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101. Durvalumab in combination with BCG for BCG-naive, high-risk, non-muscle-invasive bladder cancer (POTOMAC): final analysis of a randomised, open-label, phase 3 trial.
作者: Maria De Santis.;Joan Palou Redorta.;Hiroyuki Nishiyama.;Michał Krawczyński.;Artur Seyitkuliev.;Andrey Novikov.;Félix Guerrero-Ramos.;Ruslan Zukov.;Minoru Kato.;Takashi Kawahara.;Lieven Goeman.;Javier Puente.;Eva Hellmis.;Thomas Powles.;Piotr Radziszewski.;Kilian M Gust.;Paul Vasey.;Pierre Bigot.;Yves Fradet.;Jarmo Hunting.;Jon Armstrong.;Suliman Boulos.;Stephan Hois.;Neal D Shore.; .
来源: Lancet. 2025年406卷10516期2221-2234页
Patients with high-risk non-muscle-invasive bladder cancer (NMIBC) often have recurrence or progression after transurethral resection of bladder tumour (TURBT) and subsequent BCG therapy. We aimed to evaluate whether 1 year of durvalumab with BCG could improve outcomes versus BCG alone for these patients.
102. Sultiame once per day in obstructive sleep apnoea (FLOW): a multicentre, randomised, double-blind, placebo-controlled, dose-finding, phase 2 trial.
作者: Winfried Randerath.;Ludger Grote.;Kaj Stenlöf.;Ingo Fietze.;Julia Chevts.;Erik Buntinx.;Javier Albares.;Katrin Kuhn.;Corinna Hansen.;Andreas Völp.;Jan Hedner.; .
来源: Lancet. 2025年406卷10514期1983-1992页
Obstructive sleep apnoea (OSA) is highly prevalent but approved pharmacological treatment options are missing. Sultiame improves the ventilatory response and upper airway muscle activity by inhibiting carbonic anhydrase. This study aimed to prospectively assess the efficacy and safety of three dosages of sultiame in OSA.
103. Ibrutinib and rituximab versus immunochemotherapy in patients with previously untreated mantle cell lymphoma (ENRICH): a randomised, open-label, phase 2/3 superiority trial.
作者: David J Lewis.;Mats Jerkeman.;Lexy Sorrell.;David Wright.;Ingrid Glimelius.;Christian B Poulsen.;Annika Pasanen.;Andrew Rawstron.;Karin F Wader.;Nick Morley.;Catherine Burton.;Andrew J Davies.;Ingemar Lagerlöf.;Surita Dalal.;Ruth De Tute.;Chris McNamara.;Nicola Crosbie.;Helle Erbs Toldbod.;Jeanette Sanders.;Victoria Allgar.;Sree Aroori.;Mark Warner.;Claire Scully.;Brian Wainman.;Jacob Haaber Christensen.;Jon Riise.;Kristina Sonnevi.;Mark J Bishton.;Toby A Eyre.;Simon Rule.; .
来源: Lancet. 2025年406卷10514期1953-1968页
Ibrutinib, a Bruton tyrosine kinase inhibitor, prolongs progression-free survival when added to immunochemotherapy as first line treatment. The ENRICH trial compared the chemotherapy-free combination of ibrutinib and the anti-CD20 antibody rituximab (ibrutinib-rituximab) with standard immunochemotherapy (R-CHOP [rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisolone] or bendamustine-rituximab) in patients 60 years and older with untreated mantle-cell lymphoma.
104. Effect of repurposed simvastatin on disability progression in secondary progressive multiple sclerosis (MS-STAT2): a phase 3, randomised, double-blind, placebo-controlled trial.
