短波透热疗法辅助高频胸壁振荡治疗慢性阻塞性肺疾病急性加重：一项随机对照试验。
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摘要 目的：本研究旨在评估短波透热疗法（SWD）联合高频胸壁振荡（HFCWO）与单独HFCWO及常规治疗相比，对因慢性阻塞性肺疾病急性加重（AECOPD）住院患者的疗效和安全性。 方法：这项单中心、平行分组随机对照试验纳入2024年3月至2025年3月期间在永康市第一人民医院住院的89例AECOPD患者。受试者被随机分配（1:1:1）接受单独常规治疗（对照组）、常规治疗加HFCWO（HFCWO组）或常规治疗加SWD和HFCWO联合治疗（联合组），持续72小时。在基线和干预72小时后评估主要和次要结局，并进行组内和组间比较。主要结局包括慢性阻塞性肺疾病评估测试（CAT）和呼吸困难、咳嗽和咳痰量表（BCSS）评分的变化。次要结局包括肺功能参数（FEV1、FVC和FEV1/FVC）、动脉血气参数（PaO2和PaCO2）、炎症标志物（白细胞介素-6、C反应蛋白和白细胞计数）以及定量痰液指标（24小时痰量、总细胞计数和分类计数）。 结果：在72-h干预后，联合治疗组在CAT和BCSS评分方面的降幅均显著大于高频胸壁振荡（HFCWO）组和对照组（p < 0.05）。与单独HFCWO或常规治疗相比，联合治疗在动脉血气参数（PaO2和PaCO2）和痰液清除指标（24-h痰量以及中性粒细胞和嗜酸性粒细胞百分比）方面也取得了更优的改善。相比之下，肺功能参数（FEV1和FVC）和炎症标志物（IL-6、CRP和WBC）未观察到显著差异。 结论：与单独HFCWO或常规治疗相比，联合干预可显著改善慢性阻塞性肺疾病急性加重（AECOPD）患者的呼吸症状、动脉氧合和痰液清除。加用热疗增强了机械气道廓清的临床疗效，为AECOPD急性期管理提供了一种可行的辅助策略。 1. 引言 慢性阻塞性肺疾病急性加重（AECOPD）以呼吸症状超出日常变异的急性恶化为特征，是该疾病自然病程中的关键事件 [, ]。根据2024年慢性阻塞性肺疾病全球倡议（GOLD）指南，目前感染性AECOPD的标准治疗包括控制性氧疗、短效支气管扩张剂和抗生素 []。尽管接受标准药物治疗，持续的痰液潴留和气道阻塞仍会导致肺功能下降、细菌定植、住院时间延长和医疗费用增加 [, ]。因此，旨在促进黏液清除和改善生活质量的辅助物理治疗，作为AECOPD综合管理的重要组成部分，已日益受到关注。 目前，高频胸壁振荡（HFCWO）是增强呼吸疾病患者气道清除的主要物理治疗方式之一[]。该技术采用充气背心以12–15 Hz的频率对胸壁产生振荡性压迫，将振动能量传递至气道以清除支气管壁上的黏液，并通过脉冲气流促进其向头侧移动[]。尽管HFCWO在囊性纤维化和支气管扩张中已显示出疗效，但其仅依赖机械振动可能不足以有效清除在AECOPD患者中观察到的典型粘稠、顽固的痰液[]。短波透热疗法（SWD）提供了一种机制上互补的方法，利用高频电磁能产生深部组织热效应，从而降低痰液粘度，改善局部血液循环，增强黏液纤毛转运功能，并可能增加潴留分泌物的顺应性[, ]。理论上，SWD与HFCWO的序贯联合构成了一种协同策略，其中预处理热调节降低痰液顽固性并改善其流变学特性，从而促进后续HFCWO的机械松动和排出。然而，这种联合治疗尚未在随机对照试验中得到严格评估，现有的物理治疗研究缺乏客观定量的痰液指标、全身炎症标志物的动态监测，以及联合t的评估。 治疗方式。因此，临床医生缺乏明确的指导，无法确定辅助性物理治疗——尤其是热力与机械联合干预——在急性情况下是否比标准药物治疗能提供显著的额外获益。 本研究旨在通过一项单中心、随机对照试验，评估短波透热疗法（SWD）联合高频胸壁振荡（HFCWO）与单独HFCWO及单独常规治疗在慢性阻塞性肺疾病急性加重期（AECOPD）患者症状缓解、肺功能改善和痰液清除方面的疗效和安全性。本研究结果将为AECOPD急性期物理治疗的选择提供循证指导，并探讨热力与机械干预联合的临床应用价值。 这是一项单中心、平行组随机对照试验，于2024年3月至2025年3月在永康市第一人民医院进行。符合纳入标准的AECOPD患者按1:1:1的比例随机分配，分别接受单独HFCWO、SWD联合HFCWO或单独常规治疗。随机化使用计算机生成的随机序列（https://www.jyshare.com/front-end/6680）进行，并通过按顺序编号、不透明、密封的信封实现分配隐藏。由于物理干预的性质，参与者和治疗医师无法设盲；然而，结局评估者和数据分析师在整个研究期间对分组分配保持盲态。基于AECOPD患者的治疗时间窗和气道廓清技术的即时生理效应，干预时间设定为72小时（3天），在基线和第3天进行评估。本研究遵循《赫尔辛基宣言》进行，并获得永康市第一人民医院伦理委员会批准（批准号：YKSDYRMYYEC2024‐KT‐HS‐024‐02）。所有参与者均获得书面知情同意。 样本量是根据主要结局——COPD评估测试（CAT）评分从基线到72小时的变化——事先估算的。在正式试验之前，我们中心进行的一项预试验提供了初步数据，显示对照组平均降低1.5分，HFCWO组平均降低4.0分，联合组平均降低6.5分，合并标准差为6.0分。使用单因素方差分析（ANOVA）比较三个独立组（G∗Power 3.1.9.7；德国杜塞尔多夫海因里希·海涅大学），采用双侧显著性水平0.05和统计功效0.80，所需的最小总样本量为84例患者（每组28例）。考虑到10%的预期脱落率，目标入组人数设定为93例。总共99例患者被随机分组并完成了干预，达到了计划样本量。 总共有89例因AECOPD住院的患者于2024年3月至2025年3月期间从永康市第一人民医院呼吸内科和急诊科招募。感染性急性加重被定义为呼吸困难加重、咳嗽和咳痰增多、痰液颜色或性状改变以及发热，并伴有影像学上的肺实变证据。 纳入标准如下：（1）符合GOLD 2024慢性阻塞性肺疾病急性加重（AECOPD）诊断标准，即在14天内呼吸困难、咳嗽或咳痰急性加重，超出日常变异，需要调整治疗，并伴有脓性痰或胸部影像学证实的肺部感染，且GOLD分级为3–4级；（2）年龄50–80岁，男性或女性；（3）意识清楚，能够配合量表评估和肺功能检查，并签署知情同意书；（4）入组前2周内未使用全身性皮质类固醇、黏液溶解剂或接受物理治疗。 排除标准如下：（1）合并气胸、肺栓塞、急性心力衰竭或需要紧急复苏的肺性脑病；（2）物理治疗禁忌证，包括胸部金属植入物、皮肤病变或感染、胸廓畸形，或近期（3个月内）胸部手术；（3）合并支气管扩张、活动性肺结核、肺癌或其他肺实质疾病；（4）严重肝或肾功能不全、活动性出血或凝血功能障碍；（5）妊娠或哺乳期，或近30天内参加过另一项介入性临床试验；（6）严重认知障碍、精神疾病或语言障碍，无法进行充分评估。 2.3 干预 所有入组患者均根据2024年GOLD指南接受慢性阻塞性肺疾病急性加重（AECOPD）的常规治疗。治疗措施包括控制性氧疗、短效支气管扩张剂（沙丁胺醇2.5 mg联合异丙托溴铵500 μg，每6–8小时雾化吸入一次）、全身性糖皮质激素（泼尼松等效剂量1 mg/kg/天，最大60 mg/天，连续3天）、抗生素及健康教育。参与者按1:1:1的比例随机分配至三个平行组：对照组仅接受常规治疗；高频胸壁振荡（HFCWO）组接受常规治疗加HFCWO；联合治疗组接受常规治疗加HFCWO和短波透热疗法（SWD）。 高频胸壁振荡（HFCWO）使用包裹在患者胸壁上的充气背心（PT‐200HM，河南迈通实业有限公司，中国）进行。设备振荡频率设置为10–14 Hz，振荡强度根据患者个体耐受性进行调整。每次治疗持续20分钟，每日两次（早晚各一次，两次间隔≥4小时），连续3天。治疗期间，患者取半卧位（床头抬高30°–45°），并被要求每5分钟进行一次哈气咳嗽。