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。     

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。     

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。     

他克莫司软膏治疗儿童特应性皮炎疗效和安全性的meta分析

目的 :系统评价他克莫司软膏治疗儿童特应性皮炎的有效性及安全性。方法 :搜索电子数据库MEDLINE and PubMed、the Cochrane Central Register of Controlled(CENTRAL)、EMbase、中国知网、万方数据库以及维普数据库,检索时间从建库到2016年9月。检索他克莫司软膏治疗儿童特应性皮炎的随机对照试验(RCT)并根据Cochrane系统评价方法评价纳入文献质量,提取相关数据并用Stata/SE11.0软件进行meta分析。结果:最终纳入18个RCT共计2821例中到重度儿童特应性皮炎儿童患者。结果显示:(1)0.03%和0.1%他克莫司软膏可以有效治疗儿童特应性皮炎且无明显不良反应;(2)他克莫司软膏疗效优于氢化可的松软膏,但与甲泼尼龙和氟轻松相比差异无统计学意义;(3)0.1%与0.03%他克莫司软膏疗效及不良反应发生率差异无统计学意义。结论:外用他克莫司软膏可有效治疗儿童特应性皮炎,且具有较低的不良反应发生率。     

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。     

他克莫司软膏治疗成人特应性皮炎随机对照试验的Meta分析

目的:评价局部应用他克莫司治疗成人特应性皮炎(AD)的疗效和安全性.方法:计算机检索Ovid:http://gateway.ovid.com/:Cochrane图书馆(2008年第1期)、检索MEDLINE(1966～2007年),Embase数据库(1974～2007年),http://www.cnki.net/index.htm,纳入他克莫司治疗AD的随机对照试验,两名研究者独立进行各临床试验的质量评估.采用Cochrane协作网提供的RevMan 4.2.8进行统计分析.结果:共纳入6个随机对照试验(RCT),包括1 441例临床诊断为中、重度AD患者.Meta分析显示:0.03%、0.1%他克莫司软膏治疗特应性皮炎有较好疗效,0.1%他克莫司软膏疗效优于0.03%者,OR为0.65(0.48, 0.86),0.1%他克莫司软膏疗效与0.1%丁酸氢化可的松相似.主要的不良反应轻微,多为灼热感和瘙痒.结论:局部应用他克莫司治疗成人AD安全有效.     

他克莫司软膏治疗特应性皮炎疗效观察及患者生活质量评价

目的:评价0.03%和0.1%他克莫司软膏治疗中国成人和儿童中、重度特应性皮炎(AD)患者后其生活质量的改善情况。方法:采用多中心、双盲、随机、赋形剂平行对照的方法对327例中、重度AD患者给予0.03%和0.1%他克莫司软膏治疗3周,在治疗前、后采用皮肤病学生活质量指数量表对患者进行生活质量评价。结果:3周后成人组总体生活质量评分及症状、日常活动和休闲3个方面评分的改善有统计学差异(P<0.05)。儿童组总体生活质量评分及症状、休闲、学校、假期、日常活动、睡眠和治疗的影响各方面改善均有统计学差异(P<0.05)。幼儿组各方面的改善无统计学差异(P>0.05)。结论:0.03%和0.1%他克莫司软膏治疗中国成人和儿童中、重度AD患者3周后,成人及儿童(>4岁)患者的生活质量均有显著改善。     

他克莫司软膏治疗儿童特应性皮炎疗效和依从性评价

目的评价0.03%他克莫司软膏治疗儿童轻、中度特应性皮炎(AD)的疗效和安全性及依从性。方法采用随机双盲平行对照方法将入选的60例AD患儿分为对照组和试验组,每组各30例。试验组患儿外用0.03%他克莫司软膏,对照组患儿外用凡士林乳膏、夫西地酸软膏,两组均连续治疗3周,采用AD评分评价疗效。结果试验组患儿瘙痒、症状积分下降明显大于对照组(P<0.05);症状控制时间和临床治愈用药时间明显短于对照组(P<0.05)。试验组和对照组治疗的有效率分别为93.3%和69.5%,两组疗效比较差异有统计学意义(P<0.05);试验组和对照组依从率分别为100%和76.7%,两组比较差异具有统计学意义(P<0.05)。结论 0.03%他克莫司软膏治疗儿童轻、中度AD安全而有效,患儿依从性良好。     

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.     

