支气管热成形术诱导重症哮喘患者气道平滑肌减少和临床反应：TASMA随机试验
2020/08/20
摘要
背景：支气管热成形术(BT)是针对气道平滑肌(ASM)的重症哮喘的支气管镜治疗。观察性研究显示BT后ASM质量减少，但缺乏合适的对照组。此外，由于治疗反应是可变的，因此确定最佳的BT治疗非常重要。
目的：第一，评估BT对ASM质量的影响；第二，确定与BT反应相关的患者特征。
方法：将40例重症哮喘患者随机分为即刻BT治疗(n=20)和延迟BT治疗(n=20)。在随机分组之前，收集临床、功能、血液和气道活检数据。在延迟对照组，在6个月的标准临床治疗后进行重新评估包括活检，然后再行BT。两组患者在6个月后都获得了包括活检在内的BT后数据。用自动数字分析软件计算ASM质量(阳性蛋白或α-平滑肌肌动蛋白面积占总活检面积的百分比)。探讨基线特征与哮喘控制和哮喘生活质量问卷(ACQ/AQLQ)改善之间的关系。
结果：与延迟对照组(n=19)相比，即刻BT组(n=17)ASM质量中位数减少>50%(p=0.0004)。与延迟组的0.09(-0.25；1.17IQR)相比，即刻组的ACQ得分提高了-0.79(-1.61；0.02IQR)(p=0.006)。与延迟组的-0.02(-0.77；0.75 IQR)相比，AQLQ得分提高0.83(-0.15；1.69 IQR) (p=0.04)。总体组(n=35)的治疗反应与血清IgE和嗜酸性粒细胞呈正相关，但与ASM基线质量无关。
结论：与随机非BT治疗的对照组相比，BT治疗后ASM质量显著减少。治疗反应与血清IgE和嗜酸性粒细胞水平有关，但与ASM质量无关。
Bronchial Thermoplasty Induced Airway Smooth Muscle Reduction and Clinical Response in Severe Asthma: The TASMA Randomized Trial.
Annika W M Goorsenberg, Julia N S d'Hooghe, Karthikan Srikanthan, Nick H T Ten Hacken, Els J M Weersink, Joris J T H Roelofs, Samuel V Kemp, Elisabeth H Bel, Pallav L Shah, Jouke T Annema, Peter I Bonta, TASMA research group.
Abstract
BACKGROUND:Bronchial Thermoplasty (BT) is a bronchoscopic treatment for severe asthma targeting airway smooth muscle (ASM). Observational studies have shown ASM mass reduction after BT but appropriate control groups are lacking. Furthermore, as treatment response is variable, identifying optimal candidates for BT treatment is important.
OBJECTIVE:First, to assess the effect of BT on ASM mass and second, to identify patient characteristics that correlate with BT-response.
METHODS:Severe asthma patients (n=40) were randomized to immediate (n=20) or delayed (n=20) BT-treatment. Prior to randomization, clinical, functional, blood and airway biopsy data were collected. In the delayed control group, re-assessment, including biopsies, was performed after 6 months of standard clinical care, followed by BT. In both groups, post-BT data including biopsies were obtained after 6 months. ASM mass (% positive desmin or α-smooth muscle actin area in the total biopsy) was calculated with automated digital analyses software. Associations between baseline characteristics and Asthma Control and Asthma Quality of Life Questionnaire (ACQ/AQLQ) improvement were explored.
RESULTS:Median ASM mass decreased by >50% in the immediate BT group (n=17) versus no change in the delayed control group (n=19) (p=0.0004). In the immediate group ACQ scores improved with -0.79 (-1.61;0.02 IQR) compared to 0.09 (-0.25;1.17 IQR) in the delayed group (p=0.006). AQLQ scores improved with 0.83 (-0.15;1.69 IQR) versus -0.02 (-0.77;0.75 IQR) (p=0.04). Treatment response in the total group (n=35) was positively associated with serum IgE and eosinophils, but not with baseline ASM mass.
CONCLUSIONS:ASM mass significantly decreases after BT when compared to a randomized non-BT treated control group. Treatment response was associated with serum IgE and eosinophil levels but not with ASM mass.
