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1. 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.
2. 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.
3. Antisense oligonucleotide DGAT-2 inhibitor, ION224, for metabolic dysfunction-associated steatohepatitis (ION224-CS2): results of a 51-week, multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.
作者: Rohit Loomba.;Erin Morgan.;Keyvan Yousefi.;Dan Li.;Richard Geary.;Sanjay Bhanot.;Naim Alkhouri.; .
来源: Lancet. 2025年406卷10505期821-831页
ION224, a liver-directed antisense inhibitor of diacylglycerol O-acyltransferase 2 (DGAT2), suppresses de novo lipogenesis, an important metabolic pathway associated with lipotoxicity and the underlying inflammation, hepatocellular injury, and fibrosis in metabolic dysfunction-associated steatohepatitis (MASH). This study aimed to prospectively assess the safety and efficacy of ION224 in patients with MASH and fibrosis.
4. Safety and efficacy of once-weekly efruxifermin versus placebo in metabolic dysfunction-associated steatohepatitis (HARMONY): 96-week results from a multicentre, randomised, double-blind, placebo-controlled, phase 2b trial.
作者: Mazen Noureddin.;Juan P Frias.;Guy W Neff.;K Jean Lucas.;Cynthia Behling.;Pierre Bedossa.;Julie Dubourg.;Doreen Chan.;Mark Burch.;Erica Fong.;Brittany de Temple.;Matt Minerva.;Kim Barrett.;Reshma Shringarpure.;Erik J Tillman.;Timothy Rolph.;Andrew Cheng.;Kitty Yale.
来源: Lancet. 2025年406卷10504期719-730页
Efruxifermin is a bivalent fibroblast growth factor 21 analogue in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). This trial aimed to prospectively assess the safety and efficacy of efruxifermin administration for 96 weeks in individuals with MASH and moderate (stage 2; F2) or severe (stage 3; F3) fibrosis.
5. Spironolactone in patients on chronic haemodialysis at high risk of adverse cardiovascular outcomes (ALCHEMIST): a multicentre, double-blind, randomised, placebo-controlled trial and updated meta-analysis.
作者: Patrick Rossignol.;Faiez Zannad.;Ziad Massy.;Michel Azizi.;Fatima Chorfa.;Julien Coadic.;João Pedro Ferreira.;Francisca Saraiva.;Dominique Mottier.;Francis Guillemin.;Willy Ngueyon Sime.;Sanae Bouali.;Bénédicte Rossignol.;Joëlle Nortier.;Isabelle Simon.;Christophe Robino.;Manuela Davin.;Pierre M Bataille.;François Chantrel.;Nelly Castin.;Vincent Esnault.;Isabelle Kazes.;Thierry Hannedouche.;Nassim Kamar.;Jean-Michel Achard.;Caroline Fenerol.;Carine Achard-Hottelart.;Yves Dimitrov.;Nicolas Girerd.;Delphine Maucourt-Boulch.;Luc Frimat.; .
来源: Lancet. 2025年406卷10504期705-718页
No pharmacological therapy has been shown with certainty to improve the cardiovascular prognosis in patients with kidney failure on chronic haemodialysis. We aimed to investigate the effects of the steroidal mineralocorticoid receptor antagonist spironolactone on cardiovascular outcomes in patients on haemodialysis who are at high risk of cardiovascular events.
6. Spironolactone versus placebo in patients undergoing maintenance dialysis (ACHIEVE): an international, parallel-group, randomised controlled trial.
作者: Michael Walsh.;David Collister.;Martin Gallagher.;Patrick B Mark.;Janak R de Zoysa.;Jessica Tyrwhitt.;Karthik Tennankore.;Gilmar Reis.;Denis Xavier.;Wen J Liu.;Li Zuo.;Amanda Y Wang.;Camilo Félix.;Laura Sola.;Mustafa Arici.;Russell Villanueva.;Vivekanand Jha.;Dalton Précoma.;Christian G Rabbat.;Sheik Sulthan Alavudeen.;Atiya R Faruqui.;Mavel López-Flecher.;Lonnie Pyne.;Ron Wald.;Fei Yuan.;Kumar Balasubramanian.;Shun Fu Lee.;Alena Kuptsova.;Courtney Christou.;P J Devereaux.; .
