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GRAAZAX（®）：一种舌下免疫治疗疫苗，用于治疗花粉症：从概念到商业化。

GRAZAX®: a sublingual immunotherapy vaccine for Hay fever treatment: from concept to commercialization.

机构信息

School of Medicine, Institute for Applied Molecular Medicine (IMMA), Universidad CEU San Pablo, Madrid, Spain.

Allergy Department, Hospital Universitario de la Princesa, Madrid, Spain.

出版信息

Hum Vaccin Immunother. 2019;15(12):2887-2895. doi: 10.1080/21645515.2019.1622976. Epub 2019 Jun 20.

DOI:10.1080/21645515.2019.1622976
PMID:31157592
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6930101/
Abstract

Allergen immunotherapy has been used for more than 100 y, but only recently underlying immunological mechanisms have started to be understood. New Allergy vaccines are now considered to be full pharmaceutical products, that should comply with general as well as specific pharmaceutical legal framework. GRAZAX® is the first global allergy vaccine developed in compliance with the new legal environment and is thus a reference for developing new allergy vaccines. Here, we provide a rationale description of GRAZAX®, providing a sequential description of its pharmaceutical and clinical development. With more than 25 clinical trials, involving more than 8000 patients, including as well three 5-y prospective clinical trials, GRAZAX® is a key product to understand the unique position of allergen-specific immunotherapy as a disease-modifying intervention.

摘要

变应原免疫疗法已经使用了 100 多年，但直到最近才开始了解其潜在的免疫学机制。现在，新型过敏原疫苗被认为是完整的药物产品，应该符合一般和特定的药物法律框架。GRAZAX®是第一个按照新的法律环境开发的全球过敏疫苗，因此是开发新的过敏疫苗的参考标准。在这里，我们提供了 GRAZAX®的基本原理描述，按顺序描述了其药物和临床开发。通过超过 25 项临床试验，涉及 8000 多名患者，包括三项 5 年前瞻性临床试验，GRAZAX®是理解过敏原特异性免疫疗法作为疾病修饰干预的独特地位的关键产品。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b2f/6930101/e7f0c645ef06/khvi-15-12-1622976-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b2f/6930101/7d93e865f922/khvi-15-12-1622976-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b2f/6930101/1995c57231eb/khvi-15-12-1622976-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b2f/6930101/8fec211e5618/khvi-15-12-1622976-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b2f/6930101/e7f0c645ef06/khvi-15-12-1622976-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b2f/6930101/7d93e865f922/khvi-15-12-1622976-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b2f/6930101/1995c57231eb/khvi-15-12-1622976-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b2f/6930101/8fec211e5618/khvi-15-12-1622976-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8b2f/6930101/e7f0c645ef06/khvi-15-12-1622976-g004.jpg

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本文引用的文献

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Intra-Seasonal Initiation of the SQ-Standardised Grass Allergy Immunotherapy Tablet Routinely Applied by Allergy Specialists and General Practitioners with Experience in Treatment of Allergy: A Non-Interventional Observational Study.季节性草花粉标准化变应原特异性免疫治疗片在过敏专科医生和有过敏治疗经验的全科医生中的季内起始应用：一项非干预性观察研究
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The Importance of Tablet Formulation on Allergen Release Kinetics and Efficiency: Comparison of Freeze-dried and Compressed Grass Pollen Sublingual Allergy Immunotherapy Tablet Formulations.片剂配方对过敏原释放动力学和效率的重要性：冻干和压缩的舌下草花粉变应原免疫治疗片剂配方的比较。
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Front Immunol. 2021 Feb 25;12:623805. doi: 10.3389/fimmu.2021.623805. eCollection 2021.
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Exploring novel systemic biomarker approaches in grass-pollen sublingual immunotherapy using omics.利用组学技术探索新型花粉舌下免疫治疗的系统性生物标志物方法。
Allergy. 2021 Apr;76(4):1199-1212. doi: 10.1111/all.14565. Epub 2020 Sep 22.
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EAACI Allergen Immunotherapy User's Guide.EAACI 过敏原免疫治疗用户指南。
Pediatr Allergy Immunol. 2020 May;31 Suppl 25(Suppl 25):1-101. doi: 10.1111/pai.13189.
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Metabolomics strategies to discover new biomarkers associated to severe allergic phenotypes.用于发现与严重过敏表型相关的新生物标志物的代谢组学策略。
Asia Pac Allergy. 2019 Oct 28;9(4):e37. doi: 10.5415/apallergy.2019.9.e37. eCollection 2019 Oct.
Two grass pollen tablets commercially available for allergy immunotherapy display different IgE epitope repertoires.两种市售的用于过敏免疫疗法的草花粉片剂表现出不同的IgE表位谱。
Clin Transl Allergy. 2019 Feb 27;9:13. doi: 10.1186/s13601-019-0253-z. eCollection 2019.
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