难治性哮喘伴肥胖患者的一年体重管理计划：一项随机对照研究
2025/07/15
摘要
背景：肥胖相关性哮喘显著增加患者发病率及死亡率。本研究通过一项单中心随机对照试验，评估为期一年的体重管理方案（Counterweight-Plus计划，CWP）与常规护理（UC）在合并肥胖的难治性哮喘患者中的疗效差异。
研究问题：对于合并肥胖的难治性哮喘患者，与UC相比，CWP能否在一年内改善哮喘控制水平和生活质量？
研究设计和方法：纳入合并肥胖（BMI≥30 kg/m²）的难治性哮喘成人患者，按1:1比例随机分配至CWP组或UC组。CWP方案由营养师支持实施，包括为期12周的全饮食替代阶段（每日850千卡低能量配方饮食）、之后恢复饮食以及维持阶段，总干预时间为一年。主要结局指标包括六项哮喘控制问卷（ACQ-6）和哮喘生活质量问卷（AQLQ）评分，次要指标涵盖医疗资源使用情况。ACQ-6和AQLQ的最小临床重要差异（MCID）均为0.5分。
结果：36例入组患者中，29例完成52周随访（CWP组13例，UC组16例）。52周后，CWP组体重降幅显著优于UC组（中位数：-14 kg [四分位数间距(IQR)：-15至-9 kg] vs 2 kg [IQR：-7至8 kg]；P=0.015）。AQLQ达到MCID的患者比例CWP组显著高于UC组（71% vs 6%，P<0.001），但ACQ-6未见组间差异。CWP组哮喘急性发作中位数从4次（IQR：2-5）降至0次（IQR：0-2）（P<0.001），但组间差异未达统计学意义。CWP组中70%患者实现≥10%体重减轻，其ACQ-6（平均差异：-1.1；95%CI：-1.9至-0.3；P=0.018）和AQLQ（平均差异：1.2；95%CI：0.4至2.1；P=0.011）均呈现显著改善。
结论：在营养师支持的体重管理计划干预下，患者实现持续减重，有望成为肥胖型哮喘的潜在治疗方法。与常规护理相比，CWP方案显著提升AQLQ达标率。组内AQLQ改善和急性发作减少提示CWP潜在临床价值。本研究结果支持开展更大样本量的临床试验以验证其哮喘相关结局的改善作用。
关键词：哮喘；哮喘缓解；难治性哮喘；肥胖；重症哮喘；体重管理
A 1-Year Weight Management Program for Difficult-to-Treat Asthma With Obesity A Randomized Controlled Study
CHEST 2025; 167(1):42-53
Varun Sharma, MD; Helen Clare Ricketts, MD; Louise McCombie, BSc; Naomi Brosnahan, PhD; Luisa Crawford, BSc; Lesley Slaughter, BSc; Anna Goodfellow, BN; Femke Steffensen, MSc; Rekha Chaudhuri, MD; Michael E. J. Lean, MD; and Douglas C. Cowan, PhD
Abstract
BACKGROUND: Obesity-associated asthma results in increased morbidity and mortality. We report 1-year asthma outcomes with a weight management regimen, the Counterweight-Plus Programme (CWP), compared with usual care (UC) in a single-center, randomized controlled trial in patients with difficult-to-treat asthma and obesity.
RESEARCH QUESTION: Can use of the CWP result in improved asthma control and quality of life compared with UC at 1 year in patients with difficult-to-treat asthma and obesity?
STUDY DESIGN AND METHODS: Adults with difficult-to-treat asthma and BMI≥30 kg/m2 were randomized (1:1 CWP:UC) to treatment. The CWP, with dietitian support, included a 12 week total diet replacement phase (850 kcal/d low-energy formula), and then subsequent food reintroduction and maintenance phases up to 1 year. Outcomes include results of the six-item Asthma Control Questionnaire (ACQ-6) and Asthma Quality of Life Questionnaire (AQLQ), as well as health care usage. A minimal clinically important difference (MCID) is 0.5 for ACQ-6 and AQLQ.
RESULTS: Of 36 patients recruited, 29 attended visits at 52 weeks (13 CWP and 16 UC). The CWP resulted in greater weight change (median,–14 kg [interquartile range (IQR),–15 to–9 kg]) compared with UC (median, 2 kg [IQR,–7 to 8 kg]; P = .015) at 52 weeks. A greater proportion achieved MCID with the CWP vs UC in AQLQ (71% vs 6%, respectively; P < .001). No between-group differences were observed in ACQ-6. Median exacerbation frequency was reduced over 52 weeks with the CWP from 4 (IQR, 2 to 5) to 0 (IQR, 0 to 2) (P < .001), although no between-group difference was observed. Seventy percent of the CWP group lost $ 10% body weight and had improvement in ACQ-6 (mean difference,–1.1; 95% CI,–1.9 to–0.3; P = .018) and AQLQ (mean difference, 1.2; 95% CI, 0.4, 2.1; P =.011) across 52 weeks.
INTERPRETATION: In this study, the use of a dietitian-supported weight management program resulted in sustained weight loss and is a potential treatment for obesity in asthma. The CWP resulted in a higher proportion achieving MCID improvements in AQLQ compared with UC. Within-group differences in AQLQ and exacerbation frequency suggest potential with the CWP. These encouraging signals justify a larger sample study to further assess asthma-related outcomes.
