BMJ Open Respiratory Research最新文献

{"title":"Comparison of stability of the GOLD and STAR lung function classification for chronic obstructive pulmonary disease.","authors":"I-Lin Tsai, Chang Ting-Chia, Tang-Hsiu Huang, Chen Chang-Wen, Tzuen-Ren Hsiue, Yu Tsung, Chin-Wei Kuo","doi":"10.1136/bmjresp-2024-002830","DOIUrl":"10.1136/bmjresp-2024-002830","url":null,"abstract":"<p><strong>Background: </strong>The diagnosis of chronic obstructive pulmonary disease (COPD) typically relies on spirometric measurements. The Staging of Airflow Obstruction by Ratio (STAR) classification, a newly proposed system for grading the severity of pulmonary function, has been suggested as a potentially better predictor of outcomes than other classifications. However, the long-term stability of the STAR classification, especially in comparison to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification, remains unclear.</p><p><strong>Methods: </strong>In this retrospective cohort study, we analysed data from 622 patients with COPD, enrolled in a pay-for-performance programme at two university hospitals in Taiwan. Patients were classified according to the GOLD and STAR classifications, based on post-bronchodilator spirometry results. The study assessed the agreement between these classifications and the stability of each over a 3-year period, categorising patients into four patterns: no change (stable stage throughout), progression (persistent shift to severe stage), instability (fluctuating between higher and lower stages) and reversal (sustained improvement to a less severe stage).</p><p><strong>Results: </strong>The STAR classification system identified a higher proportion of patients with instability or reversal patterns (42.1%) compared with the GOLD classification (31.0%). While fair coherence was noted between the two classifications over 3 years, the STAR classification demonstrated greater variability. Compared with the GOLD classification, the STAR classification exhibited a higher proportion of instability or reversal patterns in stage 2 but a lower proportion of these patterns in stage 4.</p><p><strong>Conclusion: </strong>Compared with the GOLD classification, the STAR classification demonstrated higher instability and reversal patterns, suggesting the need for careful consideration for its use in long-term COPD management. Further research is required to explore the clinical implications of these findings and to refine the use of these classifications.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12086878/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimal dose of maintenance steroid therapy for relapse of chronic eosinophilic pneumonia: a multicentre retrospective study.","authors":"Kenichiro Atsumi, Shunichi Nishima, Toru Tanaka, Koichiro Kamio, Namiko Taniuchi, Yoshinobu Saito, Masamitsu Shimizu, Tetsuya Okano, Masahiro Seike, Takashi Hirose","doi":"10.1136/bmjresp-2024-002697","DOIUrl":"10.1136/bmjresp-2024-002697","url":null,"abstract":"<p><strong>Background: </strong>Long-term maintenance steroid therapy (MST) is often necessary for repeated relapses of chronic eosinophilic pneumonia (CEP). Because relapse does not indicate a worse prognosis, determining the optimal steroid dose to avoid overtreatment presents a clinical challenge. Our primary objective was to evaluate the optimal MST dose to prevent repeated relapses, and the secondary objectives included identifying serum eosinophil count at relapse and background factors of relapse.</p><p><strong>Methods: </strong>A multicentre retrospective study was conducted on patients with steroid-treated CEP. Background characteristics were compared between the non-relapse and relapse groups. The optimal MST dose was determined based on dose at relapse and the final relapse prevention dose. Additionally, serum eosinophil count at relapse was assessed.</p><p><strong>Results: </strong>A total of 79 patients were included, with 44 in the non-relapse group and 35 in the relapse group. The prednisolone doses required to achieve relapse-free rates of 50% (ED₅₀) were 7.2 mg (95% CI, 4.6 to 23.6). The median serum eosinophil count at relapse was 1125 /µL (IQR, 735-2108). No clinically significant background factors were identified between the non-relapse and relapse groups.</p><p><strong>Conclusion: </strong>Our study demonstrated that a prednisolone dose of 7.2 mg achieved a 50% relapse-free rate in the relapse group. Based on these findings, we encourage clinicians to evaluate individual minimum effective steroid doses.