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Gender Disparities in Patients with Atrial Fibrillation and Sleep Apnea. 房颤和睡眠呼吸暂停患者的性别差异。
IF 3.8 3区 医学 Q2 RESPIRATORY SYSTEM Pub Date : 2025-11-14 DOI: 10.1159/000549552
Susana Sousa, Joana Dias, Dina Grencho, Sara Dias, Teresa Pinheiro, Marta Drummond, António Bugalho

Introduction: Atrial fibrillation (AF) and obstructive sleep apnea syndrome (OSAS) manifest differently in men and women, which may influence treatment decisions and adherence. The aim of our study was to investigate clinical, polysomnographic, and biological characteristics of AF-OSAS patients and to compare gender differences in this specific population.

Methods: In a prospective single center study, the authors analyzed a population of consecutive patients with AF (paroxysmal or persistent). Anthropometric measurements, clinical and polysomnographic parameters were collected and evaluated. Soluble ST2, a serum biomarker of myocardial fibrosis, was measured.

Results: The study included 89 consecutive participants with AF, 67% were male (n = 60), with a mean age of 63 years (31-76 years), and mean body mass index (BMI) of 30 kg/m2. All patients had an apnea-hypopnea index (AHI) ≥5 events/hour. No significant differences were observed between men and women regarding BMI, hypersomnolence or snoring. Women had a lower arousal threshold (p = 0.04), lower hypoxic burden (p = 0.03), and lower ventilatory burden (p = 0.006), whereas men had elevated ST2 serum levels (p = 0.02) and a higher AHI (p = 0.01).

Conclusion: This study highlights the importance of systematically evaluating patients with atrial fibrillation for obstructive sleep apnea, due to its high prevalence, even in the absence of classic symptoms. The observed gender differences in clinical, laboratory, and polysomnographic parameters among AF patients emphasize the need for personalized diagnostic and management approaches.

房颤(AF)和阻塞性睡眠呼吸暂停综合征(OSAS)在男性和女性中的表现不同,这可能影响治疗决策和依从性。本研究的目的是调查AF-OSAS患者的临床、多导睡眠图和生物学特征,并比较这一特定人群的性别差异。方法:在一项前瞻性单中心研究中,作者分析了一组连续的房颤患者(阵发性或持续性)。收集并评估人体测量、临床和多导睡眠图参数。测定可溶性ST2(心肌纤维化的血清生物标志物)。结果:该研究纳入89例AF患者,其中67%为男性(n=60),平均年龄63岁(31-76岁),平均BMI为30 kg/m²。所有患者AHI≥5次/小时。在BMI、嗜睡和打鼾方面,男性和女性没有显著差异。女性有较低的唤醒阈值(p=0.04),较低的缺氧负担(p= 0.03)和较低的通气负担(p= 0.006),而男性有较高的ST2血清水平(p=0.02)和较高的AHI (p=0.01)。结论:本研究强调了系统评估心房颤动阻塞性睡眠呼吸暂停患者的重要性,因为即使在没有典型症状的情况下,心房颤动的患病率也很高。在房颤患者中观察到的临床、实验室和多导睡眠图参数的性别差异强调了个性化诊断和治疗方法的必要性。
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引用次数: 0
Drug-Induced Interstitial Lung Disease in Lung Cancer Patients. 肺癌患者药物性间质性肺病的研究
IF 3.8 3区 医学 Q2 RESPIRATORY SYSTEM Pub Date : 2025-11-12 DOI: 10.1159/000548862
Gilles Vanhandsaeme, Karolien Viskens, Valerie Van Ballaer, Walter De Wever, Gilles Defraene, Maarten Lambrecht, Elena Donders, Pierre Van Mol, Els Wauters

Background: Pulmonary toxicity is a possible adverse event (AE) of all systemic treatments for lung cancer. Drug-induced parenchymal and interstitial lung disease (D-ILD) is a rare but potentially life-threatening pulmonary AE. Its clinical and radiological manifestations are highly variable and nonspecific, making recognition and diagnosis particularly challenging.

Summary: Effective management of D-ILD requires a high degree of clinical suspicion, supported by education of both patients and healthcare providers. Any lung cancer patient who develops new respiratory symptoms and/or new radiographic abnormalities should be promptly evaluated for possible D-ILD. However, the differential diagnosis is broad, including both infectious and noninfectious etiologies. Clinical, laboratory, microbial, and imaging findings should be incorporated to adjudicate the possibility of D-ILD. Given the absence of a definitive diagnostic test, D-ILD remains a complex diagnosis of exclusion that benefits from a multidisciplinary approach. Pulmonologists play an active role in an integrated diagnostic work-up and management of D-ILD, and they should therefore remain actively engaged in this clinically relevant subject.

