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Expert Consensus Statement on the Disease Burden and Vaccination for Respiratory Syncytial Virus Infection in Adults. 成人呼吸道合胞病毒(RSV)感染的疾病负担和疫苗接种专家共识声明。
IF 3 Q2 RESPIRATORY SYSTEM Pub Date : 2026-01-01 Epub Date: 2025-11-19 DOI: 10.4046/trd.2025.0173
Joon Young Choi, Chin Kook Rhee, Yong-Il Hwang, Ji-Yong Moon, Kwang Ha Yoo, Hyoung Kyu Yoon

Respiratory syncytial virus (RSV) is a leading cause of acute respiratory infection in adults, with higher morbidity and mortality in older adults and those with chronic obstructive pulmonary disease (COPD) or asthma. Despite the burden, disease awareness remains low and treatment is limited to supportive care. Recent advances have led to the approval of multiple vaccines and updated guideline recommendations. We reviewed current literature, surveillance data, and international guidelines to assess the burden of RSV in adults and to evaluate evidence for vaccination in high-risk groups. Globally, RSV accounts for millions of infections and substantial hospitalizations and deaths among adults ≥60 years. COPD and asthma patients show disproportionately high risks of RSV-related hospitalization, exacerbations, and mortality. South Korean studies confirm RSV as a major contributor to pneumonia, COPD and asthma exacerbations, and bronchiectasis. As of 2025, three RSV vaccines (Arexvy, Abrysvo, mRESVIA) have US Food and Drug Administration approval; only Arexvy is approved in Korea for older adults. Advisory Committee on Immunization Practices (ACIP) now recommends vaccination for all adults ≥75 years and high-risk adults aged 50-74 years, while Global Initiative for Chronic Obstructive Lung Disease (GOLD), Global Initiative for Asthma (GINA), and Korean COPD guidelines endorse RSV vaccination for chronic respiratory disease patients. RSV is underrecognized yet imposes significant disease and healthcare burdens in older adults and those with chronic respiratory diseases. In the absence of effective antivirals, vaccination is a key preventive strategy. Expanding vaccination uptake, improving awareness, and integrating RSV vaccines into national immunization programs could substantially reduce RSV-related morbidity and mortality.

呼吸道合胞病毒(RSV)是成人急性呼吸道感染的主要原因,在老年人和COPD或哮喘患者中发病率和死亡率较高。尽管有负担,但对疾病的认识仍然很低,治疗仅限于支持性护理。最近的进展导致批准了多种疫苗和更新的指南建议。我们回顾了目前的文献、监测数据和国际指南,以评估成人呼吸道合胞病毒的负担,并评估高危人群接种疫苗的证据。在全球范围内,60岁以上的成年人中有数百万人感染RSV,并有大量住院治疗和死亡。COPD和哮喘患者出现rsv相关住院、病情恶化和死亡的风险高得不成比例。韩国的研究证实,呼吸道合胞病毒是导致肺炎、慢性阻塞性肺病和哮喘加重以及支气管扩张的主要因素。截至2025年,三种RSV疫苗(Arexvy, Abrysvo, mRESVIA)已获得FDA批准;在韩国,只有阿雷维被批准用于老年人。ACIP现在建议所有≥75岁的成年人和50-74岁的高危成年人接种疫苗,而GOLD、GINA和韩国COPD指南支持慢性呼吸道疾病患者接种RSV疫苗。呼吸道合胞病毒未得到充分认识,但对老年人和慢性呼吸道疾病患者造成了重大的疾病和医疗负担。在缺乏有效抗病毒药物的情况下,接种疫苗是一项关键的预防战略。扩大疫苗接种率,提高认识,并将RSV疫苗纳入国家免疫规划,可大大降低RSV相关的发病率和死亡率。
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引用次数: 0
Effects of Forceful Breathing Maneuvers of Spirometry on Respiratory Impedance Measured by Oscillometry. 肺活量测定中强力呼吸动作对振荡法测量呼吸阻抗的影响。
IF 3 Q2 RESPIRATORY SYSTEM Pub Date : 2026-01-01 Epub Date: 2025-11-19 DOI: 10.4046/trd.2025.0114
Sajal De

Background: Deep inspiratory maneuvers can modify airway diameter, leading to shortterm fluctuations in respiratory impedance (Zrs). However, the impact of the forceful breathing maneuvers used in spirometry on Zrs has not been systematically investigated. This study was designed to assess and compare the effects of spirometry maneuvers on Zrs, as measured by oscillometry, in adult patients with obstructive airway diseases (group I) versus those presenting with respiratory symptoms but without airflow obstruction on spirometry (group II).