背景：支气管热成形术(BT)是针对气道平滑肌(ASM)的重症哮喘的支气管镜治疗。观察性研究显示BT后ASM质量减少，但缺乏合适的对照组。此外，由于治疗反应是可变的，因此确定最佳的BT治疗非常重要。
目的：第一，评估BT对ASM质量的影响；第二，确定与BT反应相关的患者特征。
方法：将40例重症哮喘患者随机分为即刻BT治疗(n=20)和延迟BT治疗(n=20)。在随机分组之前，收集临床、功能、血液和气道活检数据。在延迟对照组，在6个月的标准临床治疗后进行重新评估包括活检，然后再行BT。两组患者在6个月后都获得了包括活检在内的BT后数据。用自动数字分析软件计算ASM质量(阳性蛋白或α-平滑肌肌动蛋白面积占总活检面积的百分比)。探讨基线特征与哮喘控制和哮喘生活质量问卷(ACQ/AQLQ)改善之间的关系。
结果：与延迟对照组(n=19)相比，即刻BT组(n=17)ASM质量中位数减少>50%(p=0.0004)。与延迟组的0.09(-0.25；1.17IQR)相比，即刻组的ACQ得分提高了-0.79(-1.61；0.02IQR)(p=0.006)。与延迟组的-0.02(-0.77；0.75 IQR)相比，AQLQ得分提高0.83(-0.15；1.69 IQR) (p=0.04)。总体组(n=35)的治疗反应与血清IgE和嗜酸性粒细胞呈正相关，但与ASM基线质量无关。
结论：与随机非BT治疗的对照组相比，BT治疗后ASM质量显著减少。治疗反应与血清IgE和嗜酸性粒细胞水平有关，但与ASM质量无关。
(中日友好医院呼吸与危重症医学科 王瑞茵 摘译 林江涛 审校)
(Am J Respir Crit Care Med. 2020 Jul 28.)
(Am J Respir Crit Care Med. 2020 Jul 28.)
Bronchial Thermoplasty Induced Airway Smooth Muscle Reduction and Clinical Response in Severe Asthma: The TASMA Randomized Trial.
Annika W M Goorsenberg, Julia N S d'Hooghe, Karthikan Srikanthan, Nick H T Ten Hacken, Els J M Weersink, Joris J T H Roelofs, Samuel V Kemp, Elisabeth H Bel, Pallav L Shah, Jouke T Annema, Peter I Bonta, TASMA research group.
Abstract
BACKGROUND:Bronchial Thermoplasty (BT) is a bronchoscopic treatment for severe asthma targeting airway smooth muscle (ASM). Observational studies have shown ASM mass reduction after BT but appropriate control groups are lacking. Furthermore, as treatment response is variable, identifying optimal candidates for BT treatment is important.
OBJECTIVE:First, to assess the effect of BT on ASM mass and second, to identify patient characteristics that correlate with BT-response.
METHODS:Severe asthma patients (n=40) were randomized to immediate (n=20) or delayed (n=20) BT-treatment. Prior to randomization, clinical, functional, blood and airway biopsy data were collected. In the delayed control group, re-assessment, including biopsies, was performed after 6 months of standard clinical care, followed by BT. In both groups, post-BT data including biopsies were obtained after 6 months. ASM mass (% positive desmin or α-smooth muscle actin area in the total biopsy) was calculated with automated digital analyses software. Associations between baseline characteristics and Asthma Control and Asthma Quality of Life Questionnaire (ACQ/AQLQ) improvement were explored.
RESULTS:Median ASM mass decreased by >50% in the immediate BT group (n=17) versus no change in the delayed control group (n=19) (p=0.0004). In the immediate group ACQ scores improved with -0.79 (-1.61;0.02 IQR) compared to 0.09 (-0.25;1.17 IQR) in the delayed group (p=0.006). AQLQ scores improved with 0.83 (-0.15;1.69 IQR) versus -0.02 (-0.77;0.75 IQR) (p=0.04). Treatment response in the total group (n=35) was positively associated with serum IgE and eosinophils, but not with baseline ASM mass.
CONCLUSIONS:ASM mass significantly decreases after BT when compared to a randomized non-BT treated control group. Treatment response was associated with serum IgE and eosinophil levels but not with ASM mass.
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