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12086887/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ending nuclear weapons, before they end us.","authors":"Chris Zielinski","doi":"10.1136/bmjresp-2025-003434","DOIUrl":"10.1136/bmjresp-2025-003434","url":null,"abstract":"","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083303/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144075667","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"COVID-19 severity and risk of SARS-CoV-2-associated asthma exacerbation by time since booster vaccination: a longitudinal analysis of data from the COVIDENCE UK study.","authors":"Giulia Vivaldi, Mohammad Talaei, Paul E Pfeffer, Seif O Shaheen, Adrian R Martineau","doi":"10.1136/bmjresp-2025-003158","DOIUrl":"10.1136/bmjresp-2025-003158","url":null,"abstract":"<p><strong>Background: </strong>COVID-19 booster vaccinations are offered annually to priority groups, but many people have not been vaccinated in over a year. We therefore assessed the association between time since booster vaccination and breakthrough infection characteristics. We also explored whether incident COVID-19 associates with asthma exacerbations in boosted individuals with asthma and if the risk of COVID-19-associated exacerbation is affected by time since vaccination.</p><p><strong>Methods: </strong>COVIDENCE UK is a prospective, longitudinal, population-based study of COVID-19. We included adult participants who had received ≥1 booster vaccination. Time since vaccination was binarised at 6 or 12 months according to vaccine eligibility subgroup. We used regression models to obtain adjusted estimates for the association between time since vaccination and breakthrough infection severity (requiring bedrest vs milder symptoms), symptom duration, and impact on health-related quality of life (EQ-5D-3L Index). We then assessed the association of incident COVID-19 with asthma exacerbations using multilevel mixed models, by time since vaccination.</p><p><strong>Results: </strong>7391 boosted participants reported at least one breakthrough infection. Across all eligibility subgroups, greater time since vaccination associated with increased odds of severe symptoms (ORs ranging from 1.31 (95% CI 1.06 to 1.62) to 1.61 (1.29 to 2.01)). Not receiving a booster vaccination in the previous 12 months was associated with longer time to recovery overall (HR for recovery 0.90, 95% CI 0.81 to 0.99), but evidence for vaccination subgroups was weak. Greater time since vaccination was associated with a small decrease in EQ-5D-3L Index overall (-0.02, 95% CI -0.03 to -0.00) and among participants younger than 75 years, but did not reach our estimates for a minimum clinically important difference. Among 2100 participants with asthma, incident COVID-‍19 associated with increased risk of asthma exacerbation, both within 12 months of vaccination (OR 5.11 (95% CI 4.19 to 6.24)) and later (5.60 (2.98 to 10.53)), with a greater difference in point estimates when considering severe exacerbations (6.59 (4.70 to 9.22) vs 9.20 (3.56 to 23.78)).</p><p><strong>Conclusion: </strong>Longer time since booster vaccination consistently associates with more severe infections and may increase the risk of severe asthma exacerbations in people with asthma. These findings highlight the importance of ensuring those currently eligible receive their boosters, and the need for research on further vaccinations in people with asthma no longer eligible for boosters.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083257/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085896","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and efficacy of inhalable ambroxol hydrochloride aerosol for adult patients with respiratory diseases: an open-label, single-arm, multicentre study.","authors":"Jinfang Ma, Jinping Zheng, Liping Chen, Zhengguang He, Zuke Xiao, Xiaohong Yang, Gang Chen, Changli Yu, Tianli Wang, Dan Zhu, Liangping Mao, Wei Wang, Zhenshan Wang, Xiaoju Zhang, Jie Meng, Xianwei Ye, Rui Chen, Jianqing Zhao, Ting Yang, Keying Xue, Zhiyi He, Baosong Xie, Xiaohong Chen, Ruifeng Zhang, Yuanlin Song, Weiquan Liang, Lin Su, Huili Zhu, Wanjun Yu, Yilan Sun, Jie Zhang, Xiaoping Ren, Faguang Jin, Shujuan Jiang, Tiantuo Zhang, Yi Hu, Zhancheng Gao, Gongping Chen","doi":"10.1136/bmjresp-2023-002096","DOIUrl":"10.1136/bmjresp-2023-002096","url":null,"abstract":"<p><strong>Background: </strong>Airway mucus hypersecretion is a key pathophysiological feature in many respiratory diseases and could lead to airway obstruction and repeated infections, consequently accelerating disease progression, which impacts on pulmonary function and quality of life (QoL), highlighting the importance of mucolytic therapy targeting airway mucus hypersecretion.</p><p><strong>Objectives: </strong>To investigate the safety and efficacy of inhalable ambroxol hydrochloride aerosol for adult patients with respiratory diseases.</p><p><strong>Design: </strong>An open-label, single-arm, multicentre postmarketing surveillance study.