缓解触发吸入糖皮质激素治疗黑人和拉丁裔成人哮喘
2022/02/28
摘要
背景：黑人和拉丁裔患者承受着不成比例的哮喘负担。降低不成比例的发病率的努力大多没有成功，指南建议也没有基于对这些人群的研究。
方法：在这项实用的开放标签试验中，我们随机分配给患有中重度哮喘的黑人和拉丁裔成年使用患者激活、缓解触发的吸入糖皮质激素策略（丙酸倍氯米松，80μg）加上常规护理（干预）或继续常规护理。参与者进行了一次教学访问，随后进行了15次月度问卷调查。主要终点是重度哮喘发作的年化率。次要终点包括通过哮喘控制测试（ACT；范围，5[差]到25[完全控制]）测量的每月哮喘控制，通过哮喘症状效用指数（ASUI；范围，0到1，分数越低表明损伤越大）测量的生活质量，以及参与者报告的缺勤、缺课、缺课天数，或日常活动。还对安全性进行了评估。
结果：在1201名成年人（603名黑人和598名拉丁裔）中，600人被分配到干预组，601人被分配到常规护理组。干预组重度哮喘发作的年化率为0.69（95%可信区间[CI]，0.61至0.78），常规护理组为0.82（95%可信区间0.73至0.92）（危险比0.85；95%可信区间0.72至0.999；P=0.048）。干预组ACT评分增加了3.4分（95%可信区间3.1至3.6），常规护理组ACT评分增加了2.5分（95%可信区间2.3至2.8）（差异为0.9；95%可信区间0.5至1.2）；ASUI得分分别增加了0.12分（95%可信区间为0.11至0.13）和0.08分（95%可信区间为0.07至0.09）（差异为0.04；95%可信区间为0.02至0.05）。干预组误工天数的年化率为13.4，常规护理组为16.8（比率比为0.80；95%可信区间为0.67至0.95）。12.2%的受试者发生严重不良事件，组间分布均匀。
结论：在患有中重度哮喘的黑人和拉丁裔成年人中，在常规护理的基础上，提供吸入糖皮质激素和一次性使用指导，可降低重度哮喘的发作率。
Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma
Elliot Israel, Juan-Carlos Cardet, Jennifer K Carroll, Anne L Fuhlbrigge, Lilin She, Frank W Rockhold, Nancy E Maher, Maureen Fagan, Victoria E Forth, Barbara P Yawn, Paulina Arias Hernandez, Jean M Kruse, Brian K Manning, Jacqueline Rodriguez-Louis, Joel B Shields, Brianna Ericson, Alex D Colon-Moya, Suzanne Madison, Tamera Coyne-Beasley, Gretchen M Hammer, Barbara M Kaplan, Cynthia S Rand, Janet Robles, Opal Thompson, Michael E Wechsler, Juan P Wisnivesky, M Diane McKee, Sunit P Jariwala, Elina Jerschow, Paula J Busse, David C Kaelber, Sylvette Nazario, Michelle L Hernandez, Andrea J Apter, Ku-Lang Chang, Victor Pinto-Plata, Paul M Stranges, Laura P Hurley, Jennifer Trevor, Thomas B Casale, Geoffrey Chupp, Isaretta L Riley, Kartik Shenoy, Magdalena Pasarica, Rafael A Calderon-Candelario, Hazel Tapp, Ahmet Baydur, Wilson D Pace
Abstract
Background：Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations.
Methods：In this pragmatic, open-label trial, we randomly assigned Black and Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled glucocorticoid strategy (beclomethasone dipropionate, 80 μg) plus usual care (intervention) or to continue usual care. Participants had one instructional visit followed by 15 monthly questionnaires. The primary end point was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed.
Results：Of 1201 adults (603 Black and 598 Latinx), 600 were assigned to the intervention group and 601 to the usual-care group. The annualized rate of severe asthma exacerbations was 0.69 (95% confidence interval [CI], 0.61 to 0.78) in the intervention group and 0.82 (95% CI 0.73 to 0.92) in the usual-care group (hazard ratio, 0.85; 95% CI, 0.72 to 0.999; P = 0.048). ACT scores increased by 3.4 points (95% CI 3.1 to 3.6) in the intervention group and by 2.5 points (95% CI, 2.3 to 2.8) in the usual-care group (difference, 0.9; 95% CI, 0.5 to 1.2); ASUI scores increased by 0.12 points (95% CI, 0.11 to 0.13) and 0.08 points (95% CI, 0.07 to 0.09), respectively (difference, 0.04; 95% CI, 0.02 to 0.05). The annualized rate of missed days was 13.4 in the intervention group and 16.8 in the usual-care group (rate ratio, 0.80; 95% CI, 0.67 to 0.95). Serious adverse events occurred in 12.2% of the participants, with an even distribution between the groups.
Conclusions：Among Black and Latinx adults with moderate-to-severe asthma, provision of an inhaled glucocorticoid and one-time instruction on its use, added to usual care, led to a lower rate of severe asthma exacerbations.
