Respiratory medicine最新文献_第9页

Reproducibility of three 6-min walk tests in patients with COPD referred for pulmonary rehabilitation 三种六分钟步行试验在COPD患者转介肺部康复中的可重复性

IF 3.5 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Respiratory medicine

Pub Date : 2025-01-01 DOI: 10.1016/j.rmed.2024.107884

Jeannet M. Delbressine , Anouk W. Vaes , Wieteke A.M. Stoop , Dirk Van Ranst , Martijn A. Spruit , Alex van ’t Hul

Introduction and objectives

The 6-min walk test (6MWT) is used to assess functional capacity in patients with COPD. A significant number of studies have shown that most patients walk further in a second 6MWT. Research on a further increase in the 6-min walk distance (6MWD) during a 3rd test performed in accordance with current guidelines has not been done. Therefore, this study aimed to investigate 1) the reproducibility of three 6MWTs in patients with COPD referred for pulmonary rehabilitation (PR) and 2) predictors of improvement on a third 6MWT.

Materials and methods

Before the start of PR, 1167 COPD patients (50 % male, age: 62 ± 9 years; FEV1: 42 ± 18%pred) performed three 6MWTs (6MWT1, 6MWT2, and 6MWT3). A predetermined threshold of ≥42m improvement in 6MWD in consecutive 6MWT's was used to identify improvers. Reproducibility between tests was assessed using a Bland-Altman plot and logistic regression analyses were performed to assess effects of sex, age, body mass index, GOLD-stage, 6MWD, use of supplemental oxygen and use of walking aids.

Results

Generally, the 6MWD improved (6MWT1: 343 ± 115m; 6MWT2: 367 ± 115m; 6MWT3: 381 ± 116m). 210 patients (18 %) improved ≥42m from 6MWT2 to 6MWT3. The Bland-Altman plot showed that the 95 % limits of agreement of 6MWT3 vs 6MWT2 exceeded 42m, indicating that 6MWT2 is not reproducible. Predictors of improvement in 6MWT3 were GOLD stage I/II and a low 6MWD (<350m) in the previous two 6MWTs.

Conclusions

These results indicate that three 6MWTs may be required to obtain the largest pre-PR functional capacity in COPD patients. Patients with a 6MWD <350m and GOLD-stage I/II are more likely to improve ≥42m in a third 6MWT.

介绍和目的：6分钟步行试验（6MWT）用于评估COPD患者的功能能力。大量研究表明，大多数患者在第二个6MWT中走得更远。在按照现行指南进行的第三次测试中，关于进一步增加6分钟步行距离（6MWD）的研究尚未完成。因此，本研究旨在探讨1)三种6MWT在COPD患者肺康复（PR）中的可重复性，以及2)第三种6MWT改善的预测因素。材料与方法：PR开始前，1167例COPD患者(50%男性，年龄：62±9岁；FEV1: 42±18%pred)分别进行6MWT1、6MWT2和6MWT3三组6MWTs。采用连续6MWT的6MWD改善≥42m的预定阈值来识别改善者。采用Bland-Altman图评估试验之间的可重复性，并进行logistic回归分析以评估性别、年龄、体重指数、gold分期、6MWD、使用补充氧和使用助行器的影响。结果：6MWD总体改善(6MWT1: 343±115m；6 mwt2: 367±115米;6 mwt3: 381±116米)。210例（18%）患者从6MWT2到6MWT3改善≥42m。Bland-Altman图显示6MWT3与6MWT2的95%一致性限超过42m，表明6MWT2不可重复。6MWT3改善的预测因子是GOLD期I/II期和低6MWD(结论：这些结果表明，COPD患者可能需要3个6MWTs才能获得最大的pr前功能容量。6MWD患者

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引用次数: 0

Hypersensitivity pneumonitis radiologic features in interstitial lung diseases 间质性肺病的超敏性肺炎影像学特征。

IF 3.5 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Respiratory medicine

Pub Date : 2025-01-01 DOI: 10.1016/j.rmed.2024.107901

Tamar Shalmon , Ophir Freund , Ori Wand , Sonia Schneer , Tzlil Hershko , Yitzhak Hadad , Galit Aviram , Amir Bar-Shai , Yochai Adir , David Shitrit , Avraham Unterman

Background

The radiologic criteria of hypersensitivity pneumonitis (HP) guidelines focus on four HP compatible features (HPCF) in high-resolution computed tomography (HRCT): ground glass opacities, mosaic attenuation, air-trapping, and centrilobular nodules. However, evidence to support these criteria are limited.

