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Hypoallergenic animals: A promise of hope for allergic patients? 低过敏性动物:过敏症患者的希望?
Pub Date : 2024-03-21 eCollection Date: 2024-01-01 DOI: 10.5414/ALX02454E
Christiane Hilger, Bente Janssen-Weets, Kyra Swiontek

Furry pets are beloved companion animals; horse riding is a popular leisure activity. So-called hypoallergenic animals have gained high interest as sensitization to animal dander and allergy to furry animals are widespread. Allergen immunotherapy to furry animals is still limited, and allergen avoidance in addition to symptomatic pharmaceutical treatment is often the only available option. Patients with an existing allergy to furry animals or with an atopic background are seeking for a hypoallergenic alternative. This review summarizes current knowledge and discusses future strategies.

毛茸茸的宠物是人见人爱的伴侣动物;骑马是一项很受欢迎的休闲活动。由于对动物皮屑过敏和对毛茸茸的动物过敏的现象十分普遍,所谓的低过敏性动物已经引起了人们的高度关注。针对毛茸茸动物的过敏原免疫疗法仍然有限,除了对症药物治疗外,避免接触过敏原通常是唯一的选择。已经对毛茸茸的动物过敏或有特应性背景的患者正在寻求一种低过敏原替代疗法。本综述总结了当前的知识,并讨论了未来的策略。
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引用次数: 0
Role of FEF25-75 in characterizing outpatients with asthma in clinical practice. FEF25-75 在临床实践中描述门诊哮喘患者特征的作用。
Pub Date : 2024-01-12 eCollection Date: 2024-01-01 DOI: 10.5414/ALX02453E
Giorgio Ciprandi, Irene Schiavetti

Background: Asthma is characterized by variable airflow limitation. FEF25-75 has been proposed as a reliable marker for bronchial obstruction, especially when FEV1 and FEV1/FVC are normal.

Objectives: To investigate the role of FEF25-75 in patients with asthma seen in clinical settings.

Materials and methods: The cross-sectional study included 439 (181 females and 255 males; mean age 39 years) outpatients with asthma who consecutively visited an allergy clinic for a routine assessment. History, physical examination, asthma control, and spirometry were evaluated.

Results: FEF25-75 was impaired (< 65% of predicted) in 136 (31%) outpatients. Considering only subjects with normal FEV1 and FEV1/FVC, FEF25-75 was impaired in 71 (19.6%) subjects. In this subset, impaired FEF25-75 was associated with low FEV1 and FEV1/FVC values (OR 0.91 and 0.85, respectively), and presence of asthma symptoms (OR 2.19).

Conclusion: FEF25-75 deserves adequate and careful consideration in patients with asthma and normal FEV1 and FEV1/FVC, as the presence of impaired FEF25-75 in this subset suggests a more specific approach.

背景:哮喘的特点是不同程度的气流受限。FEF25-75被认为是支气管阻塞的可靠标志物,尤其是当FEV1和FEV1/FVC正常时:调查 FEF25-75 在临床哮喘患者中的作用:横断面研究纳入了 439 名(女性 181 名,男性 255 名;平均年龄 39 岁)连续到过敏诊所接受常规评估的哮喘门诊患者。对病史、体格检查、哮喘控制情况和肺活量进行了评估:结果:136 名门诊患者(31%)的 FEF25-75 值受损(低于预测值的 65%)。仅考虑 FEV1 和 FEV1/FVC 正常的受试者,71 名(19.6%)受试者的 FEF25-75 受损。在这一群体中,FEF25-75受损与FEV1和FEV1/FVC值偏低(OR分别为0.91和0.85)以及出现哮喘症状(OR为2.19)有关:结论:对于 FEV1 和 FEV1/FVC 值正常的哮喘患者,FEF25-75 值值得充分、仔细地考虑,因为在这部分患者中存在 FEF25-75 值受损的情况,建议采用更具针对性的方法。
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引用次数: 0
Allergen immunotherapy for allergic asthma. 过敏性哮喘的过敏原免疫疗法。
Pub Date : 2024-01-12 eCollection Date: 2024-01-01 DOI: 10.5414/ALX02451E
J Christian Virchow, Oliver Pfaar, Marek Lommatzsch

Remission is the goal of modern asthma treatment. Allergen immunotherapy (AIT) is an essential component in the armamentarium of personalized asthma therapy. Subcutaneous AIT (SCIT) or sublingual AIT (SLIT) offer the possibility to prevent asthma in patients with allergic rhinitis (reduction of the risk of developing asthma) and the possibility to achieve remission in patients with allergic asthma. Accordingly, AIT should always be considered in patients with asthma and a documented, clinically relevant allergy. However, precise phenotyping of the patient is an essential prerequisite for a success of AIT in asthma.