短波透热疗法（SWD）使用一台短波透热治疗仪（DL‐C‐M，汕头医疗器械厂有限公司，中国）实施。电容电极置于患者胸背部（T3–T10椎体水平）。治疗参数设置为连续模式，初始功率为50 W，根据个体耐受性逐渐增加至患者可耐受的温热感。使用红外体温计（ThermoScan 7，德国博朗有限公司）监测皮肤温度，维持皮肤温度≤41°C。每次短波透热治疗持续20分钟，每日一次，在高频胸壁振荡前立即进行，连续3天。治疗期间电极与皮肤距离维持在3–5 cm，并在皮肤表面涂抹凡士林以防止烧伤。 主要终点是患者症状评分的变化，采用CAT和呼吸困难、咳嗽和咳痰量表（BCSS）进行评估。CAT量表用于评估COPD患者的健康相关生活质量，涵盖咳嗽、咳痰、胸闷、呼吸困难、睡眠、精力、情绪和运动耐量八个维度，总分为0–40分，其中0分表示健康状况最佳，分数越高表示生活质量越差。BCSS用于评估COPD患者核心呼吸道症状的严重程度，包括呼吸困难、咳嗽和咳痰三个项目，每个项目根据严重程度评0–4分，总分0–12分，分数越高表示症状越严重。两种量表均由经过培训的评估者在入组（基线）时和治疗第3天进行测评，并使用标准化指导语以确保评分一致性。 次要终点包括（1）肺功能指标：第1秒用力呼气容积（FEV1）、用力肺活量（FVC）及FEV1/FVC比值；（2）血气分析指标：动脉血氧分压（PaO2）和动脉血二氧化碳分压（PaCO2）；（3）炎症指标：白细胞介素-6（IL-6）、C反应蛋白（CRP）和白细胞计数（WBC）；（4）痰液指标：24-h痰量（MSV）、痰液总细胞计数（TCC）和分类细胞计数（中性粒细胞百分比[NEU]、淋巴细胞百分比[LYM]和嗜酸性粒细胞百分比[EOS]）。肺功能和血气分析由专业技术人员完成。IL-6采用酶联免疫吸附法检测。CRP、WBC和血细胞分类计数由自动血液分析仪测定。痰液在24-h内通过自然咳痰收集。痰液湿重采用电子天平称量。痰液离心后，取沉渣进行总细胞计数和分类计数。计数过程由不了解分组情况的实验室技术人员完成。所有指标均在基线和治疗后第3天收集和测定。采集时间为上午8:00–10:00，以避免昼夜节律影响。 2.5. 统计分析 定量变量的正态性采用Shapiro–Wilk检验评估。正态分布数据以均值±标准差表示，非正态分布数据以中位数（四分位数间距 [IQR]）表示，分类变量以绝对数和相对频率描述。正态分布数据的两组间比较采用t检验，三组间比较采用方差分析（ANOVA）进行。非正态分布数据采用Kruskal–Wallis检验进行分析。分类数据采用卡方检验进行比较。统计分析使用SPSS软件（版本22，IBM公司，美国纽约州阿蒙克）进行。CAT和BCSSs的中位数使用GraphPad Prism软件（版本9.0，GraphPad Software公司，美国）进行比较和绘图。显著性水平α设定为0.05。 3. 结果 3.1. 描述性分析 共筛查了129名患者的合格性，其中25名因符合排除标准被排除，4名拒绝参与，1名因其他原因被排除，剩下89名患者符合纳入标准。研究流程图及排除原因见图。最终研究样本包括99名患者，随机分配到I组（常规治疗，n = 30）、II组（常规治疗 + HFCWO，n = 29）和III组（常规治疗 + HFCWO + SWD，n = 30）。表列出了对照组、HFCWO组和HFCWO + SWD组患者的基线人口统计学、临床、功能和炎症特征。三组间任何基线参数均未发现统计学显著差异（所有p > 0.05），表明基线可比性良好。 详细说明研究方法的流程图。 三组参与者基线人口统计学、临床、功能和炎症特征。 注：数据以均值 ± 标准差、中位数（IQR）或n（%）表示。p值 < 0.05；连续变量采用F检验，分类变量采用χ²检验。 缩写：BCSS，呼吸困难、咳嗽和痰液量表；CAT，慢性阻塞性肺疾病评估测试；CRP，C反应蛋白；EOS，嗜酸性粒细胞百分比；FEV1，第一秒用力呼气容积；FEV1/FVC，第一秒用力呼气容积/用力肺活量；FVC，用力肺活量；IL-6，白细胞介素-6；LYM，淋巴细胞百分比；MSV，黏液痰量；NEU，中性粒细胞百分比；PaCO2，动脉血二氧化碳分压；PaO2，动脉血氧分压；TCC，总细胞计数；WBC，白细胞计数。 3.2. 主要结局 采用Kruskal-Wallis检验比较三组间的CAT和BCSS评分。基线时各组间差异无统计学意义（均p > 0.05）。72小时干预后，三组评分均较基线下降。对照组CAT评分中位数为18.0，HFCWO组为17.5，联合组为7.0；BCSS评分中位数分别为7.0、6.5和4.0。Kruskal-Wallis检验显示三组间CAT和BCSS评分差异均有统计学意义（p < 0.001）。两两比较显示，联合组的CAT和BCSS评分均显著低于对照组和HFCWO组（均校正后p < 0.05），而对照组与HFCWO组之间差异无统计学意义（校正后p > 0.05）。见图。 三组从基线至第3天CAT和BCSS评分的中位变化。 3.3. 次要结局 与对照组相比，两种治疗方法均改善了多项患者指标（FEV1、FVC、FEV1/FVC、PaO2、PaCO2、MSV、TCC、NEU 和 EOS）。然而，HFCWO 组与 HFCWO + SWD 组的直接比较显示，联合治疗组在血气参数（PaO2 和 PaCO2）和痰液指标（MSV、NEU 和 EOS）方面有显著改善（p < 0.05）。这些结果分别见表、、和。此外，在 72‐h 干预期间，三组均未记录到与治疗相关的不良事件。没有参与者出现与 SWD 或 HFCWO 相关的不适，包括皮肤发红、烧灼感、胸痛、呼吸困难加重、头晕或恶心。 三组治疗前后肺功能和血气参数的比较。 缩写：FEV1，第1秒用力呼气容积；FEV1/FVC，第1秒用力呼气容积/用力肺活量；FVC，用力肺活量。 ∗组内比较（治疗前 vs. 治疗后）差异有统计学意义（p < 0.05）。 †治疗后两两组间比较。 三组治疗前后血液学和炎症参数的比较。 缩写：CRP，C反应蛋白；IL‐6，白细胞介素‐6；WBC，白细胞计数。 ∗组内比较（治疗前 vs. 治疗后）差异有统计学意义（p < 0.05）。 †治疗后两两组间比较。 三组治疗前后痰量和痰细胞计数的比较。 缩写：EOS，嗜酸性粒细胞百分比；LYM，淋巴细胞百分比；MSV，黏液性痰量；NEU，中性粒细胞百分比；TCC，总细胞计数。 ∗组内比较（治疗前 vs. 治疗后）具有统计学意义（p < 0.05）。 †治疗后组间两两比较。 4. 讨论 本随机对照试验研究了在AECOPD住院患者中将SWD与HFCWO联合应用的疗效。我们的主要发现表明，与单独使用HFCWO或常规治疗相比，联合干预在72小时治疗期间对呼吸系统症状、动脉血气参数和定量痰液指标均有显著更大的改善。具体而言，接受联合治疗的患者CAT和BCSS评分显著降低，同时氧合状况更佳、高碳酸血症减轻、中性粒细胞性痰液清除增强。这些结果为以下观点提供了初步证据：热预处理可能增强机械气道廓清技术在AECOPD管理中的临床效果，为在住院关键早期阶段加速症状缓解和黏液排出提供了一种可行的辅助策略。