作者: Jeremy Chataway.;Thomas Williams.;James Blackstone.;Nevin John.;Marie Braisher.;Floriana De Angelis.;Alessia Bianchi.;Alberto Calvi.;Anisha Doshi.;Sean Apap Mangion.;Charles Wade.;Ekaterina Bordea.;Rachel Merry.;Gil Barton.;Dawn Lyle.;Elisabeth Jarman.;Don Mahad.;Abdullah Shehu.;Tarunya Arun.;Gavin McDonnell.;Ruth Geraldes.;Matthew Craner.;Charles Hillier.;Jeban Ganesalingam.;Leonora Fisniku.;Jeremy Hobart.;Cord Spilker.;Neil P Robertson.;Seema Kalra.;Stefano Pluchino.;Sreedharan Harikrishnan.;Miriam Mattoscio.;Timothy Harrower.;Carolyn Young.;Martin Lee.;Suresh Kumar Chhetri.;Fayyaz Ahmed.;David Rog.;Eli Silber.;Paul Gallagher.;Martin Duddy.;Agne Straukiene.;Richard Nicholas.;Claire Rice.;Susan Tebbs.;Annie Hawton.;Rachael Hunter.;Gavin Giovannoni.;Olga Ciccarelli.;Judy Beveridge.;Stuart Nixon.;Alan J Thompson.;John Greenwood.;Owen R Pearson.;Nikos Evangelou.;Basil Sharrack.;Ian Galea.;Emma Gray.;Sue Pavitt.;Siddharthan Chandran.;Helen L Ford.;Chris Frost.;Jennifer M Nicholas.; .
来源: Lancet. 2025年406卷10512期1611-1624页
Despite the success of immune modulation in the treatment of relapsing multiple sclerosis, disability progression is a major problem driven by multiple mechanisms. Comorbidities (eg, vascular risk) and ageing are thought to augment these neurodegenerative pathologies. In the phase 2b MS-STAT trial of simvastatin (80 mg) versus placebo in secondary progressive multiple sclerosis (SPMS), the adjusted difference in brain atrophy rate between groups was -0·254% per year: a 43% reduction. In this phase 3 MS-STAT2 trial, we aimed to assess the efficacy of simvastatin versus placebo in slowing the progression of disability in SPMS.
105. Budesonide-formoterol versus salbutamol as reliever therapy in children with mild asthma (CARE): a 52-week, open-label, multicentre, superiority, randomised controlled trial.
作者: Lee Hatter.;Mark Holliday.;Karen Oldfield.;Ciléin Kearns.;Tasmin Barry.;Melissa Black.;Pepa Bruce.;Atalie Colman.;Emily Dickinson.;Allie Eathorne.;Matire Harwood.;Thomas Hills.;Rebekah Lamb.;Kyley Kerse.;Srinidhi Krishnamoorthy.;John Martindale.;Alex Semprini.;Nick Shortt.;David McNamara.;Catherine A Byrnes.;Stuart R Dalziel.;Andrew Bush.;Mark Weatherall.;Richard Beasley.; .
来源: Lancet. 2025年406卷10511期1473-1483页
Combination inhaled corticosteroid-formoterol reliever monotherapy reduces the rate of asthma attacks compared to short-acting β2-agonist (SABA) reliever monotherapy in adults. Its comparative efficacy in children has not been established.
106. A clinical decision tool including a decision tree, point-of-care testing of CRP, and safety-netting advice to guide antibiotic prescribing in acutely ill children in primary care in Belgium (ARON): a pragmatic, cluster-randomised, controlled trial.
作者: Jan Yvan Verbakel.;Ruben Burvenich.;Erinn D'hulster.;Liselore De Rop.;Ann Van den Bruel.;Sibyl Anthierens.;Samuel Coenen.;An De Sutter.;Stefan Heytens.;Louise Joly.;Marina Digregorio.;Annouschka Laenen.;Jeroen Luyten.;Tine De Burghgraeve.
来源: Lancet. 2025年406卷10512期1599-1610页
Antimicrobial resistance is a global health threat. Many children with acute illness in ambulatory care are unnecessarily prescribed antibiotics. We assessed the clinical effectiveness of a clinical decision tool for these children, including a validated decision tree, guided point-of-care C-reactive protein testing (POCT of CRP), and safety-netting advice.
