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Allergen characteristics, quality, major allergen content and galenics for mite allergen-specific immunotherapy preparations 螨过敏原特异性免疫治疗制剂的过敏原特性、质量、主要过敏原含量和galenics
Q3 Medicine Pub Date : 2022-11-24 DOI: 10.1007/s40629-022-00233-6
Randolf Brehler, Ludger Klimek

Summary

House dust mite extracts for allergen-specific immunotherapy (AIT) require in Germany as other common allergens (pollen from sweet grasses [except maize], birch, alder, hazel; bee and wasp venom) marketing authorisation according to the German Therapy Allergen Ordinance (“Therapieallergene-Verordnung”, [TAV]). Mite allergen extracts that have been approved and also those which are in the approval process are subject to government batch testing. Batch test passing is a prerequisite for marketability. Appropriate quality, efficacy, and safety are prerequisites for the approval of house dust mite extracts. Five HDM allergen extracts from four manufacturers are currently approved in Germany for subcutaneous or sublingual therapy; further extracts are in the approval process. The allergen strength of different products is not comparable; manufacturers use company-specific units to describe the strength. Of the three known major allergens (Group 1 allergens: Der p 1, Der f 1, Group 2 allergens: Der p 2, Der f 2 and Group 23: Der p 23, Der f 23) only Group 1 and Group 2 allergens are usually used to standardize the extracts. Group 23 allergens are localized in the outer membrane of mite faeces, and elution requires special extraction methods. To be efficacious in a single patient an allergen extracts used for AIT must contain all allergen components against which the patient is sensitised. Based on post hoc analyses of large clinical studies, it has been proven for house dust mite tablets that Der p 23 is also contained. In Germany, the Paul Ehrlich Institute is responsible for the approval of therapeutic allergens. For the marketing authorisation information on production procedures, and quality are necessary efficacy and safety (positive benefit risk ratio) of the product must be demonstrated in clinical trials according to the current state of the art.

根据德国治疗过敏原条例(“Therapie变应原Verordnung”,[TAV]),用于过敏原特异性免疫疗法(AIT)的SummaryHouse尘螨提取物需要在德国作为其他常见过敏原(甜草花粉[玉米除外]、桦树、赤杨、榛子;蜜蜂和黄蜂毒液)的上市许可。已经批准的螨过敏原提取物以及正在批准过程中的提取物都要接受政府的批量测试。批量测试通过是市场化的先决条件。适当的质量、功效和安全性是批准室内尘螨提取物的先决条件。来自四家制造商的五种HDM过敏原提取物目前在德国被批准用于皮下或舌下治疗;进一步的摘录正在审批过程中。不同产品的过敏原强度不具有可比性;制造商使用公司特定的单位来描述强度。在三种已知的主要过敏原(第1组过敏原:Der p1、Der f1、第2组过敏源:Der p2、Der f2和第23组:Der p23、Der f23)中,通常只有第1组和第2组的过敏原用于标准化提取物。第23组过敏原定位于螨粪的外膜,洗脱需要特殊的提取方法。为了对单个患者有效,用于AIT的过敏原提取物必须包含患者敏感的所有过敏原成分。根据对大型临床研究的事后分析,已证明屋尘螨片中也含有Der p 23。在德国,Paul Ehrlich研究所负责批准治疗性过敏原。对于上市许可信息,生产程序和质量是必要的,必须根据当前技术状态在临床试验中证明产品的有效性和安全性(正收益风险比)。
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引用次数: 0
Biology of house dust mites and storage mites 室内尘螨和仓库尘螨的生物学
Q3 Medicine Pub Date : 2022-11-15 DOI: 10.1007/s40629-022-00231-8
Karl-Christian Bergmann

Summary

House dust mites and storage mites have a high allergenic potential and lead to sensitization through the formation of specific IgE antibodies. Due to their preferred residence in houses, they belong to the group of house mites, which are referred to as “domestic mites” in English. Their anatomy and biology account for their amazing adaptability to changing environmental situations (including temperature, humidity, food) and make it understandable that measures to reduce their abundance are usually difficult to implement in practice.