Methods: All participants underwent oscillometry assessments both before and immediately following spirometry. Paired t-tests and unpaired t-tests were conducted to compare differences within and between groups, respectively. Bland-Altman plots were utilized to display the percentage change in Zrs parameters against the mean, along with the limits of agreement (LoA).

Results: In this cross-sectional study, 166 patients were enrolled (53% male), with a mean age of 40.4 years. Group I accounted for 62% of cases, while group II composed 38%. Patients in group I demonstrated greater impairment in both spirometry and Zrs parameters. Nearly all patients experienced changes in Zrs after spirometry compared to pre-spirometry values, regardless of group assignment. Except for R5 in group I, statistically significant paired differences in Zrs parameters were not observed between pre- and post-spirometry in either group. The cohort demonstrated mean biases between pre- and post-spirometry as follows: R5 4.6% (LoA: -44.8%, 54%); X5 5.8% (LoA: -69.5%, 81.2%); AX 4.3% (LoA: -93.9%,102.6%); and Fres 0.5% (LoA: -30.8%, 31.8%). The broad and random LoA reflect marked inter-individual variability.

Conclusion: Spirometry maneuvers cause fluctuations in Zrs parameters, especially in R5. Oscillometry performed after spirometry may cause clinically meaningful changes in Zrs parameters.

背景:深吸气动作可以改变气道直径,导致呼吸阻抗(Zrs)的短期变异性。然而,肺量测定的强力呼吸操作对Zrs的影响仍未被探索。本研究旨在评价和比较肺活量测定方法对成人阻塞性气道疾病患者(I组)和肺活量测定中有呼吸道症状且无气流阻塞的患者(II组)用振荡法测量Zrs的影响。方法:所有参与者在肺活量测定之前和之后立即进行振荡测量。配对和非配对t检验分别用于组内和组间比较。构建Bland-Altman图以评估Zrs相对于平均值的百分比变化,并具有一致性限制(LoA)。结果:本横断面研究纳入166例患者(53%为男性),平均年龄40.4岁。第一组占62%,第二组占38%。I组患者肺量测定和Zrs均有显著增高。与肺量测定前相比,几乎所有患者在进行肺量测定后的Zrs都发生了变化,与基础组无关。除第一组的R5外,两组肺量测定前后Zrs均无显著的配对差异。队列中肺量测定前后的平均偏差为:R5 4.6% (LoA: -44.8%, 54%);X5 5.8%(贷款:-69.5%,81.2%);AX 4.3% (LoA: -93.9%,102.6%);Fres 0.5%(贷款:-30.8%,31.8%)。广泛而随机的LoA表明个体间存在显著差异。结论:肺活量计操作会引起Zrs的变异性,尤其是R5。在肺活量测定之后进行的振荡测量可能会产生与临床相关的Zrs变化。
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引用次数: 0
Tropheryma whipplei: An Underestimated Pathogen Associated with Pulmonary Infections? 惠氏滋养瘤:与肺部感染相关的一种被低估的病原体?
IF 3 Q2 RESPIRATORY SYSTEM Pub Date : 2026-01-01 Epub Date: 2025-10-28 DOI: 10.4046/trd.2025.0152
Jingjing Jiang, Haimin Wang, Haijian Zhou, Hai Jiang, Wei Liu, Wenguo Jiang, Mingfang Xu, Kun Li
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引用次数: 0
Biologic Therapies in Severe Asthma and Eosinophilic Granulomatosis with Polyangiitis: Targeted Therapy and Personalized Care. 重度哮喘和EGPA的生物治疗:靶向治疗和个性化护理。
IF 3 Q2 RESPIRATORY SYSTEM Pub Date : 2026-01-01 Epub Date: 2025-10-15 DOI: 10.4046/trd.2025.0131
Sang Hyuk Kim

Biologic agents have revolutionized severe asthma management by supporting biomarker‑driven approaches. Five monoclonal antibodies-omalizumab, mepolizumab, reslizumab, benralizumab, and dupilumab-are in widespread use, while the recently approved tezepelumab, an anti-thymic stromal lymphopoietin, broadens therapeutic possibilities to encompass the type 2 inflammation‑low phenotype. Although biologics have become more accessible, clinicians frequently encounter difficulties in choosing the most appropriate initial biologic therapy. This review describes real‑world cases that demonstrate phenotype‑guided selection of biologics for individuals with asthma or eosinophilic granulomatosis with polyangiitis. Additionally, current advances in biologic therapies are examined regarding their capacity to improve both accessibility and clinical efficacy. Moving forward, the integration of emerging evidence with patient-specific factors could further promote disease modification in the management of severe asthma.