Key messages: This review discusses the incidence, risk factors, clinical and radiographic features, and management strategies for D-ILD in the context of current systemic treatments for lung cancer. A practical framework for differential diagnosis is also provided to support clinical decision-making.

肺毒性是所有系统性肺癌治疗中可能出现的不良事件。药物性肺实质和间质性疾病(D-ILD)是一种罕见的肺部AE,但可危及生命。从临床和放射学的角度来看,D-ILD的表现是可变的和非特异性的。因此,对D-ILD的良好管理需要高度的怀疑,这应该通过对患者和临床医生的教育来建立。一旦怀疑,临床医生应及时评估有新的呼吸系统疾病和/或新的放射学异常的肺癌患者是否存在D-ILD。然而,鉴别诊断是广泛的,包括感染性和非感染性原因。临床,实验室,微生物和影像学检查结果应结合判断D-ILD的可能性。在缺乏结论性诊断测试的情况下,D-ILD是一种具有挑战性的排除诊断,受益于多学科方法。肺科医生在D-ILD的综合诊断检查和管理中发挥着积极作用,因此他们应该积极参与这一临床相关课题。本综述将讨论目前肺癌标准全身治疗下的发病率、危险因素、临床和影像学表现以及D-ILD的管理。此外,还提供了一个实用的鉴别诊断框架。
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引用次数: 0
Acquired Tracheal Stenosis in an HIV-Positive Child Presenting with Persistent Respiratory Symptoms after Being Ventilated for Pneumocystis jirovecii Pneumonia and Cytomegalovirus Pneumonia: Diagnosis and Management in a Severely Immunosuppressed Child. 1例HIV阳性儿童因PJP和巨细胞病毒肺炎通气后出现持续呼吸道症状的获得性气管狭窄:严重免疫抑制儿童的诊断和治疗
IF 3.8 3区 医学 Q2 RESPIRATORY SYSTEM Pub Date : 2025-11-10 DOI: 10.1159/000549478
Pierre Goussard, Ernst Eber, Lisa Frigati, Leonore Greybe, Shyam Sunder B Venkatakrishna, Jacques Janson, Zane Ismail, Pawel Tomasz Schubert, Lars Ebert, Janette Verster, Andre Gie, Savvas Andronikou

Introduction: Pneumocystis jirovecii pneumonia (PJP) is a significant cause of morbidity and mortality in children with advanced HIV disease (AHD) and other immunosuppressive conditions. Acquired tracheal stenosis in children living with HIV (CLHIV) has not been described.

Case presentation: A 4-month and 3-week-old child living with HIV presented with persistent respiratory symptoms after mechanical ventilation for 10 days for confirmed PJP and cytomegalovirus (CMV) pneumonia at the age of 3 months and 1 week. She tested positive for HIV at 3 months of age and had a high viral load of log 2.7 copies/mL. She was re-admitted to the PICU with multilobar pneumonia, requiring non-invasive ventilation with metapneumovirus identified from nasopharyngeal aspirate. Persistent wheeze and stridor were noted. During hospitalization, the mother was diagnosed with confirmed tuberculosis (TB). The child was referred for bronchoscopy due to the possibility of pulmonary TB and airway compression. A chest CT scan revealed short segment tracheal stenosis of >50% but no signs of TB as a possible cause. Bronchoscopy demonstrated significant narrowing occurring in the midtracheal region with the acquired nature configuration. The stenosis was successfully dilated twice, first with rigid bronchoscopy, followed by dilatation with flexible bronchoscopy and an angioplasty balloon.

Conclusion: Acquired tracheal stenosis in CLHIV is not well documented, although many young children with HIV infection have been ventilated for severe pneumonia. Bronchoscopy should be considered in children with persistent respiratory symptoms, and endoscopic procedures can be safely performed in immunosuppressed children.

