Lancet Respiratory Medicine最新文献

{"title":"Hypothermia for expanded criteria organ donors in kidney transplantation in France (HYPOREME): a multicentre, randomised controlled trial.","authors":"","doi":"10.1016/S2213-2600(24)00117-6","DOIUrl":"10.1016/S2213-2600(24)00117-6","url":null,"abstract":"<p><strong>Background: </strong>Expanded criteria donors help to increase graft availability, but provide organs with an increased risk of delayed graft function. We aimed to investigate whether donor hypothermia decreases the risk of delayed graft function compared with normothermia.</p><p><strong>Methods: </strong>We did this multicentre, randomised, controlled, parallel-arm trial at 53 intensive care units and transplant centres in France. We included expanded criteria donors in whom death was diagnosed based on neurological criteria, in compliance with French law, and the recipients of their kidney grafts. Eligible expanded criteria donors were older than 60 years or were aged 50-59 years and had at least two other risk factors (history of hypertension, creatinine >132 μmol/L, or cerebrovascular cause of death). Donors were randomly assigned to hypothermia (34-35°C) or normothermia (36·5-37·5°C). Machine perfusion was used routinely. Randomisation was done using a computer-generated, interactive, web-response system, in permuted blocks (block size six), stratified by centre. Outcome assessors were masked; investigator masking was not feasible. The primary outcome was the proportion of kidney recipients with delayed graft function, defined as renal replacement therapy within 7 days after transplantation, assessed in the modified intention-to-treat (mITT) population, which included all recipients who received at least one kidney from an expanded criteria donor, with the exception of those under guardianship. Secondary outcomes in expanded criteria donors were the number of organs recovered and transplanted, kidney function, body temperature, total volume of fluids administered, blood pressure and need for vasopressors and inotropes, and adverse events (cardiovascular events, metabolic disturbances, and coagulation disorders). Secondary outcomes in kidney recipients were duration of hospital stay, kidney graft function and vital status at day 7, day 28, 3 months, and 1 year after transplantation, and adverse events (infections, cardiovascular events, and surgical complications). Secondary outcomes were assessed in the mITT population. The trial was registered at ClinicalTrials.gov, NCT03098706.</p><p><strong>Findings: </strong>Between Nov 9, 2017, and March 3, 2021, 365 donors were randomly assigned, of whom 298 (151 [51%] male, 147 [49%] female) provided kidneys to 526 recipients (323 [61%] male, 203 [39%] female). 251 recipients in the hypothermia group and 275 recipients in the normothermia group were included in the analysis. Graft function was delayed in 40 (16%) of 251 recipients in the hypothermia group and 58 (21%) of 275 recipients in the normothermia group (odds ratio 0·71 [95% CI 0·44-1·13]; p=0·14; absolute difference -5·2% [95% CI 11·8-1·5]). Compared with donors in the normothermia group, donors in the hypothermia group had higher highest mean arterial pressure (115 mm Hg [SD 22] vs 108 mm Hg [20]; p=0·001). 1 year after transplant","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":" ","pages":"693-702"},"PeriodicalIF":38.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141321987","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient-reported outcomes: missing in asthma remission.","authors":"Amy Hai Yan Chan, Paul Leong, John Politis, Vanessa M McDonald, Philip Bardin","doi":"10.1016/S2213-2600(24)00242-X","DOIUrl":"10.1016/S2213-2600(24)00242-X","url":null,"abstract":"","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":" ","pages":"665-666"},"PeriodicalIF":38.