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MEGA项目:一项关于哮喘发病机制及病程的研究。哮喘队列的建立与长期随访。

The MEGA Project: A Study of the Mechanisms Involved in the Genesis and Disease Course of Asthma. Asthma Cohort Creation and Long-Term Follow-Up.

作者信息

Muñoz Xavier, Álvarez-Puebla María José, Arismendi Ebymar, Arochena Lourdes, Ausín María Del Pilar, Barranco Pilar, Bobolea Irina, Cañas Jose Antonio, Cardaba Blanca, Crespo Astrid, Del Pozo Victora, Domínguez-Ortega Javier, Fernandez-Nieto María Del Mar, Giner Jordi, González-Barcala Francisco Javier, Luna Juan Alberto, Mullol Joaquim, Ojanguren Iñigo, Olaguibel José María, Picado César, Plaza Vicente, Quirce Santiago, Ramos David, Rial Manuel, Romero-Mesones Christian, Salgado Francisco Javier, San-José María Esther, Sánchez-Diez Silvia, Sastre Beatriz, Sastre Joaquin, Soto Lorena, Torrejón Montserrat, Urnadoz Marisa, Valdes Luis, Valero Antonio, Cruz María Jesús

机构信息

Servicio de Neumología, Hospital Vall d'Hebron, Barcelona, España; CIBER de Enfermedades Respiratorias (CIBERES), España; Departamento de Biología Celular, Fisiología e Inmunología, Universitat Autònoma de Barcelona, Barcelona, España.

Servicio de Alergología, Complejo Hospitalario de Navarra, Pamplona, Navarra, España.

出版信息

Arch Bronconeumol (Engl Ed). 2018 Mar 19. doi: 10.1016/j.arbres.2017.12.012.

DOI:10.1016/j.arbres.2017.12.012
PMID:29566971
Abstract

The general aim of this study is to create a cohort of asthma patients with varying grades of severity in order to gain greater insight into the mechanisms underlying the genesis and course of this disease. The specific objectives focus on various studies, including imaging, lung function, inflammation, and bronchial hyperresponsiveness, to determine the relevant events that characterize the asthma population, the long-term parameters that can determine changes in the severity of patients, and the treatments that influence disease progression. The study will also seek to identify the causes of exacerbations and how this affects the course of the disease. Patients will be contacted via the outpatient clinics of the 8 participating institutions under the auspices of the Spanish Respiratory Diseases Networking System (CIBER). In the inclusion visit, a standardized clinical history will be obtained, a clinical examination, including blood pressure, body mass index, complete respiratory function tests, and FENO will be performed, and the Asthma Control Test (ACT), Morisky-Green test, Asthma Quality of Life Questionnaire (Mini AQLQ), the Sino-Nasal Outcome Test 22 (SNOT-22), and the Hospital Anxiety and Depression scale (HADS) will be administered. A specific electronic database has been designed for data collection. Exhaled breath condensate, urine and blood samples will also be collected. Non-specific bronchial hyperresponsiveness testing with methacholine will be performed and an induced sputum sample will be collected at the beginning of the study and every 24 months. A skin prick test for airborne allergens and a chest CT will be performed at the beginning of the study and repeated every 5 years.

摘要

本研究的总体目标是创建一组具有不同严重程度等级的哮喘患者队列,以便更深入地了解该疾病发生和发展过程的潜在机制。具体目标集中在各项研究上,包括影像学、肺功能、炎症和支气管高反应性,以确定表征哮喘人群的相关事件、可确定患者严重程度变化的长期参数以及影响疾病进展的治疗方法。该研究还将试图确定病情加重的原因以及这如何影响疾病进程。将通过西班牙呼吸系统疾病网络系统(CIBER)支持下的8个参与机构的门诊诊所联系患者。在纳入访视中,将获取标准化临床病史,进行包括血压、体重指数、完整呼吸功能测试和呼出气一氧化氮(FENO)检测在内的临床检查,并实施哮喘控制测试(ACT)、莫利斯基-格林测试、哮喘生活质量问卷(Mini AQLQ)、鼻窦结局测试22(SNOT-22)以及医院焦虑抑郁量表(HADS)。已设计了一个特定的电子数据库用于数据收集。还将收集呼出气冷凝物、尿液和血液样本。在研究开始时以及每24个月进行一次用乙酰甲胆碱进行的非特异性支气管高反应性测试,并收集诱导痰样本。在研究开始时进行空气中变应原皮肤点刺试验和胸部CT扫描,并每5年重复一次。

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