107. Oral iptacopan therapy in patients with C3 glomerulopathy: a randomised, double-blind, parallel group, multicentre, placebo-controlled, phase 3 study.
作者: David Kavanagh.;Andrew S Bomback.;Marina Vivarelli.;Carla M Nester.;Giuseppe Remuzzi.;Ming-Hui Zhao.;Edwin K S Wong.;Yaqin Wang.;Induja Krishnan.;Imelda Schuhmann.;Angelo J Trapani.;Nicholas J A Webb.;Matthias Meier.;Rubeen K Israni.;Richard J H Smith.; .
来源: Lancet. 2025年406卷10512期1587-1598页
C3 glomerulopathy is an ultra-rare, severe form of glomerulonephritis caused by overactivation of the alternative complement pathway. We aimed to assess efficacy and safety of iptacopan (LNP023), an oral, proximal complement inhibitor that targets factor B to selectively inhibit the alternative pathway of the complement cascade.
108. Once-daily oral icotrokinra versus placebo and once-daily oral deucravacitinib in participants with moderate-to-severe plaque psoriasis (ICONIC-ADVANCE 1 & 2): two phase 3, randomised, placebo-controlled and active-comparator-controlled trials.
作者: Linda Stein Gold.;April W Armstrong.;Robert Bissonnette.;Nina Magnolo.;Ronald B Vender.;Michael Sebastian.;Maria Laura Galimberti.;Athanasios Tsianakas.;Marcelo Arnone.;Paul Wallace.;Margrit Simon.;Josep Riera-Monroig.;Sascha Gerdes.;Jill Waibel.;Alvaro Gonzalez-Cantero.;Beate Schwarz.;Yayoi Tada.;Michael Cecchini.;Benjamin Ehst.;Leon Kircik.;Lea Kephart.;Ofelia Reyes-Servin.;Bassey Effiom Edem.;Jennifer H Campbell.;Yaung-Kaung Shen.;Kellen Cresswell.;Shu Li.;Cynthia M C DeKlotz.;Fabio Nunes.;Kim A Papp.
来源: Lancet. 2025年406卷10510期1363-1374页
Monoclonal antibodies targeting interleukin-23 and interleukin-12 are efficacious in treating plaque psoriasis but must be delivered via intravenous or subcutaneous injection. Here, we aimed to evaluate the efficacy and safety of icotrokinra (JNJ-77242113), a targeted oral peptide that selectively binds the interleukin-23 receptor, compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque psoriasis.
109. Minimum effective low dose of antithymocyte globulin in people aged 5-25 years with recent-onset stage 3 type 1 diabetes (MELD-ATG): a phase 2, multicentre, double-blind, randomised, placebo-controlled, adaptive dose-ranging trial.
作者: Chantal Mathieu.;Julie Wych.;A Emile J Hendriks.;Lisa Van Ryckeghem.;Timothy Tree.;Piotr Chmura.;Christopher Möller.;Kristina Casteels.;Thomas Danne.;Felix Reschke.;Darja Šmigoc Schweiger.;Tadej Battelino.;Jesper Johannesen.;Birgit Rami-Merhar.;Thomas Pieber.;Christophe De Block.;Mark Evans.;Robert Hilbrands.;Emanuele Bosi.;Ruben H Willemsen.;Supriyo Basu.;Mari-Anne Pulkkinen.;Mikael Knip.;Miriam Cnop.;Almut Nitsche.;Anke M Schulte.;Elisabeth Niemöller.;Mark Peakman.;Charlotte Wilhelm-Benartzi.;David Gillespie.;Lut Overbergh.;Adrian P Mander.;M Loredana Marcovecchio.; .
来源: Lancet. 2025年406卷10510期1375-1388页
Type 1 diabetes remains an important health-care problem, with no disease-modifying therapies available in people with recent-onset, clinical type 1 diabetes. Adaptive trial designs, allowing faster evaluation of treatment modalities, remain underexplored in this stage of the disease. We aimed to identify the minimum effective dose of antithymocyte globulin (ATG) in people aged 5-25 years with recent-onset, clinical type 1 diabetes.
