他克莫司软膏治疗儿童特应性皮炎疗效和安全性研究

目的评价0．03％他克莫司软膏治疗儿童中、重度特应性皮炎的疗效和安全性。方法采用多中心．随机、双肓、赋形剂平行对照的临床研究,受试者每日2次外搽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周各随访1次,进行疗效和安全性评价。结果 5个中心共有139例中、重度儿童特应性皮炎患者纳入疗效分析。治疗结束时,0.03％他克莫司软膏组治疗有效率为84.6％,明显高于赋形剂组的29.0％(P<0．001)。其他疗效评估指标包括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／监护人对瘙痒自我评分。在治疗后第1、2、3周0.03％他克莫司软膏组明显优于赋形剂组,且均于治疗后第1周始即明显改善(P=0.002～P<0．001)。0.03％他克莫司软膏组药物相关不良反应发生率为32.9％,赋形剂组为37.7％,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 0.03％他克莫司软膏对治疗儿童特应性皮炎具有良好的疗效和安全性。     

他克莫司软膏治疗成人中、重度特应性皮炎的临床研究

目的:比较0.1%,0.03%他克莫司软膏与赋形剂治疗中、重度特应性皮炎(AD)的疗效和安全性.方法:采用随机、双盲、赋形剂平行对照临床研究方法,入选病例按1:1:1比例分为三组,分别随机接受0.1%,0.03%他克莫司软膏或赋形剂治疗,每天2次外搽患处,共3周.结果:有效率:他克莫司软膏0.1%组和0.03%组分别为88.9%和87.5%,赋形剂组为25%;治愈率:他克莫司软膏0.1%组和0.03%组分别为55.6%和50%,赋形剂组为25%,差异有统计学意义(P＜0.05).结论:他克莫司软膏(0.1%和0.03%)治疗成人中、重度特应性皮炎疗效好,安全和耐受性均良好.     

0.03%他克莫司软膏治疗儿童特应性皮炎的疗效观察

目的:观察外用0.03%他克莫司软膏治疗儿童特应性皮炎的临床疗效和安全性。方法:将60例患者随机分为2组,每组30例,分别对两组患者外用0.03%他克莫司软膏和赋形剂,每天1次,疗程为3周。比较两组疗效。结果:他克莫司软膏组和外用赋形剂的对照组的有效率分别为85.7%和36.7%,两组比较差异有统计学意义(2=12.58,P0.05)。治疗组中7.14%的患者局部有刺激反应,症状于1周后消失。结论:他克莫司软膏用于治疗儿童特应性皮炎疗效明显,个别病例出现局部瘙痒不良反应。     

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.     

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观察

目的观察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。方法采用随机双盲、赋形剂平行对照的临床试验,共入组54例成人中重度特应性皮炎患者,年龄18~65岁,共用药3周,其中49例患者完成本试验。结果治疗结束时0.1%和0.03%他克莫司软膏痊愈率分别为46.7%(7/15)和23.5%(4/17),显效率分别为46.7%(7/15)和47.1%(8/17),与赋形剂组的痊愈率17.7%(3/17)和显效率11.8%(2/17)相比,差异有统计学意义;0.1%和0.03%他克莫司软膏治疗有效率分别为93.3%(14/15)和70.6%(12/17),均明显高于赋形剂对照组的29.4%(5/17),差异具有高度统计学意义。在0.1%和0.03%他克莫司软膏中,主要不良反应表现为用药部位出现瘙痒(38.9%和27.8%)、灼热感(33.3%和16.7%)、刺痛(16.7%和22.2%)等,严重程度多为轻到中度,并且均为一过性。治疗前后实验室检查也无明显异常改变。结论0.1%和0.03%他克莫司软膏是一种安全、有效的治疗成人中、重度特应性皮炎的药膏。     