缓解是现代哮喘治疗的目标。过敏原免疫疗法(AIT)是个性化哮喘疗法的重要组成部分。皮下注射过敏原免疫疗法(SCIT)或舌下注射过敏原免疫疗法(SLIT)可预防过敏性鼻炎患者的哮喘(降低哮喘发病风险),并可缓解过敏性哮喘患者的病情。因此,对于患有哮喘并有临床相关过敏记录的患者,应始终考虑使用 AIT。然而,对患者进行精确的表型分析是 AIT 成功治疗哮喘的必要前提。
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引用次数: 0
Asthma therapy concepts through the ages. 历代哮喘治疗理念
Pub Date : 2024-01-12 eCollection Date: 2024-01-01 DOI: 10.5414/ALX02445E
Marek Lommatzsch

The development and approval of DMAADs ("disease-modifying anti-asthmatic drugs"), in particular inhaled steroids (alone or in combination with long-acting bronchodilators), biologics and modern allergen immunotherapies, has fundamentally changed the asthma therapy concept from symptom control to symptom prevention. This concept is linked to the new asthma treatment goal of asthma remission: long-term absence of symptoms (good asthma control), absence of exacerbations, and stable lung function, without the use of systemic steroids for asthma therapy. Three types of asthma remission are distinguished: spontaneous remission (e.g., childhood asthma), remission "off treatment" (e.g., after successful allergen immunotherapy), and remission "on treatment" (e.g., during inhaled therapy or biologic therapy). A treat-to-target approach is used, as in rheumatoid arthritis or chronic inflammatory bowel disease: The goal is to achieve asthma remission, through individually tailored treatment with highly effective drugs with minimal side effects. However, this requires precise phenotyping of the patient, including detailed history taking, pulmonary function diagnostics, allergological diagnostics, and measurement of type 2 biomarkers.

DMAADs("改变病情的抗哮喘药物"),特别是吸入类固醇(单独使用或与长效支气管扩张剂联合使用)、生物制剂和现代过敏原免疫疗法的开发和批准,从根本上改变了哮喘治疗的概念,从症状控制转变为症状预防。这一概念与新的哮喘治疗目标 "哮喘缓解 "相关:即长期无症状(良好的哮喘控制)、无恶化和肺功能稳定,且无需使用全身性类固醇治疗哮喘。哮喘缓解分为三种类型:自发缓解(如儿童哮喘)、"非治疗 "缓解(如过敏原免疫治疗成功后)和 "治疗 "缓解(如吸入治疗或生物治疗期间)。与类风湿性关节炎或慢性炎症性肠病一样,采用的是 "靶向治疗 "方法:目标是通过使用副作用最小的高效药物进行个体化治疗,实现哮喘缓解。然而,这需要对患者进行精确的表型分析,包括详细的病史采集、肺功能诊断、过敏诊断和 2 型生物标志物的测量。
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引用次数: 0
AIT in pediatric allergology: Opportunities and difficulties on the home stretch of the Therapy Allergen Ordinance. 儿科过敏学中的 AIT:治疗过敏原条例》的机遇与困难并存。
Pub Date : 2023-12-12 eCollection Date: 2023-01-01 DOI: 10.5414/ALX02443E
Christian Vogelberg, Michael Gerstlauer