基洛氏肺囊虫肺炎(PJP)是晚期HIV疾病(AHD)和其他免疫抑制疾病患儿发病和死亡的重要原因。感染HIV (CLHIV)的儿童获得性气管狭窄尚未见报道。病例介绍:一名4个月零3周大的艾滋病毒感染儿童在机械通气10天后出现持续呼吸道症状,确诊为PJP和巨细胞病毒肺炎,3个月零1周大。她在3个月大时HIV检测呈阳性,病毒载量高达log 2.7拷贝/毫升。她因多叶性肺炎再次入住PICU,需要无创通气,并从鼻咽吸入物中发现偏肺病毒。注意到持续的喘息和喘鸣。在住院期间,母亲被确诊患有肺结核。由于肺结核和气道压迫的可能性,儿童被转介进行支气管镜检查。胸部CT扫描显示短段气管狭窄bbbb50 %,但没有迹象表明结核病可能的原因。支气管镜检查显示明显的狭窄发生在气管中部,具有获得性结构。狭窄成功扩张两次,第一次是刚性支气管镜,随后是柔性支气管镜和血管成形术球囊。结论:尽管许多HIV感染的幼儿因严重肺炎而进行了通气治疗,但CLHIV患者的获得性气管狭窄尚未得到充分的证实。有持续呼吸道症状的儿童应考虑支气管镜检查,免疫抑制的儿童可以安全地进行内镜检查。
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引用次数: 0
First European Results of Shape-Sensing Robotic-Assisted Bronchoscopy. 形状感应机器人辅助支气管镜检查的第一个欧洲结果。
IF 3.8 3区 医学 Q2 RESPIRATORY SYSTEM Pub Date : 2025-11-07 DOI: 10.1159/000549197
Judith Maria Brock, A Susanne Dittrich, Konstantina Kontogianni, Claus-Peter Heussel, Laura V Klotz, Hauke Winter, Mavi Schellenberg, Ulrich Keppler, Felix Herth

Introduction: Shape-sensing robotic-assisted bronchoscopy (ssRAB) was shown to be superior in diagnosing peripheral pulmonary nodules (PPNs) compared to conventional bronchoscopy. Although RAB is established in the USA since 2019, the ION™ Endoluminal System was not CE marked in Europe until 2023.

Methods: The first prospective European single-center, premarket study, conducted between 2022 and 2023, assessed the diagnosis of PPNs with ssRAB, using the ION™ Endoluminal System. Patients with suspected lung cancer or metastasis, PPNs of 1-3 cm, and ≥3 airway generations out were included in this study and followed up for up to 6 months. The primary outcome was the rate of tool-in-lesion (TIL), confirmed by mobile cone-beam computed tomography or with malignant index biopsy finding. Secondary outcomes included procedural characteristics, diagnostic yield, and adverse events.

Results: A total of 43 patients with a mean nodule size of 19.2 × 16.9 × 15.8 mm, a mean distance of 17.4 ± 15.5 mm to the pleura, and mean 6.6th generation of airway were analyzed. TIL was achieved in 90.7% of all cases. Strict diagnostic yield was 67.4% and sensitivity for malignancy was 78.6%. No pneumothorax and no adverse events were reported outside of 3 cases of Nashville ≤2 bleeding. Predictors for successful diagnosis were the inner or middle third location (OR: 4.19, p = 0.039), CT bronchus sign (OR: 4, p = 0.044), and distance from pleural wall (OR: 1.05, p = 0.048). The lower lobe location (OR: 0.06, p < 0.001) was associated with nondiagnostic cases.

Conclusion: The first European cases show ssRAB is a safe procedure with promising results for enabling diagnosis of PPNs.

背景和目的:与传统支气管镜检查相比,形状传感机器人辅助支气管镜检查(ssRAB)在诊断周围性肺结节(PPN)方面具有优势。尽管RAB自2019年以来在美国成立,但欧洲尚未公布描述其在医疗保健系统中的使用的数据。方法:欧洲首个前瞻性单中心研究使用ION™腔内系统评估ssRAB对PPN的诊断。本研究纳入疑似肺癌或转移的患者,PPN为1-3cm,≥3代气道外,随访6个月。主要结果是病变内工具(TIL)的发生率,由移动锥束计算机断层扫描(mCBCT)或恶性指数活检发现证实。次要结局包括手术特征、诊断率和不良事件。结果:本研究共分析43例患者,平均结节大小为19.2x16.9x15.8 mm,平均距离胸膜17.4±15.5 mm,平均为6.6代气道。90.7%的病例达到TIL。严格诊断率为67.4%,敏感性为78.6%。除3例纳什维尔≤2型出血外,无气胸,无不良事件报告。成功诊断的预测因子为内三分位或中三分位(or 4.19, p=0.039)、CT支气管征象(or 4, p=0.044)和胸膜距离(or 1.05, p=0.048)。结论:欧洲的第一例病例表明,ssRAB是一种安全的方法,在诊断PPN方面具有良好的效果。
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引用次数: 0
Drug-Induced Interstitial Lung Disease: A Real-World Pharmacovigilance Study Based on an Adverse Event Reporting System. 药物性间质性肺疾病:基于不良事件报告系统的真实世界药物警戒研究
IF 3.8 3区 医学 Q2 RESPIRATORY SYSTEM Pub Date : 2025-10-31 DOI: 10.1159/000549124
Yahui Cui, Xiaowen Han, Shichao Dong, Xingchen Meng, Chuan Sun

Introduction: Drug-induced interstitial lung disease (DILD) involves different pathogenic mechanisms, and it is difficult for clinicians to identify the culprit drug. There is currently no systematic research that allows us to understand the comprehensive situation of potential risk drugs and culprit drugs for DILD.

