Carpagnano Giovanna Elisiana, Bonini Matteo, Latorre Manuela, Nucera Eleonora, Prediletto Irene, Puggioni Francesca, Scioscia Giulia, Santus Pierachille, Sotgiu Giovanni, Blasi Francesco, Canonica Giorgio Walter, Paggiaro Pierluigi, Aruanno Arianna, Baiardini Ilaria, Bagnasco Diego, Bondi Benedetta, Candeliere Giulia, Cefaloni Francesca, Fontanili Gabriele, Melissari Laura, Mincarini Marcello, Paoletti Giovanni, Radovanovic Dejan, Pinelli Valentina, Tondo Pasquale, Quaranta Vitaliano Nicola, Vallara Rachele, Braido Fulvio
Sezione di Malattie dell'Apparato Respiratorio, Dipartimento di Biomedicina Traslazionale e Neuroscienze (DiBraiN), Università degli Studi di Bari Aldo Moro, Bari, Italy.
Department of Public Health and Infectious Diseases, Sapienza Università di Roma, Italy.
World Allergy Organ J. 2025 Jul 3;18(8):101082. doi: 10.1016/j.waojou.2025.101082. eCollection 2025 Aug.
Although 90% of asthmatic patients suffer from mild and moderate disease, little is known about the burden on health status and quality of life, the long-term trajectory of disease severity, and the socio-economic impact. The Mild Moderated Asthma Network of Italy (MANI) is a real-world, cross-sectional, prospective, observational cohort study designed to explore these issues. Here we aimed to provide an identikit of asthmatic patients receiving treatment according to GINA steps 1-4, and enrolled in the centers of excellence participating in the MANI. Among 679 analyzed patients, 63% were female, and the mean age was 50 ± 16 years. Asthma was mild in 15.8% of patients (GINA steps 1-2) and moderate in 84.2% (GINA steps 3-4). The mean age of asthma diagnosis was 34.3 ± 17.7 years, 50% of patients were suffering from allergic rhinitis, and 13% from nasal polyposis. Mean FEV1% was 91.4 ± 19.4%, predicted with a FEV1/FVC ratio of 74.7 ± 11.9. The mean asthma control test value was 21.2 ± 3.73, and AQLQ score was 5.74 ± 1.07. Among the included patients, 17.2% had at least one asthma exacerbation in the previous year, with 14.2% requiring systemic steroids; 6.2% were referred to an emergency room in the year prior to enrollment; 2.2% required an asthma-related hospitalization; and 0.6% had been admitted to an Intensive Care Unit (ICU). Unscheduled visits were necessary for 3.8% of patients, 6.5% reported ≥5 lost work days due to asthma, and 11.5% declared ≥10 lost days of spare time. About 70% of patients were receiving treatment according to GINA Track 1. Uncontrolled cases constituted 16.7% of patients treated according to GINA steps 1-2, and 26.3% of patients treated according to GINA steps 3-4 were uncontrolled. Compared to patients with mild asthma, those with moderate asthma had more impaired lung function (FEV1% 88.5 ± 18.4 vs 94.4 ± 17.9, p = 0.05; FEV1/FVC 73.0 ± 9.76 vs 79.6 ± 9.56, p > 0.001), exhibited greater need for systemic corticosteroids for treating exacerbations (13.8% vs 2.3%, p = 0.032), and showed greater adherence to therapy (TAI score 50.0 ± 5.66 vs 45.7 ± 8.42, p < 0.001). Overall, mild/moderate asthma exhibited a substantial clinical and care impact. Patients treated with GINA steps 3-4 constituted the vast majority of patients attending specialist centers. A quarter of these patients were uncontrolled, and therefore need re-evaluation or treatment upgrade. Expanding recruitment of the MANI study will allow further phenotyping of these patients.
尽管90%的哮喘患者患有轻度和中度疾病，但对于其对健康状况和生活质量的负担、疾病严重程度的长期轨迹以及社会经济影响，我们了解甚少。意大利轻度中度哮喘网络（MANI）是一项真实世界、横断面、前瞻性观察队列研究，旨在探索这些问题。在此，我们旨在提供一份按照全球哮喘防治创议（GINA）第1 - 4步接受治疗且登记参与MANI卓越中心研究的哮喘患者概况。在679例分析患者中，63%为女性，平均年龄为50±16岁。15.8%的患者哮喘为轻度（GINA第1 - 2步），84.2%为中度（GINA第3 - 4步）。哮喘诊断的平均年龄为34.3±17.7岁，50%的患者患有过敏性鼻炎，13%患有鼻息肉。平均第一秒用力呼气容积（FEV1）百分比为91.4±19.4%，FEV1/用力肺活量（FVC）比值为74.7±11.9。哮喘控制测试平均得分为21.2±3.73，哮喘生活质量问卷（AQLQ）评分为5.74±1.07。在纳入患者中，17.2%的患者在前一年至少有一次哮喘发作，其中14.2%需要全身使用类固醇；6.2%在入组前一年被送往急诊室；2.2%需要因哮喘住院治疗；0.6%曾入住重症监护病房（ICU）。3.8%的患者需要进行非计划就诊，6.5%的患者报告因哮喘误工天数≥5天，11.5%的患者宣称休闲时间损失天数≥10天。约70%的患者按照GINA第1条路径接受治疗。按照GINA第1 - 2步治疗的患者中，16.7%为控制不佳病例；按照GINA第3 - 4步治疗的患者中，26.3%为控制不佳病例。与轻度哮喘患者相比，中度哮喘患者的肺功能受损更严重（FEV1% 88.5±18.4 vs 94.4±17.9，p = 0.05；FEV1/FVC 73.0±9.76 vs 79.6±9.56，p>0.001），治疗发作时对全身皮质类固醇的需求更大（13.8% vs 2.3%，p = 0.032），且对治疗的依从性更高（治疗依从性指数（TAI）评分50.0±5.66 vs 45.7±8.42，p<0.001）。总体而言，轻度/中度哮喘表现出显著的临床和护理影响。按照GINA第3 - 4步治疗的患者占专科中心就诊患者的绝大多数。这些患者中有四分之一控制不佳，因此需要重新评估或升级治疗。扩大MANI研究的招募将有助于对这些患者进行进一步的表型分析。
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