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。     

Tacrolimus ointment for the treatment of atopic dermatitis is not associated with an increase in cutaneous infections

OBJECTIVE: The purpose of this study was to evaluate the risk of cutaneous infection in patients with atopic dermatitis treated with tacrolimus ointment. METHODS: Data for 1554 patients with atopic dermatitis, treated with tacrolimus ointment in 5 clinical trials, were analyzed. RESULTS: In 3 controlled studies, the 12-week adjusted incidence of all cutaneous infections in patients treated with the vehicle, 0.03%, and 0.1% tacrolimus ointment, respectively, was 18.0%, 24.8%, and 17.7% for adult patients, and 20.9%, 19.6%, and 23.6% for pediatric patients. The incidence of any individual cutaneous infection was not significantly higher in the tacrolimus group than in the vehicle group, with the exception of folliculitis in adults. In two open-label studies, there was no evidence of an increased risk of cutaneous infections with long-term use of 0.1% tacrolimus ointment (up to 1 year), based on the incidence of adverse events, incidence by cumulative length of exposure, or hazard rates. CONCLUSION: Treatment with tacrolimus ointment (0.03% or 0.1%) does not increase the risk of cutaneous bacterial, viral, or fungal infections in patients with atopic dermatitis.     

Role of Topical Therapies in the Management of Cutaneous Disease

Within the last decade, healthcare providers have had a larger selection of effective novel topical immunomodulatory agents to treat many dermatologic conditions. Novel mechanisms of action of newer topical agents have facilitated differentiation from well-established topical agents such as corticosteroids and 5-fluorouracil. Further, because of a growing understanding of the immune mechanisms within the skin, the opportunity has arisen to use the body’s immune system to effectively treat many dermatologic conditions, such as condyloma acuminata, actinic keratosis, basal cell carcinoma, and atopic dermatitis, while maintaining a favorable safety profile. Imiquimod 5% cream, an immune response modifier, is safe and effective in the treatment of condyloma acuminata, actinic keratosis, and primary superficial basal cell carcinoma (sBCC). Pimecrolimus cream 1% and tacrolimus ointment (0.1% and 0.03%) are safe and effective in the treatment of atopic dermatitis. This review highlights newer data on approved and investigational indications for these topical immunomodulatory agents.     

Role of topical therapies in the management of cutaneous disease

Within the last decade, healthcare providers have had a larger selection of effective novel topical immunomodulatory agents to treat many dermatologic conditions. Novel mechanisms of action of newer topical agents have facilitated differentiation from well-established topical agents such as corticosteroids and 5-fluorouracil. Further, because of a growing understanding of the immune mechanisms within the skin, the opportunity has arisen to use the body's immune system to effectively treat many dermatologic conditions, such as condyloma acuminata, actinic keratosis, basal cell carcinoma, and atopic dermatitis, while maintaining a favorable safety profile. Imiquimod 5% cream, an immune response modifier, is safe and effective in the treatment of condyloma acuminata, actinic keratosis, and primary superficial basal cell carcinoma (sBCC). Pimecrolimus cream 1% and tacrolimus ointment (0.1% and 0.03%) are safe and effective in the treatment of atopic dermatitis. This review highlights newer data on approved and investigational indications for these topical immunomodulatory agents.     

Spotlight on Topical Pimecrolimus in Pediatric Atopic Dermatitis

Topical pimecrolimus 1% cream (Elidel®) [hereafter referred to as topical pimecrolimus] is a nonsteroidal alternative in the treatment of pediatric atopic dermatitis. In vehicle-controlled, short-term, continuous-use trials in pediatric patients with mild to moderate atopic dermatitis, topical pimecrolimus was effective in treating disease symptoms. Topical pimecrolimus was effective in preventing disease flares and reducing the need for topical corticosteroids in longer term, intermittent-use trials. In addition, topical pimecrolimus was associated with improvements in the health-related quality of life of pediatric patients with atopic dermatitis and their parents. In vehicle-controlled trials, topical pimecrolimus was generally as well tolerated as vehicle. Topical pimecrolimus showed similar efficacy to topical tacrolimus 0.03% ointment in a short-term, continuous-use trial and the two agents had a generally similar tolerability profile. Although comparative data between topical pimecrolimus and topical corticosteroids are lacking in pediatric patients, and the long-term tolerability (beyond 1–2 years) of topical pimecrolimus is yet to be established, topical pimecrolimus is a useful agent in the management of pediatric patients with mild to moderate atopic dermatitis who do not achieve satisfactory treatment with other topical pharmacologic treatments, including topical corticosteroids.