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Basophil activation test in Hymenoptera venom allergy. 嗜碱性粒细胞活化试验在膜翅目昆虫毒液过敏症中的应用。
Pub Date : 2024-08-19 eCollection Date: 2024-01-01 DOI: 10.5414/ALX02522E
Bernadette Eberlein, Knut Brockow, Ulf Darsow, Tilo Biedermann, Simon Blank

Before starting venom-specific immunotherapy (VIT), systemic sting reactions to Hymenoptera venoms require allergological workup in order to prove an IgE-mediated reaction and to identify the culprit insect venom. In addition to skin tests and the determination of specific IgE antibodies, the basophil activation test (BAT) using flow cytometry has emerged as a powerful tool and sensitive marker for this purpose in recent years. BAT seems to have a better informative value in terms of clinical relevance compared to the other tests. In Hymenoptera venom allergies, BAT is particularly useful for the diagnosis of cases with unclear or contradictory history and sensitization profile. Its results are associated with adverse reactions during VIT and efficacy of VIT and therefore have a certain predictive value for side effects and treatment failure of VIT. In research, it is mainly used to characterize the allergenic components of Hymenoptera venoms. This review article focuses on these topics.

在开始毒液特异性免疫疗法(VIT)之前,对膜翅目昆虫毒液的全身性蛰伤反应需要进行过敏学检查,以证明是 IgE 介导的反应,并确定罪魁祸首的昆虫毒液。除了皮肤试验和特异性 IgE 抗体测定外,近年来,使用流式细胞仪进行的嗜碱性粒细胞活化试验(BAT)已成为一种强大的工具和灵敏的标记物。与其他检测方法相比,嗜碱性粒细胞活化检测在临床相关性方面似乎更有参考价值。在膜翅目昆虫毒液过敏症中,BAT 尤其适用于诊断病史和过敏特征不明确或相互矛盾的病例。其结果与 VIT 期间的不良反应和 VIT 的疗效有关,因此对 VIT 的副作用和治疗失败有一定的预测价值。在研究中,它主要用于描述膜翅目昆虫毒液中致敏成分的特征。本综述文章将重点讨论这些主题。
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引用次数: 0
Possible manufacture of test allergens in public pharmacies for the diagnosis of type I allergies: Legal aspects. 可能在公共药房生产用于诊断 I 型过敏症的过敏原检测试剂:法律问题。
Pub Date : 2024-07-22 eCollection Date: 2024-01-01 DOI: 10.5414/ALX02514E
Robin Jost, Sabine Kespohl, Kathrin E Paulus-Tremel, Julia Zimmer, Andreas Bonertz, Ingrid Sander, Thomas Klose, Lena-Maria Altin, Simone Heller, Ralph Heimke-Brinck, Frank Dörje, Susanne Philippus, Matthias Meyer, Sabrina Segebrecht, Torsten Wessel, Dieter Starke, Stefan Schülke, Monika Raulf, Vera Mahler

The availability of high-quality skin test allergens is a prerequisite for the reliable diagnosis of occupational type I allergies. Due to the withdrawal of existing marketing authorizations (MAs) by pharmaceutical companies and the lack of new MAs for commercial test allergens, there is an increasing diagnostic gap in Germany and other EU member states, which makes it necessary to investigate alternative ways of providing in vivo diagnostics. The German Medicinal Products Act (Arzneimittelgesetz = AMG) allows for the possibility of preparing medicinal products in pharmacies without the need for an MA or a manufacturing authorization pursuant to Section 13 (2) No. 1 in conjunction with Section 13 (2a) Sentence 2 No. 3 AMG. This also includes test allergens. In addition to the AMG, the requirements of the German Ordinance on the Operation of Pharmacies (Apothekenbetriebsordnung - ApBetrO) and the European Pharmacopoeia apply in particular. Medicolegal and practical challenges, as well as potentials of manufacturing skin prick test solutions in public pharmacies are presented based on examples of different allergen source materials.

