他克莫司软膏联合窄谱UVB治疗斑块状银屑病临床疗效观察

目的观察外用0.1%他克莫司软膏联合窄谱中波紫外线(NB-UVB)治疗中、重度斑块状银屑病的临床疗效及安全性。方法将92例银屑病患者随机分为试验组和对照组,每组46例。试验组外用0.1%他克莫司软膏,2次/d,同时采用NB-UVB照射,对照组仅采用NB-UVB照射,疗程均为8周。结果 8周后试验组和对照组的有效率分别为91.30%和65.22%;治愈率分别为63.04%和34.78%,差异有统计学意义(P0.01),试验组的PASI评分和DLQI评分与对照组比较,差异有统计学意义(P0.05);试验组中仅6例出现局部轻度的刺激反应。结论他克莫司软膏联合NB-UVB治疗中、重度斑块状银屑病有较好的疗效,安全性较高。     

他克莫司软膏治疗寻常型银屑病临床疗效观察

为观察他克莫司软膏治疗寻常型斑块状银屑病的临床疗效,将80例寻常型斑块状银屑病患者随机分为治疗组和对照组(各40例),治疗组给予0.1%他克莫司软膏,对照组给予卡泊三醇软膏,涂搽患处,每日2次,配合矿泉浴疗,用药4周.用PASI积分评定疗效,观察不良反应.结果:治疗组有效率为92.5%,对照组为65%(P<0.01).治疗组平均起效时间约为7d,对照组为14d.治疗组发生皮肤刺激反应4例(10%).     

0.03％他克莫司软膏联合多磺酸粘多糖乳膏治疗儿童面部白色糠疹的临床观察

目的:观察外用0.03%他克莫司软膏联合多磺酸粘多糖乳膏治疗儿童面部白色糠疹的疗效及安全性。方法:将115例患儿随机分为治疗组和对照组。治疗组予局部外用0.03%他克莫司软膏联合多磺酸粘多糖乳膏;对照组予单用0.03%他克莫司软膏。治疗8周后观察疗效和不良反应。结果:治疗组和对照组患者的治疗有效率分别为88.33%和70.91%,差异有统计学意义(P0.05)。结论:外用他克莫司软膏联合多磺酸粘多糖乳膏治疗儿童面部白色糠疹疗效优于单用他克莫司软膏,不良反应较小。     

0.03%他克莫司软膏治疗面部斑块状银屑病疗效和安全性观察

他克莫司软膏是一种新型非糖皮质激素(以下简称激素)类抗炎药物,已成功用于治疗特应性皮炎,国外有报道治疗面部斑块状银屑病有效[1-3].国内用于面部斑块状银屑病的治疗仅见个例报告[4].为此,我们于2006年6月-2007年1月,应用0.03%他克莫司软膏治疗22例面部寻常性斑块状银屑病,现将疗效和安全性报告如下.     

强脉冲光联合他克莫司软膏治疗面部脂溢性皮炎疗效观察

目的探讨强脉冲光联合他克莫司软膏治疗面部脂溢性皮炎的临床疗效。方法纳入面部脂溢性皮炎患者60例,随机分为试验组和对照组。试验组予以强脉冲光联合他克莫司软膏治疗,对照组予以他克莫司软膏治疗,疗程共8周,治疗结束后评估疗效及不良反应。结果试验组临床症状改善明显优于对照组,试验组有效率更高(64.52%vs.34.48%),差异有统计学意义(P0.05)。两组均未见明显不良反应。结论强脉冲光联合他克莫司软膏治疗面部脂溢性皮炎安全有效。     

0.1%他克莫司软膏联合火针治疗稳定型白癜风临床观察

目的研究火针联合0.1%他克莫司软膏治疗白癜风的疗效及优越性。方法将入选的62例白癜风患者随机分为两组,对照组(31例),用0.1%他克莫司软膏外用2次/d治疗。治疗组(31例),采用0.1%他克莫司软膏外用2次/d,联合火针每2周治疗1次,治疗12周后评定临床疗效。结果治疗12周后,治疗组有效率为93.55%对照组有效率为83.87%。结论火针联合0.1%他克莫司软膏治疗安全有效,不良反应少,可明显改善患者临床症状,值得推广应用。     

