There was side effect (3.7 %) of skin irritation, but the drug was not discontinued.

Conclusions

Based on its safety and effectiveness, sertaconazole cream may be considered a new alternative for DDC treatment.     

复方环丙酮胺治疗浅部真菌病的疗效观察

观察复方环丙酮胺喷剂治疗浅部真菌病的疗效。第Ⅰ批给予复方环丙酮胺喷剂,1次/d喷于患处,用药4周后观察疗效;第Ⅱ批随机入A、B组,A组给予复方环丙酮胺喷剂+曲安奈德喷剂,B组给予复方环丙酮胺喷剂,均1次/d喷于患处,用药2周、4周后观察疗效。第Ⅰ批治疗4周总有效率为80%;第Ⅱ批A、B组治疗2周总有效率分别为75%及82.35%,治疗4周总有效率分别为94.74%及100%。复方环丙酮胺喷剂和复方环丙酮胺喷剂+曲安奈德喷剂治疗浅部真菌病的疗效相似(P>0.05),且疗效显著、局部刺激小、瘙痒缓解明显、安全性较高。     

Coated mesalazine (5-aminosalicylic acid) versus sulphasalazine in the treatment of active ulcerative colitis: a randomised trial.

OBJECTIVE--To assess the safety and efficacy of a preparation of mesalazine (5-aminosalicylic acid) coated with a pH dependent resin (Eudragit L) as compared with sulphasalazine in patients with active mild to moderate ulcerative colitis. DESIGN--Eight week randomised double blind parallel group study. SETTING--Forty six gastroenterology outpatient clinics in seven countries. PATIENTS--Two hundred and twenty patients aged 18-70 who met the following criteria: clinical activity index greater than or equal to 6 and endoscopic index greater than or equal to 4; no concomitant treatment for ulcerative colitis; no hypersensitivity to salicylates or sulphonamides. Of the 164 patients eligible for efficacy analysis, 87 received the coated preparation of mesalazine and 77 sulphasalazine. Most of the remaining patients (28 in each group) were ineligible for the efficacy analysis because of treatment with steroid enemas. All pretrial characteristics were comparable in the two treatment groups. INTERVENTIONS--Coated mesalazine (Mesasal) 1.5 g daily or sulphasalazine 3.0 g daily for eight weeks. Compliance monitored by pill counts. END POINT--Clinical and endoscopic remission. MEASUREMENTS AND MAIN RESULTS--Clinical activity measured by daily diary cards, assessment by investigators, and laboratory findings. Endoscopic evaluation at week 8. After four weeks 50 of 70 patients (71%) taking coated mesalazine and 38 of 58 (66%) taking sulphasalazine had achieved remission of their disease by eight weeks remission rates were 74% (37/50 patients) and 81% (35/43) in the two treatment groups respectively. Endoscopic remission at eight weeks was recorded in 20 of 41 patients (49%) taking coated mesalazine and 18 of 38 (47%) taking sulphasalazine. There was a higher incidence of adverse events among patients taking sulphasalazine (25/105; 24%) than among those taking coated mesalazine (16/115; 14%). CONCLUSION--Mesalazine coated with Eudragit L is a safe, logical alternative to sulphasalazine.     

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。     

Nd：YAG1064nm激光、伊曲康唑治疗轻中度甲真菌病近期疗效分析

目的 观察Nd：YAG1064nm激光治疗机、伊曲康唑治疗甲真菌病的有效性及安全性.方法 选取符合入组条件的患者60例,病甲共125个.将60例患者随机分为A、B两组,A组予以Nd：YAG1064nm激光治疗;B组予以伊曲康唑口服治疗.每组均于第8周、第16周、第24周时随访,随访时予以真菌学评价及临床疗效评价.结果 A组第8周、16周、24周有效率分别为78.9％、52.6％、52.6％,B组第8周、16周、24周有效率分别为80.9％、66.2％、67.6％.A、B两组临床疗效差异无统计学意义（P＞0.05）.结论 激光治疗甲真菌病疗效肯定,且元不良反应.在轻中度甲真菌病患者中,激光治疗和药物治疗有效率差异不大.     

伊曲康唑联合外用药物治疗花斑糠疹临床研究

目的探讨伊曲康唑胶囊联合1%盐酸布替萘芬乳膏和2%酮康唑洗剂治疗花斑糠疹的疗效及不良反应。方法入选患者按单双日分为两组,两组均口服伊曲康唑0.2g,1次/d,连续7d,同时外用1%盐酸布替萘芬乳膏,1次/d,连续14d,对照组停药观察,试验组同时使用2%酮康唑洗剂洗浴,每周2次,连用3个月。分别于治疗前、治疗后1、3、6、12个月评价疗效。结果试验组114例患者3个月时痊愈率78.1%,6个月时痊愈率90.4%,对照组125例患者3个月时痊愈率72.8%,6个月时痊愈率75.2%,12个月后试验组复发率1.8%,对照组为18.4%。结论伊曲康唑胶囊短时口服联合外用布替萘芬和酮康唑洗剂洗浴疗效较好,安全性高,使用方便,可大大降低花斑糠疹的复发率。     

Hormonal treatment for unilateral inguinal testis: comparison of four different treatments.

BACKGROUND: Hormonal treatment of cryptorchidism has been used since the 30s, but controversies persist on its efficacy. It is also unclear whether there are differences with the use of different hormonal trials. Aims: To evaluate the efficacy of four hormonal treatments on testicular descent in a homogeneous group of cryptorchid boys. PATIENTS: 155 patients (age 10-48 months) with unilateral inguinal palpable testis were studied. Methods: The patients were subdivided into four groups according to hormonal treatment: group 1 = hCG [500 IU/week (if the chronological age was <2 years) or 1,000 IU/week (if the chronological age was >2 years) for 6 weeks]; group 2 = hCG + hMG (hCG as in group 1 + hMG 75 IU/week for 6 weeks); group 3 = GnRH (1,200 microg/daily for 28 days); group 4 = GnRH + hCG (1,200 microg/daily for 28 days + 1,500 IU/week for 3 weeks, respectively). The results were evaluated at the end of the treatment period and 6 months later to exclude temporarily positive results. RESULTS: At the end of the hormonal therapy, scrotal testicular descent was present in 30 of 155 boys (success rate 19.3%). Seven testes relapsed during follow-up (23.3%). The long-term success rate was 14.8% (23/155 testes). No significant differences were observed in success rates as well as in relapse rates among the four groups. CONCLUSIONS: Hormonal therapy induced permanent testicular descent in a minority of young cryptorchid boys with inguinal palpable testis. Similar results were obtained with four different trials.