他克莫司软膏联合窄谱中波紫外线照射治疗白癜风的临床疗效观察

目的观察外用0.1%他克莫司软膏和窄谱中波紫外线(NB-UVB)照射治疗白癜风的临床疗效。方法对78例白癜风患者进行随机分组,对照组采用0.1%他克莫司软膏外涂患处,每日2次;试验组采用窄谱中波紫外线照射联合0.1%他克莫司软膏外用。结果两组的有效率分别为57.5%和81.6%。两组间疗效比较差异有统计学意义(P<0.05)。结论提示窄谱中波紫外线照射联合0.1%他克莫司软膏外用治疗白癜风安全、有效,但其治疗的疗程均需进一步研究。     

0.03%他克莫司软膏和得宝松注射液治疗口腔扁平苔藓的临床对比研究

目的 比较0.03%他克莫司软膏外用和得宝松注射液皮损内注射对口腔扁平苔藓患者的疗效、不良反应和复发率.方法 选择口腔扁平苔藓患者60例并随机分成2组.治疗组用0.03%他克莫司软膏2次/d皮损处外用,连续4周;对照组皮损局部应用得宝松2周1次连续注射4周治疗.按REU评分评价4周后疗效、不良反应和治疗结束后随访4周复发率.结果 治疗组有效率为69.33%,对照组有效率为79.31%;治疗组复发率为5.26%,对照组复发率为4.37%,两组疗效及复发率差异无统计学意义（P〉0.05）.治疗组不良反应率低于对照组（13.33% vs 34.48%,P〈0.05）.结论 0.03%他克莫司软膏外用与得宝松注射液皮损内注射治疗口腔扁平苔藓均有良好的临床疗效,他克莫司乳膏更为安全.     

他克莫司软膏治疗慢性手部湿疹临床观察

目的:评价外用0.1%他克莫司软膏治疗慢性手部湿疹的临床效果和安全性;方法:给予28例慢性手部湿疹患者外用0.1%他克莫司软膏,2/d,晚间行封包治疗(≥6 h),共4周;于治疗前及治疗后1、2、4周和停药后2周各随访1次,疗效评估使用标准的手部湿疹评分(JHS)和临床严重性分级,并记录不良反应.结果:28例中26例完成临床试验.治疗后2周同治疗前相比JHS明显下降,直到研究结束其分值持续下降,最终12例(46.2%)完全治愈.临床分级也得到明显改善.药物相关性不良反应主要表现为用药部位烧灼感(15.4%)和瘙痒(11.5%),严重程度多为轻到中度,且均为一过性.结论:0.1%他克莫司软膏对治疗慢性手部湿疹具有良好的疗效,安全性较高.     

他克莫司软膏治疗慢性手部湿疹临床观察

目的:评价外用0.1%他克莫司软膏治疗慢性手部湿疹的临床效果和安全性;方法:给予28例慢性手部湿疹患者外用0.1%他克莫司软膏,2/d,晚间行封包治疗(≥6 h),共4周;于治疗前及治疗后1、2、4周和停药后2周各随访1次,疗效评估使用标准的手部湿疹评分(JHS)和临床严重性分级,并记录不良反应.结果:28例中26例完成临床试验.治疗后2周同治疗前相比JHS明显下降,直到研究结束其分值持续下降,最终12例(46.2%)完全治愈.临床分级也得到明显改善.药物相关性不良反应主要表现为用药部位烧灼感(15.4%)和瘙痒(11.5%),严重程度多为轻到中度,且均为一过性.结论:0.1%他克莫司软膏对治疗慢性手部湿疹具有良好的疗效,安全性较高.     

他克莫司软膏治疗成人和儿童特应性皮炎51例

目的:评价他克莫司软膏治疗特应性皮炎的疗效和安全性。方法:运用随机双盲平行对照方法,将成人特应性皮炎分为3组(每组均15例),分别外用0.1%,0.03%他克莫司软膏和赋形剂;将儿童特应性皮炎分为2组,分别外用0.03%他克莫司软膏(21例)和赋形剂(21例)。每日2次,疗程为3wk。结果:成人他克莫司软膏0.1%组、0.03%组和赋形剂对照组的有效率分别为100%,80%和27%;儿童他克莫司软膏0.03%组和赋形剂对照组的有效率分别为85%和33%。成人和儿童他克莫司软膏治疗组的有效率均显著高于赋形剂组(P<0.01),症状和体征显著缓解。成人他克莫司软膏0.1%组,0.03%组和赋形剂对照组不良反应发生率分别为47%,40%和27%(P>0.05)。不良反应主要为用药部位的灼热、瘙痒、红斑等,大部分可自行消退。结论:0.1%和0.03%他克莫司软膏治疗成人特应性皮炎及0.03%他克莫司软膏治疗儿童特应性皮炎是有效和安全的。     

