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生物制剂在重症哮喘中的应用:来自登记处的真实世界证据的作用。

Biologics in severe asthma: the role of real-world evidence from registries.

机构信息

IRCCS Humanitas Research Hospital, Milan, Italy.

Dept of Biomedical Sciences, Humanitas University, Milan, Italy.

出版信息

Eur Respir Rev. 2022 Jun 7;31(164). doi: 10.1183/16000617.0278-2021. Print 2022 Jun 30.

Abstract

Asthma is one of the most common noncommunicable diseases; in the majority of patients it is well controlled with inhaled bronchodilators and inhaled corticosteroids, but the management of severe asthma has been a significant challenge historically. The introduction of novel biologic drugs in the past few decades has revolutionised the field, presenting physicians with a variety of biologic drugs with different mechanisms for the treatment of severe asthma.It is of crucial importance to evaluate the effectiveness of these drugs by following their "real-life" effectiveness rather than relying solely on their efficacy, established in carefully designed clinical trials, which therefore do not necessarily match the profile of the real-life patient. Understanding the actual effectiveness of the specific drugs in real-life patients is a crucial part of tailoring the right drugs to the right patients. Registries serve as an important tool in obtaining real-life evidence, since they are in effect observational studies, following the entire patient population.

摘要

哮喘是最常见的非传染性疾病之一;在大多数患者中,使用吸入性支气管扩张剂和吸入性皮质类固醇可很好地控制病情,但严重哮喘的治疗一直是一个重大挑战。在过去几十年中,新型生物药物的问世彻底改变了这一领域,为医生提供了多种具有不同作用机制的生物药物,用于治疗严重哮喘。通过跟踪这些药物的“实际疗效”来评估其有效性至关重要,而不能仅仅依靠精心设计的临床试验中所确定的疗效,因为临床试验的结果不一定符合真实患者的情况。了解特定药物在真实患者中的实际疗效是为合适的患者选择合适药物的关键部分。注册研究是获取真实证据的重要工具,因为它们实际上是观察性研究,可跟踪整个患者群体。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b8e6/9489006/93c2f3659bfa/ERR-0278-2021.01.jpg

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