初始治疗和控制状态的事后分析：一项对新诊断哮喘患者的观察性研究
Post hoc analysis of initial treatments and control status in the INITIAL study: an observational study of newly diagnosed patients with asthma.
机构信息
Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, No.2 Yinghua East Street, Chaoyang District, Beijing, 100029, China.
Department of Pulmonary and Critical Care Medicine, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, 010050, China.
出版信息
BMC Pulm Med. 2020 Apr 9;20(1):87. doi: 10.1186/s12890-020-1069-2.
BACKGROUND
The 12-week, multicentre, observational INITIAL study (NCT02143739) assessed asthma severity in newly diagnosed Chinese patients.
METHODS
Post hoc analysis of medication combinations prescribed per routine clinical practice at baseline, and the impact on control levels evaluated using 2012 vs 2018 Global Initiative for Asthma (GINA) criteria.
RESULTS
In total, 4491 patients were included in the analysis. At baseline, intermittent, mild, moderate and severe asthma was reported in 3.9, 12.0, 22.6 and 61.6% of patients, respectively. Most patients (90.2%) were prescribed inhaled corticosteroid/long-acting β agonist (ICS/LABA). ICS/LABA plus ≥1 additional medication(s) was prescribed to 66.7% of patients, with leukotriene receptor antagonist (LTRA, 54.7%) being the most common additional medication. Distribution of ICS/LABA vs ICS/LABA+LTRA was comparable in patients with intermittent (3.2% vs 3.0%), mild (11.5% vs 9.7%), moderate (21.2% vs 19.9%) and severe asthma (64.1% vs 67.4%). Control levels among patients using ICS/LABA+LTRA vs ICS/LABA were comparable using GINA 2012 and lower using GINA 2018 criteria. The proportion of patients using ICS/LABA+LTRA vs ICS/LABA with intermittent, mild, moderate and severe asthma controlled at Week 12 (using GINA 2012) were 78.1% vs 80.0, 86.5% vs 85.8, 78.5% vs 71.3, and 59.6% vs 61.8%, respectively. Using GINA 2018 criteria proportions were 86.8% vs 95.9, 86.1% vs 93.2, 82.1% vs 85.3, and 71.9% vs 77.6%, respectively.
CONCLUSIONS
Asthma control was not improved by adding LTRA to ICS/LABA and may have been unnecessary for some newly diagnosed patients. These findings were irrespective of the GINA criteria (2012 vs 2018) used and baseline severity.
背景
这项为期 12 周、多中心、观察性的 INITIAL 研究（NCT02143739）评估了新诊断的中国患者的哮喘严重程度。
方法
根据常规临床实践在基线时规定的药物组合进行事后分析，并使用 2012 年和 2018 年全球哮喘倡议（GINA）标准评估对控制水平的影响。
结果
共有 4491 名患者纳入分析。基线时，间歇性、轻度、中度和重度哮喘分别报告为 3.9%、12.0%、22.6%和 61.6%的患者。大多数患者（90.2%）接受吸入皮质类固醇/长效β激动剂（ICS/LABA）治疗。66.7%的患者接受 ICS/LABA 加≥1种附加药物治疗，白三烯受体拮抗剂（LTRA，54.7%）是最常见的附加药物。在间歇性（3.2% vs 3.0%）、轻度（11.5% vs 9.7%）、中度（21.2% vs 19.9%）和重度哮喘（64.1% vs 67.4%）患者中，ICS/LABA 与 ICS/LABA+LTRA 的分布相当。使用 GINA 2012 标准时，使用 ICS/LABA+LTRA 的患者与使用 ICS/LABA 的患者的控制水平相当，而使用 GINA 2018 标准时则较低。使用 GINA 2012 标准，在第 12 周时使用 ICS/LABA+LTRA 的患者中，间歇性、轻度、中度和重度哮喘控制的比例分别为 78.1% vs 80.0%、86.5% vs 85.8%、78.5% vs 71.3%和 59.6% vs 61.8%，而使用 ICS/LABA 的患者比例分别为 86.8% vs 95.9%、86.1% vs 93.2%、82.1% vs 85.3%和 71.9% vs 77.6%。
结论
在 ICS/LABA 中加入 LTRA 并没有改善哮喘控制，并且对一些新诊断的患者可能是不必要的。这些发现与使用的 GINA 标准（2012 年与 2018 年）和基线严重程度无关。
Zotero 插件