生物制剂通过实现生物标志物驱动的护理,改变了严重哮喘的管理。五种单克隆抗体-omalizumab, mepolizumab, reslizumab, benralizumab和dupilumab-目前被广泛使用,最近批准的Tezepelumab,一种抗胸腺基质淋巴生成素,扩大了治疗选择,包括2型低炎症表型。尽管生物制剂的可用性越来越高,但临床医生在选择初始生物治疗时往往面临挑战。这篇综述介绍了真实世界的病例,说明表型指导的生物制剂选择用于哮喘或嗜酸性肉芽肿病合并多血管炎患者。此外, 生物制剂的新兴治疗创新讨论了他们的潜力,以提高可及性和有效性。在未来,将不断发展的证据与患者特异性特征相结合可能有助于严重哮喘的疾病改变。
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引用次数: 0
Impact of Microplastic Exposure on Airway Inflammation in an Acute Asthma Murine Model. 微塑料暴露对急性哮喘小鼠模型气道炎症的影响。
IF 3 Q2 RESPIRATORY SYSTEM Pub Date : 2026-01-01 Epub Date: 2025-10-23 DOI: 10.4046/trd.2025.0091
Joon Young Choi, Jung Hur, Yong Suk Jo, Chin Kook Rhee

Background: Widely distributed in the environment, microplastics (MPs) are increasingly recognized as potential respiratory hazards. While several studies suggest their role in worsening allergic airway diseases, findings remain inconsistent. This study aimed to investigate the immunologic effects of repeated MP exposure in an acute murine model of ovalbumin (OVA)-induced asthma.

Methods: Female BALB/c mice were assigned to four groups: control with vehicle, control with MPs, OVA-sensitized with vehicle, and OVA-sensitized with MPs. An acute asthma model was established by sensitizing and challenging mice with OVA. Spherical polystyrene MPs of 1-5 μm were administered intranasally at 300 μg daily from day 0 to 21. Lung inflammation was assessed via bronchoalveolar lavage fluid (BALF) analysis, histopathology, cytokine measurements, and macrophage polarization by immunofluorescence.

Results: MP exposure did not exacerbate allergic inflammation in OVA-sensitized mice. Instead, it led to reduced eosinophilic infiltration and lower levels of interleukin 5 (IL-5) and IL-13, compared to vehicle-treated OVA mice. In contrast, MP exposure in control mice increased tumor necrosis factor-α and decreased interferon-γ levels, upregulated epithelial alarmins (IL-25 and IL-33), and elevated inflammation scores. Alarmin levels, including IL-25 and IL-33, were elevated by MP exposure in control mice, whereas no significant differences were observed between vehicle- and MP-treated mice in the OVA-sensitized group. Macrophage analysis showed a shift toward M1 polarization only in control mice.

Conclusion: While MP exposure aggravated inflammatory responses in healthy lungs, it did not exacerbate airway inflammation in asthmatic mice.

