支气管热成形术对严重哮喘气道平滑肌减少及临床反应的影响。塔斯马随机试验
2021/02/09
摘要
背景:支气管热成形术(BT)是一种针对气道平滑肌(ASM)的支气管镜治疗方法。观察性研究表明，BT术后ASM质量减少，但缺乏适当的对照组。此外，由于治疗反应是可变的，确定最佳的候选BT治疗是重要的。
目的:首先，评估BT对ASM质量的影响，其次，确定与BT反应相关的患者特征。
方法:严重哮喘患者(n = 40)被随机分为立即(n = 20)或延迟(n = 20) BT治疗。随机分组前，收集临床、功能、血液和气道活检数据。延迟对照组在标准临床护理6个月后进行包括活检在内的重新评估，然后进行BT治疗。两组在6个月后获得包括活检在内的BT治疗后数据。用自动数字分析软件计算ASM肿块(总活检中%的desmin阳性或α-平滑肌肌动蛋白区)。探讨基线特征与哮喘控制问卷和哮喘生活质量问卷(AQLQ)改善的关系。
结果:即刻BT组(n = 17)的ASM中位质量下降了50%，而延迟对照组(n = 19)没有变化(P = 0.0004)。
在即时组中，哮喘控制问卷得分提高了- 0.79(四分位数范围[IQR]，- 1.61-0.02)，而延迟组为0.09 (IQR，- 0.25-1.17)(P = 0.006)。AQLQ得分提高了0.83 (IQR，−0.15 - 1.69)，而−0.02 (IQR，−0.77 - 0.75)(P = 0.04)。总组(n = 35)的治疗反应与血清IgE和嗜酸性粒细胞呈正相关，但与基线ASM质量无关。
结论:与随机的非BT治疗对照组相比，BT治疗后ASM质量显著下降。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
Goorsenberg AWM, d'Hooghe JNS, Srikanthan K, et al
Abstract
Rationale: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.
Objectives:First, to assess the effect of BT on ASM mass, and second, to identify patient characteristics that correlate with BT response.
Methods:Patients with severe asthma (n = 40) were randomized to immediate (n = 20) or delayed (n = 20) BT treatment. Before randomization, clinical, functional, blood, and airway biopsy data were collected. In the delayed control group, reassessment, 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 analysis software. Associations between baseline characteristics and Asthma Control Questionnaire and Asthma Quality of Life Questionnaire (AQLQ) improvement were explored.
Measurements and Main 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, Asthma Control Questionnaire scores improved with −0.79 (interquartile range [IQR], −1.61 to 0.02) compared with 0.09 (IQR, −0.25 to 1.17) in the delayed group (P = 0.006). AQLQ scores improved with 0.83 (IQR, −0.15 to 1.69) versus −0.02 (IQR, −0.77 to 0.75) (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 with 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)是一种针对气道平滑肌(ASM)的支气管镜治疗方法。观察性研究表明，BT术后ASM质量减少，但缺乏适当的对照组。此外，由于治疗反应是可变的，确定最佳的候选BT治疗是重要的。
目的:首先，评估BT对ASM质量的影响，其次，确定与BT反应相关的患者特征。
方法:严重哮喘患者(n = 40)被随机分为立即(n = 20)或延迟(n = 20) BT治疗。随机分组前，收集临床、功能、血液和气道活检数据。延迟对照组在标准临床护理6个月后进行包括活检在内的重新评估，然后进行BT治疗。两组在6个月后获得包括活检在内的BT治疗后数据。用自动数字分析软件计算ASM肿块(总活检中%的desmin阳性或α-平滑肌肌动蛋白区)。探讨基线特征与哮喘控制问卷和哮喘生活质量问卷(AQLQ)改善的关系。
结果:即刻BT组(n = 17)的ASM中位质量下降了50%，而延迟对照组(n = 19)没有变化(P = 0.0004)。
在即时组中，哮喘控制问卷得分提高了- 0.79(四分位数范围[IQR]，- 1.61-0.02)，而延迟组为0.09 (IQR，- 0.25-1.17)(P = 0.006)。AQLQ得分提高了0.83 (IQR，−0.15 - 1.69)，而−0.02 (IQR，−0.77 - 0.75)(P = 0.04)。总组(n = 35)的治疗反应与血清IgE和嗜酸性粒细胞呈正相关，但与基线ASM质量无关。
结论:与随机的非BT治疗对照组相比，BT治疗后ASM质量显著下降。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 李春晓 摘译 林江涛 审校）
（Am J Respir Crit Care Med, 2021, 203(2): 175-184.）
（Am J Respir Crit Care Med, 2021, 203(2): 175-184.）
Bronchial Thermoplasty Induced Airway Smooth Muscle Reduction and Clinical Response in Severe Asthma. The TASMA Randomized Trial
Goorsenberg AWM, d'Hooghe JNS, Srikanthan K, et al
Abstract
Rationale: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.
Objectives:First, to assess the effect of BT on ASM mass, and second, to identify patient characteristics that correlate with BT response.
Methods:Patients with severe asthma (n = 40) were randomized to immediate (n = 20) or delayed (n = 20) BT treatment. Before randomization, clinical, functional, blood, and airway biopsy data were collected. In the delayed control group, reassessment, 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 analysis software. Associations between baseline characteristics and Asthma Control Questionnaire and Asthma Quality of Life Questionnaire (AQLQ) improvement were explored.
Measurements and Main 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, Asthma Control Questionnaire scores improved with −0.79 (interquartile range [IQR], −1.61 to 0.02) compared with 0.09 (IQR, −0.25 to 1.17) in the delayed group (P = 0.006). AQLQ scores improved with 0.83 (IQR, −0.15 to 1.69) versus −0.02 (IQR, −0.77 to 0.75) (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 with 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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在严重难治性哮喘中支气管热成形术治疗反应的临床和组织病理学预测因素
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对2型炎症型未控制持续性哮喘治疗中的关键问题的认识
