美国布列根和妇女医院Elliot Israel团队研究了缓解触发吸入糖皮质激素治疗黑人和拉丁裔哮喘成人患者的疗效。2022年2月25日出版的《新英格兰医学杂志》发表了这项成果。

黑人和拉丁裔患者承受着很重的哮喘负担。降低高发病率的努力大多没有成功，指南建议也没有针对该人群的研究。

在这项务实、开放标签的试验中，研究组随机分配患有中重度哮喘的黑人和拉丁裔成年人，使用患者激活、缓解触发的吸入糖皮质激素策略（二丙酸倍氯米松）加常规治疗（干预组）或继续进行常规治疗。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。

主要终点是严重哮喘加重的年化率。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]）评估的每月哮喘控制，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）评估的生活质量，参与者报告缺勤、缺课或无法参与日常活动的天数。还对安全性进行了评估。

1201名成年人包括603名黑人和598名拉丁裔，其中600人被分配到干预组，601人被分配到常规治疗组。干预组严重哮喘加重的年化率为0.69，常规护理组为0.82，危险比为0.85，组间差异显著。

干预组ACT评分增加了3.4分，常规治疗组增加了2.5分，差异为0.9分；两组ASUI得分分别增加了0.12分和0.08分，差异为0.04分。干预组缺勤的年化率为13.4，常规护理组为16.8，比率比为0.80。共有12.2%的受试者发生严重不良事件，但组间分布均匀。

研究结果表明，对于患有中重度哮喘的黑人和拉丁裔成年患者，在常规治疗的基础上，提供吸入糖皮质激素和一次性使用指导，可降低重度哮喘的恶化率。

附：英文原文

Title: Reliever-Triggered Inhaled Glucocorticoid in Black and Latinx Adults with Asthma | NEJM

Author: Elliot Israel, M.D.,, Juan-Carlos Cardet, M.D., M.P.H.,, Jennifer K. Carroll, M.D., M.P.H.,, Anne L. Fuhlbrigge, M.D.,, Lilin She, Ph.D.,, Frank W. Rockhold, Ph.D.,, Nancy E. Maher, M.P.H.,, Maureen Fagan, D.N.P., F.N.P.-B.C.,, Victoria E. Forth, M.M.S., P.A.-C.,, Barbara P. Yawn, M.D.,, Paulina Arias Hernandez, M.S.W.,, Jean M. Kruse, B.A.,, Brian K. Manning, M.P.H.,, Jacqueline Rodriguez-Louis, M.P.H., M.Ed.,, Joel B. Shields, M.A.,, Brianna Ericson, M.P.H.,, Alex D. Colon-Moya, M.P.H.,, Suzanne Madison, Ph.D., M.P.H.,, Tamera Coyne-Beasley, M.D., M.P.H.,, Gretchen M. Hammer, M.P.H.,, Barbara M. Kaplan, M.P.H.,, Cynthia S. Rand, Ph.D.,, Janet Robles, B.B.A.,, Opal Thompson, B.S.,, Michael E. Wechsler, M.D.,, Juan P. Wisnivesky, M.D., Dr.P.H.,, M. Diane McKee, M.D.,, Sunit P. Jariwala, M.D.,, Elina Jerschow, M.D.,, Paula J. Busse, M.D.,, David C. Kaelber, M.D., Ph.D., M.P.H.,, Sylvette Nazario, M.D.,, Michelle L. Hernandez, M.D.,, Andrea J. Apter, M.D.,, Ku-Lang Chang, M.D.,, Victor Pinto-Plata, M.D.,, Paul M. Stranges, Pharm.D.,, Laura P. Hurley, M.D., M.P.H.,, Jennifer Trevor, M.D.,, Thomas B. Casale, M.D.,, Geoffrey Chupp, M.D.,, Isaretta L. Riley, M.D., M.P.H.,, Kartik Shenoy, M.D.,, Magdalena Pasarica, M.D., Ph.D.,, Rafael A. Calderon-Candelario, M.D.,, Hazel Tapp, Ph.D.,, Ahmet Baydur, M.D.,, and Wilson D. Pace, M.D.

Issue&Volume: 2022-02-25

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.

DOI: 10.1056/NEJMoa2118813

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2118813