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Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M最新文献

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The EAMG position on the regulation of existing products for treatment with special reference to named patient products (NPPs). EAMG对现有治疗产品的监管立场，特别提及命名患者产品(NPPs)。
Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M
Pub Date : 2003-01-01
Albert M Kroon

Allergen products have a long history in both diagnosis and management of allergic disease. It is emphasized that the availability of named patient products presents a valuable and indispensable option for the effective and safe treatment of patients suffering from IgE-mediated allergic diseases. A regulatory climate should be achieved in which these products can survive until a safe and effective alternative is borne out. Within the context of the paper the following definition is used: A named patient product or NPP is an allergen product, prepared with a specific reference number in accordance with a prescription for an individual patient, identified by the name of this patient and the reference number, and delivered after control of consistency with previous treatments. It is stressed that the standards of quality that hold for registered products are also applicable for named patient preparations which, for various reasons, can not be filed for registration. The paper frequently refers to a Position Paper that has recently been adopted by the European Allergen Manufacturers Group, the EAMG. The presentation breaks a lance for a concerted approach of the NPP-concept by striving at harmonization of legal, regulatory, manufacturing, and distribution conditions.

过敏原产品在过敏性疾病的诊断和治疗方面有着悠久的历史。强调的是，命名的患者产品的可用性为有效和安全治疗患有ige介导的过敏性疾病的患者提供了宝贵和不可或缺的选择。应该营造一种监管氛围，使这些产品能够在安全有效的替代品问世之前存活下来。在本文的上下文中，使用了以下定义:命名患者产品或NPP是一种过敏原产品，根据单个患者的处方制备了特定的参考编号，由该患者的姓名和参考编号标识，并在与以往治疗的一致性控制后交付。需要强调的是，注册产品的质量标准也适用于由于各种原因不能申请注册的指定患者制剂。该文件经常引用欧洲过敏原制造商集团(EAMG)最近通过的立场文件。该报告通过努力协调法律、监管、制造和分销条件，打破了npp概念的协调方法。
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引用次数: 0
Peptide-based immunotherapy: new developments. 基于肽的免疫治疗:新进展。
Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M
Pub Date : 2003-01-01
Mark Larché
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引用次数: 0
Hypoallergenic variants of the Parietaria judaica major allergen Par j 1: in vitro and in vivo evaluation. 犹太顶棚主要过敏原的低过敏性变异:体外和体内评估。
Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M
Pub Date : 2003-01-01
Paolo Colombo
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引用次数: 0
Engineering and validation of recombinant proteins for allergen vaccines. 过敏原疫苗重组蛋白的工程和验证。
Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M
Pub Date : 2003-01-01
Michael D Spangfort
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引用次数: 0
Recombinant food allergens in the diagnosis of pollen-related food allergy. 重组食物过敏原在花粉相关食物过敏诊断中的应用。
Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M
Pub Date : 2003-01-01
Barbara K Ballmer-Weber, Andrea Wangorsch, Stephan Scheurer
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引用次数: 0
Alternative approaches to immunotherapy of allergy. 过敏免疫治疗的替代方法。
Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M
Pub Date : 2003-01-01
Irwin Ziment

Alternative therapies for allergic diseases may be prescribed by physicians or provided by other practitioners or selected by patients without resorting to consultation with a health advisor. The most popular alternative therapies include dietary manipulation and exaggerated avoidance of allergens. Established medical therapies include herbs (Western and Asian), homeopathy and acupuncture; many publications suggest they are of value in allergic disease management. However, most studies lack sufficient power, do not have adequate controls, fail to duplicate standard clinical practices, or utilize a heterogeneous group of subjects. Careful analysis suggest that popular alternative therapies might offer a minimal benefit over placebos, but further studies are required for more rigorous evaluation of outcomes. Numerous esoteric or non-specific methods of treating allergic diseases are also available which may be promoted by enthusiastic practitioners or supported by satisfied patients. The majority of such therapies will never be scientifically evaluated, and the results of such modalities will be difficult to separate out from those of true placebo treatments. It is evident that while the "prose" of scientifically established therapies is appealing to a declining number of patients, the "poetry" of complementary therapies resonates with an increasing majority of the public who believe in the magic of alternative medicine.

过敏疾病的替代疗法可以由医生开处方或由其他从业人员提供，或由患者自行选择，而无需咨询健康顾问。最流行的替代疗法包括饮食控制和过度避免过敏原。现有的医学疗法包括草药(西方和亚洲)、顺势疗法和针灸;许多出版物表明它们在过敏性疾病管理中有价值。然而，大多数研究缺乏足够的力量，没有足够的对照，不能重复标准的临床实践，或者使用异质组的受试者。仔细的分析表明，流行的替代疗法可能比安慰剂提供最小的好处，但需要进一步的研究来更严格地评估结果。许多深奥或非特异性治疗过敏性疾病的方法也可用，这可能是由热心的从业者或支持满意的病人。大多数这样的治疗方法永远不会被科学地评估，而且这种方式的结果将很难与真正的安慰剂治疗区分开来。很明显，虽然科学疗法的“散文”正在吸引越来越少的患者，但补充疗法的“诗歌”却与越来越多相信替代医学魔力的公众产生了共鸣。
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引用次数: 0
Parallels between parasite infections and specific immunotherapy. 寄生虫感染与特异性免疫治疗的相似之处。
Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M
Pub Date : 2003-01-01
Ronald van Ree, Maria Yazdanbakhsh
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引用次数: 0
Mechanisms of immunotherapy with allergoids: lessons for the development of recombinant allergens with reduced IgE-binding activity. 类过敏原免疫治疗的机制:开发具有降低ige结合活性的重组过敏原的经验教训。
Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M
Pub Date : 2003-01-01
Oliver Cromwell, Helga Kahlert, Gabriele Schramm, Roland Suck, Andreas Nandy, Bernhard Weber, Helmut Fiebig
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引用次数: 0
Criteria for clinical efficacy--readout and monitoring of clinical studies. 临床疗效标准——临床研究的读数和监测。
Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M
Pub Date : 2003-01-01
Hans-Jørgen Malling
{"title":"Criteria for clinical efficacy--readout and monitoring of clinical studies.","authors":"Hans-Jørgen Malling","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":77490,"journal":{"name":"Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M","volume":" 94","pages":"119-23; discussion 123-5"},"PeriodicalIF":0.0,"publicationDate":"2003-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"24496875","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Expression of allergens in E. coli and plants--benefits and drawbacks. 大肠杆菌和植物中过敏原的表达——利弊。
Arbeiten aus dem Paul-Ehrlich-Institut (Bundesamt fur Sera und Impfstoffe) zu Frankfurt a.M
Pub Date : 2003-01-01
Heimo Breiteneder, Birgit Wagner

Recombinant allergens are quickly becoming the reagents of choice for diagnosis and therapy of type I allergic diseases. Consequently, the different methods for the production of recombinant proteins that are available today are of great interest to allergologists. Without doubt, bacterial expression will continue to play a pivotal role. In addition, plant-based expression systems will be needed to overcome problems inherent in the E. coli systems and to allow the production of glycoallergens or allergens of more complex folding.

重组过敏原正迅速成为I型过敏性疾病诊断和治疗的首选试剂。因此，目前可用的生产重组蛋白的不同方法引起了过敏症专家的极大兴趣。毫无疑问，细菌表达将继续发挥关键作用。此外，基于植物的表达系统将需要克服大肠杆菌系统固有的问题，并允许产生糖过敏原或更复杂折叠的过敏原。
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引用次数: 0
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