Methods: This study retrospectively analyzed all adverse events related to DILD in FAERS, compiled a list of potential risk drugs leading to DILD and calculated the reporting ratio. In addition, all drugs within the list were detected using disproportionality analysis, a list of culprit drugs was developed based on the signal detection results, and the signal distribution characteristics were summarized.

Results: We obtained 108,891 DILD-related reports and identified 1,445 potential risk drugs from them. Overall, the drug with the highest number of reports was methotrexate, followed by amiodarone, nivolumab, pembrolizumab, and rituximab. Classifying all potential risk drugs (second-level ATC subgroup), the subgroup with the highest number of reports is antineoplastic agents. Finally, we determined the list of culprit drugs, and 171 drugs showed positive signals by signal detection, while the other 1,274 drugs were determined to be negative, with amiodarone obtaining the highest number of positive signals. All the culprit drugs were classified and distributed them positively and negatively. The number of drugs with positive signals is less than that with negative signals, and antineoplastic agents (L01) have the highest proportion among all positive drugs.

Conclusion: This study comprehensively displays all drugs related to DILD from a landscape perspective, promoting the rational use of drugs in clinical practice.

背景与目的药物性间质性肺疾病(DILD)涉及多种致病机制,临床医生难以确定罪魁祸首药物。目前还没有系统的研究可以让我们全面了解DILD的潜在风险药物和罪魁祸首药物的情况。方法回顾性分析FAERS中所有与DILD相关的不良事件,编制导致DILD的潜在风险药物清单,并计算报告率。此外,利用歧化分析对清单内所有药物进行检测,根据信号检测结果编制元凶药物清单,并总结信号分布特征。结果共获得108891份与dild相关的报告,从中鉴定出1445种潜在风险药物。总的来说,报告最多的药物是甲氨蝶呤,其次是胺碘酮、纳武单抗、派姆单抗和利妥昔单抗。对所有潜在风险药物进行分类(二级ATC亚组),报告数量最多的亚组是抗肿瘤药物。最后,我们确定了罪魁祸首药物名单,通过信号检测,171种药物呈阳性信号,1274种药物呈阴性信号,其中胺碘酮阳性信号最多。对所有的毒品进行分类,并进行正反两方面的分配。阳性信号药物数量少于阴性信号药物,其中抗肿瘤药物(L01)在所有阳性药物中所占比例最高。结论本研究从景观角度全面展示了与DILD相关的所有药物,促进了临床药物的合理使用。
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引用次数: 0
Italian Translation and Cross-Cultural Adaptation of S3-NIV Questionnaire for Patients on Long-Term Home Noninvasive Mechanical Ventilation. 长期家庭无创机械通气患者S-3-NIV问卷的意大利语翻译与跨文化适应
IF 3.8 3区 医学 Q2 RESPIRATORY SYSTEM Pub Date : 2025-10-27 DOI: 10.1159/000549156
Paola Pierucci, Claudia Crimi, Maria Luisa de Candia, Gualtiero Ermando Romano, Alessandro Pilon, Nicola Bartolomeo, Letizia Lorusso, Anna Annunziata, Paolo Banfi, Antonietta Coppola, Giuseppe Fiorentino, Teresa Renda, Raffaele Scala, Giovanna Elisiana Carpagnano, Annalisa Carlucci

Introduction: Long-term home noninvasive ventilation (LTH-NIV) supports patients with chronic respiratory failure. The S3-NIV questionnaire is an easy and quick tool to evaluate outpatients initiated to home mechanical ventilation. The aim of our study was to translate and validate the Italian version of the S3-NIV questionnaire and test its internal consistency and factorial structure, providing with Italian cultural adaptation of the original S3-NIV questionnaire.

Methods: This is a prospective, national, observational, multicenter study enrolling consecutive outpatients accessing between December 2023 and June 2024 to a dedicated ambulatory for chronic respiratory failure requiring LTH-NIV for different underlying diseases (i.e., chronic obstructive pulmonary disease, neuromuscular disorders, obesity hypoventilation syndrome). Internal consistency was assessed using Cronbach's alpha.

