一项日本多中心研究：未接受生物制剂哮喘患者的临床缓解情况分析
2025/03/03
摘要
背景：临床缓解（CR）是支气管哮喘患者的一个新型实际管理目标，不涉及疾病严重程度。
目的：本研究旨在探讨吸入性糖皮质激素/长效β2受体激动剂（ICS/LABA）和非生物制剂治疗患者的临床缓解（CR）率以及达到CR患者的特征。
方法：本研究在日本进行，系一项多中心横断面事后分析研究。三效CR的定义为无恶化、未使用维持性口服糖皮质激素、无明显哮喘症状（5项哮喘控制问卷<1.5）。四效CR的定义为三效CR基础上增加肺功能正常化（1秒用力呼气量[%FEV1]≥80%）。深度缓解的定义为四效CR加2型气道炎症受抑制（呼出气一氧化氮[FeNO]<35ppb）。
结果：三效CR、四效CR和深度缓解的符合率分别为56.9%、35.0%和24.7%。与达到三效CR的患者相比，未达到CR患者的FEV1百分比较低（77.6%对85.4%；P<0.0001），FeNO水平较高（42 ppb对34 ppb；P=0.0182），医患对哮喘控制判断的差异更大（38.5%对9.3%；P<0.0001）。在逻辑回归分析中，即使校正FEV1百分比和FeNO，医患判断差异也是阻碍三效CR实现的独立因素（比值比为0.397；P<0.0001）。
结论：在接受ICS/LABA、不使用生物制剂治疗的情况下，患者实现CR具有挑战性。医患对哮喘控制的判断存在差异是实现CR的重要阻碍。
背景：临床缓解（CR）是支气管哮喘患者的一个新型实际管理目标，不涉及疾病严重程度。
目的：本研究旨在探讨吸入性糖皮质激素/长效β2受体激动剂（ICS/LABA）和非生物制剂治疗患者的临床缓解（CR）率以及达到CR患者的特征。
方法：本研究在日本进行，系一项多中心横断面事后分析研究。三效CR的定义为无恶化、未使用维持性口服糖皮质激素、无明显哮喘症状（5项哮喘控制问卷<1.5）。四效CR的定义为三效CR基础上增加肺功能正常化（1秒用力呼气量[%FEV1]≥80%）。深度缓解的定义为四效CR加2型气道炎症受抑制（呼出气一氧化氮[FeNO]<35ppb）。
结果：三效CR、四效CR和深度缓解的符合率分别为56.9%、35.0%和24.7%。与达到三效CR的患者相比，未达到CR患者的FEV1百分比较低（77.6%对85.4%；P<0.0001），FeNO水平较高（42 ppb对34 ppb；P=0.0182），医患对哮喘控制判断的差异更大（38.5%对9.3%；P<0.0001）。在逻辑回归分析中，即使校正FEV1百分比和FeNO，医患判断差异也是阻碍三效CR实现的独立因素（比值比为0.397；P<0.0001）。
结论：在接受ICS/LABA、不使用生物制剂治疗的情况下，患者实现CR具有挑战性。医患对哮喘控制的判断存在差异是实现CR的重要阻碍。
（中日友好医院呼吸与危重症医学科 张婧媛 摘译 林江涛 审校）
（J Allergy Clin Immunol Pract. 2025 Feb;13(2):328-332. doi: 10.1016/j.jaip.2024.10.037. Epub 2024 Nov 6.）
Clinical Remission in Patients With Biologic-Naïve Asthma: A Multicenter Study in Japan.
Oishi K, Hamada K, Fukatsu-Chikumoto A, Murata Y, Asami-Noyama M, Edakuni N, Hirano T, Matsunaga K.
Abstract
BACKGROUND:Clinical remission (CR) is a new realistic management goal for patients with asthma, regardless of the disease severity.
OBJECTIVE:To investigate the rate of achievement of CR in patients treated with inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) and nonbiologics and the characteristics of patients who achieved CR.
METHODS:We performed a post hoc analysis from a multicenter, cross-sectional survey in Japan. 3-way CR was defined as the absence of exacerbation, no use of maintenance oral corticosteroids, and the absence of significant asthma symptoms (5-item Asthma Control Questionnaire < 1.5). We defined 4-way CR as 3-way CR plus having normalized lung function (forced expiratory volume in 1 second [%FEV1] ≥ 80%). Deep remission was defined as 4-way CR plus suppressed type 2 airway inflammation (fraction of exhaled nitric oxide [FeNO] < 35 ppb).
RESULTS:The criteria for 3-way CR, 4-way CR, and deep remission were met by 56.9%, 35.0%, and 24.7% of patients, respectively. Compared with patients who achieved the 3-way CR, unachieved patients have lower %FEV1 (77.6% vs 85.4%; P < .0001) and higher FeNO levels (42 ppb vs 34 ppb; P = .0182), and there were more discordances in asthma control perception between patient and physicians (38.5% vs 9.3%; P < .0001). Physician-patient discordance was an independent factor that prevented the achievement of the 3-way CR in the logistic regression analysis, even when adjusted for %FEV1 and FeNO (odds ratio 0.397; P < 0.0001).
CONCLUSION:Achieving CR in patients treated with ICS/LABA without biologics is challenging. Discrepancies between patient and physician perceptions on asthma control are significant barriers to achieving CR.
Oishi K, Hamada K, Fukatsu-Chikumoto A, Murata Y, Asami-Noyama M, Edakuni N, Hirano T, Matsunaga K.
Abstract
BACKGROUND:Clinical remission (CR) is a new realistic management goal for patients with asthma, regardless of the disease severity.
OBJECTIVE:To investigate the rate of achievement of CR in patients treated with inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) and nonbiologics and the characteristics of patients who achieved CR.
METHODS:We performed a post hoc analysis from a multicenter, cross-sectional survey in Japan. 3-way CR was defined as the absence of exacerbation, no use of maintenance oral corticosteroids, and the absence of significant asthma symptoms (5-item Asthma Control Questionnaire < 1.5). We defined 4-way CR as 3-way CR plus having normalized lung function (forced expiratory volume in 1 second [%FEV1] ≥ 80%). Deep remission was defined as 4-way CR plus suppressed type 2 airway inflammation (fraction of exhaled nitric oxide [FeNO] < 35 ppb).
RESULTS:The criteria for 3-way CR, 4-way CR, and deep remission were met by 56.9%, 35.0%, and 24.7% of patients, respectively. Compared with patients who achieved the 3-way CR, unachieved patients have lower %FEV1 (77.6% vs 85.4%; P < .0001) and higher FeNO levels (42 ppb vs 34 ppb; P = .0182), and there were more discordances in asthma control perception between patient and physicians (38.5% vs 9.3%; P < .0001). Physician-patient discordance was an independent factor that prevented the achievement of the 3-way CR in the logistic regression analysis, even when adjusted for %FEV1 and FeNO (odds ratio 0.397; P < 0.0001).
CONCLUSION:Achieving CR in patients treated with ICS/LABA without biologics is challenging. Discrepancies between patient and physician perceptions on asthma control are significant barriers to achieving CR.
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