背景:微塑料(MPs)广泛分布于环境中,越来越被认为是潜在的呼吸危害。虽然有几项研究表明它们在加重过敏性气道疾病中的作用,但研究结果仍不一致。本研究旨在探讨反复暴露MP对急性卵清蛋白(OVA)诱发哮喘小鼠模型的免疫影响。方法:将雌性BALB/c小鼠分为四组:载药对照组、MPs对照组、载药致敏ova组和MPs致敏ova组。用卵清蛋白(OVA)致敏攻毒小鼠,建立急性哮喘模型。从第0天至第21天,给予球形聚苯乙烯MPs (1-5 μm),每日300 μg。通过支气管肺泡灌洗液(BALF)分析、组织病理学、细胞因子测量和免疫荧光巨噬细胞极化来评估肺部炎症。结果:MP暴露不会加重ova致敏小鼠的变应性炎症。相反,与载体处理的卵子小鼠相比,它导致嗜酸性粒细胞浸润减少,IL-5和IL-13水平降低。相比之下,MP暴露在对照小鼠中,TNF-α升高,IFN-γ水平降低,上皮报警因子(IL-25和IL-33)上调,炎症评分升高。对照组小鼠暴露于MP后,警示素(包括IL-25和IL-33)水平升高,而ova致敏组小鼠与MP处理小鼠之间无显著差异。巨噬细胞分析显示,仅在对照组小鼠中,巨噬细胞向M1极化方向转移。结论:MP暴露虽然加重了健康肺部的炎症反应,但并未加重哮喘小鼠的气道炎症。
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引用次数: 0
Aspergilloma Presenting as Endobronchial Mass. 曲菌瘤表现为支气管内肿块。
IF 3 Q2 RESPIRATORY SYSTEM Pub Date : 2026-01-01 Epub Date: 2025-09-10 DOI: 10.4046/trd.2025.0117
Ali Chour, David Laville, Benjamin Chappuy, Nicolas Marc
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引用次数: 0
Clinical Characteristics of Individuals with Chronic Obstructive Pulmonary Disease (COPD), Pre-COPD, Smokers with Normal Lung Function in Korea: Updated Analysis of the Korea COPD Subgroup Study Cohort. 韩国COPD患者、COPD前期患者、肺功能正常的吸烟者的临床特征:KOCOSS队列的最新分析
IF 3 Q2 RESPIRATORY SYSTEM Pub Date : 2026-01-01 Epub Date: 2025-09-10 DOI: 10.4046/trd.2025.0040
Jong Geol Jang, Youlim Kim, Jung-Kyu Lee, Hye Yun Park, Dong Il Park, Seung Won Ra, Hyun-Kuk Kim, Myung Goo Lee, Yong Bum Park, Kwang Ha Yoo

Background: Chronic obstructive pulmonary disease (COPD) is a heterogeneous lung disease characterized by persistent airflow limitation and is a leading cause of mortality worldwide. Pre-COPD refers to a pre-disease state associated with an increased risk of COPD development. This study aims to evaluate the clinical characteristics of individuals with COPD, pre-COPD, and smokers with normal lung function in South Korea, and to provide an updated analysis of the Korea COPD subgroup study (KOCOSS) cohort data.

Methods: We analyzed data from 4,502 participants in the KOCOSS database collected between 2012 and 2025, including 4,197 with COPD, 126 with pre-COPD, and 179 smokers with normal lung function. Baseline characteristics were compared across these groups.

Results: Patients with COPD were more likely to be male, older, and had a lower body mass index than those with pre-COPD and smokers with normal lung function. Symptom burden, as assessed by the COPD Assessment Test and modified Medical Research Council dyspnea scale, was highest in patients with COPD, followed by pre- COPD and smokers with normal lung function. Patients with COPD had the highest overall use of respiratory medications (89.3%), including inhalers and other treatments, followed by pre-COPD individuals (61.5%) and smokers with normal lung function (47.4%). Hypertension was the most common comorbidity across all groups, with no significant differences in the prevalence of comorbidities.

Conclusion: This analysis of the KOCOSS cohort highlights the distinct clinical characteristics of individuals with COPD, pre-COPD, and smokers with normal lung function. Notably, individuals without spirometric COPD still showed substantial symptom burden and inhaler use.