Methods

Consecutive interstitial lung disease (ILD) patients who underwent HRCT between 2016 and 2021 in three medical centers were included. We assessed the prevalence of HPCF in each ILD and their association with HP diagnosis. We evaluated the impact of HPCF amount for HP diagnosis and the performance of the radiologic criteria by the ATS/JRS/ALAT and CHEST HP guidelines.

Results

436 patients with ILD were included (mean age 66, 48 % females), of them, 56 (13 %) with HP. All four HPCF were more prevalent in HP than in non-HP ILD (p < 0.001 for all). In multivariate analysis, air-trapping was the strongest independent predictor (AOR 4.1, 95 % CI 2–8.4, p < 0.001). Centrilobular nodules were present almost exclusively in HP and smoking-related ILD. The amount of HPCF in HRCT had an excellent predictive ability for HP diagnosis (receiver operating characteristic AUC 0.85, 95 % CI 0.80–0.90). The radiologic criteria of both guidelines had high specificity for "typical HP" and high sensitivity for "compatible with HP", although with low positive predictive values. Our findings remained robust even when including only patients that had a diagnostic biopsy.

Conclusion

The presence and amount of HPCF in HRCT predicted HP diagnosis in real-life settings. While current HP radiologic criteria demonstrated good diagnostic performance, our findings highlight areas for future improvement.

背景：超敏性肺炎（HP）的放射学标准指南侧重于高分辨率计算机断层扫描（HRCT）中的四个HP相容特征（HPCF）：磨玻璃混浊，马赛克衰减，空气捕捉和小叶中心结节。然而，支持这些标准的证据有限。方法：纳入2016年至2021年在三个医疗中心接受HRCT的连续间质性肺疾病（ILD）患者。我们评估了每个ILD中HPCF的患病率及其与HP诊断的关系。我们通过ATS/JRS/ALAT和CHEST HP指南评估HPCF量对HP诊断的影响以及放射学标准的表现。结果：纳入436例ILD患者（平均年龄66岁，女性48%），其中HP患者56例（13%）。所有四种HPCF在HP中比在非HP ILD中更为普遍(结论：HRCT中HPCF的存在和数量预测了现实生活中HP的诊断。虽然目前的HP放射学标准显示出良好的诊断性能，但我们的研究结果强调了未来改进的领域。

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引用次数: 0

Peripheral airways dysfunction measured by oscillometry differentiates asthma from inducible laryngeal obstruction 周围气道功能障碍的振荡测量区分哮喘与诱导性喉梗阻。

IF 3.5 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Respiratory medicine

Pub Date : 2025-01-01 DOI: 10.1016/j.rmed.2024.107905

Patrick Donohue , Margaret Connolly , Marcus D'Alfonso , Gerriann Jackson , Liane C. Grasso , Xueya Cai , Ashley P. O'Connell Ferster , G Todd Schneider , Sandhya Khurana , Steve N. Georas

Background

Inducible laryngeal obstruction (ILO, also called vocal cord dysfunction) can be difficult to distinguish clinically from asthma. Limited studies have explored the use of respiratory oscillometry to detect changes unique to ILO, but more study is needed to determine if routine oscillometry can differentiate these two clinical entities.

Objective

Determine if impedance variables measured on routine oscillometry over tidal breathing vary between individuals with asthma and ILO.

Methods

Subjects with asthma and ILO were recruited to participate in a single-center, observational study at the University of Rochester Medical Center. Oscillometry measurements were obtained over tidal breathing according to technical standards. Exploratory oscillometry variables were analyzed, as well as standard oscillometry variables including measures of peripheral airways dysfunction.