Results: The translation and back-translation process from the English version was performed. A total of 228 out of 340 screened patients were enrolled Internal consistency of the total score was good (Cronbach's α coefficient of 0.84) as well as for the "respiratory symptoms" and the 'sleep and side effects' subdomains (0.82 and 0.74, respectively). Kaiser exploratory analysis confirmed good homogeneity: 0.85.

Conclusion: The S3-NIV questionnaire Italian translation and cultural adaptation has good global reliability and internal consistency. This tool has been confirmed to be a simple, quickly available, and easy-to-use tool for the outpatients' clinical assessment of stable patients with chronic respiratory failure initiated on LTH-NIV.

背景:长期家庭无创通气(LTH-NIV)支持慢性呼吸衰竭患者。S-3-NIV问卷是一种简单、快速的工具,用于评估开始使用家庭机械通气的门诊患者。我们的研究目的是翻译和验证意大利语版的S3-NIV问卷,并测试其内部一致性和析因结构,提供原始S-3-NIV问卷的意大利文化适应性。方法:这是一项前瞻性、全国性、观察性、多中心研究,纳入了2023年12月至2024年6月期间到专门门诊治疗不同基础疾病(如慢性阻塞性肺疾病慢性阻塞性肺疾病(COPD)、神经肌肉疾病(NMD)、肥胖低通气综合征(OHS))需要LTH-NIV的慢性呼吸衰竭的连续门诊患者。进行结构信度测试。结果:完成了英文版本的翻译和反翻译过程。在340名筛选的患者中,共有228名患者入组,总体评分的内部一致性良好(Cronbach's α系数为0.84),“呼吸症状”和“睡眠和副作用”子域的内部一致性良好(分别为0.82和0.74)。Kaiser探索性分析证实了良好的同质性:0.85。NMD患者的S3-NIV总分和呼吸系统评分明显低于OHS组。结论:S3-NIV问卷意大利语翻译与文化适应具有良好的全球信度和内部一致性。该工具已被证实是一种简单、快速、易于使用的工具,可用于LTH-NIV启动的稳定型慢性呼吸衰竭患者的门诊临床评估。
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引用次数: 0
"An Amazing Transformation!" The Lived Experiences of Elexacaftor/Tezacaftor/Ivacaftor in Adults with Cystic Fibrosis. “一个惊人的转变!”成人CF患者的脱出/脱出/脱出生活经验。
IF 3.8 3区 医学 Q2 RESPIRATORY SYSTEM Pub Date : 2025-10-23 DOI: 10.1159/000549098
Naomi Chapman, Sona Vekaria, Kylie Hill, Vinicius Cavalheri, Siobhain Mulrennan, Daniel F Gucciardi

Introduction: Cystic fibrosis (CF) is associated with a high respiratory symptom and treatment burden. Elexacaftor/tezacaftor/ivacaftor (ETI) provides substantial improvements in physiological outcomes such as respiratory function and sweat chloride. This study sought to comprehensively examine an area of limited research in this field: the lived experiences of adults with CF after ETI initiation.

Methods: Adults with CF completed semi-structured interviews at least 6 weeks following the initiation of ETI. Participants shared their experiences regarding respiratory-related symptoms, airway clearance routines, and their capacity to participate in physical activity. Interviews were audio-recorded, transcribed verbatim and analysed using the Framework Method.

Results: Seventeen participants completed interviews (FEV1 range before ETI initiation 31 to 87 % predicted). All participants reported improvements in respiratory-related symptoms including cough, sputum expectoration, dyspnoea, and chest tightness. As a result, there was a reduction in participants airway clearance treatment burden and improvements in their capacity to participate in physical activity, health-related quality of life and outlook for the future. The overall theme highlighted in this study was that ETI had "completely changed everything" and they can now do "everything I wasn't able to do before" due to the reductions in symptom and treatment burden.

Conclusion: Participants consistently described their experiences with ETI in positive terms. The results of this study confirm that ETI is in fact perceived to be a "miracle drug" and has had a transformative effect on the everyday lives of adults with CF through improved HRQoL and overall wellbeing, which led to positive views regarding their future with CF and ongoing medical care.