背景:慢性阻塞性肺疾病(COPD)是一种以持续气流受限为特征的异质性肺部疾病,是世界范围内死亡的主要原因。COPD前期是指与COPD发展风险增加相关的疾病前期状态。本研究旨在评估韩国COPD患者、COPD前期患者和肺功能正常的吸烟者的临床特征,并提供KOCOSS队列数据的最新分析。方法:我们分析了2012年至2025年间收集的KOCOSS数据库中4502名参与者的数据,其中包括4197名COPD患者、126名COPD前期患者和179名肺功能正常的吸烟者。比较各组的基线特征。结果:与COPD前期患者和肺功能正常的吸烟者相比,COPD患者多为男性、年龄较大、体重指数较低。根据COPD评估测试和改良的医学研究委员会呼吸困难量表评估,COPD患者的症状负担最高,其次是COPD前期和肺功能正常的吸烟者。COPD患者呼吸系统药物的总体使用率最高(89.3%),包括吸入器和其他治疗,其次是COPD前期患者(61.5%)和肺功能正常的吸烟者(47.4%)。高血压是所有组中最常见的合并症,合并症的患病率无显著差异。结论:对KOCOSS队列的分析突出了COPD患者、COPD前期患者和肺功能正常的吸烟者的独特临床特征。值得注意的是,没有肺量计COPD的个体仍然表现出明显的症状负担和吸入器使用。
{"title":"Clinical Characteristics of Individuals with Chronic Obstructive Pulmonary Disease (COPD), Pre-COPD, Smokers with Normal Lung Function in Korea: Updated Analysis of the Korea COPD Subgroup Study Cohort.","authors":"Jong Geol Jang, Youlim Kim, Jung-Kyu Lee, Hye Yun Park, Dong Il Park, Seung Won Ra, Hyun-Kuk Kim, Myung Goo Lee, Yong Bum Park, Kwang Ha Yoo","doi":"10.4046/trd.2025.0040","DOIUrl":"10.4046/trd.2025.0040","url":null,"abstract":"<p><strong>Background: </strong>Chronic obstructive pulmonary disease (COPD) is a heterogeneous lung disease characterized by persistent airflow limitation and is a leading cause of mortality worldwide. Pre-COPD refers to a pre-disease state associated with an increased risk of COPD development. This study aims to evaluate the clinical characteristics of individuals with COPD, pre-COPD, and smokers with normal lung function in South Korea, and to provide an updated analysis of the Korea COPD subgroup study (KOCOSS) cohort data.</p><p><strong>Methods: </strong>We analyzed data from 4,502 participants in the KOCOSS database collected between 2012 and 2025, including 4,197 with COPD, 126 with pre-COPD, and 179 smokers with normal lung function. Baseline characteristics were compared across these groups.</p><p><strong>Results: </strong>Patients with COPD were more likely to be male, older, and had a lower body mass index than those with pre-COPD and smokers with normal lung function. Symptom burden, as assessed by the COPD Assessment Test and modified Medical Research Council dyspnea scale, was highest in patients with COPD, followed by pre- COPD and smokers with normal lung function. Patients with COPD had the highest overall use of respiratory medications (89.3%), including inhalers and other treatments, followed by pre-COPD individuals (61.5%) and smokers with normal lung function (47.4%). Hypertension was the most common comorbidity across all groups, with no significant differences in the prevalence of comorbidities.</p><p><strong>Conclusion: </strong>This analysis of the KOCOSS cohort highlights the distinct clinical characteristics of individuals with COPD, pre-COPD, and smokers with normal lung function. Notably, individuals without spirometric COPD still showed substantial symptom burden and inhaler use.</p>","PeriodicalId":23368,"journal":{"name":"Tuberculosis and Respiratory Diseases","volume":" ","pages":"75-85"},"PeriodicalIF":3.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12784127/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145030625","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Spirometry-Defined Restriction Modifies the Association between Forced Vital Capacity and Bronchiectasis Exacerbation. 肺活量测定法定义的限制改变了强制肺活量与支气管扩张加剧之间的关系。
IF 3 Q2 RESPIRATORY SYSTEM Pub Date : 2026-01-01 Epub Date: 2025-11-06 DOI: 10.4046/trd.2024.0187
Jang Ho Lee, Hyun Lee, Seonok Kim, Bumhee Yang, Hayoung Choi, Chin Kook Rhee, Yong Bum Park, Yeon-Mok Oh, Seung Won Ra

Background: Obstructive ventilatory defect (OVD) is the most common ventilatory pattern in bronchiectasis, with low forced expiratory volume in 1 second (FEV1), which is a well-known risk factor for acute exacerbation (AE). However, the impact of spirometry- defined restrictive components (restrictive ventilatory defects [RVD] or mixed ventilatory defects [MVD]) on AE remains unreported. This study evaluated the association between spirometry-defined restrictive components and AE risk in patients with bronchiectasis.

Methods: In this prospective cohort study, patients from 51 referral hospitals in the Republic of Korea were classified into the normal (FEV1/forced vital capacity (FVC) ≥ lower limit of normal [LLN] and FVC≥LLN, n=62), OVD (FEV1/FVC<LLN and FVC≥LLN, n=59), RVD (FEV1/FVC≥LLN and FVC<LLN, n=148), and MVD (FEV1/FVC<LLN and FVC<LLN, n=223) groups. Incidence rate ratios (IRRs) of AE associated with ventilatory defects were compared using the normal group as a reference group.