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【Abstract】 OBJECTIVE: This study aimed to evaluate the efficacy and safety of combining short-wave diathermy (SWD) with high-frequency chest wall oscillation (HFCWO) compared with HFCWO alone and routine treatment in patients hospitalized for acute exacerbation of chronic obstructive pulmonary disease (AECOPD). METHODS: This single-center, parallel-group randomized controlled trial enrolled 89 patients with AECOPD admitted to Yongkang First People's Hospital between March 2024 and March 2025. Participants were randomly assigned (1:1:1) to receive routine treatment alone (control group), routine treatment plus HFCWO (HFCWO group), or routine treatment plus combined SWD and HFCWO (combined group) for 72 h. Primary and secondary outcomes were assessed at baseline and after 72 h of intervention, with both within-group and between-group comparisons performed. Primary outcomes included changes in the COPD Assessment Test (CAT) and Breathlessness, Cough, and Sputum Scale (BCSS) scores. Secondary outcomes included lung function parameters (FEV1, FVC, and FEV1/FVC), arterial blood gas parameters (PaO2 and PaCO2), inflammatory markers (interleukin-6, C-reactive protein, and white blood cell count), and quantitative sputum indices (24-h sputum volume, total cell count, and differential counts). RESULTS: After the 72-h intervention, the combined therapy group demonstrated significantly greater reductions in CAT and BCSS scores compared with both the HFCWO group and the control group (p < 0.05). Combined therapy also achieved superior improvements in arterial blood gas parameters (PaO2 and PaCO2) and sputum clearance indices (24-h sputum volume and neutrophil and eosinophil percentages) compared with HFCWO alone or routine treatment. In contrast, no significant differences were observed in lung function parameters (FEV1 and FVC) or inflammatory markers (IL-6, CRP, and WBC). CONCLUSIONS: The combined intervention significantly improves respiratory symptoms, arterial oxygenation, and sputum clearance in patients with AECOPD compared with HFCWO alone or routine treatment. The addition of thermal therapy enhances the clinical efficacy of mechanical airway clearance, offering a feasible adjunctive strategy for acute-phase management of AECOPD. 【1. Introduction】 Acute exacerbation of chronic obstructive pulmonary disease (AECOPD), characterized by acute deterioration of respiratory symptoms beyond day‐to‐day variability, represents a critical event in the natural history of the disease [, ]. According to the 2024 Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, current standard management for infective AECOPD includes controlled oxygen therapy, short‐acting bronchodilators, and antibiotics []. Despite standard pharmacotherapy, persistent sputum retention and airway obstruction still drive lung function decline, bacterial colonization, longer hospital stays, and higher medical costs [, ]. Consequently, adjunctive physical therapies aimed at enhancing mucus clearance and improving quality of life have gained increasing attention as integral components of comprehensive AECOPD management. Currently, high‐frequency chest wall oscillation (HFCWO) represents one of the principal physical therapeutic modalities for enhancing airway clearance in patients with respiratory diseases []. This technique employs an inflatable vest to generate oscillatory compressions at frequencies of 12–15 Hz against the chest wall, transmitting vibrational energy to the airways to dislodge mucus from the bronchial walls and