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141918063","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-term outcomes of early exposure to repeated general anaesthesia in children with cystic fibrosis (CF-GAIN): a multicentre, open-label, randomised controlled phase 4 trial.","authors":"Claire Elizabeth Wainwright, Suzanna Vidmar, Vicki Anderson, Pierrick Bourgeat, Catherine Byrnes, John Brooke Carlin, Joyce Cheney, Peter Cooper, Andrew Davidson, Nicholas Gailer, Jasmin Grayson-Collins, Alexandra Quittner, Colin Robertson, Olivier Salvado, Diana Zannino, Floyd Daniel Armstrong","doi":"10.1016/S2213-2600(24)00170-X","DOIUrl":"10.1016/S2213-2600(24)00170-X","url":null,"abstract":"<p><strong>Background: </strong>Long-term effects of early, recurrent human exposure to general anaesthesia remain unknown. The Australasian Cystic Fibrosis Bronchoalveolar Lavage (ACFBAL) trial provided an opportunity to examine this issue in children randomly assigned in infancy to either repeated bronchoalveolar-lavage (BAL)-directed therapy with general anaesthesia or standard care with no planned lavages up to 5 years of age when all children received BAL-directed therapy under general anaesthesia.</p><p><strong>Methods: </strong>This multicentre, randomised, open-label phase 4 trial (CF-GAIN) used the original ACFBAL trial randomisation at 3·6 months (SD 1·6) to BAL-directed therapy or standard-care groups to assess the impact of general anaesthesia exposures over early childhood. Children who completed the ACFBAL trial, with a mean age of 5·1 (SD 0·18) years, received standardised neurobehavioural and health-related-quality-of-life assessment and brain MRI scans between Oct 8, 2013, and June 30, 2017, at a mean age of 12·8 (SD 1·7) years at three hospitals in Australia and one hospital in New Zealand. The primary outcome was a composite score of performance on a standardised, computer-based assessment of child attention, processing speed, and response inhibition skills (Conners Continuous Performance test, second edition). Secondary outcomes included intellectual function, other neurobehavioural measures, and brain imaging as an exploratory outcome. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN 12613000057785) and is completed.</p><p><strong>Findings: </strong>At 2 years, the BAL-directed therapy group (n=52) and standard-care group (n=45) had a median of 2·0 (IQR 1·0-3·0) and 0·0 (0·0-0·0) exposures, respectively. At completion of the ACFBAL trial, the BAL-directed therapy group had a median of 6·0 (4·0-9·5) exposures and the standard-care group 2·0 (1·0-4·0) exposures. At CF-GAIN completion, the BAL-directed therapy group had a median of 10·0 (IQR 6·5-14·5) exposures and the standard-care group 4·0 (3·0-7·0) exposures. Cumulative general anaesthesia exposure time was not prospectively collected but, for those with complete cumulative exposure time data to the end of the ACFBAL trial, the median cumulative exposure time for the BAL-directed therapy group (n=29) was 180 (IQR 140-285) min and for the standard-care group (n=32) was 48 (30-122) min. The mean Conners Continuous Performance test, second edition composite score was 51 (SD 8·1) in BAL-directed therapy group and 53 (8·8) in the standard-care group; difference -1·7 (95% CI -5·2 to 1·7; p=0·32) with similar performance on other neurobehavioural measures, including measures of executive function, intellectual quotient scores, and brain imaging.</p><p><strong>Interpretation: </strong>Our findings suggest that repeated general anaesthesia exposure in young children with cystic fibrosis is not related to functional impairment in attention, inte","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":" ","pages":"703-713"},"PeriodicalIF":38.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141293932","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Further insights into MARS 2 - Authors' reply.","authors":"Eric Lim, Chris Rogers","doi":"10.1016/S2213-2600(24)00247-9","DOIUrl":"https://doi.org/10.1016/S2213-2600(24)00247-9","url":null,"abstract":"","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":"12 9","pages":"e55"},"PeriodicalIF":38.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142114579","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Foritinib in advanced ROS1-rearranged non-small-cell lung cancer in China: a multicentre, open-label, single-arm, phase 2 study.","authors":"Jin-Ji Yang, Jianying Zhou, Si-Yang Maggie Liu, Mingjun Li, Zhiye Zhang, Ying Cheng, Yun Fan, Hongming Pan, Baoqing Wang, Gongyan Chen, Ke Wang, Liyan Jiang, Yanping Hu, Jianhua Shi, Xiaorong Dong, Cuimin Ding, Yunpeng Liu, Zhe Liu, Wangjun Liao, Wei Li, Jun Wang, Shanyong Yi, Qiong Zhao, Aimin Zang, Yuan Chen, Jiuwei Cui, Pengfei Luo, Xionghu Shen, Meili Sun, Changli Wang, Yi-Long Wu","doi":"10.1016/S2213-2600(24)00171-1","DOIUrl":"10.1016/S2213-2600(24)00171-1","url":null,"abstract":"<p><strong>Background: </strong>Currently approved targeted treatment for ROS1-rearranged non-small-cell lung cancer (NSCLC) has either inadequate intracranial activity or CNS-related toxicities. We evaluated the efficacy and safety of foritinib, a novel ALK and ROS1 inhibitor, in patients with advanced ROS1-rearranged NSCLC.