Results: The MVD group had the highest annual severe AE IRR (3.557; 95% confidence interval [CI], 0.918 to 17.851), followed by the RVD (2.678; 95% CI, 0.704 to 13.422) and OVD groups (1.926; 95% CI, 0.379 to 11.430) (p for trend=0.051) compared to the normal group. Lower FVC and FEV₁ were significantly associated with increased risk of any AE and severe AE in the RVD and MVD groups. The spirometry-defined restrictive component significantly affected the relationships of any AE and severe AE with FVC (p for interaction <0.05), not with FEV1.

Conclusion: The presence of a spirometry-defined restrictive component was associated with higher annual rates for any AE and severe AE, which modified the FVC, not FEV1, effect on the risk for such events.

背景:阻塞性通气缺陷(OVD)是支气管扩张最常见的通气模式,其1秒用力呼气量(FEV1)低,是众所周知的急性加重(AE)的危险因素。然而,肺活量测定定义的限制性成分(限制性通气缺陷[RVD]或混合性通气缺陷[MVD])对AE的影响仍未见报道。本研究评估了肺活量测定定义的限制性成分与支气管扩张患者AE风险之间的关系。方法:将韩国51家转诊医院的患者分为正常组(FEV1/用力肺活量(FVC)≥正常[LLN]下限及FVC≥LLN, n=62)、OVD组(FEV1/ fvr)。结果:MVD组的年严重AE IRR最高(3.557;0.918-17.851),其次是RVD组(2.678;0.704-13.422)和OVD组(1.926;0.379-11.430)(P趋势=0.051)。在RVD组和MVD组中,较低的FVC和FEV1与任何AE和严重AE的风险增加显著相关。肺活量定义的限制性成分显著影响任何AE和严重AE与FVC的关系(P为相互作用)。结论:肺活量定义的限制性成分的存在与任何AE和严重AE的年发生率较高相关,这改变了FVC,而不是FEV1对此类事件风险的影响。
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引用次数: 0
Protocol of a Nationwide Observational Cohort Study for Long-Term Impacts on Lung Health and Life after Tuberculosis in Korea (LIFE-TB). 韩国结核病对肺健康和寿命的长期影响的全国性观察队列研究方案(Life - tb)
IF 3 Q2 RESPIRATORY SYSTEM Pub Date : 2026-01-01 Epub Date: 2025-10-15 DOI: 10.4046/trd.2025.0109
Chiwook Chung, Jinsoo Min, Doosoo Jeon, Yong-Soo Kwon, Jeongha Mok, Hyung Woo Kim, Youngmok Park, Young Ae Kang

Background: Growing concern has emerged regarding the disease burden and longterm outcomes associated with post-tuberculosis lung disease (PTLD). This study is designed to assess the long-term effects of tuberculosis (TB) on lung health and quality of life, aiming to fill the critical evidence gap in PTLD research.

Methods: This investigation utilizes a nationwide, prospective, multicenter observational cohort design. Seven tertiary healthcare centers in Korea will recruit at least 350 participants in the treatment-phase group (with a minimum of 50 participants per site) between June 2025 and December 2026. Eligible participants are individuals aged ≥19 years who are either in the course of anti-TB treatment (treatment-phase group), or have previously completed treatment for pulmonary TB (post-treatment group). Exclusion criteria are diagnosis limited to extrapulmonary TB, age <19 years, or refusal to provide consent. Data will be gathered at baseline and annually for up to 5 years until December 2031. Baseline assessments will capture demographic characteristics, TB-related clinical history, relevant comorbidities, and medication use. Initial laboratory evaluations will cover blood analysis, urinalysis, and electrocardiographic measurements. Comprehensive clinical evaluations include symptom scoring, spirometry, chest imaging, and administration of quality of life questionnaires. Annual follow-up will involve repeating spirometry, chest imaging, and quality of life assessments. No additional interventions beyond routine clinical care will be mandated by the study protocol. All collected data will be anonymized and managed securely, adhering to both institutional and ethical regulatory standards (ClinicalTrials.gov: NCT06946784).

Conclusion: This will be the first nationwide observational cohort investigating PTLD in Korea, delivering key real-world evidence to inform national and international post-TB management policies.