夏季室内尘螨和储藏螨具有高致敏潜力,并通过形成特异性IgE抗体导致致敏。由于它们喜欢住在房子里,所以属于屋螨类,在英语中被称为“家螨”。它们的解剖学和生物学解释了它们对不断变化的环境状况(包括温度、湿度、食物)的惊人适应性,并使减少其丰度的措施在实践中通常很难实施,这是可以理解的。
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引用次数: 4
Frequency of sensitizations and allergies to house dust mites 对室内尘螨过敏和过敏的频率
Q3 Medicine Pub Date : 2022-11-07 DOI: 10.1007/s40629-022-00229-2
Karl-Christian Bergmann

Summary

Domestic mites is the term used to describe dust mites and storage mites that prefer to live in houses and to which many people develop sensitization through the formation of specific IgE antibodies due to the high allergenic potency of mite allergens. As a result, mites can trigger allergic diseases of the upper and lower respiratory tract as well as cross-reactions to other allergens. Sensitization to house mites is widespread in the German population. About 11 million adults are sensitized in Germany (15.9%). Men are more frequently affected than women, and sensitizations occur more frequently in large cities and with higher socioeconomic status. Sensitizations are less frequent in old age. They can lead to diagnostic problems as clinically silent sensitizations, which is the case in about 40% of sensitizations.

摘要家螨是一个用来描述喜欢住在房子里的尘螨和储藏螨的术语,由于螨类过敏原的高致敏效力,许多人通过形成特异性IgE抗体而对其产生致敏作用。因此,螨虫会引发上呼吸道和下呼吸道的过敏性疾病,以及对其他过敏原的交叉反应。对屋螨的致敏作用在德国人群中广泛存在。德国约有1100万成年人(15.9%)被致敏。男性比女性更容易受到影响,而在社会经济地位较高的大城市,致敏发生的频率更高。老年人的敏感程度较低。它们可能会导致诊断问题,即临床上无症状的致敏,大约40%的致敏都是这种情况。
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引用次数: 3
The long road from the first symptoms of mite allergy to mite-specific immunotherapy 从最初的螨过敏症状到螨特异性免疫疗法的漫长道路
Q3 Medicine Pub Date : 2022-10-19 DOI: 10.1007/s40629-022-00230-9
Norbert Mülleneisen MD, Manfred Springob, Stephanie Salge, Annika Völkel, Friederike Magnet, Jens Callegari

Summary

The path from first symptoms to initiation of allergen-specific immunotherapy (AIT) is too long in our survey, at just under 12 years. Even from diagnosis to AIT, it still takes 8.5 years. The reasons are manifold. The complaints are mostly sneezing (75%), runny and stuffy nose (65 and 63%, respectively), itching of the eyes and nose (59%), but also breathing difficulties (40%). Most of our patients were polysensitized (78%) and had asthma (63%). AIT should be considered earlier in mite allergic patients.

总结在我们的调查中,从最初出现症状到开始过敏原特异性免疫疗法(AIT)的时间太长,不到12年。即使从诊断到AIT,也需要8.5年的时间。原因是多方面的。投诉主要是打喷嚏(75%)、流鼻涕和鼻塞(分别为65%和63%)、眼睛和鼻子发痒(59%),还有呼吸困难(40%)。我们的大多数患者是多敏症(78%)和哮喘(63%)。对螨过敏的患者应尽早考虑AIT。
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引用次数: 2
Tree of heaven (Ailanthus altissima) pollen—a possible new source of sensitization in Central Europe 天树(Ailanthus altissima)花粉-中欧可能的致敏新来源
Q3 Medicine Pub Date : 2022-10-07 DOI: 10.1007/s40629-022-00228-3
Matthias Werchan, Dominik Flener, Karl-Christian Bergmann
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引用次数: 0
A case of protracted eosinopenia after a single subcutaneous dose of benralizumab 单次皮下注射benralizumab后长期嗜酸性粒细胞减少1例
Q3 Medicine Pub Date : 2022-09-27 DOI: 10.1007/s40629-022-00227-4
Joana Miranda MD, José Luís Plácido MD, Luís Amaral MD
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引用次数: 1
Allergens from house dust and storage mites 来自房屋灰尘和储藏螨的过敏原
Q3 Medicine Pub Date : 2022-09-27 DOI: 10.1007/s40629-022-00226-5
Susanne Vrtala

Summary

House dust mites are among the most important allergy triggers worldwide. While mites of the genus Dermatophagoides occur almost worldwide, the tropical mite Blomia tropicalis and storage mites are only of importance for certain areas or groups of people. The most important allergens of Dermatophagoides pteronyssinus are Der p 1, Der p 2, and Der p 23 with immunoglobulin E (IgE)-binding frequencies of more than 70% and high allergenic activity. Also of importance are Der p 5, Der p 7, and Der p 21, which have IgE-binding frequencies of about 30%. According to the current state of knowledge, these six allergens are the allergens of clinical relevance which are also required for diagnosis and immunotherapy with individual components.