Results

25 subjects (12 with asthma and 13 with ILO) were recruited and included in the analysis. Measures of peripheral airways dysfunction including frequency dependence of resistance (R5-R20), area under the reactance curve (AX), and reactance at 5 Hz (X5) were significantly more abnormal in asthma subjects compared to ILO subjects (p = 0.039, p = 0.008, and p = 0.0327 respectively). Resistance at 5 Hz (R5) was not statistically different between asthma and ILO (p = 0.301). Exploratory variables, including inspiratory impedance and the standard deviation of impedance, were not significantly different between asthma and ILO.

Conclusion

Measures of peripheral airways dysfunction by oscillometry were significantly different in subjects with asthma compared to ILO and more significant in subjects with poor asthma control. There were no exploratory oscillometry variables that were significantly different between ILO and asthma.

背景：诱导性喉梗阻（ILO，也称为声带功能障碍）在临床上很难与哮喘区分。有限的研究探索了使用呼吸振荡测量法来检测ILO特有的变化，但需要更多的研究来确定常规振荡测量法是否可以区分这两种临床实体。目的：确定常规振荡法测量的潮汐呼吸阻抗变量在哮喘患者和ILO患者之间是否存在差异。方法：在罗切斯特大学医学中心招募哮喘和ILO患者参加一项单中心观察性研究。根据技术标准对潮汐呼吸进行了振荡测量。分析了探索性振荡测量变量，以及标准振荡测量变量，包括周围气道功能障碍的测量。结果：25名受试者（12名哮喘患者，13名ILO患者）被纳入分析。周围气道功能障碍指标，包括阻抗频率依赖性（R5-R20）、电抗曲线下面积（AX）和5hz电抗（X5），哮喘组明显高于ILO组（p=0.039、p=0.008和p=0.0327）。5 Hz阻力（R5）在哮喘和ILO之间无统计学差异（p=0.301）。包括吸气阻抗和阻抗标准差在内的探索性变量在哮喘和ILO之间没有显著差异。结论：与ILO相比，哮喘患者采用振荡法测量周围气道功能障碍有显著差异，哮喘控制不佳的患者更明显。没有探索性振荡测量变量在ILO和哮喘之间有显著差异。

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引用次数: 0

Associations between serum indium levels and preserved ratio impaired spirometry among non-smoking industrial workers: A nationwide cross-sectional study in Taiwan 台湾非吸烟工业工人血清铟水平与肺功能受损之关系：一项全国性横断面研究。

IF 3.5 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Respiratory medicine

Pub Date : 2025-01-01 DOI: 10.1016/j.rmed.2024.107908

I-Jen Chang , Chuan-Yen Sun , Wei-Chih Chen , Ting-An Yang , Hao-Yi Fan , Yang-Chieh Brian Chen , Yu-Chung Tsao

Background

Indium, a rare heavy metal, extensively used in flat panel display manufacturing, poses potential respiratory health risks to workers. Preserved ratio impaired spirometry (PRISm), a term describing nonobstructive lung function abnormalities, is associated with adverse health outcomes. Despite known risks, the relationship between serum indium levels and PRISm remains underexplored.

Methods

A cross-sectional cohort study among non-smoking industry workers potentially exposed to indium in Taiwan was conducted in 2020. Demographic data, and pulmonary function tests were collected comprehensively. Serum indium levels were quantified using inductively coupled plasma mass spectrometry, and respiratory symptoms were obtained via questionnaire. PRISm was defined as FEV₁/FVC ≥0.7 with FEV1 < 80 % predicted. Univariate, and multivariate logistic regression analyses were conducted to identify risk factors associated with PRISm.

Results

Among 2575 eligible participants, those with abnormal serum indium levels (≥3 ng/mL) were older, predominantly male, and had longer total working duration. PRISm prevalence was significantly higher in individuals with abnormal indium levels (22.7 % vs. 7.6 %). PRISm subjects exhibited a higher proportion of abnormal indium levels. Multivariate analysis revealed that serum indium levels ≥3 ng/mL and female sex were significant risk factors for PRISm after adjusting sex, age, body mass index and working duration.