0.03%他克莫司软膏治疗儿童特应性皮炎的疗效观察及生活质量评价

目的:评价0.03%他克莫司软膏治疗儿童特应性皮炎的疗效和安全性。方法:采用随机、双盲、平行对照方法,分别对两组儿童特应性皮炎患者外用0.03%他克莫司软膏和赋形剂,疗程为3周。每周对患儿进行随访观察,并在治疗前、后对5～17岁患者作皮肤病学生活质量指数(DLQI)问卷调查。结果:0.03%他克莫司软膏组和对照组的有效率分别为85.0%和33.3%,两组疗效比较差异有非常显著性(P<0.001)。问卷调查表明患者治疗后生活质量明显改善。结论:0.03%他克莫司软膏治疗儿童特应性皮炎安全、有效,治疗后患者的生活质量明显改善。     

薇诺娜舒敏保湿特护霜联合0.03%他克莫司软膏治疗激素依赖性皮炎临床分析

目的观察外用薇诺娜舒敏保湿特护霜与0.03%他克莫司软膏治疗激素依赖性皮炎临床疗效和安全性。方法符合入选条件的60例激素依赖性皮炎患者随机分为两组,治疗组薇诺娜舒敏保湿特护霜与0.03%他克司软膏联合外用。对照组单独外用0.03%他克莫司软膏。于治疗4周后观察临床疗效。结果治疗组疗效明显优于对照组,不良反应少。结论应用薇诺娜舒敏保湿特护霜与0.03%他克莫司软膏治疗激素依赖性皮炎,安全、迅速、有效。     

0.03%他克莫司软膏治疗面部激素依赖性皮炎74例疗效观察

目的观察0.03%他克莫司软膏治疗面部激素依赖性皮炎的疗效和安全性。方法将74例面部激素依赖性皮炎患者随机分成两组,治疗组38例,对照组36例。治疗组外用0.03%他克莫司软膏2次/d。对照组外敷3%硼酸溶液2次/d。共4周。结果治疗组和对照组有效率分别为84.21%和61.11%,差异有统计学意义(P0.05)。结论 0.03%他克莫司软膏治疗面部激素依赖皮炎疗效显著,耐受性好,安全性高。     

他克莫司软膏治疗儿童特应性皮炎的临床研究

目的　评价他克莫司软膏治疗儿童特应性皮炎 (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 36例儿童AD患者随机分为两组,按 1∶1比例分别接受 0. 03%他克莫司软膏或赋形剂治疗,观察治疗第 1, 2和 3周的临床疗效和不良反应。结果　0. 03%他克莫司软膏组有效率为 83. 3% (15 /18),明显高于赋形剂组的 27. 8% (5 /18),差异非常显著(P<0. 001);总体疗效比较,他克莫司软膏组亦优于赋形剂组 (P=0. 002);治疗后第 1,2, 3周患者的主要症状 /体征指标平均值均明显低于赋形剂组,组间差异显著(P<0.01~P<0. 05),治疗后患者的生活质量亦明显改善。药物相关不良反应主要表现为一过性局部刺激,组间比较差异无显著性 (P>0. 05)。两组患者均未出现严重不良反应。结论　0. 03%他克莫司软膏治疗儿童特应性皮炎安全有效。     

0.03%他克莫司软膏治疗面部脂溢性皮炎临床疗效观察

目的探讨外用0.03%他克莫司软膏治疗面部脂溢性皮炎临床疗效和安全性。方法将78例患者随机分成两组,治疗组40例,外用0.03%他克莫司软膏2次/d;对照组38例,外用丁苯羟酸软膏。疗程均为4周。结果治疗组和对照组临床有效率分别为87.50%和60.53%,治疗组疗效优于对照组。治疗组7例局部出现刺激症状,均发生在用药后1周内。他克莫司组不良反应发生率高于丁苯羟酸组,但二者差异无显著性(P>0.05)。结论他克莫司软膏治疗面部脂溢性皮炎安全、有效。     

A multicentre, randomized, double-blind, controlled study of long-term treatment with 0.1% tacrolimus ointment in adults with moderate to severe atopic dermatitis