KEY WORDS: asthma; asthma remission; difficult-to-treat asthma; obesity; severe asthma; weight management
背景：肥胖相关性哮喘显著增加患者发病率及死亡率。本研究通过一项单中心随机对照试验，评估为期一年的体重管理方案（Counterweight-Plus计划，CWP）与常规护理（UC）在合并肥胖的难治性哮喘患者中的疗效差异。
研究问题：对于合并肥胖的难治性哮喘患者，与UC相比，CWP能否在一年内改善哮喘控制水平和生活质量？
研究设计和方法：纳入合并肥胖（BMI≥30 kg/m²）的难治性哮喘成人患者，按1:1比例随机分配至CWP组或UC组。CWP方案由营养师支持实施，包括为期12周的全饮食替代阶段（每日850千卡低能量配方饮食）、之后恢复饮食以及维持阶段，总干预时间为一年。主要结局指标包括六项哮喘控制问卷（ACQ-6）和哮喘生活质量问卷（AQLQ）评分，次要指标涵盖医疗资源使用情况。ACQ-6和AQLQ的最小临床重要差异（MCID）均为0.5分。
结果：36例入组患者中，29例完成52周随访（CWP组13例，UC组16例）。52周后，CWP组体重降幅显著优于UC组（中位数：-14 kg [四分位数间距(IQR)：-15至-9 kg] vs 2 kg [IQR：-7至8 kg]；P=0.015）。AQLQ达到MCID的患者比例CWP组显著高于UC组（71% vs 6%，P<0.001），但ACQ-6未见组间差异。CWP组哮喘急性发作中位数从4次（IQR：2-5）降至0次（IQR：0-2）（P<0.001），但组间差异未达统计学意义。CWP组中70%患者实现≥10%体重减轻，其ACQ-6（平均差异：-1.1；95%CI：-1.9至-0.3；P=0.018）和AQLQ（平均差异：1.2；95%CI：0.4至2.1；P=0.011）均呈现显著改善。
结论：在营养师支持的体重管理计划干预下，患者实现持续减重，有望成为肥胖型哮喘的潜在治疗方法。与常规护理相比，CWP方案显著提升AQLQ达标率。组内AQLQ改善和急性发作减少提示CWP潜在临床价值。本研究结果支持开展更大样本量的临床试验以验证其哮喘相关结局的改善作用。
关键词：哮喘；哮喘缓解；难治性哮喘；肥胖；重症哮喘；体重管理
（四川大学华西医院呼吸与危重症医学科 万山1 王霁1 王刚1 译）
（CHEST 2025; 167(1):42-53）
A 1-Year Weight Management Program for Difficult-to-Treat Asthma With Obesity A Randomized Controlled Study
CHEST 2025; 167(1):42-53
Varun Sharma, MD; Helen Clare Ricketts, MD; Louise McCombie, BSc; Naomi Brosnahan, PhD; Luisa Crawford, BSc; Lesley Slaughter, BSc; Anna Goodfellow, BN; Femke Steffensen, MSc; Rekha Chaudhuri, MD; Michael E. J. Lean, MD; and Douglas C. Cowan, PhD
Abstract
BACKGROUND: Obesity-associated asthma results in increased morbidity and mortality. We report 1-year asthma outcomes with a weight management regimen, the Counterweight-Plus Programme (CWP), compared with usual care (UC) in a single-center, randomized controlled trial in patients with difficult-to-treat asthma and obesity.
RESEARCH QUESTION: Can use of the CWP result in improved asthma control and quality of life compared with UC at 1 year in patients with difficult-to-treat asthma and obesity?
STUDY DESIGN AND METHODS: Adults with difficult-to-treat asthma and BMI≥30 kg/m2 were randomized (1:1 CWP:UC) to treatment. The CWP, with dietitian support, included a 12 week total diet replacement phase (850 kcal/d low-energy formula), and then subsequent food reintroduction and maintenance phases up to 1 year. Outcomes include results of the six-item Asthma Control Questionnaire (ACQ-6) and Asthma Quality of Life Questionnaire (AQLQ), as well as health care usage. A minimal clinically important difference (MCID) is 0.5 for ACQ-6 and AQLQ.
RESULTS: Of 36 patients recruited, 29 attended visits at 52 weeks (13 CWP and 16 UC). The CWP resulted in greater weight change (median,–14 kg [interquartile range (IQR),–15 to–9 kg]) compared with UC (median, 2 kg [IQR,–7 to 8 kg]; P = .015) at 52 weeks. A greater proportion achieved MCID with the CWP vs UC in AQLQ (71% vs 6%, respectively; P < .001). No between-group differences were observed in ACQ-6. Median exacerbation frequency was reduced over 52 weeks with the CWP from 4 (IQR, 2 to 5) to 0 (IQR, 0 to 2) (P < .001), although no between-group difference was observed. Seventy percent of the CWP group lost $ 10% body weight and had improvement in ACQ-6 (mean difference,–1.1; 95% CI,–1.9 to–0.3; P = .018) and AQLQ (mean difference, 1.2; 95% CI, 0.4, 2.1; P =.011) across 52 weeks.
INTERPRETATION: In this study, the use of a dietitian-supported weight management program resulted in sustained weight loss and is a potential treatment for obesity in asthma. The CWP resulted in a higher proportion achieving MCID improvements in AQLQ compared with UC. Within-group differences in AQLQ and exacerbation frequency suggest potential with the CWP. These encouraging signals justify a larger sample study to further assess asthma-related outcomes.
KEY WORDS: asthma; asthma remission; difficult-to-treat asthma; obesity; severe asthma; weight management
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黏液栓评分可预测重度哮喘患者对生物制剂的临床及肺功能反应
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