Conclusion

This study demonstrates a significant association between elevated serum indium levels and increased PRISm prevalence among non-smoking workers in Taiwan. Findings highlight the importance of assessing serum indium levels in occupational health surveillance and revising exposure standards to mitigate respiratory health risks associated with indium exposure.

背景：铟是一种罕见的重金属，广泛用于平板显示器制造，对工人的呼吸道健康构成潜在风险。保留比例肺功能受损（PRISm）是一种描述非阻塞性肺功能异常的术语，与不良健康结果相关。尽管存在已知的风险，但血清铟水平与PRISm之间的关系仍未得到充分探讨。方法：对2020年台湾非吸烟行业潜在暴露于铟的工人进行横断面队列研究。全面收集人口统计资料和肺功能检查结果。采用电感耦合血浆质谱法测定血清铟水平，并通过问卷调查获得呼吸道症状。PRISm定义为FEV1/FVC≥0.7，预测FEV1 < 80%。进行单因素和多因素logistic回归分析，以确定PRISm相关的危险因素。结果：在2575名符合条件的参与者中，血清铟水平异常（≥3ng /mL）的患者年龄较大，主要为男性，总工作时间较长。铟水平异常个体的PRISm患病率明显更高（22.7%比7.6%）。PRISm受试者表现出较高比例的异常铟水平。多因素分析显示，调整性别、年龄、体重指数和工作时间后，血清铟水平≥3 ng/mL和女性是PRISm的显著危险因素。结论：本研究显示台湾非吸烟劳工血清铟水平升高与PRISm患病率升高有显著关联。研究结果强调了在职业健康监测中评估血清铟水平和修订接触标准以减轻与铟接触相关的呼吸系统健康风险的重要性。

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引用次数: 0

Stratifying risk in pulmonary arterial hypertension: Should we expect more? 肺动脉高压的分层风险：我们应该期待更多吗？

IF 3.5 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Respiratory medicine

Pub Date : 2024-12-31 DOI: 10.1016/j.rmed.2024.107926

Adriano R Tonelli, Sandeep Sahay

引用次数: 0

Characteristics of rehabilitation programs for chronic respiratory diseases in Asia: A scoping review 亚洲慢性呼吸系统疾病康复项目的特点：范围综述

IF 3.5 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Respiratory medicine

Pub Date : 2024-11-25 DOI: 10.1016/j.rmed.2024.107885

Navneet Chadha , Felicity C. Blackstock , Sheree Smith , Pat G. Camp , Clarice Tang

The rates of chronic respiratory disease (CRD) is rising in Asia. Pulmonary rehabilitation (PR) has been shown to be a highly efficacious intervention for people with CRD. While PR models are well established in Western countries, environmental, cultural and societal factors may influence how rehabilitation programs for people with CRD are conducted in Asia. This review aims to identify the characteristics of rehabilitation programs for people with CRD within Asia and identify differences between these rehabilitation programs to the recently updated American Thoracic Society (ATS) PR guidelines. Utilising the PRISMA scoping review guidelines, five databases– CINAHL, Medline, Embase, Web of Science and Health and Medical Collection were searched from inception until 13th December 2023. A total of 137 studies (n = 19,128) were included in the review. As many as 113 studies (83 %) included aerobic exercises as part of rehabilitation, only 90 studies (66 %) included resistance training. Thirty-nine studies included interventions such as Tai Chi, Qigong and Yoga. Comparing to the 2023 ATS PR guidelines, only 22 % of the included studies evaluated a rehabilitation program that was consistent with the guidelines. Improvement in exercise capacity (76 %) and quality of life (QOL) (73 %) were the most frequent outcomes used to evaluate program efficacy. The results suggest that models of rehabilitation varied greatly within the Asia region, with some more heavily adapted to suit the local context as compared to others. Further consideration on how to balance adaptation of PR with fidelity of the intervention needs to be taken.