facilitating cephalad movement through pulsatile airflow []. Although HFCWO has demonstrated efficacy in cystic fibrosis and bronchiectasis, its reliance on mechanical vibration alone may be insufficient to effectively clear the characteristically viscous, tenacious sputum observed in AECOPD patients []. Short‐wave diathermy (SWD) offers a mechanistically complementary approach, utilizing high‐frequency electromagnetic energy to produce deep tissue thermal effects that reduce sputum viscosity, improve local blood circulation, enhance mucociliary transport function, and potentially increase the compliance of retained secretions [, ]. Theoretically, the sequential combination of SWD and HFCWO constitutes a synergistic strategy wherein pretreatment thermal conditioning reduces sputum tenacity and improves rheological properties, thereby facilitating subsequent mechanical loosening and evacuation by HFCWO. Nevertheless, this combined therapy has not been rigorously evaluated in randomized controlled trials, and existing physical therapy studies lack objective quantitative sputum indices, dynamic monitoring of systemic inflammatory markers, and assessment of combined treatment modalities. Consequently, clinicians lack clear guidance regarding whether adjunctive physical therapies—particularly combined thermal and mechanical interventions—provide significant incremental benefit over standard pharmacological treatment in acute settings. This study aims to evaluate the efficacy and safety of combined SWD and HFCWO versus HFCWO alone and routine treatment alone in symptom relief, lung function improvement, and sputum clearance among patients with AECOPD through a single‐center, randomized controlled trial. The findings of this study will provide evidence‐based guidance for the selection of physical therapy during the acute phase of AECOPD and explore the clinical application value of combined thermal and mechanical intervention. 【2. Study Design and Methods】 【2.1. Design】 This was a single‐center, parallel‐group randomized controlled trial conducted at Yongkang First People’s Hospital from March 2024 to March 2025. Eligible patients with AECOPD were randomly assigned in a 1:1:1 ratio to receive either HFCWO alone, SWD combined with HFCWO, or routine treatment alone. Randomization was performed using a computer‐generated random sequence (https://www.jyshare.com/front-end/6680) with allocation concealment achieved through sequentially numbered, opaque, sealed envelopes. Due to the nature of physical interventions, blinding of participants and treating physicians were not feasible; however, outcome assessors and data analysts remained blinded to group allocation throughout the study. Based on the treatment window for AECOPD patients and the immediate physiological effects of airway clearance techniques, the intervention period was set at 72 h (3 days), with assessments conducted at baseline and Day 3. This study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of Yongkang First People’s Hospital (Approval Number: YKSDYRMYYEC2024‐KT‐HS‐024‐02). Written informed consent was obtained from all participants. 