他克莫司软膏治疗头面部银屑病临床疗效

目的探讨他克莫司软膏外用治疗头面部银屑病的临床安全性和有效性。方法选取2012年12月-2013年12月收治的74例头面部银屑病患者,随机分为治疗组和对照组,分别给予0.1%他克莫司软膏和5%松馏油软膏进行治疗,比较评价治疗前及治疗后2、4、8周患者治疗效果。结果治疗后2、4、8周,治疗组总有效率分别为90.0%、92.5%和95.0%,均高于对照组的总有效率67.4%、73.5%和76.5%,差异均具统计学意义（P〈0.05）;使用0.1%他克莫司软膏的治疗组患者并无出现明显不良反应。结论 0.1%他克莫司软膏用于临床治疗头面部银屑病安全有效。     

他克莫司软膏联合脱敏止痒膜治疗面部激素依赖性皮炎疗效观察

目的观察他克莫司软膏联合脱敏止痒膜治疗面部激素依赖性皮炎临床疗效。方法136例患者随机分成两组,治疗组68例,他克莫司软膏联合脱敏止痒膜外用,对照组68例,单用他克莫司软膏外用对患者临床疗效、不良反应临床观察。结果治疗4周后,治疗组有效率82%,对照组65%,两组总有效率差异有统计学意义,P<0.05。结论他克莫司软膏联合脱敏止痒膜治疗激素依赖性皮炎有较好的临床疗效。     

他克莫司软膏联合口服药物递减疗法治疗女阴湿疹临床观察

目的 观察0.1%他克莫司软膏联合口服药物递减法治疗慢性女阴湿疹临床效果及复发率。方法 72例女阴湿疹患者,随机分为观察组与对照组,各36例。两组均口服复方甘草酸苷片及五维甘草那敏胶囊治疗,观察组外用他克莫司软膏,对照组外用地奈德乳膏。比较两组疗效、复发率及不良反应发生情况。结果 观察组治疗总有效率83.33%与对照组的72.22%比较,差异无统计学意义(P>0.05)。观察组复发率6.67%(2/30)低于对照组的26.92%(7/26),差异有统计学意义(P<0.05)。观察组不良反应发生率27.78%与对照组的16.67%比较,差异无统计学意义(P>0.05)。结论 0.1%他克莫司软膏联合口服药物治疗慢性女阴湿疹临床有效率高,安全性好,复发率低,可供临床借鉴。     

他克莫司软膏治疗白癜风的随机对照开放研究

目的探讨他克莫司软膏治疗白癜风的临床疗效和安全性。方法将182例患者随机分为治疗组和对照组,治疗组外用0.1%他克莫司软膏,对照组外用0.05%卤米松乳膏,每日2次,疗程3个月,每1个月随访1次,疗程结束后观察临床疗效及不良反应。结果疗程结束后,治疗组有效率为71.4%,对照组有效率为73.6%,经统计学分析,P>0.05。结论外用他克莫司软膏治疗白癜风疗效确切,安全性高,且不良反应小,不产生皮肤萎缩、毛细血管扩张等副作用。     

他克莫司软膏联合重组牛碱性成纤维细胞生长因子凝胶治疗面部激素依赖性皮炎的疗效观察

目的探讨他克莫司软膏联合重组牛碱性成纤维细胞生长因子凝胶治疗面部激素依赖性皮炎的临床疗效。方法将入选的90例患者随机分为两组,治疗组45例患者给予他克莫司软膏联合重组牛碱性成纤维细胞生长因子凝胶外用治疗,对照组48例患者仅给予他克莫司软膏外用治疗,疗程均为4周,进行疗效观察。结果治疗组的总有效率为88.89%,对照组的总有效率为66.67%,两组疗效差异具有统计学意义(P<0.05),治疗组不良反应的发生率为4.44%(2/45),对照组不良反应的发生率26.67%(12/45)。结论他克莫司软膏联合重组牛碱性成纤维细胞生长因子凝胶治疗面部激素依赖性皮炎临床症状、体征消失早,临床疗效高,不良反应发生少。     