</p><p><strong>Methods: </strong>Adult patients with acute or chronic respiratory diseases were eligible to receive aerosol inhalation of ambroxol hydrochloride (3 mL and 7.5 mg/mL) using a nebuliser two times per day given at least 6 hours apart between doses. The treatment lasted for a maximum of 7 days. The primary safety outcome was the frequency and severity of adverse events (AEs), and the primary efficacy outcome was changes in sputum scale scores.</p><p><strong>Results: </strong>Among 1201 eligible patients, 1192 received study medication and were included in the full analysis set and the safety set. Any grade AEs occurred in 16.3% of the patients, including serious AEs in four (0.3%) patients. The three most frequent AEs were respiratory symptoms and signs (1.5%), nausea and vomiting (0.8%) and digestive tract symptoms and signs (0.7%). In the full analysis set, the patients showed a mean reduction of 77.6% (95% CI, 75.9% to 79.3%) in the sputum scale score at the end of treatment, with a mean difference of -1.7±0.7 from baseline (p<0.001).</p><p><strong>Conclusion: </strong>Inhalable ambroxol hydrochloride aerosol is well tolerated and effective in easing expectoration and alleviating cough, reducing sputum and improving the QoL of adult patients with acute and chronic respiratory diseases.</p><p><strong>Trial registration number: </strong>ChiCTR2100043736.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083361/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143953689","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Predictive machine learning algorithm for COPD exacerbations using a digital inhaler with integrated sensors.","authors":"Laurie D Snyder, Michael DePietro, Michael Reich, Megan L Neely, Njira Lugogo, Roy Pleasants, Thomas Li, Lena Granovsky, Randall Brown, Guilherme Safioti","doi":"10.1136/bmjresp-2024-002577","DOIUrl":"10.1136/bmjresp-2024-002577","url":null,"abstract":"<p><strong>Purpose: </strong>By using data obtained with digital inhalers, machine learning models have the potential to detect early signs of deterioration and predict impending exacerbations of chronic obstructive pulmonary disease (COPD) for individual patients. This analysis aimed to determine if a machine learning algorithm capable of predicting impending exacerbations could be developed using data from an integrated digital inhaler.</p><p><strong>Patients and methods: </strong>A 12-week, open-label clinical study enrolled patients (≥40 years old) with COPD to use ProAir Digihaler, a digital dry powder inhaler with integrated sensors, to deliver their reliever medication (albuterol, 90 µg/dose; 1-2 inhalations every 4 hours, as needed). The Digihaler recorded inhaler use through timestamps, peak inspiratory flow (PIF), inhalation volume, inhalation duration, and time to PIF throughout the study. By applying machine learning methodology to data downloaded from the inhalers after study completion, along with clinical and demographic information, a model predictive of impending exacerbations was generated.</p><p><strong>Results: </strong>The predictive analysis included 336 patients, 98 of whom experienced a total of 111 exacerbations. PIF and inhalation volume were observed to decline in the days preceding an exacerbation. Using gradient-boosting trees with data from the Digihaler and baseline patient characteristics, the machine learning model was able to predict an exacerbation over the following 5 days with a receiver operating characteristic area under curve of 0.77 (95% CI: 0.71-0.83). Features of the model with the highest weight were baseline inhalation parameters and changes in inhalation parameters before an exacerbation compared with baseline.</p><p><strong>Conclusion: </strong>We demonstrated the development of a proof-of-concept machine learning model predictive of impending COPD exacerbations using data from the integrated digital reliever inhaler. This approach may potentially support patient monitoring, help improve disease management, and enable pre-emptive interventions to minimise exacerbations.</p><p><strong>Clinical trial registration number: </strong>NCT03256695.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083419/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143975516","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Uncertainty and decision-making in critical care: lessons from managing COVID-19 ARDS in preparation for the next pandemic.","authors":"Kenki Matsumoto, John R Prowle, Zudin Puthucheary, Maurizio Cecconi, Brigitta Fazzini, Hannah Malcolm, Peter Nydahl, Magda Osman, Alessandro Santini, Stefan J Schaller, William Thomson, Danielle van den Berke, Marcel Poll, Timothy Stephens","doi":"10.1136/bmjresp-2024-002637","DOIUrl":"10.1136/bmjresp-2024-002637","url":null,"abstract":"<p><strong>Purpose: </strong>Coronavirus disease 2019 (COVID-19) acute respiratory distress syndrome (ARDS) was an emergent syndrome that led to high volumes of critically ill ventilated patients. We explored influences on decision-making regarding management of COVID-19 ARDS mechanical ventilation to identify modifiable factors to improve preparedness for future pandemics.