获得高质量的皮试过敏原是可靠诊断职业性 I 型过敏的前提条件。由于制药公司撤销了现有的市场授权(MA),而且缺乏新的商业过敏原测试授权,德国和其他欧盟成员国的诊断缺口越来越大,因此有必要研究提供体内诊断的替代方法。德国《医药产品法》(Arzneimittelgesetz = AMG)第 13 (2) 条第 1 款以及 AMG 第 13 (2a) 条第 2 句第 3 款规定,在药房配制医药产品无需获得 MA 或生产许可。这也包括过敏原测试。除 AMG 外,《德国药房经营条例》(Apothekenbetriebsordnung - ApBetrO)和《欧洲药典》的要求也特别适用。根据不同过敏源材料的实例,介绍了在公共药房生产皮肤点刺试验解决方案所面临的医学法律和实际挑战以及潜力。
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引用次数: 0
Protocol for the systematic reviews on the desirable and undesirable effects of pharmacological treatments of allergic rhinitis informing the ARIA 2024 guidelines. 关于过敏性鼻炎药物治疗的理想效果和不良效果的系统综述议定书,为 ARIA 2024 指南提供信息。
Pub Date : 2024-07-22 eCollection Date: 2024-01-01 DOI: 10.5414/ALX02515E
Rafael José Vieira, Maria Inês Torres, Antonio Bognanni, Sara Gil-Mata, Renato Ferreira-da-Silva, Nuno Lourenço-Silva, António Cardoso-Fernandes, André Ferreira, Henrique Ferreira-Cardoso, João Teles, Miguel Campos-Lopes, João A Fonseca, Juan José Yepes-Nuñez, Ludger Klimek, Torsten Zuberbier, Holger Schünemann, Jean Bousquet, Bernardo Sousa-Pinto

There is insufficient evidence regarding the comparative efficacy and safety of pharmacological treatments of allergic rhinitis (AR). In the context of informing the 2024 revision of the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines, we plan to perform three systematic reviews of randomized controlled trials (RCTs) comparing the desirable and undesirable effects (i) between intranasal and oral medications for AR; (ii) between combinations of intranasal and oral medications versus nasal or oral medications alone; and (iii) among different intranasal specific medications. We will search four electronic bibliographic databases and three clinical trials databases for RCTs examining patients ≥ 12 years old with seasonal or perennial AR. Assessed outcomes will include the Total Nasal Symptom Score, the Total Ocular Symptom Score, and the Rhinoconjunctivitis Quality-of-Life Questionnaire. We will assess the methodological quality of included primary studies by using the Cochrane risk-of-bias tool. If appropriate, we will perform a pairwise random-effects meta-analysis for each pair of assessed medication classes and outcomes, as well as a network meta-analysis to assess the comparative efficacy of intranasal medications among each other. Heterogeneity will be explored by sensitivity and subgroup analyses. This set of systematic reviews will allow for a comprehensive assessment of the effectiveness and safety of pharmacological interventions for AR and inform recommendations in the context of the ARIA guidelines.

