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Add-on LAMA therapy in asthma: an underused strategy for exacerbation prevention 哮喘的附加LAMA治疗:一种未充分利用的预防加重策略
IF 76.2 1区 医学 Q1 CRITICAL CARE MEDICINE Pub Date : 2026-02-12 DOI: 10.1016/s2213-2600(26)00006-8
Clarus Leung, Don D Sin
No Abstract
没有抽象的
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引用次数: 0
Budesonide–glycopyrronium–formoterol fumarate dihydrate in uncontrolled asthma (KALOS and LOGOS): twin multicentre, double-blind, double-dummy, parallel-group, randomised, phase 3 trials 布地奈德-甘炔罗-富马酸福莫特罗二水合物治疗未控制哮喘(KALOS和LOGOS):双多中心、双盲、双虚拟、平行组、随机、3期试验
IF 76.2 1区 医学 Q1 CRITICAL CARE MEDICINE Pub Date : 2026-02-12 DOI: 10.1016/s2213-2600(25)00457-6
Alberto Papi, Robert A Wise, David J Jackson, Njira Lugogo, Ruchong Chen, Teodora Trasieva, Chidi Obasi, Charlotta Movitz, Jesse Helman, Patricia Salter, Katarzyna Springer, Marco Bondoc, Mihir Shah, Katharine Knappenberger, Karin Bowen, Hitesh Pandya, Ayman Megally, Mehul Patel
<h3>Background</h3>Long-acting muscarinic antagonists (LAMA) can be added to inhaled corticosteroid– (ICS)–long-acting β<sub>2</sub>-agonist (LABA) therapy for inadequately controlled asthma. We aimed to evaluate the efficacy and safety of budesonide–glycopyrronium–formoterol fumarate dihydrate (BGF) versus budesonide–formoterol fumarate dihydrate using Aerosphere co-suspension delivery technology (BFF<sub>A</sub>) and the current suspension formulation (Symbicort, BFF<sub>S</sub>).<h3>Methods</h3>Two multicentre, randomised, double-blind, double-dummy, phase 3 studies (KALOS and LOGOS) recruited participants aged 12–80 years with inadequately-controlled asthma despite daily medium-dose or high-dose ICS–LABA use from across 378 sites in 20 countries (KALOS), and 324 sites in 15 countries (LOGOS). Participants were randomly assigned (1:1:1:1) to BGF 320 μg, 28·8 μg, 10 μg (BGF 28·8); BGF 320 μg, 14·4 μg, 10 μg (BGF 14·4); BFF<sub>A</sub> 320 μg, 10 μg; or BFF<sub>S</sub> 320 μg, 9 μg, twice a day via pressurised metered-dose inhaler for 24–52 weeks. Primary lung function endpoints were change from baseline in FEV<sub>1</sub> area under the curve from 0 h to 3 h (AUC<sub>0–3</sub>) and in morning pre-dose trough FEV<sub>1</sub> from day 1 to week 24 (over 24 weeks; depending on regional health authority guidance). The primary pooled analysis across both studies was annualised severe exacerbations. The efficacy analysis set and safety set included all randomly assigned participants receiving any amount of study treatment but were analysed according to randomly assigned treatment and received treatment, respectively. The KALOS and LOGOS studies are registered with <span><span>ClinicalTrials.gov</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span> (<span><span>NCT04609878</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span> and <span><span>NCT04609904</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>, respectively) and are complete.<h3>Findings</h3>Between Dec 15, 2020, and March 21, 2025 (KALOS), and between March 1, 2021, and March 20, 2025 (LOGOS), 8820 participants were recruited and 4311 received treatment (1179 received BGF 28·8, 726 received BGF 14·4, 1210 received BFF<sub>A</sub>, and 1196 received BFF<sub>S</sub>). In each study, the pre-specified multiplicity-adjusted primary endpoints for all regulatory comparisons were met. Least squares mean differences favoured BGF 28·8 for change from baseline in trough FEV<sub>1</sub> and FEV<sub>1</sub> AUC<sub>0–3</sub> across al