来源: Lancet. 2025年406卷10504期695-704页
Patients undergoing maintenance dialysis for kidney failure are at substantial risk of cardiovascular morbidity and mortality. We aimed to establish if spironolactone reduces heart failure and cardiovascular deaths in these patients.
7. Post-exposure prophylaxis regimen of rabies monoclonal antibody and vaccine in category 3 potential exposure patients: a phase 4, open-label, randomised, active-controlled trial.
作者: Prasad S Kulkarni.;Anirudha Vyankatesh Potey.;Dhananjay Kapse.;Chetanraj Bhamare.;Avinash Gawande.;Renuka Munshi.;Sudhir Pawar.;Nithya J Gogtay.;Anurag Agarwal.;Muralidhar Tambe.;Sushama Thakre.;Clarence J Samuel.;Shahzada Mohmed Salim Khan.;Ravish H S.;Devang Rana.;Neha Singh.;Veena Kamath.;Hira Lal Bhalla.;Cyrus S Poonawalla.;Reeta S Mani.;Bhagwat Gunale.; .
来源: Lancet. 2025年406卷10503期627-635页
Rabies is almost invariably fatal. A rabies monoclonal antibody (RmAb) was approved in India in 2016 for passive prophylaxis. This post-marketing study aimed to evaluate the long-term safety, immunogenicity, and efficacy of a post-exposure prophylaxis (PEP) regimen containing RmAb.
8. Adagrasib versus docetaxel in KRASG12C-mutated non-small-cell lung cancer (KRYSTAL-12): a randomised, open-label, phase 3 trial.
作者: Fabrice Barlesi.;Wenxiu Yao.;Michaël Duruisseaux.;Ludovic Doucet.;Aitor Azkárate Martínez.;Vanesa Gregorc.;Oscar Juan-Vidal.;Shun Lu.;Charlotte De Bondt.;Filippo de Marinis.;Helena Linardou.;Young-Chul Kim.;Robert Jotte.;Enriqueta Felip.;Giuseppe Lo Russo.;Martin Reck.;Mary F Michenzie.;Wenjing Yang.;Julie N Meade.;Beata Korytowsky.;Tony S K Mok.; .
来源: Lancet. 2025年406卷10503期615-626页
Adagrasib is a KRASG12C inhibitor that demonstrated promising activity against KRASG12C-mutated advanced non-small-cell lung cancer (NSCLC) in a phase 2 trial. Here we aimed to compare the efficacy and safety of adagrasib versus docetaxel in patients with KRASG12C-mutated advanced NSCLC previously treated with chemotherapy and immunotherapy.
9. Adjuvant chemotherapy and hormonotherapy versus adjuvant hormonotherapy alone for women aged 70 years and older with high-risk breast cancer based on the genomic grade index (ASTER 70s): a randomised phase 3 trial.
作者: Etienne Brain.;Olivier Mir.;Emmanuelle Bourbouloux.;Olivier Rigal.;Jean-Marc Ferrero.;Sylvie Kirscher.;Djelila Allouache.;Véronique D'Hondt.;Aude-Marie Savoye.;Xavier Durando.;Francois P Duhoux.;Laurence Venat-Bouvet.;Emmanuel Blot.;Jean-Luc Canon.;Florence Rollot-Trad.;Hervé Bonnefoi.;Telma Roque.;Jérôme Lemonnier.;Aurélien Latouche.;Julie Henriques.;Magali Lacroix-Triki.;Dewi Vernerey.; .
来源: Lancet. 2025年406卷10502期489-500页
For women aged 70 years or older with oestrogen receptor-positive HER2-negative invasive breast cancer, hormonotherapy is a standard adjuvant treatment, while the role of chemotherapy is debated. We aimed to assess the effect of adjuvant chemotherapy on overall survival in these older patients with high-risk tumours according to a prognostic genomic signature.
