Background

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.

Objective

We sought to determine the long-term natural history of disease and outcomes in patients in TENOR I after more than a decade.

Methods

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.

Results

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 FEV₁ 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.

Conclusion

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.

中文翻译：

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重症或难治性哮喘患者的十多年随访：流行病学和哮喘自然史：结果和治疗方案（TENOR）II

背景

哮喘的流行病学和自然史：结果和治疗方案（TENOR I）研究表明，尽管采用标准治疗方法，重症或难以治疗的哮喘患者仍具有较高的发病率。

客观的

我们试图确定十多年后TENOR I患者的长期自然疾病史和预后。

方法

TENOR I是一项多中心观察性研究（2001年至2004年），涉及4756例严重或难治性哮喘患者。TENOR II是在2013/2014年使用单次横断面访视对TENOR I患者进行的随访研究。总体而言，参与TENOR II的研究地点最初招募了1230例TENOR I患者。评估了临床和患者报告的结局，包括根据国家心脏，肺和血液研究所指南控制的哮喘控制不佳。

结果

共有341例（27.7％）患者参加了TENOR II，代表了TENOR I队列。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％）。预测的支气管扩张剂前和支气管扩张剂FEV _1的平均百分比分别为72.7％（标准差，21.4％）和78.2％（标准差，20.7％）。317名患者中，共有231名（72.9％）对1种或更多种过敏原特异性IgE呈阳性反应。血液中嗜酸性粒细胞的平均计数为200 /μL（SD，144 /μL）。在前三个月中，有88名（25.8％）的患者出现了哮喘加重症，需要住院治疗和/或口服皮质类固醇激素，或两者兼而有之。超过一半（197/339 [58.1％]）的哮喘控制非常差。药物使用建议治疗不足。

结论

TENOR II提供纵向数据来表征患有严重或难以治疗的哮喘患者的疾病进展，异质性和严重性。研究结果显示，发病率持续升高，包括高度合并症，过敏性致敏，病情加重以及哮喘控制不佳，包括肺功能下降。