</p><p><strong>Methods: </strong>This two-part (phase 2a and 2b), multicentre, single-arm, open-label, phase 2 study was done in 29 centres in China. Eligible participants were adults (aged ≥18 years) with histologically or cytologically confirmed ROS1-rearranged, locally advanced or metastatic stage IIIB-IV NSCLC, with an Eastern Cooperative Oncology Group performance status of 2 or less. Patients who had previously received no or one ROS1 inhibitor were enrolled into phase 2a, and patients who were naive to ROS1 inhibitor therapy were enrolled into phase 2b cohort 1. Participants in phase 2a received 80, 120, 160, or 210 mg foritinib succinate (foritinib) orally once daily over 21-day cycles; patients in phase 2b received the recommended phase 2 dose of 160 mg. The primary endpoint was objective response rate, assessed by the independent review committee in the full analysis set (ie, all participants who received at least one dose of study treatment). The safety analysis set included all participants who received at least one dose of study treatment and had available safety assessments. This study is ongoing and is registered with ClinicalTrials.gov, NCT04237805.</p><p><strong>Findings: </strong>Between March 26, 2020, and Dec 29, 2022, 104 patients were enrolled and treated. Six patients who had previously received more than one ROS1 inhibitor were enrolled in phase 2a before a protocol amendment stating that patients in this phase should have received no more than one ROS1 inhibitor; these patients were included in the safety analysis but excluded from the efficacy analysis of the ROS1-inhibitor-pretreated cohort. Therefore, the efficacy analysis set (n=98) included 42 patients from phase 2a (17 who were ROS1 inhibitor naive and 25 who had previously received ROS1 inhibitor) and 56 patients from phase 2b cohort 1. In phase 2a, the objective response rate was 94% (95% CI 71-100; 16 of 17 patients) in patients who were ROS1 inhibitor naive and 40% (21-61; ten of 25) in patients who had previously received ROS1 inhibitor. In phase 2b cohort 1, the objective response rate was 88% (95% CI 76-95; 49 of 56 patients). In a prespecified exploratory analysis in 41 patients with CNS metastases at baseline, the objective response rate was 100% (95% CI 48-100; five of five patients) in patients in phase 2a who were ROS1 inhibitor naive, 40% (16-68; six of 15) in patients in phase 2a who had previously received ROS1 inhibitor, and 90% (70-99; 19 of 21) in patients in phase 2b cohort 1. Grade 3-4 treatment-related adverse events occurred in 33 (32%) of 104 patients; the most common were hyperglycaemia (12 [12%] patients) and electrocard","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":" ","pages":"671-680"},"PeriodicalIF":38.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141768007","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"FLiRTing with danger as SARS-CoV-2 variants evolve.","authors":"The Lancet Respiratory Medicine","doi":"10.1016/S2213-2600(24)00262-5","DOIUrl":"10.1016/S2213-2600(24)00262-5","url":null,"abstract":"","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":" ","pages":"655"},"PeriodicalIF":38.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141996917","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Further insights into MARS 2.","authors":"Yumna Ahmed, Agha Muhammad Hammad Khan, Calogero Casa, Ahmed Nadeem Abbasi","doi":"10.1016/S2213-2600(24)00252-2","DOIUrl":"https://doi.org/10.1016/S2213-2600(24)00252-2","url":null,"abstract":"","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":"12 9","pages":"e53"},"PeriodicalIF":38.