INITIAL研究中初始治疗和控制状态的事后分析：一项新诊断哮喘患者的观察性研究
2020/07/13
摘要
背景：为期12周、多中心、观察性INITIAL研究（NCT02143739）评估了中国新诊断哮喘患者的疾病严重程度。
方法：对，基线的常规临床实践处方的药物联合及其对哮喘控制水平的影响（采用2012年和2018年哮喘全球防治创议（GINA）标准评估）进行事后分析。
结果：研究共纳入4491例患者，基线中间歇性、轻度、中度和重度哮喘患者分别占3.9%、12.0%、22.6%和61.6%。大多数患者（90.2%）规律使用吸入性皮质类固醇激素/长效β2激动剂（ICS/LABA）。66.7%的患者使用ICS/LABA联合至少1种附加药物，其中白三烯受体拮抗剂（LTRA，54.7%）是最常见的附加药物。ICS/LABA与ICS/LABA+LTRA在间歇性哮喘（3.2%比3.0%）、轻度（11.5%比9.7%）、中度（21.2%比19.9%）和重度哮喘（64.1%比67.4%）的分布是相当的。使用ICS/LABA+LTRA和ICS/LABA的患者的控制水平采用GINA 2012标准相比是相当的，而采用GINA 2018标准相比是更低的。在第12周（使用GINA 2012）使用ICS/LABA+LTRA和ICS/LABA治疗间歇性、轻度、中度和重度哮喘的患者比例分别为78.1%比80.0%、86.5%比85.8%、78.5%比71.3%和59.6%比61.8%。使用GINA 2018标准，比例分别为86.8%比95.9%、86.1%比93.2%、82.1%比85.3%、71.9%比77.6%。
结论：ICS/LABA附加LTRA并不能提高哮喘控制水平，对一些新诊断的患者可能的没有必要的。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。
Post Hoc Analysis of Initial Treatments and Control Status in the INITIAL Study: An Observational Study of Newly Diagnosed Patients With Asthma.
Jiangtao Lin, Xiuhua Fu, Ping Jiang, Weidong Song, Xiaoyun Hu, Zhijun Jie, Chuntao Liu, Zhengguang He, Xiangdong Zhou, Huaping Tang.
Abstract
Background: The 12-week, multicentre, observational INITIAL study (NCT02143739) assessed asthma severity in newly diagnosed Chinese patients.
OBJECTIVE:The aim of this study was to examine the differences in quality of life (QOL) and health outcomes of obese and overweight children withasthma compared with normal-weight children with asthma using a descriptive comparative survey design.
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 β2 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：为期12周、多中心、观察性INITIAL研究（NCT02143739）评估了中国新诊断哮喘患者的疾病严重程度。
方法：对，基线的常规临床实践处方的药物联合及其对哮喘控制水平的影响（采用2012年和2018年哮喘全球防治创议（GINA）标准评估）进行事后分析。
结果：研究共纳入4491例患者，基线中间歇性、轻度、中度和重度哮喘患者分别占3.9%、12.0%、22.6%和61.6%。大多数患者（90.2%）规律使用吸入性皮质类固醇激素/长效β2激动剂（ICS/LABA）。66.7%的患者使用ICS/LABA联合至少1种附加药物，其中白三烯受体拮抗剂（LTRA，54.7%）是最常见的附加药物。ICS/LABA与ICS/LABA+LTRA在间歇性哮喘（3.2%比3.0%）、轻度（11.5%比9.7%）、中度（21.2%比19.9%）和重度哮喘（64.1%比67.4%）的分布是相当的。使用ICS/LABA+LTRA和ICS/LABA的患者的控制水平采用GINA 2012标准相比是相当的，而采用GINA 2018标准相比是更低的。在第12周（使用GINA 2012）使用ICS/LABA+LTRA和ICS/LABA治疗间歇性、轻度、中度和重度哮喘的患者比例分别为78.1%比80.0%、86.5%比85.8%、78.5%比71.3%和59.6%比61.8%。使用GINA 2018标准，比例分别为86.8%比95.9%、86.1%比93.2%、82.1%比85.3%、71.9%比77.6%。
结论：ICS/LABA附加LTRA并不能提高哮喘控制水平，对一些新诊断的患者可能的没有必要的。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。
(中日友好医院呼吸与危重症医学科 顾宪民 摘译 林江涛 审校 )
(BMC Pulm Med. 2020 Apr 9;20(1):87. doi: 10.1186/s12890-020-1069-2.)
(BMC Pulm Med. 2020 Apr 9;20(1):87. doi: 10.1186/s12890-020-1069-2.)
Post Hoc Analysis of Initial Treatments and Control Status in the INITIAL Study: An Observational Study of Newly Diagnosed Patients With Asthma.
Jiangtao Lin, Xiuhua Fu, Ping Jiang, Weidong Song, Xiaoyun Hu, Zhijun Jie, Chuntao Liu, Zhengguang He, Xiangdong Zhou, Huaping Tang.
Abstract
Background: The 12-week, multicentre, observational INITIAL study (NCT02143739) assessed asthma severity in newly diagnosed Chinese patients.
OBJECTIVE:The aim of this study was to examine the differences in quality of life (QOL) and health outcomes of obese and overweight children withasthma compared with normal-weight children with asthma using a descriptive comparative survey design.
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 β2 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.
上一篇：
儿童和青少年哮喘控制器依从性评价
下一篇：
哮喘发作住院：一项中国大陆29个省份的中国哮喘研究网（CARN）回顾性研究
