我国儿童特应性皮炎药物临床试验分析

目的：基于我国儿童特应性皮炎药物临床试验的登记情况及特应性皮炎治疗药品在我国的上市情况进行分析,为药品研究提供参考。方法：检索国家药品监督管理局“药物临床试验登记与信息公示平台”和“药品查询”数据库(检索时间均为2017年1月1日至2023年4月17日),获得儿童特应性皮炎临床试验注册信息及特应性皮炎治疗药品的上市信息,进行分类统计。结果：平台共登记了40项包含儿童受试者的湿疹/特应性皮炎药物临床试验,目前数据库有36家国内外生产企业的10个品种的特应性皮炎治疗药品在我国获准上市。结论：国内制药企业在儿童特应性皮炎药物研发上多集中于仿制药,目前已有2种治疗用生物制品1类药物,需要继续深耕,进一步开展药物临床试验,同时发挥我国中医药优势,发掘中药品种开展临床试验,为儿童用药添砖加瓦。     

芪血颗粒联合二维亚铁治疗小儿缺铁性贫血的临床研究

《儿童湿疹/特应性皮炎中药临床试验设计与评价技术指南》为中华中医药学会标准化项目《儿科系列常见病中药临床试验设计与评价技术指南》之一。其目的是以临床价值为导向,在病证结合模式下,讨论具有湿疹/特应性皮炎、儿童和中药特点的临床定位、试验设计与实施等相关问题,为中药治疗儿童湿疹/特应性皮炎临床试验设计与评价提供思路和方法。制定过程中先后成立指南工作组、起草专家组和定稿专家组,采用文献研究和共识会议的方法,最终形成指南送审稿定稿。该《指南》的主要内容包括临床定位、试验总体设计、诊断标准与辨证标准、受试者的选择与退出、干预措施、有效性评价、安全性观察、试验流程、试验的质量控制9部分。希望其制定和发布,能为申办者/合同研究组织、研究者在中药治疗湿疹/特应性皮炎的临床试验设计,提供借鉴与参考。     

MORA生物共振治疗仪治疗255例过敏性皮炎的效果观察

目的 观察MORA生物共振治疗仪对过敏性皮炎疾病进行脱敏治疗的临床疗效.方法 对255例过敏性皮炎患者（包括荨麻疹101例,湿疹70例,接触性皮炎61例,特应性皮炎23例）采用德国MORA生物共振治疗仪进行脱敏治疗,观察疗效及不良反应.结果 脱敏治疗的总有效率为80.8％,其中荨麻疹、湿疹、接触性皮炎、特应性皮炎4组比较差异无统计学意义（P＞0.05）.结论 MORA生物共振治疗技术,在临床上可广泛应用于过敏性皮炎的治疗,安全无不良反应,且复发率相对较低.     

特应性皮炎治疗药物临床试验设计的关键技术考虑

目的:探讨特应性皮炎治疗药物临床试验设计的技术考虑。方法:通过梳理近年来国内外特应性皮炎治疗药物临床研发情况,调研国内外特应性皮炎治疗药物技术指南进展,基于我国研发和审评的实践经验,形成相关技术考虑。结果与结论:特应性皮炎治疗药物临床试验设计应根据疾病特点、药物特性、研究目的制定整体临床研发计划。应在有前期研究证据支持并能确保受试者安全的前提下,尽早开展儿童患者临床试验。临床试验设计应选择适宜的研究人群,合理设置对照药、疗效和安全性指标、研究周期等一系列关键要素,以助力此类药物科学研发。研究人群定位应基于药物作用机制和药效作用强度选择对应严重程度的患者,疗效考察应全面评估患者皮损、症状、生活质量等改善情况,并关注用于儿童患者以及长期治疗时的疗效和安全性等。     

鼠皮炎湿疹模型建立的研究进展

皮炎湿疹是常见的变应性炎症性皮肤病,病因复杂,建立动物模型对于探讨疾病发病机制及防治具有重要意义。近年来报道的鼠皮炎湿疹模型大致可分为变态反应性接触性皮炎及慢性皮炎湿疹模型、光变态反应性皮炎模型与特应性皮炎模型三类。造模方法多样,各有特点,适用于不同的研究方向。     