BACKGROUND: Atopic dermatis (AD) is a chronic disease that often requires long-term treatment. Topical corticosteroids are the usual therapy for patients with AD, but prolonged usage can result in skin atrophy and other side-effects. OBJECTIVES: In a randomized, double-blind, comparative study, to compare the efficacy and safety of a 6-month treatment period with 0.1% tacrolimus ointment vs. a corticosteroid ointment regimen in adults with moderate to severe AD. METHODS: Treatment was applied twice daily for a maximum of 6 months. Patients in the tacrolimus treatment group (n = 487) applied 0.1% tacrolimus ointment to all affected areas over the whole body. The patients treated with the corticosteroid regimen (n = 485) applied 0.1% hydrocortisone butyrate ointment to affected areas on the trunk and extremities and 1% hydrocortisone acetate ointment to affected areas on the face and neck. The study primary endpoint was the response rate, i.e. the proportion of patients with at least 60% improvement in the modified Eczema Area and Severity Index (mEASI) between baseline and month 3. RESULTS: By month 3, more patients in the 0.1% tacrolimus group responded to treatment (72.6% vs. 52.3% in the corticosteroid group, P < 0.001). The patients treated with 0.1% tacrolimus also showed greater improvement in mEASI, EASI, affected body surface area and physician and patient assessments of global response. Patients applying 0.1% tacrolimus ointment experienced more skin burning (52.4% vs. 13.8% in the corticosteroid group; P < 0.001). In most patients, skin burning was mild to moderate in severity and decreased rapidly after the first week of treatment. There was no increase in the incidence of infections or malignancies over time in either treatment group. CONCLUSIONS: Long-term treatment with 0.1% tacrolimus ointment is significantly more efficacious than a corticosteroid ointment regimen in adults with moderate to severe AD.     

Long-term efficacy and tolerability of tacrolimus 0.03% ointment in infants:* a two-year open-label study

Background Tacrolimus ointment is effective for treatment of moderate to severe atopic dermatitis (AD) in children aged ≥2 years (Br J Dermatol, 2004; 150: 554). Here, efficacy and tolerability of tacrolimus 0.03% ointment were evaluated in 50 infants aged <2 years at start of treatment. Methods Infants with AD previously enrolled in a tacrolimus ointment pharmacokinetics trial were eligible for a 24‐month open‐label phase II study. Tacrolimus 0.03% ointment was applied to affected areas until clearance. In cases of exacerbation or clinical worsening, patients restarted treatment. Results Mean ± SD Eczema Area and Severity Index (EASI) score improved, from 11.2 ± 10.5 baseline to 2.6 ± 4.1 at endpoint (24 months); mean affected body surface area decreased from 25.2 ± 21.1% to 5.1 ± 9.0%, with improvement on all items of the Physicians’ Assessment of Individual Signs. The Physicians’ Global Evaluation of Clinical Response showed a result of “cleared”/“excellent” for 63.3% of patients; 85.7% of parents/guardians assessed symptoms as “much better.” Treatment was well tolerated, with common, nonserious respiratory infections and gastroenteritis the most frequently reported adverse events. The most common application‐site events were infections and pruritus. Over 98% of blood samples showed tacrolimus concentrations <1.0 ng/ml; >40% showed concentrations below the lower limit of quantification (0.0250 ng/ml). Conclusions Over a period of two years, tacrolimus 0.03% ointment was associated with substantial clinical improvement of AD in infants aged <2 years. Treatment tolerability was similar to that seen in older children.     

0.03% Tacrolimus ointment applied once or twice daily is more efficacious than 1% hydrocortisone acetate in children with moderate to severe atopic dermatitis: results of a randomized double-blind controlled trial

BACKGROUND: Topical corticosteroids are the usual treatment for atopic dermatitis (AD) in children but can have side-effects. OBJECTIVES: This study compared the efficacy and safety of 0.03% tacrolimus ointment applied once or twice daily over a 3-week period with the twice daily application of 1% hydrocortisone acetate (HA) ointment in children with moderate to severe AD. PATIENTS AND METHODS: Patients applied ointment daily to all affected body surface areas. The primary study endpoint was the percentage change in the modified Eczema Area and Severity Index (mEASI) between baseline and treatment end. RESULTS: Six hundred and twenty-four patients, aged 2-15 years, applied 0.03% tacrolimus ointment once daily (n = 207), twice daily (n = 210) or 1% HA twice daily (n = 207). By the end of treatment, application of 0.03% tacrolimus ointment both once or twice daily resulted in significantly greater median percentage decreases in mEASI (66.7% and 76.7%, respectively) compared with 1% HA (47.6%; P < 0.001). Furthermore, the median percentage decrease in mEASI was significantly greater for patients applying 0.03% tacrolimus twice daily compared with once daily (P = 0.007). Patients with severe AD benefited especially from twice daily application of 0.03% tacrolimus ointment compared with once daily application (P = 0.001). Transient mild to moderate skin burning occurred significantly more often in the 0.03% tacrolimus groups (P = 0.028) but resolved in most cases within 3-4 days. Laboratory parameters showed no clinically relevant changes. CONCLUSIONS: 0.03% tacrolimus ointment applied once or twice daily is significantly more efficacious than 1% HA in treating moderate-severe AD in children. Twice daily application of 0.03% tacrolimus ointment results in the greatest improvement in mEASI, and is especially effective in patients with severe baseline disease.     