【2.2. Subjects】 The sample size was estimated a priori based on the primary outcome of change in the COPD Assessment Test (CAT) score from baseline to 72 h. A pilot study conducted at our center prior to the formal trial provided preliminary data showing mean reductions of 1.5 points in the control group, 4.0 points in the HFCWO group, and 6.5 points in the combined group, with a pooled standard deviation of 6.0 points. Using one‐way analysis of variance (ANOVA) for three independent groups (G∗Power 3.1.9.7; Heinrich‐Heine‐Universität Düsseldorf, Germany), with a two‐sided significance level of 0.05 and a statistical power of 0.80, the minimum required total sample size was 84 patients (28 per group). With an anticipated dropout rate of 10%, the target enrollment was set at 93 patients. In total, 99 patients were randomized and completed the intervention, meeting the planned sample size. In total, 89 patients hospitalized with AECOPD were recruited from the Department of Respiratory Medicine and Emergency Department at Yongkang First People’s Hospital between March 2024 and March 2025. Infective acute exacerbation was defined as worsening dyspnea, increased cough and sputum production, changes in sputum color or consistency, and fever, accompanied by radiographic evidence of pulmonary consolidation. Inclusion criteria are as follows: (1) meeting GOLD 2024 AECOPD diagnostic criteria, acute worsening of dyspnea, cough, or sputum beyond day‐to‐day variability within 14 days, requiring treatment adjustment, accompanied by purulent sputum or radiographic evidence of pulmonary infection and GOLD Grades 3–4; (2) aged 50–80 years, male or female; (3) conscious, capable of cooperating with scale assessment and pulmonary function test, and signed informed consent; and (4) no systemic corticosteroids, mucolytic agents, or physical therapy within 2 weeks prior to enrollment. Exclusion criteria are as follows: (1) concomitant pneumothorax, pulmonary embolism, acute heart failure, or pulmonary encephalopathy requiring emergency resuscitation; (2) contraindications to physical therapy, including thoracic metallic implants, cutaneous lesions or infection, thoracic cage deformity, or recent thoracic surgery (within 3 months); (3) coexisting bronchiectasis, active pulmonary tuberculosis, lung cancer, or other parenchymal lung diseases; (4) severe hepatic or renal insufficiency, active bleeding, or coagulation disorders; (5) pregnancy or lactation, or participation in another interventional clinical trial within the preceding 30 days; and (6) severe cognitive impairment, psychiatric disorders, or language barriers precluding adequate assessment. 【2.3. Intervention】 All enrolled patients received routine treatment for AECOPD according to the 2024 Global Initiative for GOLD guidelines. Treatment measures included controlled oxygen therapy, short‐acting bronchodilators (salbutamol 2.5 mg combined with ipratropium bromide 500 μg via nebulization every 6–8 h), systemic corticosteroids (prednisone equivalent 1 mg/kg/day, maximum 60 mg/day for 3 days), antibiotics, and health education. Participants were randomly assigned in a 1:1:1 ratio to three parallel groups: The control group received routine treatment alone; the HFCWO group received routine treatment plus HFCWO; and the combined therapy group received routine treatment plus HFCWO and SWD. HFCWO was performed using an inflatable vest (PT‐200HM, Henan Maitong Industrial Co., Ltd., China) wrapped