食物干预儿童特应性皮炎50例临床观察

目的:观察食物干预对儿童特应性皮炎患者临床症状改善情况.方法:采用随机对照临床试验,共纳入儿童特应性皮炎患者100例,随机分成食物干预组和对照组,每组50例进行临床对照观察.结果:食物干预组的疗效明显高于对照组.结论:通过特异性IgG的检测,指导干预儿童特应性皮炎的食物结构,能有效地治疗儿童的特应性皮炎.     

常见皮肤病的诊断和治疗(Ⅰ)

1面部皮炎分为哪几种?各有何特点?临床上常见的面部皮炎包括脂溢性皮炎、接触性皮炎、湿疹皮炎、特应性皮炎、激素依赖性皮炎等。脂溢性皮炎是在皮脂溢出的基础上所引起的继发性炎症,由于皮脂分泌增多和化学成分改变导致菌群失调,马拉色菌、痤疮丙酸杆菌等大量繁殖,刺激皮肤引起炎症。临床表现为毛囊周围有红色小丘疹,     

儿童湿疹怎么用药

湿疹是对多种不同皮肤疾病的一个正确总称。特应性皮炎和接触性皮炎是儿童身上两种最常见的湿疹性皮炎。其最基本的特征是皮肤干燥、剧烈瘙痒和湿疹样皮疹。哪些情况不需要用药所有孩子都要重视非药物治疗,包括舒适的生活环境和衣着,减轻刺激,避免接触过敏原等。比较轻的湿疹,如只是有轻微红斑和一些鳞屑,则通过加强保湿润肤就可基本缓解,不需要药物治疗。     

咪唑斯汀与西替利嗪治疗湿疹和特应性皮炎的有效性及安全性

【摘要】：目的 探讨咪唑斯汀和西替利嗪对湿疹和特应性皮炎治疗的有效性和安全性。方法 将90名患者随机分为对照组、咪唑斯汀组和西替利嗪组,外用含量为1%的达克罗宁霜,在治疗三周后观察和对比三组的治疗效果和安全性,同时应用ELISA方法对特应性皮炎和湿疹患者的IL-4、IL-5、IFN-γ、TNF-α水平进行检测。结果 治疗前三组症状和各项体征之间没有任何差异。实施治疗后咪唑斯汀组的治疗效果优于西替利嗪组和对照组。在经咪唑斯汀和西替利嗪治疗后血清中IL-4、IL-5和IFN-γ的水平显著下降。结论 咪唑斯汀针对特应性皮炎和湿疹较为安全有效,其中咪唑斯汀对患者的IL-4、IL-5的影响大于西替利嗪组。     

儿童特应性皮炎的新药治疗进展

特应性皮炎是一种常见的慢性、复发性、炎症性皮肤病。目前的治疗方法仍有较多的局限性及不良反应，不能完全满足临床需求。近年来，随着对特应性皮炎复杂发病机制的深入研究，很多新药逐渐应用于治疗特应性皮炎，本文就这些药物在儿童特应性皮炎患者的应用及研究进展进行综述，以便临床医生更好地治疗和管理特应性皮炎患儿。     

Treatment of childhood eczema

Eczema in childhood is almost always atopic eczema, a common disease with huge impact on the quality of life of the child and family. Although atopic eczema constitutes part of the atopic syndrome, avoidance of allergens is never enough for disease control. Treatment of eczema in childhood has the same components as in adults. Emollients constitute the preventive background therapy in all stages of eczema, and topical corticosteroids are still the mainstay of treatment. Infectious exacerbation may require the use of a short course of topical or systemic antimicrobials. UV phototherapy should be considered as an adjunctive treatment to assist topical corticosteroids after an acute exacerbation of the disease. Cyclosporine can also be used in the treatment of childhood eczema in severe cases. Maternal allergen avoidance for disease prevention, oral antihistamines, Chinese herbs, dietary restriction in established atopic eczema, homeopathy, house-dust mite reduction, massage therapy, hypnotherapy, evening primrose oil, emollients, and topical coal tar are other temporarily used treatment modalities, without, however, firm evidence of efficacy from proper controlled trials. Calcineurin inhibitors constitute a new generation of drugs for both adult and childhood eczema already marketed in some countries. It is postulated that they will replace topical corticosteroids as first-line treatment of eczema.     