囊性纤维化(CF)与高呼吸症状和治疗负担相关。elexaftor /tezacaftor/ivacaftor (ETI)在呼吸功能和汗液氯化物等生理结果方面提供了实质性的改善。本研究旨在全面考察该领域有限的研究领域:成人CF患者在ETI启动后的生活经历。方法:成年CF患者在ETI开始后至少6周完成半结构化访谈。参与者分享了他们在呼吸相关症状、气道清除常规和参与身体活动能力方面的经验。访谈录音,逐字抄录,并使用框架方法进行分析。结果:17名参与者完成了访谈(ETI开始前的FEV1范围为31%至87%)。所有参与者都报告了呼吸相关症状的改善,包括咳嗽、咳痰、呼吸困难和胸闷。结果,参与者的气道清除治疗负担减轻,他们参与身体活动的能力、健康相关生活质量(HRQoL)和未来前景都有所改善。这项研究强调的总体主题是,ETI“完全改变了一切”,由于症状和治疗负担的减轻,他们现在可以做“我以前不能做的一切”。结论:参与者始终以积极的方式描述他们的ETI经历。本研究的结果证实,ETI实际上被认为是一种“神奇的药物”,通过改善HRQoL和整体健康,对CF成人的日常生活产生了变革性的影响,这导致了他们对CF的未来和正在进行的医疗护理的积极看法。
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引用次数: 0
First-In-Human Trial of the Implantable Artificial Bronchus: A Novel Bronchoscopically Delivered Treatment Option for Patients with Severe Emphysema. 植入式人工支气管(IAB)的首次人体试验,这是一种新的支气管镜下治疗严重肺气肿患者的选择。
IF 3.8 3区 医学 Q2 RESPIRATORY SYSTEM Pub Date : 2025-10-13 DOI: 10.1159/000548873
Hugo Goulart de Oliveira, Dirk-Jan Slebos, Felix Herth

Introduction: IAB-1 is the first-in-human study of the implantable artificial bronchus (IAB) in patients with severe emphysema. The IAB is a bronchoscopically delivered, self-expanding, tapered stent made of polyether ether ketone. By restoring the original airway and preventing expiratory collapse, it allows release of hyperinflated air. It is indifferent to collateral ventilation and disease distribution.

Methods: In a primary bronchoscopy, 1 or 2 IABs are implanted in the most diseased lobe. A secondary bronchoscopy at 30 days allows implantation of 1 or 2 additional IABs in another lobe. The primary endpoint, evaluated at 90 days, was safety, defined as any of 10 prespecified respiratory serious adverse device events (SADEs). Secondary endpoints included other related adverse events and multiple efficacy measures.

Results: Twenty patients were implanted with 53 IABs: 5 subjects formed the early termination set (ETS) because of SADEs; 15, the full analysis set (FAS), continued to the 90-day endpoint. All 5 ETS patients and 2 FAS patients experienced 4 of the 10 primary respiratory SADEs: pneumonia, airway injury, COPD exacerbation, and pneumothorax. The majority of patients improved clinically with statistically significant outcomes in all effectiveness variables (residual volume, six-minute walk distance, modified Medical Research Council, COPD Assessment Test, Saint George Respiratory Questionnaire, and EuroQual 5-Dimensional) with the exception of forced expiratory volume in 1 s.

Conclusion: IAB-1 demonstrated feasibility and a risk profile that improved during the trial by identifying and addressing the need for improved patient selection, implant site selection, implant technique, and delivery system improvements. The IAB may be desirable for emphysema patients who are ineligible for other interventional treatments and wish to avoid surgery.

IAB-1是首次在严重肺气肿患者中进行植入式人工支气管(IAB)的人体(FIH)研究。IAB是一种由聚醚醚酮(PEEK)制成的经支气管镜输送的自膨胀锥形支架。通过恢复原始气道和防止呼气塌陷,它允许释放过度充气的空气。与侧支通气和疾病分布无关。方法:在初级支气管镜检查中,在最病变的肺叶植入1或2个iab。第30天的二次支气管镜检查允许在另一个肺叶植入1或2个额外的iab。在90天评估的主要终点是安全性,定义为10个预先指定的呼吸严重不良装置事件(SADEs)中的任何一个。次要终点包括其他相关不良事件和多项疗效指标。结果:20例患者共植入53枚IABs,其中5例因SADEs形成早期终止组(Early Termination Set, ETS);15,完整分析集(FAS),持续到90天的终点。5例ETS患者和2例FAS患者均经历了10例原发性呼吸道sade中的4例:肺炎;气道损伤;慢性阻塞性肺病恶化;和气胸。除FEV1外,大多数患者临床改善,除FEV1外,所有有效性变量(RV、6MWT、mMRC、CAT、SGRQ和EQ-5D)的结果均有统计学意义。结论:IAB-1通过识别和解决改进患者选择、种植体位置选择、种植体技术和输送系统改进的需要,证明了可行性和风险概况在试验期间得到改善。对于不符合其他介入治疗条件并希望避免手术的肺气肿患者,IAB可能是可取的。
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引用次数: 0
Novel Combination of a 1.4mm Radiofrequency Ablation Catheter with Ultrathin Bronchoscope for Subpleural Peripheral Lung Tumour Ablation. 1.4mm射频消融导管与超薄支气管镜联合用于胸膜下周围性肺肿瘤消融。
IF 3.8 3区 医学 Q2 RESPIRATORY SYSTEM Pub Date : 2025-09-15 DOI: 10.1159/000548327
Sze Shyang Kho, Chan Sin Chai, Noor Annisa Darman, Swee Kim Chan, Swee Kiong Kho, Choon Seong Ang, Don Tanaka, Shashank Raina, Pei Jye Voon, Siew Teck Tie