夏季屋尘螨是全球最重要的过敏诱因之一。虽然皮螨属的螨虫几乎在世界各地都有发生,但热带斑点螨和储藏螨只对某些地区或人群重要。屋尘螨最重要的过敏原是Der p1、Der p2和Der p2 3,免疫球蛋白E(IgE)结合频率超过70%,具有高致敏活性。同样重要的是Der p 5、Der p 7和Der p 21,它们具有约30%的IgE结合频率。根据目前的知识状况,这六种过敏原是具有临床相关性的过敏原,也是诊断和免疫治疗所需的单独成分。
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引用次数: 6
Expert consensus on prophylactic treatment of hereditary angioedema 遗传性血管性水肿预防性治疗专家共识
Q3 Medicine Pub Date : 2022-09-02 DOI: 10.1007/s40629-022-00223-8
Jens Greve,  Tamar Kinaciyan, Marcus Maurer, Barbara Dillenburger, Andreas Recke, Clemens Schöffl

Summary

Hereditary angioedema (HAE) is a chronic, genetic condition which severely impacts those afflicted with intermittent recurrent vascular edema in mucosal and submucosal tissue or in the dermis and subcutis. These swellings adversely impact the wellbeing of patients, both physically and emotionally. Depending on the location, patients present to doctors in a range of disciplines, and not infrequently misdiagnoses occur, such as appendicitis or an allergy, with subsequent incorrect treatment. An HAE attack can also be life-threatening if larynx is affected. However, medications for treating the more common mast cell-induced angioedema are not effective in HAE. Correct diagnosis of the condition, which often first appears in childhood or adolescence, is therefore essential for effective treatment. De novo mutations where the family history is negative are particularly challenging here. However, a range of new treatment options can help HAE patients by preventing attacks and alleviating the burden of the disease. In this review, we summarize the symptoms experienced by patients with HAE as a result of their condition, but also as a result of misdiagnoses and incorrect treatments, as well as the role of preventive treatment (long-term prophylaxis) in improving the quality of life of those affected and their families. In addition, we provide specific information about how HAE can be detected at an early stage in order to be able to refer patients to experts as soon as possible. With reference to the recommendations of the updated WAO/EAACI guidelines (2022), we argue for a stronger role for long-term prophylaxis and the promotion of modern, patient-centered management of HAE using patient-reported outcome measures (PROMs) to manage quality of life and the burden of the disease.

摘要遗传性血管水肿(HAE)是一种慢性遗传性疾病,严重影响粘膜和粘膜下组织或真皮和皮下间歇性复发性血管水肿患者。这些肿胀会对患者的身心健康产生不利影响。根据地点的不同,患者会出现在一系列学科的医生面前,经常会出现误诊,如阑尾炎或过敏,随后会出现不正确的治疗。如果喉部受到影响,HAE发作也可能危及生命。然而,治疗更常见的肥大细胞诱导的血管性水肿的药物对HAE无效。因此,对这种情况的正确诊断对于有效治疗至关重要,这种情况通常首先出现在儿童或青少年时期。家族史为阴性的新突变在这里尤其具有挑战性。然而,一系列新的治疗方案可以通过预防发作和减轻疾病负担来帮助HAE患者。在这篇综述中,我们总结了HAE患者因其病情、误诊和错误治疗而出现的症状,以及预防性治疗(长期预防)在提高患者及其家人生活质量方面的作用。此外,我们还提供了关于如何在早期检测HAE的具体信息,以便能够尽快将患者转介给专家。参考更新后的WAO/EAACI指南(2022)的建议,我们主张在长期预防和促进HAE的现代、以患者为中心的管理方面发挥更大的作用,使用患者报告的结果测量(PROM)来管理生活质量和疾病负担。
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引用次数: 1
Treatment with IL5-/IL-5 receptor antagonists in drug reaction with eosinophilia and systemic symptoms (DRESS) IL5-/IL-5受体拮抗剂治疗嗜酸性粒细胞增多症和全身症状的药物反应(DRESS)
Q3 Medicine Pub Date : 2022-08-23 DOI: 10.1007/s40629-022-00224-7
Anna Gschwend PhD, Arthur Helbling MD, Laurence Feldmeyer PhD, Ulrich Mani-Weber MD, Cordula Meincke MD, Kristine Heidemeyer MD, Simon Bossart MD, Lukas Jörg MD