关于过敏性鼻炎(AR)药物治疗的疗效和安全性的比较证据不足。为了给 2024 年修订的《过敏性鼻炎及其对哮喘的影响》(ARIA)指南提供信息,我们计划对随机对照试验(RCT)进行三项系统综述,比较 (i) 鼻内用药和口服药物治疗 AR 的理想效果和不良效果;(ii) 鼻内用药和口服药物的组合与单独使用鼻腔或口腔药物的组合;(iii) 不同鼻内用药之间的理想效果和不良效果。我们将在四个电子文献数据库和三个临床试验数据库中搜索对年龄≥ 12 岁的季节性或常年性 AR 患者进行研究的 RCT。评估结果将包括鼻部症状总分、眼部症状总分和鼻结膜炎生活质量问卷。我们将使用 Cochrane 偏倚风险工具评估纳入的主要研究的方法学质量。如果合适,我们将对每对评估的药物类别和结果进行配对随机效应荟萃分析,并进行网络荟萃分析,以评估鼻内用药之间的疗效比较。将通过敏感性分析和亚组分析来探讨异质性。这组系统综述将有助于全面评估药物干预治疗 AR 的有效性和安全性,并为 ARIA 指南的建议提供参考。
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引用次数: 0
Maculopapular rash with multiple drug hypersensitivity to cotrimoxazole, amikacin, piperacillin/tazobactam, and meropenem in a patient with hairy cell leukemia. 一名毛细胞白血病患者因对复方新诺明、阿米卡星、哌拉西林/他唑巴坦和美罗培南等多种药物过敏而出现大面积皮疹。
Pub Date : 2024-07-22 eCollection Date: 2024-01-01 DOI: 10.5414/ALX02508E
Katie Townsend, Claire Leck, Thippeswamy Billahalli, Elizabeth Barachina, Timothy J Watts

We describe a rare case of a 54-year-old female with hairy cell leukemia, who following treatment for neutropenic sepsis, developed an extensive severe maculopapular exanthema with perifollicular hemorrhage. Cladribine, cotrimoxazole, allopurinol, domperidone, amikacin, piperacillin/tazobactam, and meropenem had all been given in the 9 days prior to eruption onset. Three months later, drug patch testing/delayed intradermal testing was positive to cotrimoxazole, trimethoprim, amikacin, piperacillin/tazobactam, and meropenem, with additional evidence of penicillin cross-reactivity. Drug challenge tests were negative to allopurinol and domperidone. She was diagnosed with multiple drug hypersensitivity to cotrimoxazole, amikacin, piperacillin/tazobactam, and meropenem. Multiple drug hypersensitivity is a novel syndrome mainly seen with severe delayed type IV drug eruptions, involving long-lasting strong T-cell reactivity to two or more structurally unrelated drugs.

我们描述了一例罕见的病例:一名 54 岁的女性毛细胞白血病患者在接受中性败血症治疗后,出现了大面积严重的斑丘疹性外伤,并伴有毛囊周围出血。发病前 9 天内曾服用过克拉利宾、复方新诺明、别嘌呤醇、多潘立酮、阿米卡星、哌拉西林/他唑巴坦和美罗培南。三个月后,药物贴片测试/延迟皮内测试结果显示,复方新诺明、三甲氧苄啶、阿米卡星、哌拉西林/他唑巴坦和美罗培南呈阳性反应,并有青霉素交叉反应的其他证据。对别嘌呤醇和多潘立酮的药物挑战试验呈阴性。她被诊断为对复方新诺明、阿米卡星、哌拉西林/他唑巴坦和美罗培南等多种药物过敏。多重药物过敏症是一种新型综合征,主要表现为严重的迟发性 IV 型药物爆发,涉及对两种或两种以上结构不相关药物的长期强烈 T 细胞反应。
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引用次数: 0
Procedure for a standardized preparation of skin prick test solutions for the diagnosis of occupational type I allergies in the absence of commercial extracts. 在没有商业提取物的情况下,用于诊断 I 型职业性过敏的皮肤点刺试验溶液的标准化制备程序。
Pub Date : 2024-07-04 eCollection Date: 2024-01-01 DOI: 10.5414/ALX02506E
Sabine Kespohl, Robin Jost, Silke Maryska, Lena-Maria Altin, Ingrid Sander, Stefan Schülke, Kathrin E Paulus-Tremel, Andreas Bonertz, Thomas Klose, Vera Mahler, Monika Raulf

