过敏原特异性免疫疗法和真实世界证据

D. Timoshenko, K. Pavlova, O. Kurbacheva
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引用次数: 0

摘要

过敏原免疫治疗是ige依赖性变应性疾病发病治疗的主要方法,在临床上得到广泛应用。尽管有大量关于过敏原免疫治疗疗效的随机安慰剂对照试验数据,但关于过敏原免疫治疗在实际应用中的疗效,仍有许多问题未得到解答。这些问题可以用现实世界的证据来回答。在进行过敏原免疫治疗的真实证据研究时,必须遵循严格的方法并对现有数据进行多变量分析。使用统计方法可以减少偏倚的风险。REACT研究是目前最大和最全面的过敏原免疫治疗的真实世界证据研究,其中包括来自德国的9万多例过敏性鼻炎患者。采用统计调整的方法,倾向评分匹配,以确保可比组和代表性获得的数据。REACT研究提供了具有基本临床和公共卫生意义的结果:过敏原免疫治疗导致变应性鼻炎和哮喘患者持续和长期的药物处方减少,改善了哮喘的控制,并防止哮喘患者恶化和呼吸道感染的发展。REACT研究是一项高质量的真实世界证据研究,具有严格的方法和代表性的结果。进一步对真实数据进行高质量的标准研究,不仅可以证实随机试验的证据,也可能成为过敏原免疫治疗在真实临床中的有效性和安全性的新证据来源。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Allergen-specific immunotherapy and real-world evidence
Allergen immunotherapy is the main method of IgE-dependent allergic diseases pathogenetic treatment which is widely used in the clinical practice. Despite the fact that there is a large amount of randomized placebo-controlled trials data on the allergen immunotherapy efficacy, a number of questions remain unanswered regarding the efficacy of the allergen immunotherapy in real practice. These questions can be answered using real-world evidence. Conducting real-world evidence studies of the allergen immunotherapy it is necessary to follow a strict methodology and to perform the multivariate analysis of the available data. Using of statistical methods reduces the risk of bias. The REACT study is currently the largest and most comprehensive real-world evidence study of the allergen immunotherapy, which included more than 90,000 patients with allergic rhinitis from Germany. The method of statistical adjustment a propensity score match was used to ensure comparable groups and representative obtained data. The REACT study provided results of fundamental clinical and public health significance: the allergen immunotherapy leads to a sustained and long-term medicine prescribing reduction in patients with allergic rhinitis and asthma, improved control of asthma, and also prevents development of exacerbations and respiratory infections in asthma patients. The REACT study is a good quality real-world evidence study with strict methodology and representative results. Further high quality standard studies of real-world data may not only confirm the randomized trials evidence, but also may become a source of new evidence for the allergen immunotherapy efficacy and safety in real clinical practice.
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