Bronchoscopic ablation is a promising minimally invasive treatment for peripheral lung tumours, avoiding the high complications associated with percutaneous approaches. However, existing ablation catheters are mostly incompatible with ultrathin bronchoscope (UTB), potentially limiting access to subpleural lesions. We report a case of successful bronchoscopic ablation using a novel 1.4 mm radiofrequency (RF) catheter delivered through a UTB. A 53-year-old woman with oligometastatic gastroesophageal adenocarcinoma underwent bronchoscopic ablation for a 12 mm apical right upper lobe metastasis. The UTB was navigated to the 8th airway generation under direct bronchoscopic vision, and the flexible RF catheter was smoothly inserted through the UTB's 1.7 mm working channel. Real-time cone-beam CT confirmed accurate catheter positioning, ensuring safe ablation without pleural puncture. A total of 26 kJ of energy was delivered over 513 seconds. The patient recovered without complications and was discharged 48 hours post-procedure. The RF catheter's small diameter and high flexibility allow UTB to remain precise and manoeuvrable in the peripheral airway. As peripheral bronchoscopy evolves beyond diagnostics, integrating miniaturized therapeutic tools such as the 1.4mm RF catheter will be crucial in expanding its clinical utility. Further results from ongoing clinical trials are highly anticipated to validate the long-term feasibility and safety of this technique.

支气管镜消融是一种很有前途的微创治疗外周肺肿瘤的方法,避免了经皮入路相关的高并发症。然而,现有的消融导管大多与超薄支气管镜(UTB)不相容,潜在地限制了对胸膜下病变的检查。我们报告一例成功的支气管镜消融使用新型1.4毫米射频(RF)导管通过UTB交付。一位53岁的女性少转移性胃食管腺癌患者因右上叶顶端12毫米转移而行支气管镜消融。在直接支气管镜下将UTB导航至第8代气道,柔性射频导管通过UTB的1.7 mm工作通道顺利插入。实时锥形束CT确认导管定位准确,确保消融安全,无需胸膜穿刺。在513秒内总共传递了26千焦的能量。患者恢复无并发症,术后48小时出院。射频导管的小直径和高灵活性使UTB在周围气道中保持精确和可操作性。随着外周支气管镜检查的发展,集成小型化的治疗工具,如1.4mm射频导管,将是扩大其临床应用的关键。正在进行的临床试验的进一步结果被高度期待来验证该技术的长期可行性和安全性。
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引用次数: 0
Development and Validation of a Nomogram to Predict Airway Fibrostenosis in Tracheobronchial Tuberculosis. 预测气管支气管结核患者气道纤维狭窄的Nomogram方法的建立与验证。
IF 3.8 3区 医学 Q2 RESPIRATORY SYSTEM Pub Date : 2025-09-15 DOI: 10.1159/000548355
Wei Zhao, Weiming Fang, Dehu Peng, Zhiyu Feng, Min Wang, Hong Zhang, Yuan Yuan, Di Wu, Zeying Chen, Xianlin Huang, Zilong Yang, Jiahua Fan, Xincai Xiao, Haobin Kuang

Background:  Airway fibrostenosis, a severe complication of tracheobronchial tuberculosis (TBTB), causes respiratory morbidity including atelectasis, pneumonia, and respiratory failure. Early risk prediction remains challenging due to the lack of validated assessment tools.

Methods:  This retrospective cohort study analyzed TBTB patients undergoing bronchoscopic interventions between January 2021 and June 2024 with 6-month follow-up. A Cox regression model was developed in all 305 patients, internally validated with 1,000 bootstrap resamples. Performance was evaluated via C-index, ROC-AUC, calibration, and decision curve analysis. Kaplan-Meier analysis was used to stratify groups, with log-rank tests assessing differences.