In order to ensure valid diagnostics for occupational test allergen solutions despite the ongoing reduction in the availability of commercial test extracts, a plan B was initiated for the possible production of skin prick test (SPT) solutions in public pharmacies. For important occupational allergen sources (wheat and rye, storage mites, animal epithelia, mold material) laboratory extraction methods were analyzed in comparison to pharmacy compatible extraction methods regarding protein quantity and quality in SDS-PAGE combined with silver staining. Subsequently, using the example of bovine epithelia, adapted extraction procedures as well as in-process and final product controls were transferred to a public pharmacy. Allergen sources with a high protein content, such as wheat and rye grains as well as storage mites, showed good comparability of the extractable protein quantity and protein pattern, regardless of the applied extraction method. In contrast, allergen source materials with a low total protein content, such as animal epithelia and molds, can benefit from laboratory extraction conditions such as mechanical disruption and specific buffer additives. In the qualitative protein silver staining, characteristic protein patterns were identified for each allergen source. Depending on the extraction method, only minor differences in total protein patterns were observed in animal epithelia and molds. Using source materials from two suppliers, the resulting allergen extracts displayed clear differences in protein content in storage mites and quantitative and qualitative differences in molds. A practical preparation attempt of SPT solutions in a public pharmacy was successful. SPT solutions prepared with adapted pharmacy extraction methods showed a comparable protein and Bos d 2 allergen content and equivalent qualities in the protein pattern compared to a previously available commercial SPT solution. Accordingly, it can be assumed that standardized SPT solutions with sufficient allergen quality for occupational allergen sources can be prepared in public pharmacies if certified allergen sources with appropriate protein content are available.

尽管商业测试提取物的供应量不断减少,但为了确保职业测试过敏原溶液的有效诊断,我们启动了一项 B 计划,以便在公共药房生产皮肤点刺测试 (SPT) 溶液。针对重要的职业过敏原来源(小麦和黑麦、贮藏螨、动物上皮、霉菌材料),将实验室提取方法与药房兼容提取方法进行了比较分析,以确定 SDS-PAGE 结合银染色法提取的蛋白质数量和质量。随后,以牛上皮细胞为例,将经过调整的提取程序以及过程控制和最终产品控制转移到公共药房。蛋白质含量较高的过敏源,如小麦和黑麦谷物以及贮藏螨,无论采用哪种提取方法,其可提取的蛋白质数量和蛋白质模式都具有良好的可比性。相比之下,总蛋白含量较低的过敏源材料,如动物上皮和霉菌,可从实验室提取条件中获益,如机械破坏和特定的缓冲添加剂。在蛋白质银染色定性分析中,每种过敏源都能识别出特有的蛋白质模式。根据提取方法的不同,在动物上皮和霉菌中观察到的总蛋白模式只有细微差别。使用来自两家供应商的源材料,所提取的过敏原在贮存螨的蛋白质含量上有明显差异,在霉菌的数量和质量上也有差异。在一家公共药房实际制备 SPT 溶液的尝试取得了成功。与之前市面上销售的 SPT 溶液相比,采用药房萃取方法制备的 SPT 溶液中蛋白质和 Bos d 2 过敏原含量相当,蛋白质模式的质量也相当。因此,可以认为,如果有经认证的、蛋白质含量适当的过敏原来源,公共药房可以制备出具有足够过敏原质量的标准化 SPT 溶液,用于职业过敏原来源。
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引用次数: 0
A case of paradoxical vocal cord movement misdiagnosed as anaphylaxis. 一例被误诊为过敏性休克的矛盾性声带运动病例。
Pub Date : 2024-07-04 eCollection Date: 2024-01-01 DOI: 10.5414/ALX02502E
Mustafa Ilker Inan, Yasemin Akgul Balaban, Sait Yesillik, Ozgur Kartal

Introduction: Anaphylaxis is a severe and life-threatening systemic hypersensitivity reaction. The most frequently encountered causes are foods, drugs, and bee venom, but anaphylaxis may also occur idiopathically. Paradoxical vocal cord movement (PVCM), is a cause of upper airway obstruction due to abnormal adduction of vocal cords during inspiration and, to some degree on expiration. It may be misdiagnosed as asthma or anaphylaxis, and there may be delays in diagnosis.