在亚洲，慢性呼吸系统疾病（CRD）的发病率正在上升。肺康复（PR）已被证明是一种对慢性呼吸系统疾病患者非常有效的干预措施。虽然肺康复模式在西方国家已经非常成熟，但环境、文化和社会因素可能会影响亚洲如何开展针对慢性呼吸系统疾病患者的康复计划。本综述旨在确定亚洲 CRD 患者康复计划的特点，并确定这些康复计划与最近更新的美国胸科学会 (ATS) PR 指南之间的差异。根据 PRISMA 范围界定综述指南，我们检索了从开始到 2023 年 12 月 13 日的五个数据库：CINAHL、Medline、Embase、Web of Science 和 Health and Medical Collection。共有 137 项研究（n = 19,128）被纳入审查范围。多达 113 项研究（83%）将有氧运动作为康复的一部分，只有 90 项研究（66%）将阻力训练作为康复的一部分。39 项研究包括太极、气功和瑜伽等干预措施。与 2023 年 ATS PR 指南相比，只有 22% 的纳入研究评估了与指南一致的康复计划。运动能力的提高（76%）和生活质量的改善（73%）是最常用来评估项目疗效的结果。研究结果表明，亚洲地区的康复模式差异很大，与其他地区相比，有些康复模式更适合当地情况。我们需要进一步考虑如何平衡康复计划的适应性与干预措施的忠实性。

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引用次数: 0

Risk factors for intensive care admission in childhood patients with COVID-19 - Results of the German nationwide inpatient sample 儿童 COVID-19 患者入住重症监护室的风险因素 - 德国全国住院病人抽样调查结果。

IF 3.5 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Respiratory medicine

Pub Date : 2024-11-23 DOI: 10.1016/j.rmed.2024.107880

Karsten Keller , Ingo Sagoschen , Volker H. Schmitt , Visvakanth Sivanathan , Ioannis T. Farmakis , Omar Hahad , Sebastian Koelmel , Frank P. Schmidt , Christine Espinola-Klein , Stavros Konstantinides , Thomas Münzel , Philipp Lurz , Lukas Hobohm

Background

COVID-19 pandemic research efforts have mainly focused on adults, but data in paediatric populations are sparse.

Methods

We used the German nationwide-inpatient-sample analysing all hospitalized children ≤18 years with confirmed COVID-19-diagnosis in Germany during the year 2020, stratified for intensive care unit (ICU) admission.

Results

Overall, 3360 hospitalization-cases of children ≤18 years with COVID-19-infection were diagnosed in Germany 2020 (median age 7.0 [IQR 0.0–15.0] years, 49.8 % female); among them 4.3 % were admitted on an ICU. In-hospital death occurred in five patients with and three without ICU admission (3.5 % vs. 0.1 %, P < 0.001) and ICU admission was independently associated with increased case-fatality (OR 21.573 [95%CI 4.191–111.044], P < 0.001).

Obesity (OR 3.419 [95%CI 1.300–8.993], P = 0.013), diabetes mellitus (OR 6.929 [95%CI 3.327–14.432], P < 0.001), pneumonia (OR 7.373 [95%CI 4.823–11.271], P < 0.001), acute respiratory distress syndrome (ARDS) (OR 48.058 [95%CI 11.689–197.588], P < 0.001) and multisystem inflammatory syndrome caused by COVID-19 (OR 9.573 [95%CI 3.036–30.191], P < 0.001), heart failure (OR 64.509 [95%CI 24.462–170.121], P < 0.001), myocarditis (OR 4.682 [95%CI 1.278–17.149], P = 0.020), acute and/or chronic kidney failure (OR 7.946 [95%CI 3.606–17.508], P < 0.001), cancer (OR 5.220 [95%CI 2.599–10.485], P < 0.001) and liver diseases (OR 5.501 [95%CI 2.177–13.899], P < 0.001) were associated with an ICU admission.

Conclusion

Proportion of hospitalized paediatric COVID-19-patients admitted on ICU in Germany was low with 4.3 % accompanied by 3.5 % case-fatality rate. Independent factors for ICU admission comprised cardio-vascular risk factors, comorbidities, and complications of COVID-19.