Results:  Airway fibrostenosis incidence was 60.33% (184/305). Eight independent predictors were identified: symptom duration, affected lung lobes, diabetes, multiple TBTB types, bronchoscopic intervention frequency, initial sputum acid-fast bacilli smear grade, neutrophil-to-lymphocyte ratio, and CD8+ T-cell count. The nomogram demonstrated strong discrimination (C-index 0.77, 95%CI 0.75-0.81) with increasing predictive accuracy over time: 6-week AUC 0.773 (0.708-0.838), 8-week 0.792 (0.740-0.844), 12-week 0.830 (0.782-0.878), and 16-week 0.883 (0.842-0.923). High-risk patients exhibited a significantly higher probability of developing airway fibrostenosis compared to low-risk patients (P<0.001). Calibration and decision curve analyses confirmed clinical utility.

Conclusions:  This validated nomogram effectively predicts airway fibrostenosis risk in TBTB patients, enabling early identification of high-risk individuals for targeted interventions.

背景:气道纤维狭窄是气管支气管结核(TBTB)的严重并发症,可引起呼吸系统疾病,包括肺不张、肺炎和呼吸衰竭。由于缺乏有效的评估工具,早期风险预测仍然具有挑战性。方法:本回顾性队列研究分析了2021年1月至2024年6月期间接受支气管镜干预的TBTB患者,随访6个月。在所有305例患者中建立了Cox回归模型,并使用1,000个bootstrap样本进行内部验证。通过c -指数、ROC-AUC、校准和决策曲线分析来评估性能。Kaplan-Meier分析用于分组,log-rank检验评估差异。结果:气道纤维狭窄发生率为60.33%(184/305)。确定了8个独立的预测因素:症状持续时间、受影响的肺叶、糖尿病、多种TBTB类型、支气管镜干预频率、初始痰抗酸杆菌涂片分级、中性粒细胞与淋巴细胞比率和CD8+ t细胞计数。nomogram显示出较强的判别性(C-index 0.77, 95%CI 0.75-0.81),且随着时间的推移,预测准确率逐渐提高:6周AUC 0.773(0.708-0.838), 8周AUC 0.792(0.740-0.844), 12周AUC 0.830(0.782-0.878), 16周AUC 0.883(0.842-0.923)。与低危患者相比,高危患者发生气道纤维狭窄的概率明显更高(p结论:这一经过验证的nomogram可有效预测TBTB患者气道纤维狭窄的风险,从而能够早期识别高危个体,进行有针对性的干预。
{"title":"Development and Validation of a Nomogram to Predict Airway Fibrostenosis in Tracheobronchial Tuberculosis.","authors":"Wei Zhao, Weiming Fang, Dehu Peng, Zhiyu Feng, Min Wang, Hong Zhang, Yuan Yuan, Di Wu, Zeying Chen, Xianlin Huang, Zilong Yang, Jiahua Fan, Xincai Xiao, Haobin Kuang","doi":"10.1159/000548355","DOIUrl":"https://doi.org/10.1159/000548355","url":null,"abstract":"<p><strong>Background: </strong> Airway fibrostenosis, a severe complication of tracheobronchial tuberculosis (TBTB), causes respiratory morbidity including atelectasis, pneumonia, and respiratory failure. Early risk prediction remains challenging due to the lack of validated assessment tools.</p><p><strong>Methods: </strong> This retrospective cohort study analyzed TBTB patients undergoing bronchoscopic interventions between January 2021 and June 2024 with 6-month follow-up. A Cox regression model was developed in all 305 patients, internally validated with 1,000 bootstrap resamples. Performance was evaluated via C-index, ROC-AUC, calibration, and decision curve analysis. Kaplan-Meier analysis was used to stratify groups, with log-rank tests assessing differences.</p><p><strong>Results: </strong> Airway fibrostenosis incidence was 60.33% (184/305). Eight independent predictors were identified: symptom duration, affected lung lobes, diabetes, multiple TBTB types, bronchoscopic intervention frequency, initial sputum acid-fast bacilli smear grade, neutrophil-to-lymphocyte ratio, and CD8+ T-cell count. The nomogram demonstrated strong discrimination (C-index 0.77, 95%CI 0.75-0.81) with increasing predictive accuracy over time: 6-week AUC 0.773 (0.708-0.838), 8-week 0.792 (0.740-0.844), 12-week 0.830 (0.782-0.878), and 16-week 0.883 (0.842-0.923). High-risk patients exhibited a significantly higher probability of developing airway fibrostenosis compared to low-risk patients (P<0.001). Calibration and decision curve analyses confirmed clinical utility.</p><p><strong>Conclusions: </strong> This validated nomogram effectively predicts airway fibrostenosis risk in TBTB patients, enabling early identification of high-risk individuals for targeted interventions.</p>","PeriodicalId":21048,"journal":{"name":"Respiration","volume":" ","pages":"1-21"},"PeriodicalIF":3.8,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145065549","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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