</p><p><strong>Methods: </strong>A systematic review and small group interviews informed the development of an international questionnaire (UK, Italy, Germany and Netherlands) on factors influencing COVID-19 ARDS ventilation decision-making in critical care professionals. Participants ranked four themes in order of importance: disease (uncertainties around COVID-19 ARDS), contextual (cognitive strain), environmental (structural logistics) and team factors. Participants also ranked the subthemes within each theme. Thematic analysis was used to derive findings from qualitative data. Kruskal-Wallis, Mann-Whitney U and Kendall's tau were used for quantitative data analysis.</p><p><strong>Results: </strong>Patient factors (comorbidities, clinical/biochemical parameters) were the most studied influences in the extant literature on decision-making; uncertainty was one of the least studied. 371 critical care professionals responded to the questionnaire. Disease uncertainty (lack of applicable guidelines, unfamiliarity with pathophysiology) was ranked as the most important influence on ventilation decision-making for COVID-19 ARDS across regions, professions and experience levels (p<0.001). Participants expressed underconfidence in their decision-making (median score: 9/20); this was unaffected by experience (p=0.79) or profession (p=0.58). Qualitative findings supported and extended the initial proposed influences, including the impact of team factors (+ve) and resource limitations (-ve) on disease uncertainty.</p><p><strong>Conclusion: </strong>Future pandemic preparedness programmes should target modifiable influences such as information sharing, teamworking and resource limitations to mitigate against the negative influence of uncertainty and thereby improve decision-making overall.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12067812/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143959904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cross-sectional study of preventive treatment for students with latent tuberculosis infection in Shanghai, China.","authors":"Xiao Xiao, Zhipeng Li, Haoyue Zhang, Xin Xin, Lili Chen, Jing Chen, Xin Shen, Xin Chen","doi":"10.1136/bmjresp-2024-002799","DOIUrl":"https://doi.org/10.1136/bmjresp-2024-002799","url":null,"abstract":"<p><strong>Introduction: </strong>Tuberculosis preventive treatment (TPT) has been initiated systematically in Shanghai supported by a public health project. This study aimed to evaluate the acceptance of TPT, identify the factors related to its refusal, and find an optimal way to promote TPT among student tuberculosis (TB) contacts.</p><p><strong>Methods: </strong>We screened contacts of the TB index case from a TB outbreak on campus. A two-step approach of first conducting a lecture of TB health literacy, followed by one-on-one TPT consultations was used to mobilise TPT among students with latent TB infection (LTBI). A semistructured questionnaire was designed between the lecture and the one-on-one TPT consultations, covering general demographic information, awareness of core TB knowledge and willingness to accept TPT, along with the reasons for refusal. Logistic regression analysis was used to identify the risk factors for refusing TPT.</p><p><strong>Results: </strong>A total of 52 contacts were identified with LTBI. After the lecture on TB health literacy, their scores on the core TB knowledge was 14.0±2.3. Students had a poor awareness rate of TB knowledge in the part of TB treatment and policy (70.2%) and <i>Mycobacterium tuberculosis</i> infection preventive measures and LTBI (67.3%) compared with the average rate (84.3%). The acceptance rate of TPT reached 42.3% at the end of the two-step promotion. The main reasons for refusing TPT included: (1) the duration for TPT was too long and follow-up management was too cumbersome; (2) the confidence in their own immunity and belief in their low risk of TB and (3) the fear of side effects of TPT.</p><p><strong>Conclusions: </strong>The two-step approach of first conducting a lecture of TB health literacy, followed by one-on-one TPT consultations, is effective for mobilising TPT. To further implement TPT, we recommend making the scientific popularisation for LTBI in a more easy-to-understand way and optimising the management of TPT.