克立硼罗软膏治疗特应性皮炎患儿的安全性

目的 探究克立硼罗软膏治疗特应性皮炎（AD）患儿的安全性。方法 选取2021年2月至2022年2月就诊于医院的92例AD患儿,按随机数表法分为两组,各46例。对照组采用丁酸氢化考的松乳膏,观察组采用克立硼罗软膏,均治疗2周。比较两组治疗2周的临床疗效。比较两组治疗前、治疗2周的皮损程度[AD积分指数（SCORAD）]、炎性因子[白细胞介素-6(IL-6)、肿瘤坏死因子α(TNF-α)]、生活质量[儿童皮肤病生活质量指数（CDLOI）]。比较两组临床症状消失时间及不良反应发生情况。结果治疗2周,观察组的总有效率比对照组高（P <0.05）;治疗2周,两组SCORAD评分、CDLQI评分低于治疗前,观察组比对照组低（P <0.05）;治疗2周,两组IL-6、TNF-α水平低于治疗前,观察组比对照组低（P <0.05）。观察组红斑、水肿及瘙痒消失时间均短于对照组（P <0.05）。两组不良反应发生率比较,差异无统计学意义（P> 0.05）。结论 克立硼罗软膏可有效减轻AD患儿的皮损程度及炎性反应,加快临床症状消失,改善患儿的生活质量,且不良反应较少,安全性较高。     

克立硼罗软膏治疗儿童特应性皮炎有效性和安全性的单组率meta分析

目的探讨克立硼罗软膏(克立硼罗)治疗儿童特应性皮炎(AD)的有效性和安全性。方法检索PubMed、Embase、Medline、中国知网、万方医学、维普网及中华医学期刊数据库(截至2022年3月), 收集克立硼罗治疗儿童AD的随机对照试验(RCT)和队列研究。应用改良Jadad量表和NOS量表分别对RCT和队列研究进行质量评价。提取接受克立硼罗治疗患儿有效率和不良事件发生率等数据, 采用Stata 15软件进行单组率的meta分析。结果共8项研究(RCT和前瞻性队列研究各4项)纳入分析, 接受克立硼罗治疗的患儿共1 855例(年龄3个月～17岁)。8项研究质量评价结果均为高质量。单组率meta分析结果显示, AD患儿应用克立硼罗治疗14～28 d的有效率为46%[95%置信区间(CI):32%～61%];治疗期间不良事件发生率为28%(95%CI:19%～38%);因不良事件终止治疗的发生率为1%(95%CI:0～2%)。克立硼罗引发的不良事件多为局部皮肤反应, 主要表现为用药局部疼痛、瘙痒、皮炎、感觉异常、局部感染等。报道用药部位疼痛的研究占7/8, 用药部位疼痛发生率为17%(95...     

保湿润肤剂联合糖皮质激素治疗儿童特应性皮炎的临床观察

目的：观察保湿润肤剂联合糖皮质激素治疗儿童特应性皮炎(AD)的临床效果。方法：选择2021年5月—2022年2月于景德镇市皮肤病医院治疗的82例AD患儿,按随机数字表法分为观察组和对照组,每组41例。对照组采用糠酸莫米松乳膏治疗,观察组于对照组基础上加用维生素E乳霜治疗。比较两组临床疗效、特应性皮炎皮损评分(SCORAD)、瘙痒程度、睡眠质量、不良反应发生率及复发率。结果：观察组治疗总有效率(RR)高于对照组,治疗后观察组SCORAD评分、瘙痒程度评分、匹兹堡睡眠质量指数(PSQI)评分及复发率低于对照组,差异有统计学意义(P<0.05);两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论：AD患儿采用保湿润肤剂与糖皮质激素联合治疗有利于缓解患儿的瘙痒症状,改善患儿睡眠质量,提高AD治疗效果,降低复发率,临床应用安全可靠。     

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。     

他克莫司软膏联合氯雷他定治疗儿童特应性皮炎的临床疗效观察

目的探讨他克莫司软膏联合氯雷他定治疗儿童特应性皮炎的临床疗效。方法选取2009年9月至2011年5月我院诊治的特应性皮炎患儿共160例,随机分为实验组和对照组,其中治疗组采用他克莫司软膏司联合氯雷他定治疗,对照组单纯口服氯雷他定。治疗后观察患者的皮肤状况,每周复诊1次,观察患儿的皮损及瘙痒情况。结果实验组与对照组的临床疗效总有效率差异具有统计学意义(97.50%VS 78.75%,P<0.05),实验组患儿的疗效总有效率明显较高;治疗结束2周后实验组患儿的临床体征与症状评分明显较低(P<0.05)。结论他克莫司软膏联合氯雷他定治疗儿童特应性皮炎,能够有效提高临床效果及改善临床体征与症状,值得在临床上推广应用。     