Case report: We present a 20-year-old male patient with coexistence of urticaria and stridor findings who was evaluated and treated as having idiopathic anaphylaxis but then was diagnosed with PVCM after recurrence of stridor attacks.

Conclusion: It is useful to bear the diagnosis of PVCM in mind in patients with recurrent and unexplained stridor or in patients with stridor that does not improve despite treatment for another diagnosis such as anaphylaxis. This way, administration of epinephrine, high-dose corticosteroids and interventions such as intubation or tracheostomy can be avoided.

导言:过敏性休克是一种严重的、危及生命的全身性超敏反应。最常见的病因是食物、药物和蜂毒,但过敏性休克也可能是特发性的。声带反常运动(PVCM)是由于声带在吸气时异常内收,并在一定程度上在呼气时异常内收而导致上呼吸道阻塞的一种病因。它可能会被误诊为哮喘或过敏性休克,而且可能会延误诊断:病例报告:我们介绍了一名 20 岁的男性患者,他同时患有荨麻疹和哮鸣音,在评估和治疗过程中被视为特发性过敏性休克,但在哮鸣音反复发作后被诊断为 PVCM:结论:对于反复发作、原因不明的绞痛患者,或在接受过敏性休克等其他诊断治疗后绞痛仍无改善的患者,牢记 PVCM 的诊断非常有用。这样,就可以避免使用肾上腺素、大剂量皮质类固醇和插管或气管切开术等干预措施。
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引用次数: 0
Scorpion sting and allergic reaction to scorpion venom: A case-based review. 蝎子蜇伤和蝎毒过敏反应:病例回顾。
Pub Date : 2024-06-25 eCollection Date: 2024-01-01 DOI: 10.5414/ALX400582
Jozélio Freire de Carvalho

Objective: To describe a young patient with scorpion sting (SS) with typical lesions of urticaria besides the local SS clinical picture.

Materials and methods: A systematic screening of articles dating from 1966 to 2021 was conducted in the main databases. All articles included the association between SS and urticaria. A new case report is added to the published list.

Results: The literature search found 5 articles with 29 patients with SS and urticaria/allergic reactions. We performed our analysis by adding our present case, resulting in a total of 30 cases. Most were male, and their ages varied from 29 to 48 years. Regarding SS severity, most were mild or moderate. In two articles, patients had more than one sting. The allergic reaction varied from urticaria, pruritus, flushing, angioedema, wheezing, rhinorrhea, sneezing, consciousness alterations, and gastrointestinal and cardiovascular alterations. In 5/6 (83%) articles, the patients were alive at the study time. One subject died from anaphylactic shock.

Conclusion: The present article systematically reviewed all published cases of SS and allergic reactions to scorpion venom. It is an infrequent association; most patients are male and in the productive age, and reaction may vary from mild to severe, including death.

摘要描述一名年轻的蝎子蜇伤(SS)患者,除了蝎子蜇伤的局部临床表现外,还伴有典型的荨麻疹皮损:在主要数据库中对 1966 年至 2021 年的文章进行了系统筛选。所有文章均包含 SS 与荨麻疹之间的关联。结果:文献检索共发现 5 篇文章,涉及 29 名 SS 和荨麻疹/过敏反应患者。我们在进行分析时加入了本病例,结果共有 30 例。大多数患者为男性,年龄从 29 岁到 48 岁不等。关于 SS 的严重程度,大多数为轻度或中度。在两篇文章中,患者被蛰了不止一次。过敏反应包括荨麻疹、瘙痒、潮红、血管性水肿、喘息、鼻出血、打喷嚏、意识改变、胃肠道和心血管改变。在5/6(83%)篇文章中,患者在研究期间仍然存活。一名患者死于过敏性休克:本文系统回顾了所有已发表的SS和蝎毒过敏反应病例。蝎毒过敏症是一种不常见的疾病,大多数患者为男性,处于生育年龄,反应从轻微到严重不等,包括死亡。
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引用次数: 0
Corrigendum of the article Reese I, Schäfer C, Ballmer-Weber B, Beyer K, Dölle-Bierke S, van Dullemen S, Jappe U, Müller S, Schnadt S, Treudler R, Worm M. Vegan diets from an allergy point of view - Position paper of the DGAKI working group on food allergy. Allergol Select. 2023; 7: 57-83. 文章更正 Reese I、Schäfer C、Ballmer-Weber B、Beyer K、Dölle-Bierke S、van Dullemen S、Jappe U、Müller S、Schnadt S、Treudler R、Worm M. 从过敏角度看素食 - DGAKI 食物过敏工作组的立场文件。Allergol Select.2023; 7: 57-83.
Pub Date : 2024-06-13 eCollection Date: 2024-01-01 DOI: 10.5414/ALX02400ECorr

