Naclerio Robert, Baroody Fuad, Bachert Claus, Bleier Benjamin, Borish Larry, Brittain Erica, Chupp Geoffrey, Fisher Anat, Fokkens Wytske, Gevaert Philippe, Kennedy David, Kim Jean, Laidlaw Tanya M, Lee Jake J, Piccirillo Jay F, Pinto Jayant M, Roland Lauren T, Schleimer Robert P, Schlosser Rodney J, Schwaninger Julie M, Smith Timothy L, Tan Bruce K, Tan Ming, Toskala Elina, Wenzel Sally, Togias Alkis
Johns Hopkins University, Baltimore, Md.
University of Chicago, Chicago, Ill.
J Allergy Clin Immunol Pract. 2020 May;8(5):1532-1549.e1. doi: 10.1016/j.jaip.2020.02.023. Epub 2020 Mar 4.
The development of biologics targeting various aspects of type 2 inflammation for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) will provide clinicians with powerful tools to help treat these patients. However, other therapies are also available, and positioning of biologics in a management algorithm will require comparative trials. In November 2019, the National Institute of Allergy and Infectious Diseases convened a workshop to consider potential future trial designs. Workshop participants represented a wide spectrum of clinical specialties, including otolaryngology, allergy, and pulmonary medicine, as well as expertise in CRSwNP pathophysiology and in trial methodology and statistics. The workshop discussed the current state of knowledge in CRSwNP and considered the advantages and disadvantages of various clinical trial or observational study designs and various clinical outcomes. The output from this workshop, which is presented in this report, will hopefully provide investigators with adequate information and ideas to design future studies and answer critical clinical questions. It will also help clinicians understand the current state of the management of CRSwNP and its gaps and be more able to interpret the new information to come.
开发针对2型炎症各个方面的生物制剂用于治疗伴鼻息肉的慢性鼻-鼻窦炎（CRSwNP），将为临床医生提供强大的工具来帮助治疗这些患者。然而，也有其他治疗方法，并且在管理方案中确定生物制剂的地位将需要进行对比试验。2019年11月，美国国立过敏与传染病研究所召开了一次研讨会，以考虑未来可能的试验设计。研讨会参与者代表了广泛的临床专业领域，包括耳鼻喉科、过敏科和肺科，以及CRSwNP病理生理学、试验方法和统计学方面的专业知识。研讨会讨论了CRSwNP的当前知识状态，并考虑了各种临床试验或观察性研究设计以及各种临床结局的优缺点。本报告中呈现的本次研讨会的成果，有望为研究人员提供足够的信息和思路来设计未来的研究并回答关键的临床问题。它还将帮助临床医生了解CRSwNP管理的当前状态及其差距，并更有能力解读即将出现的新信息。
