美国接受GINA推荐4-5级治疗哮喘患者基本特征
2018/01/05
摘要
研究背景：ERS/ATS指南均认为重症哮喘的诊治存在较大不足。
研究目的：本研究旨在描述美国接受GINA4-5级治疗哮喘患者临床负担。
方法：哮喘患者，≥12岁，接受GINA4-5级治疗，在2010年1月1日至2016年4月30日期间在美国大型变态反应治疗网络进行治疗。通过收集电子病历的方式进行回顾性分析。临床数据包括肺功能（FEV1和FEV1%），ACT症状评分，FeNO(≥25ppb提示气道炎症)，以及药物应用。随访周期为12月和24月。
结果：在120116名哮喘患者中，12922名（10.8%）为重症哮喘，68%（n=8751）接受4级治疗。平均基线应用支气管扩张剂前FEV1%为79.7%，基线ACT为17分。哮喘未控制定义为ACT评分≤19和/或FEV1%<80%和/或需要OCS≥2次，52.5%接受4级治疗患者以及57.7%接受5级治疗患者基线期处于哮喘未控制。在亚组人群中，40.9%患者嗜酸性粒细胞≥300细胞/mm3，44%患者FeNO≥25ppb。在12个月随访期（n=4022）和24个月随访期（n=2326），应用支气管扩张剂后FEV1较基线有轻微改善（0.07L和0.04L）。
结论：接受GINA4-5级治疗患者中，仍有较高比例患者处于哮喘未控制状态，需要叠加额外治疗以减轻重症哮喘临床负担。
Characterizing patients with asthma who received Global Initiative for Asthma steps 4-5 therapy and managed in a specialty care setting.
Allergy Asthma Proc. 2018 Jan 1;39(1):27-35. doi: 10.2500/aap.2018.39.4094.
Stone B, Davis JR, Trudo F, Schiffman B, Alzola C, Brown D, Fox KM.
Abstract
BACKGROUND:Severe asthma is recognized in the European Respiratory Society/American Thoracic Society guidelines as a major unmet need in the management of asthma.
OBJECTIVE:The study objective was to describe the clinical burden of Global Initiative for Asthma (GINA) steps 4-5 asthma for patients treated by specialists in the U.S. community setting.
METHODS:Patients, ages ≥12 years, with asthma who received GINA step 4 or 5 treatment and were treated at a large U.S. allergy practice network between January 1, 2010, and April 30, 2016, were retrospectively identified by using electronic health records. Clinical outcomes included lung function (forced expiratory volume in one second of expiration [FEV1] and predicted), symptom control (Asthma Control Test [ACT]), the fractional exhaled nitric oxide (FeNO) value (FeNO ≥25 ppb indicates airway inflammation), and asthma medication use. The change in outcomes from baseline to 12 and 24 months after the index date was calculated.
RESULTS:Of 120,116 patients with asthma, 12,922 (10.8%) had severe asthma, 68% (n = 8751) while on step 4 therapy. The mean baseline prebronchodilation FEV1% predicted was 79.7%, and the mean baseline ACT score was 17.0. With uncontrolled asthma defined as an ACT score of ≤19 and/or an FEV1 value of <80% predicted and/or oral corticosteroid use of ≥2 bursts, 52.5% and 57.7% of patients on step 4 and step 5 therapy, respectively, had uncontrolled asthma at baseline. Of a subset of patients, 40.9% had an eosinophil count of ≥300 cells/mm3 and 44% had an FeNO concentration of ≥25 ppb. Small increases in the FEV1 value were observed from baseline to 12 months (n = 4022) and 24 months (n = 2326) postindex (0.07 and 0.04 L, respectively).
CONCLUSION:A considerable proportion of patients had uncontrolled asthma while on current GINA steps 4-5 treatment, which indicated that additional therapies may be required to reduce the clinical burden of severe asthma.