[This corrects the article on p. 57 in vol. 7, PMID: 37056444.].

[此处更正了第 7 卷第 57 页的文章,PMID:37056444]。
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引用次数: 0
"Delabeling" by direct provocation testing in children and adolescents with a suspected history of a delayed reaction to β-lactam antibiotics: Consensus paper of Gesellschaft für pädiatrische Allergologie und Umweltmedizin (GPAU), Deutsche Gesellschaft für Allergologie und klinische Immunologie (DGAKI), and Ärzteverband deutscher Allergologen (ÄDA). 通过直接激发试验对疑似对β-内酰胺类抗生素有迟发性反应的儿童和青少年进行 "去标签化 "治疗:德国皮肤变态反应与健康医学协会 (GPAU)、德国变态反应与临床免疫学协会 (DGAKI) 和德国变态反应学家协会 (ÄDA)的共识文件。
Pub Date : 2024-05-31 eCollection Date: 2024-01-01 DOI: 10.5414/ALX02480E
Irena Neustädter, Sophie Blatt, Gerda Wurpts, Heinrich Dickel, Christian Walter, Werner Aberer, Sebastian Bode, Timo Buhl, Sunhild Gernert, Susanne Harner, Guido Heine, Sebastian Kerzel, Meike Köhler, Lars Lange, Joachim List, Hans F Merk, Thomas Nüßlein, Hagen Ott, Franziska Sattler, Antje Schuster, Helen Straube, Bettina Wedi, Torsten Zuberbier, Knut Brockow

Background: Approximately 10% of European children are classified as allergic to drugs. In the majority of these children, no allergy to β-lactam antibiotics (BLA) can be found. In most cases, the exanthema is caused by the infection.

Materials and methods: The objective of this paper is to describe the causes and consequences of a misdiagnosis of drug allergy. We propose a method for establishing a correct diagnosis in the case of a history of a delayed reaction during treatment with a BLA. For this purpose, a proposal was discussed via e-mail communication, and consensus was reached among the members of the drug allergy working groups of the participating medical societies.

Results: The suspicion of a BLA allergy based on the medical history alone can have a negative impact on future antibiotic treatment. Exanthema associated with febrile infections not related to drug administration is a frequent finding in children. This makes it all the more important to be able to recommend a standardized procedure for clarification in children and adolescents with suspected hypersensitivity reactions. The medical history should be the basis on which to diagnose either a drug allergy or another possible differential diagnosis. A mild maculopapular exanthema (MPE) can be an expression of a drug allergy or a nonspecific viral exanthema. Uncomplicated MPE is not associated with significant systemic involvement, and there is no involvement of the mucous membranes or cutaneous blistering. Only a small number of children with uncomplicated MPE show positive skin tests and only ~ 7 - 16% of suspected BLA diagnoses can be confirmed by provocation tests. Thus, in children with uncomplicated MPE, drug provocation can be performed in an outpatient setting even without prior skin testing. This paper presents a 3-day outpatient direct provocation scheme for BLA delabeling in children with uncomplicated MPE.