背景：黑人和拉丁裔患者承受着不成比例的哮喘负担。降低不成比例的发病率的努力大多没有成功，指南建议也没有基于对这些人群的研究。
方法：在这项实用的开放标签试验中，我们随机分配给患有中重度哮喘的黑人和拉丁裔成年使用患者激活、缓解触发的吸入糖皮质激素策略（丙酸倍氯米松，80μg）加上常规护理（干预）或继续常规护理。参与者进行了一次教学访问，随后进行了15次月度问卷调查。主要终点是重度哮喘发作的年化率。次要终点包括通过哮喘控制测试（ACT；范围，5[差]到25[完全控制]）测量的每月哮喘控制，通过哮喘症状效用指数（ASUI；范围，0到1，分数越低表明损伤越大）测量的生活质量，以及参与者报告的缺勤、缺课、缺课天数，或日常活动。还对安全性进行了评估。
结果：在1201名成年人（603名黑人和598名拉丁裔）中，600人被分配到干预组，601人被分配到常规护理组。干预组重度哮喘发作的年化率为0.69（95%可信区间[CI]，0.61至0.78），常规护理组为0.82（95%可信区间0.73至0.92）（危险比0.85；95%可信区间0.72至0.999；P=0.048）。干预组ACT评分增加了3.4分（95%可信区间3.1至3.6），常规护理组ACT评分增加了2.5分（95%可信区间2.3至2.8）（差异为0.9；95%可信区间0.5至1.2）；ASUI得分分别增加了0.12分（95%可信区间为0.11至0.13）和0.08分（95%可信区间为0.07至0.09）（差异为0.04；95%可信区间为0.02至0.05）。干预组误工天数的年化率为13.4，常规护理组为16.8（比率比为0.80；95%可信区间为0.67至0.95）。12.2%的受试者发生严重不良事件，组间分布均匀。
结论：在患有中重度哮喘的黑人和拉丁裔成年人中，在常规护理的基础上，提供吸入糖皮质激素和一次性使用指导，可降低重度哮喘的发作率。
(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 )
(N Engl J Med. 2022 Feb 26.doi: 10.1056/NEJMoa2118813.)
(N Engl J Med. 2022 Feb 26.doi: 10.1056/NEJMoa2118813.)
Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma
Elliot Israel, Juan-Carlos Cardet, Jennifer K Carroll, Anne L Fuhlbrigge, Lilin She, Frank W Rockhold, Nancy E Maher, Maureen Fagan, Victoria E Forth, Barbara P Yawn, Paulina Arias Hernandez, Jean M Kruse, Brian K Manning, Jacqueline Rodriguez-Louis, Joel B Shields, Brianna Ericson, Alex D Colon-Moya, Suzanne Madison, Tamera Coyne-Beasley, Gretchen M Hammer, Barbara M Kaplan, Cynthia S Rand, Janet Robles, Opal Thompson, Michael E Wechsler, Juan P Wisnivesky, M Diane McKee, Sunit P Jariwala, Elina Jerschow, Paula J Busse, David C Kaelber, Sylvette Nazario, Michelle L Hernandez, Andrea J Apter, Ku-Lang Chang, Victor Pinto-Plata, Paul M Stranges, Laura P Hurley, Jennifer Trevor, Thomas B Casale, Geoffrey Chupp, Isaretta L Riley, Kartik Shenoy, Magdalena Pasarica, Rafael A Calderon-Candelario, Hazel Tapp, Ahmet Baydur, Wilson D Pace
Abstract
Background：Black and Latinx patients bear a disproportionate burden of asthma. Efforts to reduce the disproportionate morbidity have been mostly unsuccessful, and guideline recommendations have not been based on studies in these populations.
Methods：In this pragmatic, open-label trial, we randomly assigned Black and Latinx adults with moderate-to-severe asthma to use a patient-activated, reliever-triggered inhaled glucocorticoid strategy (beclomethasone dipropionate, 80 μg) plus usual care (intervention) or to continue usual care. Participants had one instructional visit followed by 15 monthly questionnaires. The primary end point was the annualized rate of severe asthma exacerbations. Secondary end points included monthly asthma control as measured with the Asthma Control Test (ACT; range, 5 [poor] to 25 [complete control]), quality of life as measured with the Asthma Symptom Utility Index (ASUI; range, 0 to 1, with lower scores indicating greater impairment), and participant-reported missed days of work, school, or usual activities. Safety was also assessed.
Results：Of 1201 adults (603 Black and 598 Latinx), 600 were assigned to the intervention group and 601 to the usual-care group. The annualized rate of severe asthma exacerbations was 0.69 (95% confidence interval [CI], 0.61 to 0.78) in the intervention group and 0.82 (95% CI 0.73 to 0.92) in the usual-care group (hazard ratio, 0.85; 95% CI, 0.72 to 0.999; P = 0.048). ACT scores increased by 3.4 points (95% CI 3.1 to 3.6) in the intervention group and by 2.5 points (95% CI, 2.3 to 2.8) in the usual-care group (difference, 0.9; 95% CI, 0.5 to 1.2); ASUI scores increased by 0.12 points (95% CI, 0.11 to 0.13) and 0.08 points (95% CI, 0.07 to 0.09), respectively (difference, 0.04; 95% CI, 0.02 to 0.05). The annualized rate of missed days was 13.4 in the intervention group and 16.8 in the usual-care group (rate ratio, 0.80; 95% CI, 0.67 to 0.95). Serious adverse events occurred in 12.2% of the participants, with an even distribution between the groups.
Conclusions：Among Black and Latinx adults with moderate-to-severe asthma, provision of an inhaled glucocorticoid and one-time instruction on its use, added to usual care, led to a lower rate of severe asthma exacerbations.
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tezepelumab在严重哮喘中的基线2型生物标志物水平和反应
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