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呼出气一氧化氮在指导特应性患者轻度哮喘治疗中的作用及其与哮喘控制测试评分的相关性:一项随机对照试验。

Utility of exhaled nitric oxide to guide mild asthma treatment in atopic patients and its correlation with asthma control test score: a randomized controlled trial.

机构信息

Parc Sanitari Sant Joan de Dèu, Camí Vell de la colonia, 25, Sant Boi de Llobregat, Barcelona, 08830, Spain.

Bellvitge University Hospital,, Barcelona, Spain.

出版信息

BMC Pulm Med. 2024 Aug 29;24(1):421. doi: 10.1186/s12890-024-03227-y.

Abstract

BACKGROUND

Fractional exhaled nitric oxide (FeNO) is used for the diagnosis and monitoring of asthma, although its utility to guide treatment and its correlation with other tools is still under discussion. We study the possibility to withdraw inhaled corticosteroid treatment in atopic patients with mild asthma based on the FeNO level, as well as to study its correlation with other clinical control tools.

METHODS

Prospective and randomized study including atopic patients aged 18 to 65 with mild asthma, stable, on low-dose inhaled corticosteroid (ICS) treatment, who had their treatment withdrawn based on a FeNO level of 40 ppb. Patients were randomized into two groups: control group (treatment with ICS was withdrawn regardless of FeNO level) and experimental group (according to the FeNO levels, patients were assigned to one of two groups: FeNO > 40 ppb on treatment with budesonide 200 mcg every 12 h and SABA on demand; FeNO ≤ 40 ppb only with SABA on demand). Follow-up was conducted for one year, during which medical assessment was performed with FeNO measurements, asthma control test (ACT), lung function tests (FEV1, FEV1/FVC, PEF, and RV/TLC), and recording of the number of exacerbations.

RESULTS

Ninety-two patients were included, with a mean age of 39.92 years (SD 13.99); 46 patients were assigned to the control group, and 46 patients to the experimental group. The number of exacerbations was similar between the groups (p = 0.301), while the time to the first exacerbation was significantly shorter in the control group (30.86 vs. 99.00 days), p < 0.001, 95% CI (43.332-92.954). Lung function tests (FEV1, FEV1/FVC, PEF, and RV/TLC) showed no differences between the groups (p > 0.05). Both FeNO and ACT showed significant changes in the groups in which ICS was withdrawn (p < 0.05 for both parameters). A significant negative correlation was observed between FeNO and ACT (r = -0.139, p = 0.008).

CONCLUSIONS

In atopic patients with mild asthma, withdrawal of ICS based on an FeNO of 40 ppb led to worsened symptoms but without changes in lung function tests or an increase in exacerbations. There was a negative correlation between FeNO values and symptomatic control measured by the ACT.

TRIAL REGISTRATION

Clinical Trial Number: 2012-000372-42. Start Date: 2012-07-23. Trial registered prospectively ( https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-000372-42 ). This study adheres to CONSORT guidelines of randomised control trials.

摘要

背景

呼出气一氧化氮(FeNO)用于哮喘的诊断和监测,尽管其在指导治疗中的作用及其与其他工具的相关性仍在讨论中。我们研究了根据 FeNO 水平,在患有轻度哮喘的特应性患者中停用吸入性皮质类固醇(ICS)治疗的可能性,并研究了其与其他临床控制工具的相关性。

方法

前瞻性、随机研究纳入了年龄在 18 至 65 岁之间、患有轻度哮喘、稳定、接受低剂量 ICS 治疗的特应性患者,根据 FeNO 水平(40 ppb)停用治疗。患者被随机分为两组:对照组(无论 FeNO 水平如何,都停用 ICS 治疗)和实验组(根据 FeNO 水平,将患者分为两组之一:治疗时 FeNO>40 ppb,用布地奈德 200 mcg 每 12 小时一次和按需沙丁胺醇;FeNO≤40 ppb 仅按需沙丁胺醇)。进行为期一年的随访,在此期间,通过 FeNO 测量、哮喘控制测试(ACT)、肺功能测试(FEV1、FEV1/FVC、PEF 和 RV/TLC)和记录哮喘加重次数来进行医学评估。

结果

共纳入 92 例患者,平均年龄 39.92 岁(标准差 13.99);46 例患者被分配到对照组,46 例患者被分配到实验组。两组哮喘加重次数相似(p=0.301),但对照组首次哮喘加重时间明显缩短(30.86 天 vs. 99.00 天),p<0.001,95%置信区间(43.332-92.954)。肺功能测试(FEV1、FEV1/FVC、PEF 和 RV/TLC)在两组之间无差异(p>0.05)。两组中 ICS 停用后 FeNO 和 ACT 均有显著变化(p<0.05)。FeNO 和 ACT 之间存在显著负相关(r=-0.139,p=0.008)。

结论

在患有轻度哮喘的特应性患者中,基于 FeNO 为 40 ppb 停用 ICS 导致症状恶化,但肺功能测试无变化,哮喘加重次数无增加。FeNO 值与 ACT 测量的症状控制呈负相关。

试验注册

临床试验编号:2012-000372-42。开始日期:2012 年 7 月 23 日。前瞻性注册(https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-000372-42)。本研究符合随机对照试验的 CONSORT 指南。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c8ad/11360837/cde048c8d56e/12890_2024_3227_Fig1_HTML.jpg

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