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101. Efficacy and safety of low-dose IL-2 as an add-on therapy to riluzole (MIROCALS): a phase 2b, double-blind, randomised, placebo-controlled trial.
作者: Gilbert Bensimon.;P Nigel Leigh.;Timothy Tree.;Andrea Malaspina.;Christine Am Payan.;Hang-Phuong Pham.;Pieter Klaassen.;Pamela J Shaw.;Ahmad Al Khleifat.;Maria D M Amador.;Shahram Attarian.;Simon M Bell.;Stéphane Beltran.;Emilien Bernard.;William Camu.;Philippe Corcia.;Jean-Christophe Corvol.;Philippe Couratier.;Véronique Danel.;Rabab Debs.;Claude Desnuelle.;Aikaterini Dimitriou.;John Ealing.;Florence Esselin.;Marie-Céline Fleury.;George H Gorrie.;Aude-Marie Grapperon.;Adèle Hesters.;Raul Juntas-Morales.;Ivan Kolev.;Géraldine Lautrette.;Nadine Le Forestier.;Christopher J McDermott.;Nicolas Pageot.;François Salachas.;Nikhil Sharma.;Marie-Hélène Soriani.;Jemeen Sreedharan.;Juliette Svahn.;Nick Verber.;Annie Verschueren.;Ozlem Yildiz.;Carey M Suehs.;Safaa Saker-Delye.;Claudie Muller.;Christophe Masseguin.;Hana Hajduchova.;Janine Kirby.;Cecilia Garlanda.;Massimo Locati.;Henrik Zetterberg.;Bernard Asselain.;Ammar Al-Chalabi.; .
来源: Lancet. 2025年405卷10492期1837-1850页
Amyotrophic lateral sclerosis (ALS) is a life-threatening disease characterised by progressive loss of motor neurons with few therapeutic options. The MIROCALS study tested the hypothesis that low-dose interleukin-2 (IL-2LD) improves survival and function in ALS.
102. Nivolumab plus ipilimumab versus lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma (CheckMate 9DW): an open-label, randomised, phase 3 trial.
作者: Thomas Yau.;Peter R Galle.;Thomas Decaens.;Bruno Sangro.;Shukui Qin.;Leonardo G da Fonseca.;Hatim Karachiwala.;Jean-Frederic Blanc.;Joong-Won Park.;Edward Gane.;Matthias Pinter.;Ana Matilla Peña.;Masafumi Ikeda.;David Tai.;Armando Santoro.;Gonzalo Pizarro.;Chang-Fang Chiu.;Michael Schenker.;Aiwu He.;Hong Jae Chon.;Joanna Wojcik-Tomaszewska.;Gontran Verset.;Qi Qi Wang.;Caitlyn Stromko.;Jaclyn Neely.;Prianka Singh.;Maria Jesus Jimenez Exposito.;Masatoshi Kudo.; .
来源: Lancet. 2025年405卷10492期1851-1864页
Patients with unresectable hepatocellular carcinoma have a poor prognosis, and treatments with long-term benefits are needed. We report results from the preplanned interim analysis of the CheckMate 9DW trial assessing nivolumab plus ipilimumab versus lenvatinib or sorafenib for unresectable hepatocellular carcinoma in the first-line setting.
103. Fixed-dose combination of obicetrapib and ezetimibe for LDL cholesterol reduction (TANDEM): a phase 3, randomised, double-blind, placebo-controlled trial.
作者: Ashish Sarraju.;Danielle Brennan.;Kierstyn Hayden.;Amanda Stronczek.;Anne C Goldberg.;Erin D Michos.;Darren K McGuire.;Denise Mason.;Grace Tercek.;Stephen J Nicholls.;Douglas Kling.;Annie L Neild.;John Kastelein.;Michael Davidson.;Marc Ditmarsch.;Steven E Nissen.
来源: Lancet. 2025年405卷10491期1757-1768页
Reducing LDL cholesterol prevents atherosclerotic cardiovascular disease (ASCVD) events. The aim of this study was to evaluate the LDL cholesterol-lowering efficacy of a fixed-dose combination (FDC) of obicetrapib, a CETP inhibitor, and ezetimibe.
104. Treatment options to support the elimination of hepatitis C: an open-label, factorial, randomised controlled non-inferiority trial.
作者: Graham S Cooke.;Le Manh Hung.;Barnaby Flower.;Leanne McCabe.;Vu Thi Kim Hang.;Vo Thi Thu.;Dang Trong Thuan.;Nguyen Thanh Dung.;Le Thanh Phuong.;Dao Bach Khoa.;Nguyen Thi Chau An.;Pham Ngoc Thach.;Vu Thi Thu Huong.;Dang Thi Bich.;Nguyen Kim Tuyen.;M Azim Ansari.;Chau Le Ngoc.;Vo Minh Quang.;Nguyen Thi Ngoc Phuong.;Le Thi Thao.;Nguyen Bao Tran.;Evelyne Kestelyn.;Cherry Kingsley.;Rogier Van Doorn.;Motiur Rahman.;Sarah L Pett.;Guy E Thwaites.;Eleanor Barnes.;Jeremy N Day.;Nguyen Van Vinh Chau.;A Sarah Walker.