110. Efficacy and safety of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS): a randomised, double-blind, placebo-controlled, phase 3 trial.
作者: Tamara S Hannon.;Lily C Chao.;Margarita Barrientos-Pérez.;Karthik Chandrasekhar Pamidipati.;Laura Fernández Landó.;Clare J Lee.;Hiren Patel.;Brandon K Bergman.
来源: Lancet. 2025年406卷10511期1484-1496页
Current treatment options for youth-onset type 2 diabetes are limited and have demonstrated lower glycaemic efficacy than those for adult-onset type 2 diabetes. We aimed to assess the safety and efficacy of tirzepatide, a glucose-dependent insulinotropic polypeptide and GLP-1 receptor agonist, compared with placebo in youth-onset type 2 diabetes.
111. Effect of evolocumab on saphenous vein graft patency after coronary artery bypass surgery (NEWTON-CABG CardioLink-5): an international, randomised, double-blind, placebo-controlled trial.
作者: Subodh Verma.;Lawrence A Leiter.;Hwee Teoh.;G B John Mancini.;Adrian Quan.;Randi Elituv.;Meena Verma.;Elizabeth Misner.;Michael Szarek.;Kevin E Thorpe.;Tarit Saha.;Richard P Whitlock.;Bobby Yanagawa.;Béla Merkely.;Peter Jüni.;Michael J Koren.;Stephen J Nicholls.;Deepak L Bhatt.;C David Mazer.
来源: Lancet. 2025年406卷10509期1223-1234页
Saphenous vein graft (SVG) failure remains a substantial challenge after coronary artery bypass graft (CABG). LDL cholesterol (LDL-C) is a causal risk factor for atherosclerosis, but its role in SVG failure is not well established. We evaluated whether early initiation of intensive LDL-C lowering with evolocumab could reduce SVG failure.
112. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in chronic limb-threatening ischaemia (SWEDEPAD 1): a multicentre, participant-masked, registry-based, randomised controlled trial.
作者: Mårten Falkenberg.;Stefan James.;Manne Andersson.;Mattias Andersson.;Martin Delle.;Jan Engström.;Torbjörn Fransson.;Peter Gillgren.;Anna Hilbertson.;Tal M Hörer.;Eva Jacobsson.;Björn Kragsterman.;Johan Lindbäck.;Hans Lindgren.;Karin Ludwigs.;Stefan Mellander.;Olle Nelzén.;Robert Olin.;Birgitta Sigvant.;Per Skoog.;Joachim Starck.;Gustaf Tegler.;Knut Thorbjørnsen.;Maria Truedson.;Carl-Magnus Wahlgren.;Jonas Wallinder.;Andreas Öjersjö.;Joakim Nordanstig.; .
来源: Lancet. 2025年406卷10508期1103-1114页
Drug-coated devices are frequently used in coronary and peripheral interventions, but their effect on amputation risk in peripheral artery disease is unclear. We assessed whether drug-coated devices affect the rate of above-ankle amputation in patients with chronic limb-threatening ischaemia undergoing infrainguinal endovascular revascularisation.
113. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in patients with intermittent claudication (SWEDEPAD 2): a multicentre, participant-masked, registry-based, randomised controlled trial.
作者: Joakim Nordanstig.;Stefan James.;Manne Andersson.;Mattias Andersson.;Martin Delle.;Jan Engström.;Torbjörn Fransson.;Peter Gillgren.;Anna Hilbertson.;Tal M Hörer.;Eva Jacobsson.;Björn Kragsterman.;Johan Lindbäck.;Hans Lindgren.;Karin Ludwigs.;Stefan Mellander.;Olle Nelzén.;Robert Olin.;Birgitta Sigvant.;Per Skoog.;Joachim Starck.;Gustaf Tegler.;Knut Thorbjørnsen.;Maria Truedson.;Carl-Magnus Wahlgren.;Jonas Wallinder.;Andreas Öjersjö.;Mårten Falkenberg.; .