背景:人们越来越关注结核病后肺病(PTLD)的疾病负担和长期结局。本研究旨在探讨结核病(TB)对肺部健康和生活质量的长期影响,以解决了解PTLD的关键证据缺口。方法:这是一项全国性、前瞻性、多中心观察性队列研究。从2025年6月到2026年12月,韩国的7个三级保健中心将招募至少350名参与者参加治疗阶段组(每个站点至少50名)。年龄≥19岁且正在(1)接受抗结核治疗(治疗期组)或(2)有肺结核治疗史(治疗后组)的个体符合入选条件。排除标准包括:(1)仅肺外结核,(2)年龄< 19岁,或(3)拒绝同意。在至2031年12月的五年随访期内,将在基线和每年收集数据。基线信息将包括人口统计、结核病相关病史、合并症和当前药物治疗。基线实验室数据将包括血液检查、尿液分析和心电图。临床评估将包括症状评分、肺活量测定、胸部成像和生活质量问卷。在随访期间,中期评估包括肺活量测定、胸部成像和生活质量问卷。除了常规临床实践之外,不需要研究特定的干预措施。所有数据将按照机构和道德准则进行匿名和安全存储。结论:该研究将是韩国第一个全国性的PTLD观察队列研究。它将提供重要的真实数据,为国家和全球结核病后管理战略提供信息。试验注册:ClinicalTrials.gov (NCT06946784) https://clinicaltrials.gov/ct2/show/NCT06946784。
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引用次数: 0
OM-85 and Respiratory Symptoms in Korean Chronic Obstructive Pulmonary Disease: A Multicenter Observational Study. OM-85与韩国COPD患者呼吸系统症状:一项多中心观察性研究
IF 3 Q2 RESPIRATORY SYSTEM Pub Date : 2026-01-01 Epub Date: 2025-09-04 DOI: 10.4046/trd.2025.0105
Chang-Seok Yoon, Tae-Ok Kim, Hong-Joon Shin, Hak-Ryul Kim, Ki-Eun Hwang, Sung Ho Yoon, Seoung Ju Park, Yong-Soo Kwon

Background: Although OM-85 may lessen respiratory symptoms and reduce acute exacerbations in chronic obstructive pulmonary disease (COPD), proof of its overall effectiveness remains incomplete.

Methods: This prospective, observational, single-arm study was conducted at four university hospitals in South Korea from June 2022 to December 2023. Adults with spirometry-confirmed COPD who were prescribed OM-85 were enrolled, and followed for 6 months (3-months treatment, 3-months observation). Symptoms and health-related quality of life were assessed using the modified Medical Research Council scale, COPD Assessment Test (CAT), and St. George's Respiratory Questionnaire (SGRQ). Acute exacerbations and adverse events were recorded.

Results: Of the 323 patients analyzed (mean age 73.3±7.8 years; 83.9% male), 39.0% had baseline CAT ≥10. Patients in this group experienced markedly greater and sustained improvements in both CAT and SGRQ scores compared with those with CAT <10 (p for interaction <0.001 for both), and the magnitude of these changes exceeded the minimal clinically important difference (CAT: -3.21±3.85; SGRQ: -10.42±14.87 at 6 months), indicating clinically meaningful symptom relief. Among these patients, achieving SGRQ responder status at 6 months was negatively associated with an increased frequency of acute exacerbations (odds ratio, 0.246; 95% confidence interval, 0.050 to 1.207; p=0.084), showing a nonsignificant trend. OM-85 was well tolerated, with only mild, reversible drugrelated adverse events.

Conclusion: OM-85 treatment resulted in meaningful improvements in symptoms and healthrelated quality of life, particularly among patients with more severe baseline symptoms, and was in general well tolerated.

背景:虽然OM-85可以减轻慢性阻塞性肺疾病(COPD)的呼吸系统症状和急性加重,但其总体有效性仍未得到完全证实。方法:这项前瞻性、观察性、单臂研究于2022年6月至2023年12月在韩国的四所大学医院进行。接受OM-85治疗的肺活量测定确诊的成人COPD患者被纳入研究,随访6个月(治疗3个月,观察3个月)。使用改良的医学研究委员会(mMRC)量表、COPD评估测试(CAT)和圣乔治呼吸问卷(SGRQ)对症状和健康相关生活质量进行评估。记录急性加重和不良事件。结果:在分析的323例患者中(平均年龄 73.3 ± 7.8 岁;83.9%为男性),39.0%的基线CAT ≥ 10。与CAT组相比,该组患者在CAT和SGRQ评分方面均有更大且持续的改善 结论:OM 85治疗对症状和健康相关的生活质量有意义的改善,特别是在基线症状更严重的患者中,并且通常耐受性良好。
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引用次数: 0
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Tuberculosis and Respiratory Diseases
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