Conclusion: Many children and adolescents are unnecessarily denied treatment with BLA after an uncomplicated MPE while being treated with a BLA.

背景:约有 10% 的欧洲儿童被归类为对药物过敏。在这些儿童中,大多数都没有发现对β-内酰胺类抗生素(BLA)过敏。在大多数情况下,红斑是由感染引起的:本文旨在描述药物过敏误诊的原因和后果。我们提出了一种在使用 BLA 治疗期间出现延迟反应病史的情况下确定正确诊断的方法。为此,我们通过电子邮件交流的方式讨论了这一建议,并在参与医学会的药物过敏工作组成员之间达成了共识:结果:仅凭病史怀疑对 BLA 过敏会对今后的抗生素治疗产生负面影响。与用药无关的发热感染引起的红斑是儿童的常见病。因此,为疑似超敏反应的儿童和青少年推荐一个标准化的澄清程序就显得尤为重要。病史应作为诊断药物过敏或其他可能鉴别诊断的依据。轻度斑丘疹性红斑(MPE)可能是药物过敏或非特异性病毒性红斑的表现。无并发症的 MPE 不伴有明显的全身受累,也没有粘膜受累或皮肤水疱。只有少数无并发症的 MPE 患儿的皮肤测试呈阳性,只有 ~ 7 - 16% 的疑似 BLA 诊断可通过激发试验得到证实。因此,对于无并发症的 MPE 患儿,即使事先未进行皮试,也可在门诊环境中进行药物激发试验。本文介绍了一种为期 3 天的门诊直接激发方案,用于对无并发症的 MPE 儿童进行 BLA 脱标:结论:许多儿童和青少年在发生无并发症的 MPE 后,在接受 BLA 治疗的同时却被不必要地拒绝接受 BLA 治疗。
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引用次数: 0
Regulatory framework for development and marketing authorization of allergen products for diagnosis of rare type I and type IV allergies: The current status. 用于诊断罕见的 I 型和 IV 型过敏症的过敏原产品的开发和上市许可监管框架:现状。
Pub Date : 2024-05-31 eCollection Date: 2024-01-01 DOI: 10.5414/ALX02505E
Julia Zimmer, Vera Mahler

Development, production, and marketing authorization of allergen products is generally challenging due to several specific characteristics, including the natural source as well as the multitude of allergenic materials. Also, depending on the frequency of sensitization in the population, the number of patients available for inclusion in clinical trials can be a limiting factor for product development. In the development of allergen products for diagnosis of type I and type IV allergies these challenges are particularly demanding because, in contrast to certain products for allergen-specific immunotherapy, no exemptions from marketing authorization are foreseen for this product group in Directive 2001/83/EC. Thus, the regulatory framework is constantly adapted within the legal scope in order to balance necessary regulatory requirements ensuring quality, safety, and efficacy with the clinical need for a comprehensive range of diagnostic allergen products. In this article, we give an overview on the current regulatory framework for development and marketing authorization of allergen products for diagnosis of rare type I and type IV allergies.

过敏原产品的开发、生产和市场授权一般都具有挑战性,这是因为过敏原产品具有几个特定的特征,包括天然来源和多种过敏原材料。此外,根据人群中过敏发生的频率,可纳入临床试验的患者人数也可能成为产品开发的限制因素。在开发用于诊断 I 型和 IV 型过敏症的过敏原产品时,这些挑战尤为严峻,因为与某些用于过敏原特异性免疫疗法的产品不同,2001/83/EC 号指令并没有为这类产品规定上市许可豁免。因此,监管框架需要在法律范围内不断调整,以便在确保质量、安全性和有效性的必要监管要求与临床对全面诊断过敏原产品的需求之间取得平衡。在本文中,我们将概述目前用于诊断罕见的 I 型和 IV 型过敏症的过敏原产品的开发和上市许可的监管框架。
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Allergologie select
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