背景：COVID-19大流行病的研究工作主要集中在成年人身上，但儿科人群的数据却很少：我们使用了德国全国住院病人样本，分析了 2020 年期间德国所有确诊 COVID-19 的 18 岁以下住院儿童，并根据入住 ICU 的情况进行了分层：2020年，德国共有3360例18岁以下儿童确诊感染COVID-19（中位年龄7.0 [IQR0.0-15.0]岁，49.8%为女性），其中4.3%入住重症监护室。有 5 名患者在住院期间死亡，3 名未入住重症监护室（3.5% 对 0.1%）：德国COVID-19住院儿科患者入住重症监护室的比例较低，仅为4.3%，病死率为3.5%。入住 ICU 的独立因素包括心血管风险因素、合并症和 COVID-19 并发症。

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引用次数: 0

Factors associated with uncontrolled severe asthma in the biologic era 生物制剂时代未受控制的严重哮喘的相关因素。

IF 3.5 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Respiratory medicine

Pub Date : 2024-11-22 DOI: 10.1016/j.rmed.2024.107881

Hideki Yasui , Kyohei Oishi , Fumiya Nihashi , Kazuki Furuhashi , Tomoyuki Fujisawa , Yusuke Inoue , Masato Karayama , Hironao Hozumi , Yuzo Suzuki , Noriyuki Enomoto , Suguru Kojima , Mitsuru Niwa , Masanori Harada , Masato Kato , Dai Hashimoto , Koshi Yokomura , Naoki Koshimizu , Mikio Toyoshima , Masahiro Shirai , Toshihiro Shirai , Takafumi Suda

Background

Despite the development of biologics for severe asthma, individuals with uncontrolled status persist, posing a significant social problem. This multicenter prospective study aimed to identify factors associated with the uncontrolled status of patients with severe asthma in the biologic era assessed using the Asthma Control Questionnaire (ACQ).

Methods

Subjects with severe asthma diagnosed by respiratory specialists were enrolled from 11 hospitals. Clinical data and questionnaires were collected. We compared controlled (ACQ-5 <1.5) with uncontrolled severe asthma (ACQ-5 ≥1.5) and assessed factors linked to uncontrolled severe asthma using logistic regression analysis.

Results

One hundred fifty-four patients were analyzed (median age, 66 years; 62.3 % female; 52.6 % administered biologics). Among them, 56 patients (36.4 %) had uncontrolled severe asthma (ACQ-5 ≥1.5). The uncontrolled group had more frequent exacerbations (≥2 times in the previous year) and elevated blood neutrophil counts compared with the controlled group. Factors associated with uncontrolled status were analyzed in the overall population, with patients stratified into two groups: those receiving biologics and those not receiving biologics. Multivariate analysis revealed that frequent exacerbations and elevated blood neutrophil counts were associated with uncontrolled status in the overall population and in patients without biologics, whereas elevated blood neutrophil counts were significantly associated with uncontrolled status in patients receiving biologics.

Conclusion

Elevated blood neutrophil counts and frequent exacerbations were independently associated with uncontrolled severe asthma. Specifically, elevated blood neutrophil counts were a significant factor related to uncontrolled status irrespective of biologics, suggesting their potential utility as a biomarker in the biologic era.

背景：尽管开发出了治疗重症哮喘的生物制剂，但病情不受控制的患者依然存在，这构成了一个重大的社会问题。这项多中心前瞻性研究旨在通过哮喘控制问卷（ACQ）的评估，确定生物制剂时代与重症哮喘患者病情失控相关的因素：方法：从 11 家医院招募经呼吸科专家诊断为重症哮喘的受试者。收集临床数据和问卷调查。我们比较了受控患者的 ACQ-5 结果：分析了 154 名患者（中位年龄 66 岁；62.3% 为女性；52.6% 使用生物制剂）。其中，56 名患者（36.4%）患有未受控制的重症哮喘（ACQ-5 ≥1.5）。与控制组相比，未控制组患者的病情加重更频繁（去年≥2次），血液中性粒细胞计数更高。我们分析了总体人群中与未控制状态相关的因素，并将患者分为两组：接受生物制剂治疗组和未接受生物制剂治疗组。多变量分析显示，在总体人群和未接受生物制剂治疗的患者中，频繁恶化和血液中性粒细胞计数升高与病情失控有关，而在接受生物制剂治疗的患者中，血液中性粒细胞计数升高与病情失控显著相关：结论：血液中性粒细胞计数升高和频繁的病情恶化与严重哮喘未得到控制密切相关。具体而言，无论是否使用生物制剂，血液中性粒细胞计数升高都是导致病情失控的重要因素，这表明在生物制剂时代，血液中性粒细胞计数作为生物标志物具有潜在的实用性。