Allergen immunotherapy (AIT) is the only causal therapy for allergic diseases and therefore particularly important. Allergen preparations have been classified as medicinal products since 1989 (Directive 89/342/EEC) and were taken over into Directive 2001/83/EC in 2001. In addition, in 2008 the Therapy Allergen Ordinance (TAO) came into force to stricter regulate the exception for named patient products (NPP) by exclusion of common therapy allergens from the exception to be marketed as NPP. The TAO regulates the requirements for testing safety and efficacy for these common therapy allergens. Due to the long transitional provisions, the last deadlines for solving clinical shortcomings will end in 2026. The advantage of this regulation is that the market for common allergens has been cleared of products without proof of efficacy, and new preparations with an optimal dose range are developed through dose-finding studies. The demand for long-term pediatric studies has been outlined by the standard Pediatric Investigation Plan (PIP) on allergen products from the Pediatric Committee of the EMA (PDCO). This is particularly problematic, as it is foreseeable that recruitment of patients will be limited and ethical problems arise from the prolonged use of placebo. Furthermore, many newly approved preparations will not be used in pediatrics for the foreseeable future, as no marketing authorization has yet been granted for this age group. This will result in a serious supply gap for children.

过敏原免疫疗法(AIT)是治疗过敏性疾病的唯一因果疗法,因此尤为重要。过敏原制剂自 1989 年(第 89/342/EEC 号指令)起被归类为医药产品,并于 2001 年被纳入第 2001/83/EC 号指令。此外,《治疗过敏原条例》(TAO)于 2008 年生效,通过将常见治疗过敏原排除在作为 NPP 上市的例外情况之外,更严格地规范了指定患者产品(NPP)的例外情况。该条例规定了这些常见治疗过敏原的安全性和有效性测试要求。由于过渡条款较长,解决临床缺陷的最后期限将于 2026 年结束。该法规的优势在于,常见过敏原市场上没有疗效证明的产品已被清除,而具有最佳剂量范围的新制剂则是通过剂量探索研究开发出来的。欧洲药品管理局儿科委员会(PDCO)关于过敏原产品的标准儿科调查计划(PIP)概述了对长期儿科研究的需求。这一点尤其成问题,因为可以预见的是,招募的患者人数有限,而且长期使用安慰剂会产生伦理问题。此外,许多新批准的制剂在可预见的将来都不会用于儿科,因为尚未获得针对这一年龄组的上市许可。这将导致严重的儿童用药供应缺口。
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引用次数: 0
Allergen-specific immunotherapy and evidence: A European regulatory perspective. 过敏原特异性免疫疗法与证据:欧洲监管视角。
Pub Date : 2023-12-12 eCollection Date: 2023-01-01 DOI: 10.5414/ALX02413E
Detlef Bartel, Andreas Bonertz, Diana Hartenstein, Stefan Kaul, Iris Lauer, Christina Reeb, Karen Rösner-Friese, Katja Sliva, Julia Zimmer, Stefan Vieths, Vera Mahler

Allergen immunotherapy (AIT) has been performed for 112 years. In this article we summarize regulatory standards and challenges based on scientific evidence on AIT. Most crucial and timely aspects concerning AIT are addressed from the regulatory perspective of the authors as employees of a national competent authority in Europe: (1) product specificity; (2) clinical efficacy; (3) treatment for adults and children (needs for extrapolation); (4) allergen exposure chambers; (5) biomarkers; (6) standardization; (7) real-world evidence; (8) independent official batch release (benefit and challenges); (9) harmonization on the EU level. The Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, in Langen near Frankfurt/Main in Germany, examines and evaluates the benefits and risks of AIT products within the course of clinical development, marketing authorization, and subsequently throughout their entire life cycle to ensure high-quality, safe, and effective AIT products.

过敏原免疫疗法(AIT)已有 112 年的历史。本文总结了基于 AIT 科学证据的监管标准和挑战。作者作为欧洲国家主管当局的雇员,从监管角度探讨了有关 AIT 的最关键和最及时的方面:(1) 产品特异性;(2) 临床疗效;(3) 成人和儿童治疗(外推需求);(4) 过敏原暴露室;(5) 生物标志物;(6) 标准化;(7) 真实世界证据;(8) 独立官方批量发布(益处和挑战);(9) 欧盟层面的协调。保罗-埃利希研究所(PEI)是位于德国法兰克福/美因河畔兰根的联邦疫苗和生物医药研究所,负责审查和评估 AIT 产品在临床开发、上市许可过程中以及随后整个生命周期中的益处和风险,以确保 AIT 产品的高质量、安全性和有效性。
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引用次数: 0
AIT 2023: Current innovation and future outlook. AIT 2023:当前创新与未来展望。
Pub Date : 2023-12-12 eCollection Date: 2023-01-01 DOI: 10.5414/ALX02379E
Magdalena Zemelka-Wiacek, Marek Jutel