他克莫司对银屑病皮损中蛋白酶活化受体2表达的影响

目的:明确他克莫司对寻常型银屑病皮损中蛋白酶活化受体2(PAR-2)的影响。方法:免疫组化法(SP法)检测30例寻常型银屑病皮损外用0.1%他克莫司软膏治疗前后及25名正常对照PAR-2的表达情况。结果:银屑病患者皮损内角质形成细胞PAR-2的表达明显高于正常对照;经0.1%他克莫司软膏外用治疗2周后表达明显下降。结论:PAR-2在皮损角质形成细胞内过度表达可被他克莫司软膏抑制。     

0.1％他克莫司软膏治疗面部脂溢性皮炎疗效观察

目的：观察0.1%他克莫司软膏治疗面部脂溢性皮炎的疗效和安全性。方法44例面部脂溢性皮炎患者外用0.1%他克莫司软膏,每日2次,治疗4周后改为每周2次给药,于治疗后第4周和第8周复诊,观察疗效和不良反应。结果0.1%他克莫司软膏治疗第4周和第8周皮损平均积分与治疗前相比均明显下降（P＜0.05）,第4周和第8周皮损积分下降相比差异无统计学意义（P＞0.05）。结论他克莫司软膏治疗面部脂溢性皮炎疗效显著,不良反应少,每周2次给药维持治疗可以有效防止皮损复发。     

中药联合他克莫司软膏治疗面部糖皮质激素依赖性皮炎临床观察

目的观察中药联合他克莫司软膏治疗面部糖皮质激素依赖性皮炎的疗效。方法治疗组40例患者口服自拟中药加味多皮饮,同时外用0.1%他克莫司软膏,1次/d,共4周。对照组38例患者外用0.1%他克莫司软膏,1次/d,共4周。结果有效率治疗组为92.5%,对照组为68.4%,两组比较差异有统计学意义（P〈0.05）。两组治疗后积分及治疗前后积分差值比较,差异均有统计学意义（P〈0.05）。结论中药联合他克莫司软膏治疗面部糖皮质激素依赖性皮炎疗效较好。     

外用他克莫司与卡泊三醇治疗斑块状银屑病的疗效与安全性评价

目的:评价外用他克莫司和卡泊三醇软膏对四肢斑块状银屑病的疗效和安全性.方法:选取门诊斑块状银屑病患者,四肢左右两侧分别外用他克莫司软膏及卡泊三醇软膏,治疗2周及6周各复诊1次,观察四肢左右侧皮损消退情况,用单侧银屑病皮损面积及严重度指数(PASI)评分进行评价.结果:29例患者参加自身左右侧药物对比,有3例患者(10.3％)应用他克莫司后出现皮肤刺激症状而停用,其中1例患儿出现红皮病样改变.2周时有13例患者复诊,达到PASI50的患者中他克莫司侧4例,卡泊三醇侧5例；达到PASI75的患者中他克莫司侧1例,卡泊三醇侧2例.6周时14例患者复诊,达到PASI50的患者中他克莫司侧14例,卡泊三醇侧13例；达到PASI75的患者中他克莫司侧7例,卡泊三醇侧9例.2周及6周时比较双侧PASI50及PASI75,用Fisher精确概率检验法,发现两者差异无统计学意义.结论:对于四肢的斑块状银屑病,外用他克莫司和卡泊三醇软膏均有肯定疗效.部分患者应用他克莫司出现皮肤刺激症状,停药后症状多可消退.     

钙泊三醇搽剂联合丙酸倍氯米松霜治疗头皮银屑病疗效观察

目的评价钙泊三醇搽剂联合丙酸倍氯米松霜治疗头皮银屑病的疗效与安全性。方法将55例患者随机分为治疗组和对照组,治疗组每早1次使用钙泊三醇头皮搽剂,每周用量不超过15mL;每晚1次使用丙酸倍氯米松霜,每周用量不超过15mg。对照组:每日早晚各1次使用丙酸倍氯米松霜,每周用量不超过30mg,疗程均为6周。结果治疗组和对照组有效率分别为85.30%和52.38%,差异有显著性意义(X2=9.361,P<0.05)。结论钙泊三醇搽剂联合丙酸倍氯米松霜治疗头皮银屑病安全、有效。     