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引用次数: 0

Real-world impact of Elexacaftor-Tezacaftor-Ivacaftor treatment in young people with Cystic Fibrosis: A longitudinal study Elexacaftor-Tezacaftor-Ivacaftor 治疗对囊性纤维化青少年的实际影响：纵向研究。

IF 3.5 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Respiratory medicine

Pub Date : 2024-11-22 DOI: 10.1016/j.rmed.2024.107882

Connett Gj , Maguire S , Larcombe Tc , Scanlan N , Shinde Ss , Muthukumarana T , Bevan A , Keogh Rh , Legg Jp

Background

Elexacaftor, Tezacaftor, Ivacaftor (ETI) became available in the UK in August 2020 to treat people with Cystic Fibrosis (CF) aged >12 years. We report a real-world study of clinical outcomes in young people treated with ETI at our CF centre within the first two years of its availability.

Methods

Participants aged 12–17 were identified within our clinic, with demographic data supplemented by the UK CF registry. Comprehensive outcome data spanning two years pre- and two years post-initiation of CFTR modulators were compiled from various local sources, including patient records, medication delivery logs, and clinical notes.

Results

Of the 62 patients started on ETI (32 male, mean age 13.3 years), most (76 %) were homozygous for the F508del mutation. Three discontinuations occurred: one pregnancy, two related to side effects. Adherence was high (Proportion of Days covered >90 % both years). Following ETI initiation there was a significant increase in mean FEV1% (+11.7 units; 95 % CI 7.4–15.6), sustained throughout the two-year treatment period. There was no association between baseline lung function and the degree of improvement or rate of decline post-treatment. Improvements were similar for all treatable genotypes. BMI z-score increased by 0.25 units after four months of treatment, returning to baseline by 24 months. Intravenous antibiotic use decreased by 88 % (median IV days/year reduced from 32 to 4 days, p < 0.01).

Conclusions

ETI use in adolescents in a real-world setting led to sustained improvements in health outcomes, consistent with those seen in open trial extension studies.

背景：Elexacaftor、Tezacaftor和Ivacaftor（ETI）于2020年8月在英国上市，用于治疗年龄大于12岁的囊性纤维化（CF）患者。我们报告了我们的 CF 中心在 ETI 上市后头两年内对接受 ETI 治疗的青少年临床结果进行的一项真实世界研究：方法：我们在诊所内确定了 12-17 岁的参与者，并通过英国 CF 登记处补充了人口统计学数据。我们从病人记录、给药记录和临床笔记等各种本地来源收集整理了使用 CFTR 调节剂前两年和使用后两年的综合结果数据：在开始使用 ETI 的 62 名患者中（32 名男性，平均年龄 13.3 岁），大多数（76%）都是 F508del 基因突变的同型患者。有三例停药：一例是怀孕，两例与副作用有关。坚持治疗的比例很高（两年的治疗天数比例均大于 90%）。开始 ETI 治疗后，平均 FEV1% 显著增加（+11.7 个单位；95% CI 7.4 - 15.6），并在两年的治疗期内持续增加。基线肺功能与治疗后的改善程度或下降速度之间没有关联。所有可治疗基因型的改善程度相似。治疗四个月后，体重指数 Z 值增加了 0.25 个单位，24 个月后恢复到基线。静脉注射抗生素的使用减少了88%（静脉注射天数中位数从32天/年减少到4天/年，p < 0.01）：结论：在真实世界环境中，青少年使用 ETI 可持续改善健康状况，这与开放试验推广研究中的结果一致。

