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用于治疗哮喘及其他与过敏性疾病相关表现的抗IgE单克隆抗体。

Anti-IgE monoclonal antibody for the treatment of the asthma and other manifestations related to allergic diseases.

作者信息

Sarinho Emanuel, Cruz Alvaro Antonio

机构信息

Universidade Federal de Pernambuco (UFPE), Recife, PE, Brazil.

出版信息

J Pediatr (Rio J). 2006 Nov;82(5 Suppl):S127-32. doi: 10.2223/JPED.1551.

Abstract

OBJECTIVES

To report on the pharmacology, efficacy and safety of omalizumab, a new option for the treatment of asthma and allergic diseases and the first monoclonal anti-IgE antibody approved for clinical use.

SOURCES

MEDLINE, a non-systematic search including reviews and original papers, chosen according to their relevance in the authors' opinion.

SUMMARY OF THE FINDINGS

The paper emphasizes the central role IgE plays in allergic diseases and the biological rationale for its use, the evidence upon which the current recommendations for the use of anti-IgE in uncontrolled asthma are based and its possible future applications, in addition to the recommendation that in clinical practice doses must be adjusted for weight and serum IgE levels. Omalizumab was approved in Brazil for patients with severe uncontrolled asthma presenting with a positive skin prick test for one or more relevant aeroallergen, or IgE specific to a relevant allergen detected in serum, having a total IgE level of between 30 and 700 UI/mL. For the time being its use should be restricted to patients aged 12 years or more, but there are prospects that it will be licensed for use with children over 6 years old.

CONCLUSIONS

Some severe asthma cases cannot be controlled with the regular treatment options aimed at preventing symptoms and exacerbations, and so require frequent or prolonged use of systemic corticosteroids. These patients may benefit from treatment with anti-IgE, after a meticulous reevaluation of possible reasons for the failure to control asthma.

摘要

目的

报告奥马珠单抗的药理学、疗效及安全性。奥马珠单抗是治疗哮喘和过敏性疾病的一种新选择,也是首个获批临床使用的单克隆抗IgE抗体。

资料来源

MEDLINE,以及根据作者观点筛选出的包括综述和原始论文在内的非系统性检索结果。

研究结果总结

本文强调了IgE在过敏性疾病中所起的核心作用及其用药的生物学原理、目前关于在未控制的哮喘中使用抗IgE的建议所依据的证据及其未来可能的应用,此外还建议在临床实践中必须根据体重和血清IgE水平调整剂量。在巴西,奥马珠单抗被批准用于治疗严重未控制哮喘患者,这些患者对一种或多种相关气传变应原皮肤点刺试验呈阳性,或血清中检测到针对相关变应原的IgE特异性抗体,总IgE水平在30至700 UI/mL之间。目前其使用应限于12岁及以上的患者,但有望获批用于6岁以上儿童。

结论

一些严重哮喘病例无法通过旨在预防症状和加重发作的常规治疗方案得到控制,因此需要频繁或长期使用全身糖皮质激素。在对哮喘控制不佳的可能原因进行细致重新评估后,这些患者可能会从抗IgE治疗中获益。

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