around the patient’s chest wall. The device oscillation frequency was set at 10–14 Hz, and oscillation intensity was adjusted according to individual patient tolerance. Each treatment session lasted 20 min, twice daily (morning and evening, with an interval of ≥ 4 h between sessions), for 3 consecutive days. During treatment, patients were placed in a semi‐reclining position (head‐of‐bed elevation 30°–45°) and were instructed to perform huff coughing every 5 min. SWD was delivered using a SWD unit (DL‐C‐M, Shantou Medical Equipment Factory Co., Ltd., China). Capacitive electrodes were placed on the patient’s thoracic back (T3–T10 vertebral levels). Treatment parameters were set to continuous mode, with an initial power of 50 W, gradually increased to patient‐tolerable warm sensation according to individual tolerance. An infrared thermometer (ThermoScan 7, Braun GmbH, Germany) was used to monitor skin temperature, maintaining skin temperature ≤ 41°C. Each SWD session lasted 20 min, once daily, performed immediately before HFCWO, for 3 consecutive days. Electrode‐to‐skin distance was maintained at 3–5 cm during treatment, and petroleum jelly was applied to the skin surface to prevent burns. 【2.4. Outcome Measurements】 The primary endpoint was change in patient symptom scores, assessed using the CAT and the Breathlessness, Cough, and Sputum Scale (BCSS). The CAT scale is used to assess health‐related quality of life in COPD patients, covering eight dimensions including cough, sputum, chest tightness, breathlessness, sleep, energy, emotion, and exercise tolerance, with a total score of 0–40 points, where 0 indicates optimal health status and higher scores indicate worse quality of life. The BCSS is used to assess the severity of core respiratory symptoms in COPD patients, including three items: breathlessness, cough, and sputum, each scored 0–4 according to severity, with a total score of 0–12 points, where higher scores indicate more severe symptoms. Both scales were administered by trained assessors at enrollment (baseline) and on Day 3 of treatment, using standardized instructions to ensure scoring consistency. Secondary endpoints included (1) lung function indices: forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), and FEV1/FVC ratio; (2) blood gas analysis indices: arterial partial pressure of oxygen (PaO2) and arterial partial pressure of carbon dioxide (PaCO2); (3) inflammatory indices: interleukin‐6 (IL‐6), C‐reactive protein (CRP), and white blood cell count (WBC); and (4) sputum indices: 24‐h sputum volume (MSV), total sputum cell count (TCC), and differential cell counts (neutrophil percentage [NEU], lymphocyte percentage [LYM], and eosinophil percentage [EOS]). Pulmonary function and blood gas analysis were performed by professional technicians. IL‐6 was detected by enzyme‐linked immunosorbent assay. CRP, WBC, and blood cell differential counts were measured by an automated hematology analyzer. Sputum was collected through spontaneous expectoration over a 24‐h period. Sputum wet weight was measured by an electronic scale. Sputum was centrifuged, and sediment was taken for total cell count and differential count. The counting process was completed by laboratory technicians who were unaware of group allocation. All indices were collected and measured at baseline and on Day 3 after treatment. Collection time was 8:00–10:00 (AM) to avoid circadian rhythm influence. 