Although used for over 100 years, allergen immunotherapy (AIT) is still an indispensable tool in modern allergy managemen20t due to its potential to cure allergic diseases. Its current rapid development through the application of personalized and precision medicine approaches is strongly supported by advances in mHealth, component-resolved diagnosis (CRD)-based diagnostics, validation of novel biomarkers, advanced data management, and development of novel preparations. This review summarizes the key advances in the field and shows the perspectives for further development of next-generation AIT treatments.

过敏原免疫疗法(AIT)虽然已经使用了 100 多年,但由于其治疗过敏性疾病的潜力,它仍然是现代过敏症管理中不可或缺的工具20。目前,通过应用个性化和精准医疗方法,过敏原免疫疗法得到了快速发展,这得益于移动医疗、基于成分解析诊断(CRD)的诊断方法、新型生物标记物的验证、先进的数据管理以及新型制剂的开发等方面的进步。本综述总结了该领域的主要进展,并展示了下一代 AIT 治疗方法的进一步发展前景。
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引用次数: 0
Allergen immunotherapy of insect venom allergy: Almost 100 years old, but steadily updated. 昆虫毒液过敏的过敏原免疫疗法:近百年历史,不断更新。
Pub Date : 2023-12-12 eCollection Date: 2023-01-01 DOI: 10.5414/ALX02420E
Wolfgang Pfützner

llergen immunotherapy (AIT) with Hymenoptera venom (HV) shows high efficiency treating insect venom allergy, covering an almost 100-year-long history. Untreated patients with HV allergy can develop serious, potentially lethal sting reactions. Before starting AIT with HV, indication and contraindications, the presence of comorbidities and the intake of concomitant medications as well as individual risk factors have to be carefully evaluated. Application of HV-AIT entails an individually adapted procedure in case of undesired adverse events or initial failure to induce tolerance, as the final goal has to be the development of immunologic protection against anaphylactic sting reactions.

使用膜翅目昆虫毒液(HV)的过敏原免疫疗法(AIT)可高效治疗昆虫毒液过敏症,已有近 100 年的历史。未经治疗的 HV 过敏患者可能会出现严重的、可能致命的螫伤反应。在开始使用 HV-AIT 之前,必须仔细评估适应症和禁忌症、是否存在合并症、是否同时服用药物以及个人风险因素。应用 HV-AIT 需要在出现意外不良事件或最初未能诱导耐受的情况下,根据个人情况调整程序,因为最终目标必须是针对过敏性蛰伤反应建立免疫保护。
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引用次数: 0
DGAKI and PEI in dialogue 2023: Diagnostics and allergen immunotherapy. DGAKI 与 PEI 对话 2023:诊断和过敏原免疫疗法。
Pub Date : 2023-12-12 eCollection Date: 2023-01-01 DOI: 10.5414/ALX02450E
Oliver Pfaar, Eckard Hamelmann, Christian Taube, Martin Wagenmann, Bettina Wedi, Thomas Werfel, Detlef Bartel, Andreas Bonertz, Diana Hartenstein, Susanne Kaul, Vera Mahler, Margitta Worm

A roundtable discussion on February 10, 2023 between the German Society for Allergology and Clinical Immunology (DGAKI) and the Paul-Ehrlich-Institut (PEI) aimed to discuss in detail current aspects of allergen immunotherapy (AIT), its regulatory framework under the transitional provision of the Therapy Allergen Ordinance (TAO), and the consequences for the planned guideline work of the DGAKI, regulatory challenges in the approval of AIT products for children and adolescents as well as allergy diagnostics. The content and discussion points of this dialogue are summarized and are set in context with the current literature.