Colloidal oatmeal formulations as adjunct treatments in atopic dermatitis

Colloidal oatmeal has been used for decades to soothe and ameliorate atopic dermatitis and other pruritic and/or xerotic dermatoses. In-vitro and/or in-vivo studies have confirmed the anti-inflammatory, barrier repair, and moisturizing properties of this compound. A broad set of studies has been conducted in recent years to assess the effects of colloidal oatmeal as adjunct treatment in the management of atopic dermatitis (AD). This paper will review these studies. In these investigations, patients in all age groups (3 months to 60 years) with mild to moderate atopic dermatitis were included and allowed to continue their prescribed topical medications. These studies found that the daily use of moisturizers and/or cleansers containing colloidal oatmeal significantly improved many clinical outcomes of atopic dermatitis from baseline: investigator's assessment (IGA), eczema area and severity index (EASI), itch, dryness, and quality of life indices. Safety results showed that the formulations were well tolerated in babies, children, and adults with AD.     

Clobetasol propionate emollient formulation foam in the treatment of corticosteroid-responsive dermatoses

Background: Topical corticosteroids are the most common treatment modality for patients with psoriasis and atopic dermatitis; however, the efficacy of topical corticosteroids is often hampered by barriers to patient adherence, such as lack of efficacy, side effects and inconvenience. Recently published studies have investigated the safety and efficacy of a novel emollient foam (EF) formulation of clobetasol propionate (CP), a class I topical corticosteroid in psoriasis and atopic dermatitis. Objectives: To summarize recent literature on CP EF foam, and to evaluate recent Phase II and III clinical trials of CP EF foam in psoriasis and atopic dermatitis. Methods: The MEDLINE (1950 – January 2008) database was searched using the following terms: ‘clobetasol propionate foam’, ‘topical corticosteroids’, ‘topical glucocorticoids’, ‘psoriasis’ and ‘atopic dermatitis’. Results were evaluated for relevance and quality, and additional references were obtained from bibliographies of selected articles. Conclusion: CP EF foam appears to be safe and effective for corticosteroid-responsive dermatoses in adults and children ≥ 12 years of age. As compared to its hydroethanolic foam predecessor, CP EF presents a potential advance for patients who are less likely to tolerate alcohol-based foam. As alcohol-based foams can be irritating and cause stinging in non-hair-bearing areas, this new emollient formulation has the potential to widen the use of CP foam to more patients with atopic dermatitis and to more non-scalp body sites in patients with psoriasis.     

Recent advances in treatment strategies for atopic dermatitis

A wide range of different therapeutic regimens are used for atopic dermatitis. Although many treatment modalities are well established worldwide among clinicians, only the minority of these therapy recommendations are based on results of randomised controlled trials (RCTs). To close the gap between such 'generally' recommended therapies and therapies that are based on data from controlled trials, this review focuses not only on the pharmacological and clinical aspects of the currently proven agents, but also on the advantages and disadvantages of therapies that have not yet been completely tested.A review of the available literature concerning the pharmacological profile and also the level of evidence of therapeutic efficacy of all currently known topical and systemic agents for the treatment of atopic dermatitis reveals a large gap between the knowledge concerning the pharmacological action in vitro and the evidence of clinical efficacy in many cases.We agree with the conclusion of previous reviews that numerous therapies for atopic dermatitis urgently require more independent RCTs and especially comparative trials (e.g. corticosteroids vs calcineurin inhibitors). These are required in order to facilitate the choice of therapeutic strategy for the individual treatment of atopic dermatitis, with its broad spectrum of clinical manifestations and potential complications in adult patients and, particularly, in children.Finally, we also review preclinical trials with several new drugs. Immunomodulators appear to promise a new dimension for the future of therapy for atopic dermatitis, especially for severe and otherwise refractory forms or as alternatives to corticosteroids, that is, to treat facial atopic eczema without the risk of adverse effects.     