Purpose

Drug reaction with eosinophilia and systemic symptoms (DRESS) is a severe delayed drug hypersensitivity reaction with exanthema, eosinophilia, and organ manifestations. After culprit drug withdrawal, systemic corticosteroids (CS) are the most widely used treatment, often requiring high doses for months. Blocking the IL-5/IL‑5 receptor axis with mepolizumab, reslizumab, and benralizumab is a promising targeted treatment with a good safety profile and no immunosuppressive effect. The aim of this study is to summarize current experience with the anti-IL5/IL-5-receptor therapy in DRESS.

Methods

A retrospective analysis of all patients diagnosed with DRESS and treated with mepolizumab, reslizumab, or benralizumab in DRESS was performed. In addition, a PubMed–Medline search for publications on DRESS with anti-IL-5/IL‑5 receptor treatment was performed.

Results

Of the 14 cases identified, 6 patients were treated with mepolizumab, 6 with benralizumab, 1 patient with reslizumab, and 1 patient was switched from benralizumab to mepolizumab. The main indication for an IL‑5 blockade was a therapy-refractory course (7/14 [50.0%]), recurrent relapses (3/14 [21.4%]), and severe organ dysfunction (2/14 [14.3%]). In 13/14 (93%) cases, a rapid clinical improvement with suppression of eosinophilia and reduction of CS could be achieved. In all but two cases under mepolizumab (dose 100–600 mg) or reslizumab (dose according to body weight), two or more doses were necessary until resolution of DRESS. In 4/7 cases under benralizumab, a single 30 mg dose was sufficient.

Conclusion

Blockade of the IL-5/IL‑5 receptor axis appears to be a promising treatment in DRESS with fast clinical improvement, which may allow more rapid reduction of CS, and a good safety profile. In addition, a summary of recommendations on when to use blockade of the IL-5/IL‑5 receptor axis in DRESS treatment is provided.

目的药物反应伴嗜酸性粒细胞增多和全身症状(DRESS)是一种严重的迟发性药物超敏反应,伴有发疹、嗜酸性粒血球增多和器官表现。罪犯停药后,全身皮质类固醇(CS)是最广泛使用的治疗方法,通常需要数月的高剂量。用美波珠单抗、雷珠单抗和本拉利珠单抗阻断IL-5/IL-5受体轴是一种很有前途的靶向治疗方法,具有良好的安全性,没有免疫抑制作用。本研究的目的是总结目前DRESS中抗IL5/IL-5受体治疗的经验。此外,PubMed–Medline还搜索了抗IL-5/IL-5受体治疗DRESS的出版物。结果在确定的14例病例中,6例患者接受了美波利珠单抗治疗,6例接受了benralizumab治疗,1例接受了reslizumab治疗。IL‑5阻断的主要指征是治疗难治性病程(7/14[50.0%])、复发性复发(3/14[21.4%])和严重器官功能障碍(2/14[114.3%])。在13/14(93%)的病例中,可以通过抑制嗜酸性粒细胞增多和减少CS来实现快速的临床改善。在除两例外的所有病例中,使用美波珠单抗(剂量100-600 mg)或雷珠单抗(根据体重的剂量),两次或两次以上剂量是必需的,直到DRESS消退。在使用benralizumab的4/7例病例中,单个30 mg剂量就足够了。结论阻断IL-5/IL-5受体轴似乎是DRESS的一种很有前途的治疗方法,具有快速的临床改善,可以更快地减少CS,并具有良好的安全性。此外,还提供了关于何时在DRESS治疗中使用IL-5/IL-5受体轴阻断的建议摘要。
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引用次数: 6
Abstracts of the 17th German Allergy Congress, Wiesbaden, 08.–10. September 2022 第17届德国变态反应大会,威斯巴登,08 - 10。2022年9月
Q3 Medicine Pub Date : 2022-08-17 DOI: 10.1007/s40629-022-00225-6
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引用次数: 0
期刊
Allergo Journal International
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