【2.5. Statistical Analysis】 Normality of quantitative variables was assessed by the Shapiro–Wilk test. Normally distributed data were expressed as mean ± standard deviation, nonnormally distributed data were expressed as median (interquartile range [IQR]), and categorical variables were described as absolute numbers and relative frequencies. Comparisons between two groups and among three groups for normally distributed data were performed using t‐test and ANOVA, respectively. Nonnormally distributed data were analyzed using the Kruskal–Wallis test. Categorical data were compared using the chi‐square test. Statistical analysis was performed using SPSS software (version 22, IBM Corp., Armonk, NY, USA). Median values of CAT and BCSSs were compared and plotted using GraphPad Prism software (version 9.0, GraphPad Software, USA). The significance level α was set at 0.05. 【3. Results】 【3.1. Descriptive Analysis】 A total of 129 patients were screened for eligibility, of whom 25 were excluded due to meeting exclusion criteria, 4 declined to participate, and 1 was excluded for other reasons, leaving 89 patients who met the inclusion criteria. The study flow chart and reasons for exclusion are presented in Figure . The final study sample comprised 99 patients randomly assigned to Group I (routine treatment, n = 30), Group II (routine treatment + HFCWO, n = 29), and Group III (routine treatment + HFCWO + SWD, n = 30). Table presents the baseline demographic, clinical, functional, and inflammatory characteristics of patients in the control, HFCWO, and HFCWO + SWD groups. No statistically significant differences were found among the three groups in any baseline parameters (all p > 0.05), indicating good baseline comparability. Flow chart detailing study methodology. Baseline demographic, clinical, functional, and inflammatory characteristics of participants in the three groups. Note: Data are expressed as mean ± SD, median (IQR), or n (%). p‐value < 0.05; F‐test for continuous variables and χ 2 for categorical variables. Abbreviations: BCSS, Breathlessness, Cough, and Sputum Scale; CAT, COPD Assessment Test; CRP, C‐reactive protein; EOS, eosinophil percentage; FEV1, forced expiratory volume in one second; FEV1/FVC, forced expiratory volume in one second/forced vital capacity; FVC, forced vital capacity; IL‐6, interleukin‐6; LYM, lymphocyte percentage; MSV, mucoid sputum volume; NEU, neutrophil percentage; PaCO2, partial pressure of arterial carbon dioxide; PaO2, partial pressure of arterial oxygen; TCC, total cell count; WBC, white blood cell count. 【3.2. Primary Outcomes】 The Kruskal–Wallis test was used to compare CAT and BCSS scores among the three groups. No significant differences were observed at baseline (all p > 0.05). After the 72‐h intervention, scores decreased from baseline in all three groups. The median CAT scores were 18.0 in the control group, 17.5 in the HFCWO group, and 7.0 in the combined group; the median BCSS scores were 7.0, 6.5, and 4.0, respectively. The Kruskal–Wallis test revealed significant differences among the three groups for both CAT and BCSS (p < 0.001). Pairwise comparisons showed that the combined group had significantly lower CAT and BCSS scores than both the control group and the HFCWO group (all adjusted p < 0.05), whereas no significant difference was observed between the control group and the HFCWO group (adjusted p > 0.05). See Figure . Median changes in CAT and BCSS scores from baseline to Day 3 across the three groups. 