克立硼罗软膏治疗特应性皮炎的系统评价

目的 系统评价克立硼罗软膏治疗特应性皮炎(AD)的有效性和安全性。方法 检索Cochrane Library、Embase、PubMed、中国学术期刊全文数据库(CNKI)、万方数据知识服务平台(Wanfang Data)、维普中文期刊全文数据库(VIP)、中国生物医学文献服务系统(SinoMed)、中华医学期刊全文数据库(Yiigle),系统收集建库至2024年1月30日发表的克立硼罗软膏治疗特应性皮炎的临床随机对照试验(RCT)。由2名研究者独立筛选、提取信息,通过Review Manager 5.3软件进行Meta分析,所形成的证据体使用GRADE系统进行证据质量评估。结果 共纳入11项RCTs,包括2 789例AD患者。Meta分析显示:与安慰剂或空白治疗比较,克立硼罗软膏可提高研究者静态总体评分成功率[RR=1.52,95 % CI (1.28,1.80),P<0.000 01]和缓解率[RR=1.43,95 % CI (1.27,1.62),P<0.000 01],降低湿疹面积及严重程度指数(EASI)评分[MD=-2.44,95 % CI (-4.15,-0.73),P=0.005],缓解瘙痒,增加无复发维持时间,减少复发次数;与阳性对照相比,具有更高的疾病疗效愈显率[RR=1.80,95 % CI (1.33,2.43),P=0.000 1],可提高生活质量;与一线药物联合使用对比单独使用一线治疗药物,联合治疗组具有更高的疾病疗效愈显率[RR=1.23,95 % CI (1.03,1.48),P=0.02],较高的EASI评分变化值[MD=-2.11,95 % CI (-3.13,-1.10),P<0.000 1],可缓解瘙痒,提高生活质量。安全性方面,不良反应主要表现为给药部位的局部反应,如给药部位刺激、疼痛、瘙痒、变色、感觉异常等,多数为轻度、中度反应,预后较好。结论 克立硼罗软膏可缓解AD疾病严重程度,缓解瘙痒,提高生活质量,病情稳定后以小剂量长期维持治疗可减少AD复发;在儿童、成人群体中应用耐受性较好,临床使用时应关注给药部位的异常局部反应。     

中西医结合外治法治疗小儿湿热蕴结型特应性皮炎的临床观察

目的:探讨中西医结合治疗小儿湿热蕴结型特应性皮炎的临床疗效.方法:将我院从2014年8月~2016年8月门诊接诊的107例湿热蕴结型特应性皮炎患者随机分为对照组和治疗组,对照组采用单纯西药氢化可的松软膏治疗,治疗组采用氢化可的松软膏联合中药外洗治疗,疗程2个月,疗程结束后对比两组疗效和特应性皮炎皮损评分指数.结果:两组治疗后SCORAD评分比较,治疗组较对照组评分优越,差异明显,P<0.05;对比两组有效率,治疗组有效率高于对照组,差异明显,P<0.05.结论:中西医结合外治法治疗小儿湿热蕴结型特应性皮炎疗效确切,值得临床推广.     

青鹏软膏治疗轻中度特应性皮炎的疗效观察

目的:探讨青鹏软膏治疗轻中度特应性皮炎(AD)的临床疗效。方法:将90例轻中度AD患者随机分为治疗组(45例)和对照组(45例)。治疗组:外用青鹏膏治疗,每日2次,连用4周;对照组:外用糠酸莫米松乳膏治疗,每日2次,连用4周,观察、对比两组治疗效果。结果:治疗组痊愈率为22.2%,有效率为66.7%;对照组痊愈率26.7%,有效率73.3%;治疗组与对照组疗效无差异性(P0.05)。结论:青鹏软膏可以明显改善轻中度AD患者皮损程度,有效控制其临床症状,并发症少,适合中长期使用,具有很好的临床应用价值。     

治疗特应性皮炎新药及其临床药理学研究有关问题探讨

对近5年来特应性皮炎代表性新药的国内外批准情况进行介绍,总结了度普利尤单抗注射液、乌帕替尼缓释片、迪高替尼乳膏、克立硼罗软膏等4种不同作用机制、不同给药途径的特应性皮炎治疗药物的申报资料中临床药理学研究主要内容,以及国内外监管机构对特应性皮炎治疗药物的审评考量,旨在为特应性皮炎新药的早期临床研发和评价提供参考依据。     