他克莫司软膏治疗慢性手部湿疹的临床研究

目的评价0．1％他克莫司软膏治疗成人慢性手部湿疹的疗效和安全性。方法86例慢性手部湿疹患者按就诊顺序进入试验组和对照组,分别接受0．1％他克莫司软膏（试验组）或丁酸氢化可的松乳膏（对照组）治疗;每日2次,疗程为4周;于治疗前及治疗后每周随访1次,疗效评估使用标准的手部湿疹评分系统（JHS）,患者作视觉尺度VAS瘙痒症状测试及皮炎改善程度的自我评估,并记录不良反应。结果经过4周的治疗后,试验组和对照组的有效率分别为83．7％和46．5％,试验组的有效率高于对照组（P〈0．05）。治疗后,试验组的JHS明显下降,与患者自我评价符合,同对照组JHS相比,差异有统计学意义。试验组9例局部出现不同程度灼热、瘙痒等不适感,均于2—3d后消失;对照组3例出现一过性皮肤发红、刺痛,停药后消失。结论0．1％他克莫司软膏治疗慢性手部湿疹安全且效果良好。     

Comparison of the efficacy and safety of 0.1% tacrolimus ointment with topical corticosteroids in adult patients with atopic dermatitis: review of randomised, double-blind clinical studies conducted in Japan

Tacrolimus (FK506) ointment is widely used in the treatment of patients with atopic dermatitis. The drug exerts its action by down-regulating antigen-specific T-cell activities and associated proinflammatory cytokine production. A number of clinical studies have evaluated the efficacy and safety of 0.1% tacrolimus ointment compared with vehicle or topical corticosteroids in adult patients with atopic dermatitis. These studies have suggested that topical tacrolimus has a rapid onset of action and exerts sustained therapeutic effects, with an efficacy similar to that of moderate to potent topical corticosteroids, but without causing skin atrophy. Two phase III randomised, controlled clinical trials have been conducted in Japanese adult patients with atopic dermatitis to compare the efficacy and safety of topical 0.1% tacrolimus with topical corticosteroid ointments. In the first study, patients with moderate or severe atopic dermatitis on the trunk and extremities were randomised to 3 weeks of treatment with topical 0.1% tacrolimus or the mid-potency topical corticosteroid 0.12% betamethasone valerate. Over 90% of the patients in each study group experienced at least a moderate improvement at the end of the study. In the second study, patients with moderate or severe atopic dermatitis on the head or neck were randomised to 1 week of treatment with 0.1% tacrolimus or the mild-potency corticosteroid 0.1% alclometasone dipropionate. Significantly greater improvements in individual symptom scores were observed with topical tacrolimus compared with alclometasone dipropionate, with overall global improvement at 1 week being statistically superior with tacrolimus. Furthermore, in a long-term open-label study involving 568 patients, at least a moderate global improvement in symptoms was observed in 85% of patients at 6 weeks, increasing to 91% at both 26 weeks and 52 weeks; this rate was maintained throughout the 2-year duration of the study. 0.1% tacrolimus ointment was considered to be safe in the majority of patients. The most prevalent adverse reactions were local application site irritations, which generally resolved with continued therapy. In summary, these findings suggest that 0.1% tacrolimus ointment is an effective and safe nonsteroidal alternative therapy for adult patients with atopic dermatitis.     

他克莫司软膏治疗斑块状寻常型银屑病18例

目的 观察他克莫司软膏治疗斑块状寻常型银屑病的，临床疗效及安全性。方法 将36例斑块状银屑病患者随机分治疗组和对照组各18例，治疗组采用0．1％他克莫司软膏和尿素软膏外涂，bid，共治疗4周；对照组用糠酸莫美松软膏和尿素软膏外涂，bid，共治疗4周。用PASI积分评价疗效，并观察不良反应。结果 治疗组治疗结束时有效率为94．4％，对照组为66．7％（P〈0．05）。治疗组起效时间平均约为10d，对照组为14d。治疗组发生皮肤刺激反应5例（27．8％）。结论 他克莫司软膏外用治疗斑块状寻常型银屑病具有良好疗效和安全性。     