10. Feasibility of interrupting the transmission of soil-transmitted helminths: the DeWorm3 community cluster-randomised controlled trial in Benin, India, and Malawi.
作者: Sitara Swarna Rao Ajjampur.;Kumudha Aruldas.;Kristjana H Ásbjörnsdóttir.;Euripide Avokpaho.;Robin Bailey.;Gilles Cottrell.;Sean R Galagan.;Katherine E Halliday.;Parfait Houngbégnon.;Moudachirou Ibikounlé.;Gideon John Israel.;Saravanakumar Puthupalayam Kaliappan.;Khumbo Kalua.;Hugo Legge.;D Timothy J Littlewood.;Adrian J F Luty.;Malathi Manuel.;Achille Massougbodji.;Arianna Rubin Means.;William E Oswald.;Nils Pilotte.;Rachel Pullan.;Rohan Michael Ramesh.;Lyson Samikwa.;James Simwanza.;Katherine K Thomas.;Steven A Williams.;Stefan Witek-McManus.;Judd L Walson.; .
来源: Lancet. 2025年406卷10502期475-488页
Soil-transmitted helminths are targeted for elimination as a public health problem. This study assessed whether, with high coverage, community-wide mass drug administration (MDA) could lead to transmission interruption.
11. Efficacy and safety of intravenous induction and subcutaneous maintenance therapy with guselkumab for patients with Crohn's disease (GALAXI-2 and GALAXI-3): 48-week results from two phase 3, randomised, placebo and active comparator-controlled, double-blind, triple-dummy trials.
作者: Remo Panaccione.;Brian G Feagan.;Anita Afzali.;David T Rubin.;Walter Reinisch.;Julián Panés.;Silvio Danese.;Tadakazu Hisamatsu.;Natalie A Terry.;Leonardo Salese.;Rian Van Rampelbergh.;Aparna Sahoo.;Marion L Vetter.;Jacqueline Yee.;Chenglong Han.;Mary Ellen Frustaci.;Kitty Y Y Wan.;Zijiang Yang.;Jewel Johanns.;Jane M Andrews.;Geert R D'Haens.;Bruce E Sands.; .
来源: Lancet. 2025年406卷10501期358-375页
Despite the availability of biological therapies, suboptimal disease control remains a problem for patients with Crohn's disease. We report the results of the GALAXI-2 and GALAXI-3 studies, which aimed to assess the efficacy and safety of intravenous induction followed by subcutaneous maintenance therapy with guselkumab over 48 weeks in adults with moderately to severely active Crohn's disease.
12. Talazoparib plus enzalutamide in men with metastatic castration-resistant prostate cancer: final overall survival results from the randomised, placebo-controlled, phase 3 TALAPRO-2 trial.
作者: Neeraj Agarwal.;Arun A Azad.;Joan Carles.;André P Fay.;Nobuaki Matsubara.;Cezary Szczylik.;Ugo De Giorgi.;Jae Young Joung.;Peter C C Fong.;Eric Voog.;Robert J Jones.;Neal D Shore.;Fred Saad.;Curtis Dunshee.;Stefanie Zschäbitz.;Jan Oldenburg.;Xun Lin.;Cynthia G Healy.;Matko Kalac.;Dana Kennedy.;Karim Fizazi.
来源: Lancet. 2025年406卷10502期447-460页
The primary analysis of this phase 3 trial combining talazoparib with enzalutamide demonstrated significantly improved radiographic progression-free survival (rPFS) versus enzalutamide plus placebo in patients with metastatic castration-resistant prostate cancer unselected for homologous recombination repair (HRR) gene alterations. Overall survival data were immature at that time. Here we report the final prespecified overall survival analysis, an updated descriptive analysis of rPFS, and safety in the cohort unselected for HRR gene alterations.
13. Talazoparib plus enzalutamide in men with HRR-deficient metastatic castration-resistant prostate cancer: final overall survival results from the randomised, placebo-controlled, phase 3 TALAPRO-2 trial.