中医药治疗异位性皮炎临床试验的系统评价

中医药治疗异位性皮炎的临床试验数量上升,但研究研究质量良莠不齐,给使用者带来了很多困惑。系统评价方法是一种全新的文献综合评价临床研究方法,将其应用于中医治法学研究是一次有益的尝试。本文通过对近几十年来有关中医药治疗异位性皮炎的文献的系统分析,旨在全面了解中医药治疗异位性皮炎的文献现状,对中医药治疗异位性皮炎的有效性和安全性进行系统评价。     

Halometasone monohydrate (0.05%) in occupational contact dermatitis

Objective:

The impact of occupational contact dermatitis (OCD) is often underestimated because of underreporting, and its management is also inadequate, especially in developing countries. Topical corticosteroids have remained the first line treatment but till date, there is no study on efficacy and safety of halometasone in OCD, and there is a paucity of data on its comparative efficacy in allergic and irritant variety. This study aims to evaluate the efficacy and safety of halometasone in OCD and to compare its effect in allergic and irritant types of OCD.

Methods:

The present study is a prospective, interventional, single arm clinical study conducted on 150 patients of OCD. Detailed history and clinical examination was done at baseline, and all enrolled patients underwent patch test with the Indian Standard Battery of allergens. Eczema severity was assessed by the Investigator''s Global Assessment (IGA) scale, SCORing Atopic Dermatitis (SCORAD) index, and patient-oriented eczema measure (POEM). Change in quality of life was assessed by using the Dermatology Life Quality Index (DLQI). After baseline assessments, they were prescribed halometasone 0.05% ointment and were followed up after 4 weeks, and efficacy variables were evaluated.

Results:

At follow-up, 19 patients were lost, and data of 131 patients were analyzed. After 4 weeks of halometasone therapy, there was statistically significant (P < 0.001) improvement in SCORAD index, IGA, POEM, and DLQI. Considering improvement in IGA as treatment success criteria, treatment was found to be successful in 87.8%. Subgroup analysis revealed no significant difference in effect of halometasone in allergic and irritant OCD.

Conclusions:

Halometasone is efficacious with a good safety profile in patients with OCD, and there is no significant difference in efficacy of the drug in allergic and irritant OCD.KEY WORDS: Dermatology Life Quality Index, halometasone, Investigator''s Global, Assessment scale, occupational contact dermatitis, patient-oriented eczema measure, SCORing atopic dermatitis     

柏倍湿疹散治疗婴儿湿疹疗效观察

目的:观察柏倍湿疹散对婴儿湿疹的治疗效果.方法:选择湿疹患儿100例,随机分为观察组50例和对照组50例,对照组进行常规西医治疗,观察组外用中药柏倍湿疹散治疗,10 d为1个疗程,比较2组疗效.结果:观察组及对照组总有效率分别为94%和 92%,差异无统计意义(P＞0.05);观察组痊愈36例(占72%),对照组痊愈32例(占64%),2组比较差异有统计意义(P＜0.05),表明柏倍湿疹散对婴儿湿疹有良好的治疗效果.结论:柏倍湿疹散是一种疗效显著、安全可靠、经济实用的中药外用治疗婴儿湿疹的散剂,值得临床推广应用.     