来源: Lancet. 2025年406卷10508期1115-1127页
Drug-coated devices are widely used to reduce restenosis after lower limb revascularisation in patients with peripheral artery disease, but their effect on patient-centred outcomes remains unclear. We assessed the effect of paclitaxel-coated devices on clinically important outcomes in patients with intermittent claudication undergoing infrainguinal endovascular revascularisation.
114. Immediate versus staged complete revascularisation during index admission in patients with ST-segment elevation myocardial infarction and multivessel disease (OPTION-STEMI): a multicentre, non-inferiority, open-label, randomised trial.
作者: Min Chul Kim.;Joon Ho Ahn.;Dae Young Hyun.;Yongwhan Lim.;Kyung Hoon Cho.;Seung Hun Lee.;Seongho Park.;Seok Oh.;Doo Sun Sim.;Young Joon Hong.;Ju Han Kim.;Myung Ho Jeong.;Jang Hyun Cho.;Sang-Rok Lee.;Dong Oh Kang.;Jin-Yong Hwang.;Young Jin Youn.;Jung-Hee Lee.;Young-Hoon Jeong.;Jong-Hwa Ahn.;Dong-Bin Kim.;Eun Ho Choo.;Chan Joon Kim.;Weon Kim.;Jay Young Rhew.;Jong-Il Park.;Sang-Yong Yoo.;Youngkeun Ahn.; .
来源: Lancet. 2025年406卷10507期1032-1043页
The optimal timing of complete revascularisation for patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease remains unclear. We aimed to assess whether immediate complete revascularisation was non-inferior to staged complete revascularisation during the index admission.
115. Vericiguat in patients with chronic heart failure and reduced ejection fraction (VICTOR): a double-blind, placebo-controlled, randomised, phase 3 trial.
作者: Javed Butler.;Ciaran J McMullan.;Kevin J Anstrom.;Irina Barash.;Marc P Bonaca.;Maria Borentain.;Stefano Corda.;Justin A Ezekowitz.;G Michael Felker.;Davis Gates.;Carolyn S P Lam.;Eldrin F Lewis.;JoAnn Lindenfeld.;Robert J Mentz.;Christopher M O'Connor.;Piotr Ponikowski.;Yogesh N V Reddy.;Giuseppe M C Rosano.;Clara Saldarriaga.;Michele Senni.;Lilin She.;Pedro Pinto Teixeira.;James Udelson.;Alessia Urbinati.;Vanja Vlajnic.;Adriaan A Voors.;Aiwen Xing.;Mahesh J Patel.;Faiez Zannad.; .
来源: Lancet. 2025年406卷10510期1341-1350页
Vericiguat is indicated to reduce the risk of cardiovascular death and hospitalisation for heart failure in patients with heart failure and reduced ejection fraction (HFrEF) following a recent worsening event. The aim of the VICTOR trial was to assess the effect of vericiguat in patients with HFrEF without recent heart failure worsening.
116. Vericiguat for patients with heart failure and reduced ejection fraction across the risk spectrum: an individual participant data analysis of the VICTORIA and VICTOR trials.
作者: Faiez Zannad.;Christopher M O'Connor.;Javed Butler.;Ciaran J McMullan.;Kevin J Anstrom.;Irina Barash.;Marc P Bonaca.;Maria Borentain.;Stefano Corda.;Davis Gates.;Justin A Ezekowitz.;Adrian F Hernandez.;Carolyn S P Lam.;Eldrin F Lewis.;JoAnn Lindenfeld.;Robert J Mentz.;Piotr Ponikowski.;Yogesh N V Reddy.;Giuseppe M C Rosano.;Clara Saldarriaga.;Michele Senni.;Pedro P Teixeira.;James Udelson.;Alessia Urbinati.;Vanja Vlajnic.;Adriaan A Voors.;Aiwen Xing.;Mahesh J Patel.;Paul W Armstrong.; .