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142114581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Estimated number of lives directly saved by COVID-19 vaccination programmes in the WHO European Region from December, 2020, to March, 2023: a retrospective surveillance study.","authors":"Margaux M I Meslé, Jeremy Brown, Piers Mook, Mark A Katz, José Hagan, Roberta Pastore, Bernhard Benka, Monika Redlberger-Fritz, Nathalie Bossuyt, Veerle Stouten, Catharina Vernemmen, Elisabet Constantinou, Marek Maly, Jan Kynčl, Ondrej Sanca, Tyra Grove Krause, Lasse Skafte Vestergaard, Tuija Leino, Eero Poukka, Kassiani Gkolfinopoulou, Kassiani Mellou, Maria Tsintziloni, Zsuzsanna Molnár, Gudrun Aspelund, Marianna Thordardottir, Lisa Domegan, Eva Kelly, Joan O'Donell, Alberto-Mateo Urdiales, Flavia Riccardo, Chiara Sacco, Viktoras Bumšteinas, Rasa Liausediene, Joël Mossong, Anne Vergison, Maria-Louise Borg, Tanya Melillo, Dragan Kocinski, Enkela Pollozhani, Hinta Meijerink, Diana Costa, João Paulo Gomes, Pedro Pinto Leite, Alina Druc, Veaceslav Gutu, Valentin Mita, Mihaela Lazar, Rodica Popescu, Odette Popovici, Monika Musilová, Maja Mrzel, Maja Socan, Veronika Učakar, Aurora Limia, Clara Mazagatos, Carmen Olmedo, Gavin Dabrera, Meaghan Kall, Mary Sinnathamby, Graham McGowan, Jim McMenamin, Kirsty Morrison, Dorit Nitzan, Marc-Alain Widdowson, Catherine Smallwood, Richard Pebody","doi":"10.1016/S2213-2600(24)00179-6","DOIUrl":"10.1016/S2213-2600(24)00179-6","url":null,"abstract":"<p><strong>Background: </strong>By March, 2023, 54 countries, areas, and territories (hereafter CAT) in the WHO European Region had reported more than 2·2 million COVID-19-related deaths to the WHO Regional Office for Europe. Here, we estimated how many lives were directly saved by vaccinating adults in the WHO European Region from December, 2020, to March, 2023.</p><p><strong>Methods: </strong>In this retrospective surveillance study, we estimated the number of lives directly saved by age group, vaccine dose, and circulating variant-of-concern (VOC) period, regionally and nationally, using weekly data on COVID-19 mortality and infection, COVID-19 vaccination uptake, and SARS-CoV-2 virus characterisations by lineage downloaded from The European Surveillance System on June 11, 2023, as well as vaccine effectiveness data from the literature. We included data for six age groups (25-49 years, 50-59 years, ≥60 years, 60-69 years, 70-79 years, and ≥80 years). To be included in the analysis, CAT needed to have reported both COVID-19 vaccination and mortality data for at least one of the four older age groups. Only CAT that reported weekly data for both COVID-19 vaccination and mortality by age group for 90% of study weeks or more in the full study period were included. We calculated the percentage reduction in the number of expected and reported deaths.</p><p><strong>Findings: </strong>Between December, 2020, and March, 2023, in 34 of 54 CAT included in the analysis, COVID-19 vaccines reduced deaths by 59% overall (CAT range 17-82%), representing approximately 1·6 million lives saved (range 1·5-1·7 million) in those aged 25 years or older: 96% of lives saved were aged 60 years or older and 52% were aged 80 years or older; first boosters saved 51% of lives, and 60% were saved during the Omicron period.</p><p><strong>Interpretation: </strong>Over nearly 2·5 years, most lives saved by COVID-19 vaccination were in older adults by first booster dose and during the Omicron period, reinforcing the importance of up-to-date vaccination among the most at-risk individuals. Further modelling work should evaluate indirect effects of vaccination and public health and social measures.</p><p><strong>Funding: </strong>US Centers for Disease Control and Prevention.</p>","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":" ","pages":"714-727"},"PeriodicalIF":38.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141914559","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Alin Gragossian: from emergency medicine resident to heart transplant recipient.","authors":"Tony Kirby","doi":"10.1016/S2213-2600(24)00220-0","DOIUrl":"10.1016/S2213-2600(24)00220-0","url":null,"abstract":"","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":" ","pages":"668-669"},"PeriodicalIF":38.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141621787","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of COVID-19 vaccination programmes in Europe: lives saved and lessons learned.","authors":"Oliver J Watson, Alexandra B Hogan","doi":"10.1016/S2213-2600(24)00214-5","DOIUrl":"10.1016/S2213-2600(24)00214-5","url":null,"abstract":"","PeriodicalId":51307,"journal":{"name":"Lancet Respiratory Medicine","volume":" ","pages":"663-664"},"PeriodicalIF":38.7,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141914560","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}