0.1％他克莫司软膏治疗青少年寻常型银屑病临床疗效观察

目的观察应用0.1%他克莫司软膏治疗青少年寻常型银屑病的临床疗效。方法选取我中心皮肤病性病门诊部治疗的寻常型银屑病未成年患者66例,利用随机数表法分为两组,每组33例,观察组应用0.1%他克莫司软膏治疗,对照组应用卤米松乳膏治疗,选取治疗前、治疗2周、治疗4周、治疗8周为观察点,比较两组患者皮损面积及严重程度的改善情况,并评价疗效。结果治疗2周、4周、8周,与治疗前相比,观察组患者的PASI(银屑病面积与严重性指数)改善水平均显著优于对照组(P <0.05);治疗期间,观察组不良反应率为6.1%,也明显低于对照组15.2%(P <0.05)。结论 0.1%他克莫司软膏用于治疗青少年寻常型银屑病安全有效,且副作用小,值得临床应用。     

Tacrolimus ointment for the treatment of severe facial plaque psoriasis

Recently, tacrolimus ointment has proved to be effective and well tolerated in patients with facial psoriasis. A few months ago we had the opportunity to treat a patient with tacrolimus ointment who had severe and recalcitrant plaque psoriasis of the face. This present case illustrates the impressive improvement of facial plaque psoriasis following 5 months of treatment with tacrolimus 0.1% ointment twice a day. Significant improvement of facial plaque psoriasis was seen after 1 month and complete clearance after 5 months of therapy. Based on the available literature and illustrated by the present case we may conclude that tacrolimus ointment 0.1% can be recommended as a first-line treatment for facial psoriasis.     

他扎罗汀倍他米松乳膏治疗斑块状银屑病后两种延长治疗方案的疗效和安全性的多中心临床观察

【摘要】 目的 探索使用他扎罗汀倍他米松乳膏治疗斑块状银屑病4周后有效但未达基愈患者的后续用药方案。方法 本研究采用多中心、随机、开放、平行、对照设计。232例完成0.05%/0.05%他扎罗汀倍他米松乳膏4周治疗,银屑病面积与严重性指数（PASI评分）改善在50% ~ 90%但未达基愈的斑块状银屑病受试者,在第5周时1∶1随机化进入试验组和对照组,试验组每日1次外用0.05%/0.05%他扎罗汀倍他米松乳膏,对照组每日1次序贯使用0.05%他扎罗汀凝胶、0.05%/0.05%他扎罗汀倍他米松乳膏（工作日使用他扎罗汀凝胶、周末使用他扎罗汀倍他米松乳膏）,进行第5 ~ 8周的治疗,第6周和第8周时评价两组的疗效和安全性。两组间计量资料的比较采用协方差分析或t检验,计数资料的比较采用卡方检验。结果 232例进入第5 ~ 8周治疗的患者中,200例完成研究,试验组和对照组的全分析集（FAS）分别为110例、112例,安全性分析集（SAS）均为113例。连续治疗6周和8周后,试验组PASI评分的下降率分别为73.05% ± 16.69%和78.46% ± 15.40%,对照组分别下降66.73% ± 21.77%和67.02% ± 34.19%,两组比较,均P < 0.05。治疗6周后,试验组达到PASI90的受试者比例（14例,12.7%）高于对照组（5例,4.5%,χ2 = 4.842,P = 0.028）;治疗8周后,试验组达到PASI75、PASI90的受试者比例（61.8%、23.6%）均高于对照组（48.2%、12.5%,均P < 0.05）。连续用药8周后,试验组和对照组的不良反应发生率（15.0%、23.9%）差异无统计学意义（χ2 = 2.822,P =0.093）。结论 使用0.05%/0.05%他扎罗汀倍他米松乳膏治疗银屑病4周后有效但未达基愈的患者,继续进行为期4周的0.05%/0.05%他扎罗汀倍他米松乳膏治疗是一种比序贯使用0.05%他扎罗汀凝胶、0.05%/0.05%他扎罗汀倍他米松乳膏更优的治疗方案。     

Tacrolimus ointment for the treatment of psoriasis on the face and intertriginous areas