来源: Lancet. 2025年406卷10510期1351-1362页
Following completion of the VICTORIA trial, vericiguat was approved for the treatment of worsening heart failure with reduced ejection fraction (HFrEF) and received a class IIb recommendation in European and North American guidelines. The subsequent VICTOR trial evaluated the use of vericiguat in patients with HFrEF and no recent worsening. We aimed to assess the effect of vericiguat on clinical endpoints through pooled analyses of patient-level data from the VICTORIA and VICTOR trials.
117. Influenza vaccination to improve outcomes for patients with acute heart failure (PANDA II): a multiregional, seasonal, hospital-based, cluster-randomised, controlled trial in China.
作者: Craig S Anderson.;Chang Hua.;Zhiyan Wang.;Chi Wang.;Chao Jiang.;Rong Liu.;Rong Han.;Qiang Li.;Sana Shan.;Laurent Billot.;C Raina Macintyre.;Anushka Patel.;Hongjia Zhang.;Changsheng Ma.;Jianzeng Dong.;Xin Du.
来源: Lancet. 2025年406卷10507期1020-1031页
Influenza vaccination is widely recommended to prevent death and serious illness in vulnerable people, including those with heart failure. However, the randomised evidence to support this practice is limited and few people are vaccinated in many parts of the world. We aimed to determine whether influenza vaccination can improve the outcome of patients after an episode of acute heart failure requiring admission to hospital in China.
118. The clinical effectiveness of clarithromycin versus endoscopic sinus surgery for adults with chronic rhinosinusitis with and without nasal polyps (MACRO): a pragmatic, multicentre, three-arm, randomised, placebo-controlled phase 4 trial.
作者: Carl Philpott.;David J Beard.;Elnaz Saeedi.;Jonathan A Cook.;Stephen Jones.;Caroline S Clarke.;Lucinda Teoh.;Mike Thomas.;Paul Little.;Jane Vennik.;Valerie Lund.;Anne G M Schilder.;Fei Long.;Stephen Durham.;James Boardman.;Claire Hopkins.; .; .
来源: Lancet. 2025年406卷10506期926-939页
A paucity of evidence regarding use of endoscopic sinus surgery and antibiotics in managing chronic rhinosinusitis has contributed to a five-times variation in endoscopic sinus surgery rates, as well as variation in the use of antibiotics. The main aim of the present trial was to compare the clinical effectiveness of endoscopic sinus surgery or 3 months of clarithromycin treatment alongside intranasal medication in adults with chronic rhinosinusitis with or without nasal polyps.
119. Efficacy and safety of single-anastomosis duodeno-ileal bypass with sleeve gastrectomy versus Roux-en-Y gastric bypass in France (SADISLEEVE): results of a randomised, open-label, superiority trial at 2 years of follow-up.
作者: Maud Robert.;Tigran Poghosyan.;Nicolas Romain-Scelle.;Sebastien Czernichow.;Dominique Delaunay.;Adrien Sterkers.;Litavan Khamphommala.;Andrea Lazzati.;Claire Blanchard.;Robert Caiazzo.;François Pattou.;Emmanuel Disse.; .
来源: Lancet. 2025年406卷10505期846-859页
Since 2007, single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) has been proposed as an alternative to Roux-en-Y gastric bypass (RYGB) in the treatment of obesity. We conducted a multicentre randomised trial, with the hypothesis that SADI-S could be more effective than RYGB at 2-year follow-up.
120. Building community capacity in mental health care with the Strong Minds-Strong Communities programme: a randomised controlled trial in the USA.
作者: Margarita Alegría.;Gabriela Livas Stein.;Mario Cruz-Gonzalez.;Irene Falgas-Bague.;Sheri Lapatin Markle.;Kari M Eddington.;Andrew Supple.;Larimar Fuentes.;Claire Poindexter.;Patrick E Shrout.
来源: Lancet. 2025年406卷10505期832-845页
Provider shortages and lack of culturally responsive care limit mental health services in reaching multicultural populations worldwide. We examined the effectiveness of a psychoeducational intervention aimed at building community capacity to address depression and anxiety among racial, ethnic, and linguistic minoritised adults.
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