Impact of Topical Calcineurin Inhibitors on Quality of Life in Patients with Atopic Dermatitis

This review considers randomized trials of topical calcineurin inhibitors in atopic dermatitis that have included quality-of-life (QOL) data. Relatively few trials were identified and several different QOL measures have been used, partly because trial subjects included adults, children, and the parents of affected infants. Tacrolimus 0.1% and 0.03% ointment and pimecrolimus 1% cream were found to be superior to vehicle treatment in terms of QOL for active AD. In adults, tacrolimus 0.1% ointment provided a greater improvement in QOL than the 0.03% strength. Pimecrolimus 1% cream was superior to vehicle treatment for flare prevention in the studies that contained QOL outcomes but no data are available for tacrolimus ointment in this regard. QOL data comparing topical calcineurin inhibitors with other active treatments such as topical corticosteroids are sparse and it would be useful for future randomized trials to include QOL measures as a primary outcome.     

Long-term safety and efficacy of tacrolimus ointment for the treatment of atopic dermatitis in children

Tacrolimus ointment is a topical calcineurin inhibitor for the treatment of atopic dermatitis. The primary objective of this open-label study was to assess the long-term safety of tacrolimus ointment. The primary end-point was the incidence of adverse events. Secondary end-points included the Eczema Area and Severity Index and a modified version of this index. A total of 466 children with atopic dermatitis, aged 2-15 years, applied 0.03% or 0.1% tacrolimus ointment twice daily for up to 29.5 months. Skin burning and pruritus were the most common application site events; their prevalence decreased over time. There was no increase in viral infections or other adverse events over time. Laboratory profiles were consistent with those reported in atopic populations. Substantial improvement in all efficacy end-points was observed by week 2 and maintained throughout the study. Long-term treatment with tacrolimus ointment is safe and effective in these patients with atopic dermatitis.     

Superiority of tacrolimus 0·1% ointment compared with fluticasone 0·005% in adults with moderate to severe atopic dermatitis of the face: results from a randomized, double-blind trial

Summary Background No specific data are available on tacrolimus ointment as a second‐line treatment in adults with facial eczema. Objectives To compare tacrolimus 0·1% and fluticasone 0·005% ointments in adults with moderate to severe atopic dermatitis (AD) of the face in whom conventional treatment was ineffective or poorly tolerated. Methods Patients were randomized to double‐blind treatment of facial AD with twice‐daily tacrolimus ointment (n = 288) or fluticasone ointment (n = 280) for 3 weeks or until clearance. After day 21, patients could continue without the study treatment, apply the same ointment once daily, or switch to the other medication twice daily, depending on lesion clearance and patient/physician satisfaction. The primary endpoint was the day‐21 response [≥ 60% reduction in the modified Local Eczema and Severity Index (mLEASI) score]. Secondary endpoints included facial erythema and pruritus, global clinical response, treatment switching at day 21 and safety. Results Response with tacrolimus ointment (93%) was superior to that with fluticasone (88%; P = 0·026). Improvements in mLEASI components were also greater with tacrolimus ointment. Facial erythema and pruritus improved in both groups. Global clinical response was rated ‘marked improvement’ or better in 88% and 79% of patients in the tacrolimus ointment and fluticasone groups, respectively. At day 21, 9% of patients switched from fluticasone to tacrolimus ointment, while 4·5% switched from tacrolimus ointment to fluticasone. Adverse events were more frequent with tacrolimus ointment as a result of the higher incidence of application‐site skin burning sensation. Safety of both drugs was in line with their respective summary of product characteristics. Conclusions Tacrolimus 0·1% ointment has superior efficacy to fluticasone 0·005% ointment for twice‐daily treatment of adults with moderate to severe facial AD in whom conventional therapy was inadequately effective or not tolerated. Tacrolimus 0·1% ointment is a safe and effective second‐line treatment for the control of moderate to severe AD of the face.     