【3.3. Secondary Outcomes】 Compared with the control group, both treatment methods improved multiple patient indices (FEV1, FVC, FEV1/FVC, PaO2, PaCO2, MSV, TCC, NEU, and EOS). However, direct comparison between the HFCWO and HFCWO + SWD groups revealed significant improvements in the combined therapy group for blood gas parameters (PaO2 and PaCO2) and sputum indices (MSV, NEU, and EOS) (p < 0.05). These results are shown in Tables , , and , respectively. In addition, no treatment‐related adverse events were recorded during the 72‐h intervention period across all three groups. No participants presented SWD‐ or HFCWO‐associated discomfort including skin redness, burning sensation, chest pain, exacerbated dyspnea, dizziness, or nausea. Comparison of lung function and blood gas parameters before and after treatment in the three groups. Abbreviations: FEV1, forced expiratory volume in one second; FEV1/FVC, forced expiratory volume in one second/forced vital capacity; FVC, forced vital capacity. ∗Within‐group comparisons (before vs. after treatment) were statistically significant (p < 0.05). †Posttreatment pairwise between‐group comparisons. Comparison of hematological and inflammatory parameters before and after treatment in the three groups. Abbreviations: CRP, C‐reactive protein; IL‐6, interleukin‐6; WBC, white blood cell count. ∗Within‐group comparisons (before vs. after treatment) were statistically significant (p < 0.05). †Posttreatment pairwise between‐group comparisons. Comparison of sputum volume and sputum cell count before and after treatment in the three groups. Abbreviations: EOS, eosinophil percentage; LYM, lymphocyte percentage; MSV, mucoid sputum volume; NEU, neutrophil percentage; TCC, total cell count. ∗Within‐group comparisons (before vs. after treatment) were statistically significant (p < 0.05). †Posttreatment pairwise between‐group comparisons. 【4. Discussion】 The present randomized controlled trial investigated the efficacy of combining SWD with HFCWO in patients hospitalized with AECOPD. Our principal findings indicate that, compared with HFCWO alone or routine treatment, the combined intervention achieved significantly greater improvements in respiratory symptoms, arterial blood gas parameters, and quantitative sputum indices over a 72‐h treatment period. Specifically, patients receiving combined therapy demonstrated marked reductions in CAT and BCSS scores, accompanied by superior oxygenation, reduced hypercapnia, and enhanced neutrophilic sputum clearance. These results provide preliminary evidence that thermal preconditioning may augment the clinical effectiveness of mechanical airway clearance techniques in the management of AECOPD, offering a feasible adjunctive strategy to accelerate symptom resolution and mucus evacuation during the critical early phase of hospitalization. The observed improvements in symptom scores hold significant clinical implications for the management of acute exacerbations. During infective exacerbation