丁酸氢化可的松乳膏联合莫匹罗星软膏治疗儿童特应性皮炎疗效观察

目的观察丁酸氢化可的松乳膏联合莫匹罗星软膏与单独涂丁酸氢化可的松乳膏治疗儿童特应性皮炎的临床疗效。方法治疗组每日交替使用丁酸氢化可的松乳膏和莫匹罗星软膏各2次;对照组涂丁酸氢化可的松乳膏,2次/d.连续用药2周。结果治疗组58例,治愈率74.14%,有效率94.83%;对照组58例,治愈率51.72%,有效率75.86%,两组有效率比较差异有显著性。结论丁酸氢化可的松乳膏联合莫匹罗星软膏治疗儿童特应性皮炎疗程短,疗效好,无明显不良反应。     

继发性线粒体功能障碍的判定与治疗

线粒体是双侧膜包被的细胞器,控制氧化磷酸化 (oxidative phosphorylation,OXPHOS)、脂肪酸氧化、三羧酸循 环(Krebs 循环)等多种代谢过程,还参与维持钙离子稳定、 氧化还原信号传递、活性氧簇的生产和调节、细胞凋亡等体 内多种重要的病理生理过程,线粒体功能一旦受损,机体功 能就会受到影响。 原发性线粒体病(primary mitochondrial disease,PMD)是指线粒体 DNA(mitochondrial DNA,mtDNA) 或编码电子传递链的核 DNA(nuclear DNA,nDNA)变异导 致氧化磷酸化障碍而引发的一组系统性疾病。 在临床工作 中,也常见到一些疾病具备 PMD 的某些或所有表型,却并 未找到与 OXPHOS 相关的 mtDNA 或 nDNA 突变,这种现象 被称为继发性线粒体功能障碍( secondary mitochondrial dysfunction,SMD)[1-2] 。     

他克莫司软膏治疗儿童中重度特应性皮炎随机双盲对照临床研究

目的 观察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 用随机双盲安慰剂平行对照临床试验，共人组30例儿童中重度特应性皮炎患者，用药3周，其中29例患者完成本试验。结果 治疗结束时，0．03％他克莫司软膏组痊愈率、显效率和有效率分别为35．7％（5／14），50．0％（7／14）和85．7％（12／14），与安慰组痊愈率6．7％（1／15）、显效率13．3％（2／15）和有效率为20．0％（3／15）相比，差异均有统计学意义。试验组主要药物不良反应多为轻到中度，且均为一过性；实验室检查治疗前后也未见明显异常。结论0．03％他克莫司软膏治疗儿童中重度特应性皮炎安全有效。     

他克莫司软膏治疗儿童与成人特应性皮炎的随机双盲对照临床研究

目的评价他克莫司软膏治疗特应性皮炎的疗效和安全性。方法用随机双盲平行对照方法，将成人特应性皮炎分为3组，分别外用0．1％，0．03％他克莫司软膏和赋形剂（对照组）；将儿童特应性皮炎分为2组，分别外用0．03％他克莫司软膏和赋形剂（对照组）；每日2次，疗程为3周；作症状和体征总评分、受累体表面积百分比（BSA％）和特应性皮炎面积与严重程度指数（EASI）评估；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。结果成人他克莫司软膏0．1％组、0．03％组和对照组的有效率分别为100％，80．0％和26．7％；儿童他克莫司软膏0．03％组和对照组的有效率分别为85．0％和33．3％。治疗组的有效率均显著高于对照组（P〈0.001）。治疗后，治疗组的症状和体征总评分、BSA％和EASI显著下降，与患者自我评价符合。药物不良反应轻微。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有效、安全。     

他克莫司软膏在儿童口周皮炎中的临床应用

目的分析0.03%他克莫司软膏在儿童口周皮炎治疗中的应用价值。方法儿童口周皮炎患儿70例,年龄2～14岁,随机分为观察组及对照组。观察组给予0.03%他克莫司软膏联合保湿软膏每日外用1次治疗。对照组采用保湿乳膏每日外用2次治疗。两组疗程均为4周。比较两组患儿治疗后1、2、4周治疗效果。结果观察组有效率高于对照组(P<0.01),观察组2周、4周的有效率明显高于1周(P<0.05)。观察组的药物不良反应发生率为13.9%(5/36),主要表现为轻微的红斑、烧灼及痒痛感。结论 0.03%他克莫司软膏治疗儿童口周皮炎疗效确切,安全性高。     

Topical [symbol: see text] tacrolimus--a role in atopic dermatitis?

Conventional treatment of atopic dermatitis includes the regular, frequent use of emollients, and intermittent application of topical corticosteroids to control acute 'flares'. [symbol: see text] Tacrolimus (pronounced ta-kro-li-mus), which is available for systemic use for the prevention of organ rejection following allogenic liver and kidney transplantation, is now formulated as an immunosuppressant ointment (Protopic-Fujisawa). This is licensed for use in adults and children aged 2 years and over with moderate to severe atopic dermatitis inadequately responsive to conventional therapy. Promotion states that, in these groups, tacrolimus is "at least as effective as topical steroids" and "without the potential side effects of conventional therapy". Here we consider the place of tacrolimus ointment in the management of atopic dermatitis.     