作者: Karim Fizazi.;Arun A Azad.;Nobuaki Matsubara.;Joan Carles.;André P Fay.;Ugo De Giorgi.;Jae Young Joung.;Peter C C Fong.;Eric Voog.;Robert J Jones.;Neal D Shore.;Curtis Dunshee.;Stefanie Zschäbitz.;Jan Oldenburg.;Dingwei Ye.;Xun Lin.;Matko Kalac.;A Douglas Laird.;Dana Kennedy.;Neeraj Agarwal.
来源: Lancet. 2025年406卷10502期461-474页
Metastatic castration-resistant prostate cancer remains incurable and is particularly aggressive in patients with alterations in DNA damage repair genes involved directly or indirectly in homologous recombination repair (HRR). In the primary analysis of TALAPRO-2, talazoparib plus enzalutamide significantly improved radiographic progression-free survival (rPFS) versus enzalutamide plus placebo in patients with metastatic castration-resistant prostate cancer harbouring HRR gene alterations. At primary analysis, overall survival was immature. Here we report final prespecified overall survival analysis, updated rPFS, safety, and patient-reported outcomes in the HRR-deficient cohort of TALAPRO-2.
14. Prademagene zamikeracel for recessive dystrophic epidermolysis bullosa wounds (VIITAL): a two-centre, randomised, open-label, intrapatient-controlled phase 3 trial.
作者: Jean Y Tang.;M Peter Marinkovich.;Karen Wiss.;Daniel McCarthy.;Amanda Truesdale.;Albert S Chiou.;Edward Eid.;Joyce K McIntyre.;Irene Bailey.;Louise K Furukawa.;Emily S Gorell.;Nicki Harris.;Rohit K Khosla.;H Peter Lorenz.;Ying Lu.;Jaron Nazaroff.;I Dmitriy Grachev.;Amanda J Moore.
来源: Lancet. 2025年406卷10499期163-173页
Recessive dystrophic epidermolysis bullosa (RDEB) is a rare genetic skin disease caused by mutations in the COL7A1 gene encoding type VII collagen. Individuals with RDEB have fragile skin and most develop large, chronic wounds. The aim of the VIITAL study was to evaluate the efficacy and safety of a one-time surgical application of prademagene zamikeracel in wound healing.
15. Biomarker risk stratification with capsule sponge in the surveillance of Barrett's oesophagus: prospective evaluation of UK real-world implementation.
作者: W Keith Tan.;Caryn S Ross-Innes.;Timothy Somerset.;Greta Markert.;Florian Markowetz.;Maria O'Donovan.;Massimiliano di Pietro.;Peter Sasieni.;Rebecca C Fitzgerald.; .
来源: Lancet. 2025年406卷10500期271-282页
Endoscopic surveillance is the clinical standard for Barrett's oesophagus, but its effectiveness is inconsistent. We have developed a test comprising a pan-oesophageal cell collection device coupled with biomarkers to stratify patients into three risk groups. We aimed to prospectively evaluate the prespecified risk stratification tool to establish whether it can identify those at highest risk of dysplasia or cancer to prioritise the timing of endoscopy; and safely be used to follow up the low-risk group, thus sparing patients from unnecessary endoscopies.
16. Once-weekly insulin efsitora alfa versus once-daily insulin glargine U100 in adults with type 2 diabetes treated with basal and prandial insulin (QWINT-4): a phase 3, randomised, non-inferiority trial.
作者: Thomas Blevins.;Dominik Dahl.;Federico C Pérez Manghi.;Sreenivasa Murthy.;Ramon Ortiz Carrasquillo.;Xiaoqi Li.;Annette M Chang.;Molly C Carr.;Michelle Katz.
来源: Lancet. 2025年405卷10497期2290-2301页
Insulin efsitora alfa (efsitora), a once-weekly basal insulin, has the potential to reduce the treatment burden of people with type 2 diabetes who require insulin. We aimed to assess the efficacy and safety of once-weekly efsitora compared with insulin glargine U100 in adults with type 2 diabetes treated with basal and prandial insulin.
17. Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 2 diabetes currently treated with basal insulin (QWINT-3): a phase 3, randomised, non-inferiority trial.
作者: Athena Philis-Tsimikas.;Richard M Bergenstal.;Timothy S Bailey.;Hideaki Jinnouchi.;James R Thrasher.;Liza Ilag.;Jit Mitra.;Kristen Syring.;Rebecca J Threlkeld.
来源: Lancet. 2025年405卷10497期2279-2289页
Once-weekly insulin efsitora alfa (efsitora) is in development for the treatment of people with diabetes. The aim of the current study was to assess the efficacy and safety of once-weekly efsitora compared with daily insulin degludec (degludec) in adults with type 2 diabetes using basal insulin.
18. Amycretin, a novel, unimolecular GLP-1 and amylin receptor agonist administered subcutaneously: results from a phase 1b/2a randomised controlled study.
作者: Kirsten Dahl.;Søren Toubro.;Sohan Dey.;Ruben Duque do Vale.;Anne Flint.;Agnes Gasiorek.;Arne Heydorn.;Ania M Jastreboff.;Cassandra Key.;Signe Beck Petersen.;Andreas Vegge.;Kasper Adelborg.
来源: Lancet. 2025年406卷10499期149-162页
Amycretin is a novel, unimolecular GLP-1 and amylin receptor agonist. The aim of this study was to investigate the safety, tolerability, pharmacokinetics, and effects on bodyweight of subcutaneous amycretin administered over a treatment period of up to 36 weeks in participants with overweight or obesity.
19. Safety, tolerability, pharmacokinetics, and pharmacodynamics of the first-in-class GLP-1 and amylin receptor agonist, amycretin: a first-in-human, phase 1, double-blind, randomised, placebo-controlled trial.
作者: Agnes Gasiorek.;Arne Heydorn.;Sanaz Gabery.;Julie B Hjerpsted.;Katrine Kirkeby.;Thomas Kruse.;Signe B Petersen.;Søren Toubro.;Andreas Vegge.;Cassandra Key.
来源: Lancet. 2025年406卷10499期135-148页
GLP-1 receptor agonists and amylin receptor agonists have shown clinically relevant weight loss and glucose-lowering effects in people with overweight, obesity, and type 2 diabetes. Amycretin is a novel, single-molecule GLP-1 receptor and amylin receptor agonist. We aimed to investigate the safety, tolerability, pharmacokinetic properties, and pharmacodynamic effects of single ascending doses (part A) and multiple ascending doses (parts B and C/D) of amycretin in adult participants with overweight or obesity.
20. Mitapivat in adults with non-transfusion-dependent α-thalassaemia or β-thalassaemia (ENERGIZE): a phase 3, international, randomised, double-blind, placebo-controlled trial.
作者: Ali T Taher.;Hanny Al-Samkari.;Yesim Aydinok.;Martin Besser.;Audra N Boscoe.;Jayme L Dahlin.;Gonzalo De Luna.;Jeremie H Estepp.;Sarah Gheuens.;Keely S Gilroy.;Andreas Glenthøj.;Ai Sim Goh.;Varsha Iyer.;Antonis Kattamis.;Sandra R Loggetto.;Susan Morris.;Khaled M Musallam.;Kareem Osman.;Paolo Ricchi.;Eduardo Salido-Fiérrez.;Sujit Sheth.;Feng Tai.;Heather Tevich.;Katrin Uhlig.;Rolandas Urbstonaitis.;Vip Viprakasit.;Maria Domenica Cappellini.;Kevin H M Kuo.; .
来源: Lancet. 2025年406卷10498期33-42页
Non-transfusion-dependent (NTD) thalassaemia is characterised by ineffective erythropoiesis and haemolytic anaemia, leading to long-term complications, poor quality of life, and early mortality. No oral disease-modifying therapies are approved for β-thalassaemia and no agents are approved for α-thalassaemia. The objective of this study was to evaluate the efficacy and safety of mitapivat, an oral activator of pyruvate kinase, in adults with NTD α-thalassaemia or NTD β-thalassaemia.
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