探索在重度哮喘中远程监测的FeNO抑制试验的长期效用
2025/06/27
摘要
背景：在开始生物制剂治疗之前，确认最佳吸入性糖皮质激素的使用是至关重要的。呼出气一氧化氮（FeNO）抑制试验（FeNOSuppT）是一种经过验证的表型技术，然而其对临床结果的长期影响仍不清楚。
目的：评估在实际临床环境中，将FeNOSuppT与数字化吸入器监测相结合的可行性，并考察其对生物制剂启动和临床结果的影响。
方法：在英国七个重度哮喘中心进行的前瞻性队列研究。患者在2020年7月至2022年6月的初次就诊期间接受了带有传感器的ICS/长效β2受体激动剂（LABA）吸入器。短期随访（通常为基线后1-3个月）时FeNO降低>42%被定义为FeNOSuppT阳性。在短期和长期（通常为基线后12个月）随访时比较了生物制剂的启动和临床结果。
结果：在353名纳入研究的患者中，有257名（72.8%）完成了FeNOSuppT，其中140名（54.5%）为阳性。与阴性测试相比，FeNOSuppT阳性与短期用力呼气量占预计值百分比（FEV1%）的更大改善（8.6% vs. -0.3%，p<0.001）和哮喘控制问卷6项（ACQ6）评分的更大改善（0.7 vs. 0.3，p=0.001）相关。在完成FeNOSuppT且符合生物制剂使用条件的168名患者中，FeNOSuppT阳性结果的患者启动生物制剂的比例更低（48.2% vs. 65.2%，p=0.035）。尽管如此，在长期随访中，与FeNOSuppT阴性患者相比，FeNOSuppT阳性患者的FEV1改善更大（11.0% vs. 2.3%，p=0.016），哮喘症状（ACQ6：0.7 vs. 0.8，p=0.623）和哮喘加重（66.7% vs. 66.7%，p=0.349）的减少幅度相似。
结论：在常规护理中，将FeNOSuppT与数字化监测相结合是可行的。FeNOSuppT阳性与生物制剂启动率降低相关，且临床结果相似。
Exploring the long-term utility of remotely monitored FeNO suppression testing in severe asthma
John Busby, Joshua Holmes, Mohammed Almutairi, Irene Berrar-Torre, Claire Butler, Christabelle Chen, Gráinne d' Ancona, Paddy Dennison, Sharron Gilbey, David J Jackson, Sumita Kerley, Sukeshi Makhecha, Adel Mansur, Anna-Louise Nichols, Pujan H Patel, Paul E Pfeffer, Hitasha Rupani, Joan Sweeney, Liam G Heaney
Abstract
Background: Confirmation of optimal inhaled corticosteroid use is essential before initiating biologic therapy. FeNO suppression testing (FeNOSuppT) is a proven phenotyping technique, however its long-term effect on clinical outcomes remains unclear.
Objectives: To assess the real-world feasibility of delivering FeNOSuppT alongside digital inhaler monitoring, and to examine its effect on biologic initiation and clinical outcomes.
Methods: Prospective cohort study within seven UK severe asthma centres. Patients received a sensor-enabled ICS/LABA inhaler during an initial appointment between July 2020 and June 2022. A positive FeNOSuppT was defined as >42% FeNO reduction at short-term follow-up (typically 1-3 months post-baseline). Biologic initiation and clinical outcomes were compared at short-term and long-term (typically 12 months post-baseline) follow-up.
Results: Of 353 included patients, 257 (72.8%) completed the FeNOSuppT and 140 (54.5%) were positive. A positive FeNOSuppT was associated with greater improvements in short-term FEV1% (8.6% vs. -0.3, p<0.001) and ACQ6 (0.7 vs. 0.3, p=0.001) compared to a negative test. Of 168 patients eligible for biologics who completed the FeNOSuppT, those with a positive result initiated biologics less often (48.2% vs. 65.2%, p=0.035). Despite this, there was a greater improvement in FEV1 (11.0% vs. 2.3%, p=0.016), and a similar reduction in both asthma symptoms (ACQ6: 0.7 vs. 0.8, p=0.623) and exacerbations (66.7% vs. 66.7%, p=0.349) at long-term follow-up when compared to those with a negative FeNOSuppT.
Conclusions: Delivering FeNOSuppT aligned with digital monitoring is feasible within routine care. A positive FeNOSuppT was associated with lower rates of biologic initiation, with similar clinical outcomes.