The safety and efficacy of 0.1% tacrolimus ointment for the treatment of psoriasis on the face, intertriginous areas, or both were evaluated in an open-label, clinical trial of 21 patients with psoriasis. Patients applied 0.1% tacrolimus ointment twice daily for 8 weeks. Efficacy was assessed through the investigator's evaluation of the individual signs and symptoms of psoriasis, and the physician's global evaluation of change in disease status. Assessments of cutaneous atrophy and other adverse events were made throughout the study to evaluate the safety of tacrolimus ointment. A total of 21 patients were enrolled in the study; 21 patients at least 18 years of age received study medication. Statistically significant improvement in the physician's assessment of the individual signs and symptoms was observed during the study. A total of 81% of patients (17 of 21) experienced complete clearance at day 57 (end of treatment). Only 2 patients reported adverse events, which were limited to itching and the feeling of warmth at the application site. None of the patients had atrophy, telangiectasia, or striae develop during the study. In summary, tacrolimus 0.1% ointment may be a safe and effective treatment option for patients with psoriasis on the face, intertriginous areas, or both.     

他克莫司软膏治疗成人特应性皮炎

目的研究他克莫司软膏治疗成人特应性皮炎(AD)的疗效与安全性.方法采用随机、双盲、赋形剂对照临床研究方法,将44例成人AD患者随机分为3组,按111比例分别接受0.1%(0.1%组)、0.03%(0.03%组)他克莫司软膏和赋形剂(赋形剂组)治疗.观察治疗第1、2和3周的临床疗效和不良反应.结果他克莫司软膏0.1%组和0.03%组的有效率分别为86.7%(13/15)和78.6%(11/14),均明显高于赋形剂组(42.9%,6/14),差异非常显著(P＜0.001).总体疗效比较0.1%组优于0.03%组,差异显著(P=0.043).治疗后第1、2、3周0.1%组和0.03%组的主要症状-体征指标平均值均明显低于赋形剂组,组间差异显著(P＜0.05～P＜0.001).治疗后患者的生活质量明显改善.药物相关不良反应主要为一过性局部刺激,但组间比较无统计学意义(P＞0.05),3组均未出现严重不良反应.结论他克莫司软膏治疗成人特应性皮炎安全有效.     

Topical tacrolimus ointment combined with 6% salicylic acid gel for plaque psoriasis treatment

BACKGROUND: While oral tacrolimus is effective for the treatment of psoriasis, tacrolimus ointment has shown only spotty efficacy in the treatment of plaque psoriasis. The efficacy of tacrolimus ointment for the treatment of facial and intertriginous psoriasis suggests that if tacrolimus penetration can be increased, the ointment could be used for effective treatment of plaque psoriasis. OBJECTIVE: To assess whether tacrolimus ointment is an effective psoriasis treatment when used in a combination regimen with the penetration-enhancer salicylic acid. METHODS: A total of 30 adult subjects with generally symmetrical plaque-type psoriasis were randomized to treatment with 6% salicylic acid gel plus vehicle or 6% salicylic acid gel plus 0.1% tacrolimus ointment in a 12-week left-right comparison study. The primary outcome was the difference between tacrolimus- and vehicle-treated target lesions in the change in the sum of erythema, scale, and thickness scores from baseline to end of treatment. RESULTS: A total of 24 subjects completed the trial. Combination treatment with tacrolimus ointment or vehicle plus salicylic acid gel was well tolerated. There was greater improvement of the sum score in the tacrolimus plus salicylic acid-treated target plaques than in the vehicle plus salicylic acid-treated plaques at weeks 1, 2, and 8 (P<.05). The efficacy of this regimen was confirmed by investigator and subject global assessments of plaque severity. CONCLUSIONS: The combination of 0.1% tacrolimus ointment and 6% salicylic acid gel is an effective treatment for psoriasis. Although the results reported herein are from a small exploratory study, the magnitude of the effect was sufficiently large as to be detectable with statistical significance (P<.05).     