卡泊三醇搽剂联合氟芬那酸丁酯软膏治疗头部慢性湿疹与神经性皮炎的疗效观察

目的:观察卡泊三醇搽剂联合氟芬那酸丁酯软膏治疗头部慢性湿疹与神经性皮炎的疗效。方法:71例头部慢性湿疹与神经性皮炎患者采用随机数字表法随机分成两组。治疗组35例,每天早晨、中午各1次将氟芬那酸丁酯软膏涂于患处;晚上外用卡泊三醇搽剂喷于皮损处后涂抹数次,每天1次。对照组36例,每天早晨、中午各1次将氟芬那酸丁酯软膏涂于患处;晚上外用哈西奈德溶液涂搽患处皮损后涂抹数次,每天1次。连用4周,治疗结束后评价疗效并记录不良反应。结果:治疗组与对照组的有效率分别为91.4%、88.9%(P>0.05);两组治疗前及治疗4周后湿疹面积及严重度指数(EASI)评分比较差异均无统计学意义(P>0.05)。结论:卡泊三醇搽剂联合氟芬那酸丁酯软膏治疗头部慢性湿疹与神经性皮炎疗效肯定、副作用少。     

除湿止痒软膏治疗神经性皮炎的临床治疗疗效观察

目的探讨除湿止痒软膏治疗神经性皮炎的临床疗效。方法 2009年1月至2010年5月,我院就诊神经性皮炎患者120例平均随机分成治疗组60例,外用除湿止痒软膏每日2次,口服氯雷他定片10 mg,每日1次,疗程4周,2、4周观察疗效;对照组60例,外用卤米松软膏1次,口服氯雷他定片每日10 mg,方法、疗程同治疗组。结果 2周疗效观察治疗组有效率75%,对照组有效率70%;4周疗效观察治疗组有效率95%,对照组有效率83.3%,两组比较,差异有统计学意义。结论较长时间使用除湿止痒软膏治疗神经性皮炎疗效显著。     

复方氟米松软膏治疗慢性湿疹、神经性皮炎的临床疗效观察

目的：观察复方氟米松软膏治疗慢性湿疹、神经性皮炎的临床疗效。方法：将100例慢性湿疹、神经性皮炎患者随机分成2组,治疗组50例,外用复方氟米松软膏每日2次,口服西替利嗪或氯雷他定片10 mg,每日1次,疗程4周,2、4周观察疗效;对照组50例,外用糠酸莫米松软膏1次,口服西替利嗪或氯雷他定片每日10 mg,方法、疗程同治疗组。结果：2周疗效观察治疗组有效率62%,对照组有效率56%;4周疗效观察治疗组有效率96%,对照组有效率86%,两组比较,差异有统计学意义。结论：较长时间使用复方氟米松软膏疗效显著。     

他克莫司软膏治疗面部复发性皮炎的疗效观察

目的探讨他克莫司软膏治疗面部复发性皮炎的疗效。方法将40例患者按照随机原则分为观察组(他克莫司软膏组)与对照组(左西替利嗪组),每组各20例患者。观察组患者外用0.03%他克莫司软膏,每日2次;对照组患者口服左西替利嗪片,每天1次,每次10mg。结果观察组患者痊愈5例(25),显效12例(60),有效率为85%;对照组患者痊愈2例(10%),显效8例(40%),有效率为50%。两组的有效率比较差异有显著性(χ2=8.02,P<0.05)。结论他克莫司软膏治疗面部复发性皮炎效果显著,安全性好,起效快,使用方便,为长期内服治疗效果不佳的面部复发性皮炎患者提供了一种新治疗方法和手段,适合广大基层医院临床推广应用。     

Topical tacrolimus for the treatment of inflammatory skin diseases

Chronic inflammatory skin disorders, such as atopic eczema, can cause considerable impairment of life quality. Their treatment is mainly driven by systemic or topical glucocorticosteroids which have the risk of many side effects. Recently, immunosuppressive macrolides which act via the inhibition of cytokine expression in T-lymphocytes have been shown to exert good therapeutic potency in inflammatory skin disorders. Cyclosporin, widely used in transplantation medicine, is also effective in psoriasis and atopic eczema but is not suitable for topical treatment. Tacrolimus (FK506) has been found to be 10-100 times more potent than cyclosporin and to penetrate skin much better due to a lower molecular weight. Initial clinical investigations have shown efficacy of topical tacrolimus in patients with atopic eczema. Large multi-centre studies have proven that long-term therapy with 0.03% and 0.1% tacrolimus ointment reveals effectiveness and safety both in adults and in children with severe atopic eczema. A burning sensation at the site of application is the most frequently observed local side effect. Relevant systemic adverse events were not detected. In Japan and the US, the drug is already licensed for the treatment of atopic eczema. The European admission for the pharmaceutical market is expected in the year 2002. Tacrolimus represents a milestone in topical therapy of inflammatory skin disorders which has so far been dominated by corticosteroid formulations and gives hope for the development of further topical immunosuppressive agents of its class in the future.