研究背景：ERS/ATS指南均认为重症哮喘的诊治存在较大不足。
研究目的：本研究旨在描述美国接受GINA4-5级治疗哮喘患者临床负担。
方法：哮喘患者，≥12岁，接受GINA4-5级治疗，在2010年1月1日至2016年4月30日期间在美国大型变态反应治疗网络进行治疗。通过收集电子病历的方式进行回顾性分析。临床数据包括肺功能（FEV1和FEV1%），ACT症状评分，FeNO(≥25ppb提示气道炎症)，以及药物应用。随访周期为12月和24月。
结果：在120116名哮喘患者中，12922名（10.8%）为重症哮喘，68%（n=8751）接受4级治疗。平均基线应用支气管扩张剂前FEV1%为79.7%，基线ACT为17分。哮喘未控制定义为ACT评分≤19和/或FEV1%<80%和/或需要OCS≥2次，52.5%接受4级治疗患者以及57.7%接受5级治疗患者基线期处于哮喘未控制。在亚组人群中，40.9%患者嗜酸性粒细胞≥300细胞/mm3，44%患者FeNO≥25ppb。在12个月随访期（n=4022）和24个月随访期（n=2326），应用支气管扩张剂后FEV1较基线有轻微改善（0.07L和0.04L）。
结论：接受GINA4-5级治疗患者中，仍有较高比例患者处于哮喘未控制状态，需要叠加额外治疗以减轻重症哮喘临床负担。
（上海交通大学医学院附属瑞金医院呼吸与危重症医学科 周剑平 万欢英 摘译）
（Allergy Asthma Proc. 2018 Jan 1;39(1):27-35. doi:10.2500/aap.2018.39.4094.）
（Allergy Asthma Proc. 2018 Jan 1;39(1):27-35. doi:10.2500/aap.2018.39.4094.）
Characterizing patients with asthma who received Global Initiative for Asthma steps 4-5 therapy and managed in a specialty care setting.
Allergy Asthma Proc. 2018 Jan 1;39(1):27-35. doi: 10.2500/aap.2018.39.4094.
Stone B, Davis JR, Trudo F, Schiffman B, Alzola C, Brown D, Fox KM.
Abstract
BACKGROUND:Severe asthma is recognized in the European Respiratory Society/American Thoracic Society guidelines as a major unmet need in the management of asthma.
OBJECTIVE:The study objective was to describe the clinical burden of Global Initiative for Asthma (GINA) steps 4-5 asthma for patients treated by specialists in the U.S. community setting.
METHODS:Patients, ages ≥12 years, with asthma who received GINA step 4 or 5 treatment and were treated at a large U.S. allergy practice network between January 1, 2010, and April 30, 2016, were retrospectively identified by using electronic health records. Clinical outcomes included lung function (forced expiratory volume in one second of expiration [FEV1] and predicted), symptom control (Asthma Control Test [ACT]), the fractional exhaled nitric oxide (FeNO) value (FeNO ≥25 ppb indicates airway inflammation), and asthma medication use. The change in outcomes from baseline to 12 and 24 months after the index date was calculated.
RESULTS:Of 120,116 patients with asthma, 12,922 (10.8%) had severe asthma, 68% (n = 8751) while on step 4 therapy. The mean baseline prebronchodilation FEV1% predicted was 79.7%, and the mean baseline ACT score was 17.0. With uncontrolled asthma defined as an ACT score of ≤19 and/or an FEV1 value of <80% predicted and/or oral corticosteroid use of ≥2 bursts, 52.5% and 57.7% of patients on step 4 and step 5 therapy, respectively, had uncontrolled asthma at baseline. Of a subset of patients, 40.9% had an eosinophil count of ≥300 cells/mm3 and 44% had an FeNO concentration of ≥25 ppb. Small increases in the FEV1 value were observed from baseline to 12 months (n = 4022) and 24 months (n = 2326) postindex (0.07 and 0.04 L, respectively).
CONCLUSION:A considerable proportion of patients had uncontrolled asthma while on current GINA steps 4-5 treatment, which indicated that additional therapies may be required to reduce the clinical burden of severe asthma.
上一篇：
重症嗜酸性粒细胞性哮喘生物学标记物
下一篇：
气道直径变化是决定呼出气一氧化氮（FENO）反应哮喘控制状态的重要因素