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12067769/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143956785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Gender, tobacco and chronic obstructive pulmonary disease: analysis of the 2020 National Health Interview Survey.","authors":"Alexander W Steinberg, Jenny E Ozga, Zhiqun Tang, Cassandra A Stanton, James D Sargent, Laura M Paulin","doi":"10.1136/bmjresp-2024-002462","DOIUrl":"https://doi.org/10.1136/bmjresp-2024-002462","url":null,"abstract":"<p><strong>Rationale: </strong>Recent studies describe an increasing prevalence of chronic obstructive pulmonary disease (COPD) and higher COPD exacerbation rates among women compared with men despite lower average cigarette use, which has raised the question of whether women are more susceptible to the effects of tobacco smoke. We examined associations between gender, cigarette smoking and COPD in a national dataset.</p><p><strong>Methods: </strong>We used cross-sectional data for US respondents aged ≥40 years from the 2020 National Health Interview Survey (NHIS). Weighted multivariable logistic regressions assessed the relationship between gender and respondent-reported physician-diagnosed COPD, adjusting for tobacco use and sociodemographic covariates. Additional analyses were performed to determine if the relationship between cigarette smoking and COPD was modified by gender.</p><p><strong>Results: </strong>Women had a higher COPD prevalence (7.8%) than men (6.5%) despite lower cigarette smoke exposure. Women were less likely to have ever smoked, and among respondents who had smoked, women had a lower average pack-year history compared with men. In multivariable regressions, female gender was associated with a higher risk of COPD (adjusted risk ratio 1.47, 95% CI 1.30 to 1.65) and the relative risk was similar for respondents both with and without a history of smoking. Moreover, there was no significant interaction between gender and smoking status or gender and pack-year exposure relating to COPD prevalence.</p><p><strong>Conclusions: </strong>Among adults aged ≥40 years, women had a roughly 50% greater risk of COPD than men. Higher susceptibility to cigarette smoking in women did not explain the difference.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12067816/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143973188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Regional comparison of efficacy and safety for vilobelimab in critically ill, invasively mechanically ventilated COVID-19 patients.","authors":"Endry H T Lim, Diederik van de Beek, Sanne de Bruin, Simon Rückinger, Claus Thielert, Renfeng Guo, Bruce P Burnett, Matthijs C Brouwer, Robert Zerbib, Camilla Chong, Niels C Riedemann, Alexander P Vlaar","doi":"10.1136/bmjresp-2023-002206","DOIUrl":"https://doi.org/10.1136/bmjresp-2023-002206","url":null,"abstract":"<p><strong>Background: </strong>Vilobelimab, a first in class C5a-specific monoclonal antibody, improved 28-day and 60-day mortality in intubated COVID-19 patients in PANAMO, a phase 3 randomised, double-blind, placebo-controlled multicentre study. All-cause mortality was pre-specified to be analysed pooling by region (western Europe, South America, South Africa/Russia).</p><p><strong>Methods: </strong>Critically ill, invasively mechanically ventilated COVID-19 patients were randomised in a 1:1 ratio within 48 hours of intubation to receive vilobelimab treatment (six, 800 mg intravenous infusions) or placebo on top of standard of care. We analysed the efficacy and safety of vilobelimab based on prespecified geographic regions.</p><p><strong>Results: </strong>368 patients were randomised and analysed: 177 in the vilobelimab group and 191 in the placebo group. In western Europe (n=209), 28-day all-cause mortality was significantly lower in the vilobelimab group (21%) compared with placebo (37%) (HR 0.51 (95% CI: 0.30, 0.87), p=0.014). In South America (n=126), mortality was similar between groups (40% vs 37%; HR 0.94 (95% CI: 0.53, 1.67), p=0.83). In South Africa/Russia (n=33), mortality was 69% in the vilobelimab group and 87% in the placebo group (HR 0.62 (95% CI: 0.28, 1.38), p=0.25). Within the Brazilian subpopulation (n=74), a significant age imbalance between the vilobelimab and placebo group was detected (median 53.5 years in the vilobelimab group vs 44.5 years in the placebo group). Occurrence of treatment-emergent adverse events between regions was similar.</p><p><strong>Conclusion: </strong>The most apparent 28-day all-cause mortality benefit for vilobelimab was in western Europe. Age imbalance between treatment groups in Brazil may have resulted in a lower efficacy signal for vilobelimab in South America compared with other regions. Overall, vilobelimab demonstrated a favourable safety profile and reduced mortality in critically ill, intubated COVID-19 patients, with regional variations influencing outcomes.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12010313/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143964959","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}