Tacrolimus ointment: a review of its use in atopic dermatitis and its clinical potential in other inflammatory skin conditions

Tacrolimus ointment (Protopic) is a topically applied macrolide lactone immunomodulator effective in the treatment of atopic dermatitis. Its mechanism of action primarily involves calcineurin inhibition, which interrupts cytokine gene expression and leads to the downregulation of T-cell activity. Tacrolimus ointment (0.03% and 0.1% for adults and 0.03% for children) is an effective treatment for atopic dermatitis of the trunk and limbs, as well as sensitive skin areas such as the face. Its efficacy is similar to or greater than that of hydrocortisone acetate 1%, hydrocortisone butyrate 0.1% and betamethsone valerate 0.12% ointments and pimecrolimus 1% cream. Systemic absorption of tacrolimus from the ointment is minimal, and adverse events, which are mostly associated with the application site and include skin burning and pruritus, tend to resolve early in treatment. Unlike topical corticosteroids, tacrolimus ointment is not associated with skin atrophy, and it is a well tolerated treatment for adults or children with atopic dermatitis, particularly when long-term treatment is indicated or the face or skin-fold regions are involved.     

A randomized, double-blind, vehicle-controlled, half-side comparison with a herbal ointment containing Mahonia aquifolium, Viola tricolor and Centella asiatica for the treatment of mild-to-moderate atopic dermatitis

OBJECTIVE: Only a few clinical trials have been published on the topical treatment of atopic dermatitis with herbal ointments. An ointment containing extracts from Mahonia aquifolium, Viola tricolor and Centella asiatica has previously been studied in open uncontrolled trials with children. However, no data exist on adult patients in a randomized controlled trial. METHODS: A total of 88 patients with mild-to-moderate atopic dermatitis were enrolled in a double-blind, vehicle-controlled, randomized, half-side comparison. Patients between 18 and 65 years of age were treated for 4 weeks with an ointment containing Mahonia aquifolium, Viola tricolor and Centella asiatica. The primary endpoint was a summary score for erythema, edema/papulation, oozing/crust, excoriation and lichenification according to a 4-point scale. Secondary efficacy variables were assessment of pruritus severity (10 cm VAS) and a global assessment of effectiveness as well as tolerability. RESULTS: The study ointment reduced the primary and secondary endpoints slightly more than the base cream which was used as vehicle; the differences were not statistically significant. Since the climatic conditions during the study duration varied from very mild and sunny to very cold and dry, a post-hoc subanalysis was performed with a subset of 64 patients whose treatment was at a mean outside temperature of 10 degrees C or less. Under these conditions the primary endpoint showed high statistical significance. CONCLUSION: In this trial, an ointment containing Mahonia aquifolium, Viola tricolor and Centella asiatica could not be proven to be superior to a base cream for patients with mild-to-moderate atopic dermatitis. However, a subanalysis indicated that the cream might be effective under conditions of cold and dry weather.     

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.     

Tacrolimus ointment: new preparation. Too many unknowns

(1) Drug therapy for exacerbations of atopic dermatitis (atopic eczema) should only be considered when simple measures and emollients are inadequate. The first-line option is a topical corticosteroid with a level of potency appropriate for the affected site and the patient's age. (2) Tacrolimus, an immunosuppressant used orally or parenterally to prevent graft rejection, is now marketed in France as an ointment, in two dose strengths, for the treatment of atopic dermatitis. It is approved for use when topical corticosteroids fail, in patients aged at least two years. (3) According to a comparative trial in adults, tacrolimus, when used as a first-line treatment, is no more effective than a class II (strong) topical corticosteroid. Several clinical trials show that it is better than the excipient in both adults and children. The 0.1% strength seems to be slightly more active than the 0.03% strength in adults. (4) It is not known whether tacrolimus is effective after topical corticosteroid failure. (5) In comparative trials the main systemic adverse events in patients using tacrolimus ointment were flu-like syndromes and headache. Local adverse events included burning or pruritus at the site of application in about 50% of patients. These local effects are due to both the excipient and tacrolimus. (6) Severe skin infections and skin cancer cannot be ruled out as serious side effects. (7) Tacrolimus uptake through the skin exposes patients to systemic adverse effects and drug interactions. (8) In practice, patients with atopic dermatitis, however severe, have no reason to use tacrolimus, at least pending studies showing it is effective after topical corticosteroid failure.