Overview of efficacy and safety of tacrolimus ointment in patients with atopic dermatitis in Asia and other areas

Objective To assess the efficacy and safety of tacrolimus ointment in a large population of patients with atopic dermatitis (AD) by pooling data from individual Asian studies, and to compare the results of this study with those in the United States, Europe, and Japan. Materials and methods We analyzed the pooled data from individual studies conducted in the eight Asian areas. The efficacy assessments included success rate based on Physician’s Global Evaluation of Clinical Response, Eczema Area Severity Index (EASI), Percent Body Surface Area (%BSA) affected, Patient’s Assessment of Itch (Itch), Dermatology Life Quality Index (DLQI) and children’s DLQI (CDLQI). The results that were published in the United States, Europe, and Japan were cited. Results A total of 860 patients were included in this study. The success rates were more than 80% in both adult and pediatric patients. Similar success rates were shown in the United States, European, and Japanese studies. There were no differences in the improvements in %BSA affected, EASI, and Itch between this study and the United States study. In both Asia and the United States, tacrolimus therapy improved total quality of life and all subscales in DLQI and CDLQI. Skin burning and pruritus were common adverse events among the Asian, United States and European studies. Conclusions Tacrolimus ointment is an effective and well‐tolerated treatment option in patients with AD in Asia. In this study, the efficacy and safety of tacrolimus are similar to those in the United States, European, and Japan studies.     

Efficacy and tolerability of topical tacrolimus ointment for the treatment of male genital psoriasis

BACKGROUND: Genital psoriasis is difficult to treat and has a significant psychological impact on affected patients. OBJECTIVE: To study the safety and efficacy of topical tacrolimus ointment in male patients with genital psoriasis. METHODS: This was an open-label study in 12 male patients with genital psoriasis. Patients received topical tacrolimus 0.1% ointment twice daily for 8 weeks followed by a 4-week observational period. Efficacy was assessed by a modification of the Psoriasis Area and Severity Index (PASI) scale adapted for genital psoriasis (male genital PASI). Severity was also evaluated individually for the glans, shaft of the penis, and scrotum. RESULTS: Male genital PASI decreased from a mean score of 15.8 at baseline to 1.2 at week 8 (p < .001). Psoriasis severity also improved significantly for the glans, shaft of the penis, and scrotum evaluated individually. Tacrolimus 0.1% ointment was very well tolerated, with only mild pruritus or burning sensation of limited duration reported. CONCLUSIONS: Topical tacrolimus ointment appears very efficacious and well tolerated in male patients with genital psoriasis.     

Long-term treatment with 0.1% tacrolimus ointment in adults with atopic dermatitis: results of a two-year, multicentre, non-comparative study

Atopic dermatitis often requires long-term treatment. This European, multicentre, non-comparative, 24-month, follow-up study investigated the efficacy and safety of 0.1% tacrolimus ointment applied to adults with atopic dermatitis. Patients (n=672) applied a thin layer of 0.1% tacrolimus ointment twice daily for 3 weeks to all affected body areas. After 3 weeks, ointment was applied once daily. Clinical improvement became apparent after 2 weeks of treatment and 65.5% of patients had a rating of clearance, excellent or marked improvement by month 3. Skin burning (31.7%) was the most common causally-related adverse event, followed by pruritus (11.3%) folliculitis (6.4%), alcohol intolerance (5.7%), herpes simplex (5.7%), skin infection (4.6%), skin erythema (3.3%) and hyperaesthesia (2.4%). The most commonly reported infections were flu syndrome (12.9%), skin infection (9.8%), folliculitis (7.4%) and herpes simplex (7.0%). Long-term treatment up to 24 months with 0.1% tacrolimus ointment is safe and efficacious in adults with atopic dermatitis.