Capital Allergy and Respiratory Disease Center, Sacramento, Calif.
EpiMetrix, Los Altos, Calif.
J Allergy Clin Immunol. 2018 May;141(5):1590-1597.e9. doi: 10.1016/j.jaci.2017.07.014. Epub 2017 Aug 7.
The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR I) study demonstrated high morbidity in patients with severe or difficult-to-treat asthma despite standard-of-care treatment.
We sought to determine the long-term natural history of disease and outcomes in patients in TENOR I after more than a decade.
TENOR I was a multicenter observational study (2001-2004) of 4756 patients with severe or difficult-to-treat asthma. TENOR II was a follow-up study of TENOR I patients using a single cross-sectional visit in 2013/2014. Overall, the sites participating in TENOR II originally enrolled 1230 patients in TENOR I. Clinical and patient-reported outcomes were assessed, including very poorly controlled asthma based on National Heart, Lung, and Blood Institute guidelines.
A total of 341 (27.7%) patients were enrolled in TENOR II and were representative of the TENOR I cohort. The most frequent comorbidities were rhinitis (84.0%), sinusitis (47.8%), and gastroesophageal reflux disease (46.3%). Mean percent predicted prebronchodilator and postbronchodilator FEV were 72.7% (SD, 21.4%) and 78.2% (SD, 20.7%), respectively. A total of 231 (72.9%) of 317 patients had positive test responses to 1 or more allergen-specific IgEs. The mean blood eosinophil count was 200/μL (SD, 144/μL). Eighty-eight (25.8%) patients experienced an asthma exacerbation in the prior 3 months requiring hospital attention, oral corticosteroids, or both. More than half (197/339 [58.1%]) had very poorly controlled asthma. Medication use suggested undertreatment.
TENOR II provides longitudinal data to characterize disease progression, heterogeneity, and severity in patients with severe or difficult-to-treat asthma. Findings show continued morbidity, including a high degree of comorbid conditions, allergic sensitization, exacerbations, and very poorly controlled asthma, including reduced lung function.
《哮喘的流行病学和自然史：结局和治疗方案（TENOR I）》研究表明，尽管采用了标准治疗，但重度或治疗困难的哮喘患者仍存在较高的发病率。
我们旨在确定 TENOR I 研究中超过十年后患者的疾病长期自然史和结局。
TENOR I 是一项多中心观察性研究（2001-2004 年），共纳入 4756 例重度或治疗困难的哮喘患者。TENOR II 是 TENOR I 患者的后续研究，于 2013/2014 年采用单次横断面访问。总体而言，参与 TENOR II 的研究点最初在 TENOR I 中招募了 1230 例患者。评估了临床和患者报告的结局，包括根据美国国立心肺血液研究所指南评估的非常差控制的哮喘。
共有 341 例（27.7%）患者入组 TENOR II，是 TENOR I 队列的代表性患者。最常见的合并症是鼻炎（84.0%）、鼻窦炎（47.8%）和胃食管反流病（46.3%）。支气管扩张剂前和支气管扩张剂后平均预测百分比的 FEV1 分别为 72.7%（标准差 21.4%）和 78.2%（标准差 20.7%）。317 例患者中有 231 例（72.9%）对 1 种或多种过敏原特异性 IgE 有阳性反应。平均血嗜酸性粒细胞计数为 200/μL（标准差 144/μL）。88 例（25.8%）患者在过去 3 个月内经历了需要住院治疗、口服皮质类固醇或两者都需要的哮喘加重。超过一半（197/339 [58.1%]）患者的哮喘非常差控制。药物使用提示治疗不足。
TENOR II 提供了纵向数据，用于描述重度或治疗困难的哮喘患者的疾病进展、异质性和严重程度。研究结果表明，包括多种合并症、过敏致敏、加重和非常差控制的哮喘（包括肺功能降低）在内的发病率仍很高。