背景：在开始生物制剂治疗之前，确认最佳吸入性糖皮质激素的使用是至关重要的。呼出气一氧化氮（FeNO）抑制试验（FeNOSuppT）是一种经过验证的表型技术，然而其对临床结果的长期影响仍不清楚。
目的：评估在实际临床环境中，将FeNOSuppT与数字化吸入器监测相结合的可行性，并考察其对生物制剂启动和临床结果的影响。
方法：在英国七个重度哮喘中心进行的前瞻性队列研究。患者在2020年7月至2022年6月的初次就诊期间接受了带有传感器的ICS/长效β2受体激动剂（LABA）吸入器。短期随访（通常为基线后1-3个月）时FeNO降低>42%被定义为FeNOSuppT阳性。在短期和长期（通常为基线后12个月）随访时比较了生物制剂的启动和临床结果。
结果：在353名纳入研究的患者中，有257名（72.8%）完成了FeNOSuppT，其中140名（54.5%）为阳性。与阴性测试相比，FeNOSuppT阳性与短期用力呼气量占预计值百分比（FEV1%）的更大改善（8.6% vs. -0.3%，p<0.001）和哮喘控制问卷6项（ACQ6）评分的更大改善（0.7 vs. 0.3，p=0.001）相关。在完成FeNOSuppT且符合生物制剂使用条件的168名患者中，FeNOSuppT阳性结果的患者启动生物制剂的比例更低（48.2% vs. 65.2%，p=0.035）。尽管如此，在长期随访中，与FeNOSuppT阴性患者相比，FeNOSuppT阳性患者的FEV1改善更大（11.0% vs. 2.3%，p=0.016），哮喘症状（ACQ6：0.7 vs. 0.8，p=0.623）和哮喘加重（66.7% vs. 66.7%，p=0.349）的减少幅度相似。
结论：在常规护理中，将FeNOSuppT与数字化监测相结合是可行的。FeNOSuppT阳性与生物制剂启动率降低相关，且临床结果相似。
（中日友好医院呼吸与危重症医学科 李红雯 摘译 林江涛 审校）
（J Allergy Clin Immunol Pract. 2025 Apr 30:S2213-2198(25)00394-0. doi: 10.1016/j.jaip.2025.04.036.）
Exploring the long-term utility of remotely monitored FeNO suppression testing in severe asthma
John Busby, Joshua Holmes, Mohammed Almutairi, Irene Berrar-Torre, Claire Butler, Christabelle Chen, Gráinne d' Ancona, Paddy Dennison, Sharron Gilbey, David J Jackson, Sumita Kerley, Sukeshi Makhecha, Adel Mansur, Anna-Louise Nichols, Pujan H Patel, Paul E Pfeffer, Hitasha Rupani, Joan Sweeney, Liam G Heaney
Abstract
Background: Confirmation of optimal inhaled corticosteroid use is essential before initiating biologic therapy. FeNO suppression testing (FeNOSuppT) is a proven phenotyping technique, however its long-term effect on clinical outcomes remains unclear.
Objectives: To assess the real-world feasibility of delivering FeNOSuppT alongside digital inhaler monitoring, and to examine its effect on biologic initiation and clinical outcomes.
Methods: Prospective cohort study within seven UK severe asthma centres. Patients received a sensor-enabled ICS/LABA inhaler during an initial appointment between July 2020 and June 2022. A positive FeNOSuppT was defined as >42% FeNO reduction at short-term follow-up (typically 1-3 months post-baseline). Biologic initiation and clinical outcomes were compared at short-term and long-term (typically 12 months post-baseline) follow-up.
Results: Of 353 included patients, 257 (72.8%) completed the FeNOSuppT and 140 (54.5%) were positive. A positive FeNOSuppT was associated with greater improvements in short-term FEV1% (8.6% vs. -0.3, p<0.001) and ACQ6 (0.7 vs. 0.3, p=0.001) compared to a negative test. Of 168 patients eligible for biologics who completed the FeNOSuppT, those with a positive result initiated biologics less often (48.2% vs. 65.2%, p=0.035). Despite this, there was a greater improvement in FEV1 (11.0% vs. 2.3%, p=0.016), and a similar reduction in both asthma symptoms (ACQ6: 0.7 vs. 0.8, p=0.623) and exacerbations (66.7% vs. 66.7%, p=0.349) at long-term follow-up when compared to those with a negative FeNOSuppT.
Conclusions: Delivering FeNOSuppT aligned with digital monitoring is feasible within routine care. A positive FeNOSuppT was associated with lower rates of biologic initiation, with similar clinical outcomes.
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通过自然语言处理提取的哮喘症状及其与轻度哮喘患者急性哮喘加重的关联
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