他克莫司软膏治疗成人特应性皮炎疗效和安全性研究

目的 评价0.1%和0.03%他克莫司软膏治疗成人中、重度特应性皮炎的疗效和安全性。方法 采用多中心、随机双盲、赋形剂平行对照的临床研究,受试者每日2次外搽0.1%或0.03%他克莫司软膏或赋形剂。疗程3周,于治疗前及治疗后第1、2、3周各访视1次,进行疗效和安全性评价。结果 6个中心共有211例中、重度特应性皮炎患者纳入疗效分析。治疗结束时,0.1%和0.03%他克莫司软膏组治疗有效率分别为88.4%和77.8%,均明显高于赋形剂组的30.0%(P<0.001)。治疗后第1、2、3周,0.1%和0.03%他克莫司软膏组湿疹面积与严重度指数、皮损受累面积百分比、症状/体征总评分、研究者对治疗临床反应总评、患者对瘙痒自我评分均明显优于赋形剂组,且多于治疗后第1周始即明显改善(P=0.002-P<0.001),0.1%他克莫司软膏组疗效优于0.03%他克莫司软膏组。0.1%和0.03%他克莫司软膏组药物相关性不良反应发生率分别为47.3%和40.0%,均高于赋形剂组的28.2%,主要表现为皮肤灼热、瘙痒/瘙痒加重或刺痛等局部刺激反应。结论 0.1%和0.03%他克莫司软膏对治疗成人特应性皮炎具有良好的疗效和安全性。     

驱白巴布期片联合他克莫司软膏治疗白癜风疗效观察

目的：评价驱白巴布期片联合他克莫司软膏治疗白癜风的疗效及安全性。方法240例白癜风患者随机分成3组,试验组给予驱白巴布期片口服,联合0.1%他克莫司软膏外用,对照组1给予驱白巴布期片口服,对照组2给予0.1%他克莫司软膏外用,3个月和6个月后评价疗效及安全性。结果治疗3个月和6个月后试验组与对照组比较差异有统计学意义（P＜0.05）,对照组1与对照组2有效率比较差异无统计学意义（P＞0.05）。3组患者均以面部疗效最好,躯干次之,四肢疗效最差。患者均未出现严重不良反应。结论驱白巴布期片联合他克莫司软膏治疗白癜风疗效好,不良反应少。 Abstract     

【开放获取】丙酸氟替卡松乳膏单独或联合卡泊三醇软膏治疗轻中度斑块状银屑病的随机自身对照研究

【摘要】 目的 评价0.05%丙酸氟替卡松乳膏单独应用及与0.005%卡泊三醇软膏联合应用治疗轻中度斑块状银屑病的短期疗效和安全性。方法 2020年10月至2021年1月,于北京友谊医院对30例轻中度斑块状银屑病患者采用随机、开放、自身对照临床研究,一侧肢体皮损处早上外用0.005%卡泊三醇软膏、晚上外用0.05%丙酸氟替卡松乳膏（联合用药组）,对侧肢体皮损处每日外用2次0.05%丙酸氟替卡松乳膏（丙酸氟替卡松组）,疗程4周。分别于治疗前、治疗1、2、4周随访,采集静态临床医生整体评估（sPGA）、银屑病面积和严重程度指数（PASI）等临床指标,并记录不良事件。采用重复测量的方差分析、多变量方差分析、Mann-Whitney U秩和检验和独立样本t检验进行疗效和安全性评价。结果 治疗前,两组sPGA评分、PASI评分差异均无统计学意义（均P > 0.05）。治疗1周,丙酸氟替卡松组sPGA（1.10 ± 0.31）分、PASI评分（1.05 ± 0.51）分显著低于联合用药组［sPGA（1.73 ± 0.45）分,PASI评分（1.38 ± 0.69）分,F = 40.74、4.38,均P < 0.05］;治疗2、4周,联合用药组sPGA为（0.83 ± 0.46）、（0.23 ± 0.43）分,PASI评分为（0.53 ± 0.47）、（0.23 ± 0.50）分,均显著低于丙酸氟替卡松组（F = 4.88、56.14、15.21、26.36,均P < 0.05）。治疗1周,丙酸氟替卡松组浸润/肥厚严重程度评分显著低于联合用药组（U = 165.00,P < 0.05）;治疗2、4周,联合用药组红斑、鳞屑严重程度评分均显著低于丙酸氟替卡松组（U = 540.00、765.00、825.00、795.00,均P < 0.05）。结论 单用0.05%丙酸氟替卡松乳膏治疗银屑病起效快,0.05%丙酸氟替卡松乳膏与0.005%卡泊三醇软膏联合用药治疗2、4周效果更好,两种方法安全性均可。