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引用次数: 0

Prognostic value of the 6-min walk test derived attributes in patients with idiopathic pulmonary fibrosis 特发性肺纤维化患者 6 分钟步行测试衍生属性的预后价值。

IF 3.5 3区医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

Respiratory medicine

Pub Date : 2024-11-20 DOI: 10.1016/j.rmed.2024.107862

Ada E.M. Bloem , Hanneke M. Dolk , Anne E. Wind , Joanne J. van der Vis , Maarten J. Kampen , Jan W.H. Custers , Martijn A. Spruit , Marcel Veltkamp

Introduction

Idiopathic pulmonary fibrosis (IPF) is a fatal progressive fibrosing lung disease. A decreased 6-min walk distance (6MWD) and exercise-induced oxygen desaturation measured during the 6-min walk test (6MWT), are known predictors of mortality in patients with IPF. However, the use of antifibrotic drugs showed a survival benefit in IPF. Therefore, this study aimed to evaluate to what extend 6MWT-derived attributes are associated with two-year survival when antifibrotic drugs were introduced as part of standard IPF-care.

Methods

This real-world data-study included patients with IPF with a 6MWT between 2015 and 2020, and used composite outcome: mortality or lung transplantation within 2 years of follow-up. Data were collected systematically, including demographics, pulmonary function tests, comorbidities, medications and 6MWT-derived attributes. The prediction attributes of 6MWT were studied with a Cox Proportional-Hazards model and Kaplan-Meier survival curves. The best discriminating attribute to predict mortality was added to the prediction model Gender-Age-Physiology (GAP).

Results

In 216 patients, 2-year transplant-free survival cut-off points were identified for the 6MWD (≥413 m), 6MWD %predicted (≥83 %), SpO₂-nadir (≥86 %) and distance-saturation-product (≥374 m%), with the best discriminative value for SpO₂-nadir (area under the curve: 0.761). 2-Year survival percentage of patients with SpO₂-nadir below or above threshold (86 %) was 37.1 % and 80.0 %, respectively. Exercise-induced oxygen desaturation added to the GAP model showed an improvement in its predictive power.

Conclusion

Patients with IPF who have an exercise-induced oxygen desaturation have worse prognosis. Addition of SpO₂-nadir to the GAP model seems promising for use in clinical care of IPF patients.

简介：特发性肺纤维化（IPF）是一种致命的进行性肺纤维化疾病：特发性肺纤维化（IPF）是一种致命的进行性肺纤维化疾病。在 6 分钟步行测试（6MWT）中测得的 6 分钟步行距离（6MWD）减少和运动诱发的氧饱和度降低是预测 IPF 患者死亡率的已知指标。然而，抗纤维化药物的使用对 IPF 患者的生存有利。因此，本研究旨在评估在将抗纤维化药物作为 IPF 标准治疗的一部分时，6MWT 衍生属性与两年生存率的相关程度：这项真实世界数据研究纳入了 2015-2020 年间进行过 6MWT 的 IPF 患者，并采用了综合结果：随访 2 年内的死亡率或肺移植。数据收集系统化，包括人口统计学、肺功能测试、合并症、药物和 6MWT 衍生属性。通过 Cox 比例-危害模型和 Kaplan-Meier 生存曲线对 6MWT 的预测属性进行了研究。预测死亡率的最佳判别属性被添加到性别-年龄-生理学（GAP）预测模型中：结果：在 216 名患者中，确定了 6MWD（≥413 米）、6MWD 预测百分比（≥83%）、SpO2-nadir（≥86%）和距离-饱和度-乘积（≥374 米）的 2 年无移植生存截断点，其中 SpO2-nadir 的判别值最佳（曲线下面积：0.761）。SpO2-nadir 低于或高于阈值（86%）的患者 2 年生存率分别为 37.1% 和 80.0%。将运动诱导的氧饱和度加入 GAP 模型后，其预测能力有所提高：结论：运动诱发氧饱和度降低的 IPF 患者预后较差。在 GAP 模型中加入 SpO2-nadir 似乎有望用于 IPF 患者的临床治疗。

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