Pharmacokinetics of tacrolimus following topical application of tacrolimus ointment in adult and pediatric patients with moderate to severe atopic dermatitis

OBJECTIVE: To characterize the pharmacokinetics of tacrolimus after topical application in adult and pediatric patients with moderate to severe atopic dermatitis from all clinical trials in which tacrolimus blood levels were obtained. METHODS: Tacrolimus ointment 0.03% or 0.1% was applied twice daily. In the adult and pediatric pharmacokinetic studies, serial blood samples were obtained after single and repeated topical application. During the 12 clinical efficacy trials of tacrolimus ointment, single blood samples were obtained at various times relative to tacrolimus ointment application. RESULTS: In the pharmacokinetic studies, 89% to 95% of tacrolimus whole blood concentration samples were less than 1 ng/mL; mean maximum concentrations ranged from 0.2 to 1.6 ng/mL and mean area under the blood concentration-time curves (0-12 hours) ranged from 1.4 to 13.1 ng x hr/mL. Likewise, in the clinical efficacy trials, the majority (85%-99%) of tacrolimus concentration samples were less than 1 ng/mL. CONCLUSIONS: Tacrolimus ointment is associated with minimal systemic absorption and no evidence of systemic accumulation in patients with moderate to severe atopic dermatitis and extensive disease.     

A multicenter, randomized, vehicle-controlled clinical study to examine the efficacy and safety of MAS063DP (Atopiclair) in the management of mild to moderate atopic dermatitis in adults

BACKGROUND: MAS063DP cream has received marketing authorization in the US and the European Union for symptom relief of atopic dermatitis (eczema) and contact dermatitis. DESIGN: A multicenter, randomized, vehicle-controlled, phase IV study was completed in the US. METHODS: 218 patients aged 18 to 84 years joined this 50-day study. Patients self-administered MAS063DP cream (N=145) or vehicle cream (N=73) 3 times per day to affected areas and those areas prone to be affected. The primary endpoint for efficacy was the change in EASI at Day 22 of treatment, comparing the 2 treatment groups. Secondary outcomes included EASI scores at other time points, IGA, pruritus (100mm VAS), % BSA, and the need for rescue medication. RESULTS: MAS063DP was statistically (p<.0001) more effective than vehicle in all outcomes at all time points. The incidence of rash was 2.1% in the MAS063DP group versus 5.5% in the vehicle group. Only 2 patients discontinued MAS063DP due to an adverse event. CONCLUSION: MAS063DP cream was confirmed to be a safe and effective treatment for mild to moderate atopic dermatitis in adults.     

Highly selective phosphodiesterase 4 inhibitors for the treatment of allergic skin diseases and psoriasis

The phosphodiesterase (PDE) 4 is the predominant cyclic AMP degrading enzyme in a variety of inflammatory cells including eosinophils, neutrophils, macrophages, T cells and monocytes. In addition, this enzyme is expressed in non-immune cells such as keratinocytes and fibroblasts. Highly selective PDE4 inhibitors are currently under evaluation for the treatment of asthma and/or chronic obstructive pulmonary disease. Due to the broad anti-inflammatory/immuno-modulatory action of PDE4 inhibitors, it has been proposed that PDE4 inhibitors might also be efficacious for skin disorders such as atopic dermatitis. Consequently, PDE4 inhibitors including cilomilast and AWD 12-281 have been tested in several models of allergic and irritant skin inflammation. These PDE4 inhibitors displayed strong anti-inflammatory action in models of allergic contact dermatitis in mice, in the arachidonic acid induced skin inflammation in mice and in ovalbumin sensitised guinea pigs. The determination of cytokines in skin homogenates revealed that both Th1 as well as Th2 cytokines are suppressed by PDE4 inhibitors, indicating an anti-inflammatory activity in both the Th2 dominated acute phase as well as the Th1 dominated chronic phase of atopic dermatitis. Due to the suppression of Th1 cytokines, activity can also be expected in psoriasis. Results of early clinical trials with both topically (cipamfylline, CP80,633) and systemically (CC-10004) active PDE4 inhibitors demonstrated efficacy in atopic dermatitis and in the case of CC-10004, also in psoriasis. AWD 12-281 (GW 842470) is currently under clinical evaluation for the topical treatment of atopic dermatitis. Results concerning clinical efficacy of this potent and selective PDE4 inhibitor are anxiously awaited.