背景:慢性毒蕈碱拮抗剂(LAMA)可加入吸入皮质类固醇(ICS) -长效β2激动剂(LABA)治疗,以治疗控制不充分的哮喘。我们的目的是利用Aerosphere共悬浮递送技术(BFFA)和目前的悬浮液配方(Symbicort, BFFS)来评估布地奈德-甘罗诺-福莫特罗二水合富马酸酯(BGF)与布地奈德-福莫特罗二水合富马酸酯(BGF)的有效性和安全性。方法两项多中心、随机、双盲、双哑的3期研究(KALOS和LOGOS)从20个国家的378个试验点(KALOS)和15个国家的324个试验点(LOGOS)招募了年龄在12-80岁之间、每日使用中剂量或高剂量ICS-LABA但哮喘控制不充分的受试者。受试者按1:1:1:1的比例随机分配至BGF 320、28.8、10组(BGF 28.8);BGF 320 μg、14.4 μg、10 μg (BGF 14.4);BFFA 320 μg, 10 μg;或BFFS 320 μg, 9 μg,加压计量吸入器每日2次,连用24-52周。主要肺功能终点为从0小时到3小时曲线下FEV1面积的基线变化(AUC0-3),以及从第1天到第24周(超过24周,取决于地区卫生当局的指导)的早晨剂量前FEV1。两项研究的主要汇总分析是年化严重恶化。疗效分析组和安全性组包括所有随机分配的接受任何研究治疗量的参与者,但分别根据随机分配的治疗和接受的治疗进行分析。KALOS和LOGOS研究已在ClinicalTrials.gov注册(分别为NCT04609878和NCT04609904)并已完成。在2020年12月15日至2025年3月21日(KALOS)和2021年3月1日至2025年3月20日(LOGOS)期间,招募了8820名参与者,4311名接受了治疗(1179名接受了BGF 28.8, 726名接受了BGF 14.4, 1210名接受了BFFA, 1196名接受了BFFS)。在每项研究中,所有调节比较的预先指定的多重调整的主要终点都得到满足。在所有比较中,FEV1槽和FEV1 AUC0-3与基线相比的变化,最小二乘平均值的差异有利于BGF 28.8(均为p<; 0.05)。BGF 28·8组与bff联合组相比,24周内早晨通过FEV1和FEV1 AUC0-3与基线相比的最小二乘平均变化差异分别为76 mL (95% CI 57-94; p< 0.0001)和90 mL (72-108; p< 0.0001)。与bff联合相比,BGF 28.8降低了严重加重率(发病率比为0.86,95% CI为0.76 - 0.97;p= 0.012),与bff相比,BGF 28.8降低了严重加重率(发病率比为0.82,95% CI为0.71 - 0.94;p= 0.0043)。BGF的加重率比为28.8,BFFA的加重率比为0.90 (95% CI 0.78 ~ 1.03; p= 0.12)。BGF组不良事件627例(53.2%),BGF组为28.8例,BGF组为14.4例(636例),BFFA组为666例(55.2%),BFFS组为698例(58.4%)。没有与治疗相关的死亡。这些研究结果表明,尽管使用中剂量或高剂量ICS-LABA,但在哮喘控制不充分的广泛人群中,BGF可改善肺功能并降低严重恶化率。考虑到这些发现是在没有最近的发作史的情况下观察到的,BGF可以使哮喘控制不充分的个体受益,而不需要在升级前最近发生ICS-LABA急性恶化。
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引用次数: 0
Survival effect of prehospital emergency anaesthesia with intubation in risk-stratified patients with major trauma: a causal modelling study 严重创伤风险分层患者院前急诊麻醉插管的生存效应:一项因果模型研究
IF 76.2 1区 医学 Q1 CRITICAL CARE MEDICINE Pub Date : 2026-02-11 DOI: 10.1016/s2213-2600(25)00370-4
Amy PK Nelson, Nick Dodds, Mohamad Zeina, Alfred Balston, Dominic Giles, William H Seligman, Ashwani Jha, Parashkev Nachev, Julian Thompson
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引用次数: 0
From data to decision: the future of prehospital intubation in major trauma 从数据到决策:重大创伤院前插管的未来
IF 76.2 1区 医学 Q1 CRITICAL CARE MEDICINE Pub Date : 2026-02-11 DOI: 10.1016/s2213-2600(26)00002-0
Amber G den Hollander, Prabath W B Nanayakkara
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引用次数: 0
JCOG0802 and CALGB140503: the gap between trial design and clinical application JCOG0802和CALGB140503:试验设计与临床应用之间的差距
IF 76.2 1区 医学 Q1 CRITICAL CARE MEDICINE Pub Date : 2026-02-10 DOI: 10.1016/s2213-2600(26)00022-6
Eric Lim
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引用次数: 0
Pulmonary hydatid disease in children: a neglected burden hidden in plain sight 儿童肺包虫病:隐藏在视线中的被忽视的负担
IF 76.2 1区 医学 Q1 CRITICAL CARE MEDICINE Pub Date : 2026-02-06 DOI: 10.1016/s2213-2600(26)00016-0
Pierre Goussard, Jacques Janson, Zane Ismail, Ernst Eber, André Gie, Savvas Andronikou
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引用次数: 0
Tackling the twin crises of tuberculosis and undernutrition 应对结核病和营养不良的双重危机
IF 76.2 1区 医学 Q1 CRITICAL CARE MEDICINE Pub Date : 2026-02-06 DOI: 10.1016/s2213-2600(26)00013-5
Ashna Ashesh, Jennfier Furin
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引用次数: 0
Fixed PEEP is not lung expansion physiology: reinterpreting the PROTHOR trial 固定PEEP不是肺扩张生理学:重新解释PROTHOR试验
IF 76.2 1区 医学 Q1 CRITICAL CARE MEDICINE Pub Date : 2026-02-03 DOI: 10.1016/s2213-2600(25)00459-x
Carsten Külls, Niloufar Dadashpour, Majid Golestanieraghi
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引用次数: 0
Breathing in sport: can we make breath work better? 运动中的呼吸:我们能让呼吸工作得更好吗?
IF 76.2 1区 医学 Q1 CRITICAL CARE MEDICINE Pub Date : 2026-02-03 DOI: 10.1016/s2213-2600(25)00437-0
Eric Harbour, Camilla Illidi, James H Hull
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引用次数: 0
Correction to Lancet Respir Med 2025; 14: 15–16 《柳叶刀呼吸医学2025》修正;14: 15 - 16
IF 76.2 1区 医学 Q1 CRITICAL CARE MEDICINE Pub Date : 2026-02-03 DOI: 10.1016/s2213-2600(25)00438-2
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引用次数: 0
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Lancet Respiratory Medicine
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