德国过敏学和临床免疫学协会(DGAKI)与保罗-埃利希研究所(PEI)于 2023 年 2 月 10 日举行了一次圆桌讨论会,旨在详细讨论过敏原免疫疗法(AIT)的当前问题、《过敏原治疗条例》(TAO)过渡条款下的监管框架、对 DGAKI 计划中的指南工作的影响、儿童和青少年过敏原免疫疗法产品审批中的监管挑战以及过敏诊断。本文总结了此次对话的内容和讨论要点,并结合当前文献进行了阐述。
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引用次数: 0
Management of allergic rhinitis improves clinical outcomes of difficult-to-treat tic disorders or attention-deficit/hyperactivity disorders. 过敏性鼻炎的治疗可改善难以治疗的抽动障碍或注意力缺陷/多动障碍的临床结果。
Pub Date : 2023-10-23 eCollection Date: 2023-01-01 DOI: 10.5414/ALX400588E
Rui-Li Yu, Jing Wang, Xue-Song Wang, Hong-Tian Wang, Xue-Yan Wang

Aims: This case series aimed to evaluate the effects of treatment for allergic rhinitis (AR) in AR-diagnosed children with previous diagnosis of tic disorders/attention-deficit/hyperactivity disorders (TD/ADHD) but unresponsive to behavioral or medical treatment.

Materials and methods: Between July 2016 and June 2021, children diagnosed with AR in our hospital were enrolled. All were diagnosed with TD/ADHD refractory to behavioral or medical treatment. The demography and clinical information were collected from medical records. The outcomes were visual analogue scale (VAS) for AR severity, Yale Comprehensive Tic Severity Scale (YGTSS) for TD symptoms, and Attention-Deficit Hyperactivity Screening Scale (SNAP-IV) for ADHD symptoms.

Results: A total of 27 children (18 boys, 9 girls) were included, with a mean age 7.4 ± 2.9 years (3 - 17 years). They had undergone behavioral or medical treatment of TD/ADHD for 3.6 ± 1.9 years but without significant improvement in TD/ADHD symptoms. After 2-6 months of systematic treatment for AR, VAS was decreased to 0.4 ± 0.1 from 0.8 ± 0.2, YGTSS to 3.5 ± 0.7 from 6.8 ± 1.4, and SNAP-IV to 0.4 ± 0.1 from 0.6 ± 0.2 (all p < 0.001). No recurrence of TD/ADHD symptoms was reported during a mean follow-up of 2.4 ± 1.1 years (0.5 - 5 years).

Conclusion: AR treatment improves TD/ADHD outcomes in children with difficult-to-treat TD/ADHD. In TD/ADHD children who are unresponsive to behavioral or drug treatment and have AR-related symptoms, AR examination and treatment are recommended for better prognosis.

目的:本系列病例旨在评估变应性鼻炎(AR)治疗对AR诊断儿童的效果,这些儿童先前诊断为抽动障碍/注意力缺陷/多动障碍(TD/DADHD),但对行为或药物治疗没有反应。材料和方法:2016年7月至2021年6月,我们医院诊断为AR的儿童被纳入研究。所有患者均被诊断为行为或药物治疗难治的TD/DADHD。人口统计学和临床信息是从医疗记录中收集的。结果是AR严重程度的视觉模拟量表(VAS)、TD症状的Yale综合Tic严重程度量表(YGTSS)和ADHD症状的注意力缺陷多动障碍筛查量表(SNAP-IV)。结果:共纳入27名儿童(18名男孩,9名女孩),平均年龄7.4±2.9岁(3-17岁)。他们接受了3.6±1.9年的TD/DADHD行为或医学治疗,但TD/DADHd症状没有显著改善。AR系统治疗2-6个月后VAS从0.8±0.2降至0.4±0.1,YGTSS从6.8±1.4降至3.5±0.7,SNAP-IV从0.6±0.2降至0.4±0.1(均p结论:AR治疗改善了难以治疗的TD/DADHD儿童的TD/DVD结果。对于对行为或药物治疗无反应且有AR相关症状的TD/DVDD儿童,建议进行AR检查和治疗以获得更好的预后。
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引用次数: 0
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Allergologie select
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