来源: Lancet. 2025年405卷10491期1769-1780页
WHO recommends treating hepatitis C infection with one of three antiviral combinations for 8-12 weeks. No randomised trials have compared these regimens, and high cure rates might be achievable with shorter durations of therapy. We aimed to compare sofosbuvir-daclatasvir with sofosbuvir-velpatasvir, and to evaluate potential novel treatment strategies.
105. Induction of labour versus standard care to prevent shoulder dystocia in fetuses suspected to be large for gestational age in the UK (the Big Baby trial): a multicentre, open-label, randomised controlled trial.
作者: Jason Gardosi.;Lauren Jade Ewington.;Katie Booth.;Debra Bick.;George Bouliotis.;Emily Butler.;Sanjeev Deshpande.;Hanna Ellson.;Joanne Fisher.;Adam Gornall.;Ranjit Lall.;Hema Mistry.;Seyran Naghdi.;Stavros Petrou.;Anne-Marie Slowther.;Sara Wood.;Martin Underwood.;Siobhan Quenby.
来源: Lancet. 2025年405卷10491期1743-1756页
The benefits and harms of early induction of labour to reduce shoulder dystocia in fetuses suspected to be large for gestational age (LGA) are uncertain. We aimed to investigate whether early induction of labour is associated with a reduced risk of shoulder dystocia compared with standard care.
106. Efficacy and safety of topical delgocitinib cream versus oral alitretinoin capsules in adults with severe chronic hand eczema (DELTA FORCE): a 24-week, randomised, head-to-head, phase 3 trial.
作者: Ana Maria Giménez-Arnau.;Andreas Pinter.;Wiebke Sondermann.;Ziad Reguiai.;Richard Woolf.;Charles Lynde.;Franz J Legat.;Antonio Costanzo.;Juan F Silvestre.;Natja Mellerup.;Marie Louise Østerdal.;Ursula Plohberger.;Lasse Ryttig.;Andrea Bauer.; .
来源: Lancet. 2025年405卷10490期1676-1688页
Chronic hand eczema is a heterogeneous, fluctuating, and long-lasting disease affecting the hands and wrists that substantially affects quality of life. For severe chronic hand eczema, topical corticosteroids are often unsatisfactory and systemic treatment can be required. The aim of the head-to-head, phase 3 DELTA FORCE trial was to evaluate the efficacy and safety of topical delgocitinib cream versus oral alitretinoin, the only currently approved systemic drug for severe chronic hand eczema.
107. Negative pressure wound therapy versus usual care in patients with surgical wound healing by secondary intention in the UK (SWHSI-2): an open-label, multicentre, parallel-group, randomised controlled trial.
作者: Catherine Arundel.;Laura Mandefield.;Caroline Fairhurst.;Kalpita Baird.;Athanasios Gkekas.;Pedro Saramago.;Ian Chetter.; .
来源: Lancet. 2025年405卷10490期1689-1699页
Surgical wound healing by secondary intention (SWHSI) presents a substantial management and financial challenge. Negative pressure wound therapy (NPWT) has increasingly been used as a treatment despite an absence of comparative evidence of effectiveness. We evaluated the effectiveness of NPWT compared with usual care for improving time to wound healing in patients with an SWHSI.
108. Oral gepotidacin for the treatment of uncomplicated urogenital gonorrhoea (EAGLE-1): a phase 3 randomised, open-label, non-inferiority, multicentre study.
作者: Jonathan D C Ross.;Janet Wilson.;Kimberly A Workowski.;Stephanie N Taylor.;David A Lewis.;Sally Gatsi.;William Flight.;Nicole E Scangarella-Oman.;Charles Jakielaszek.;Dan Lythgoe.;Marcy Powell.;Salim Janmohamed.;Judith Absalon.;Caroline Perry.
来源: Lancet. 2025年405卷10489期1608-1620页
Gepotidacin, a first-in-class, bactericidal, triazaacenaphthylene antibacterial that inhibits bacterial DNA replication, was shown to be efficacious and well tolerated in the treatment of uncomplicated urinary tract infections. We evaluated the efficacy and safety of gepotidacin for the treatment of uncomplicated urogenital gonorrhoea.
109. SAPIEN 3 versus Myval transcatheter heart valves for transcatheter aortic valve implantation (COMPARE-TAVI 1): a multicentre, randomised, non-inferiority trial.
作者: Christian Juhl Terkelsen.;Philip Freeman.;Jordi Sanchez Dahl.;Troels Thim.;Bjarne Linde Nørgaard.;Nils Sofus Borg Mogensen.;Mariann Tang.;Ashkan Eftekhari.;Jonas Agerlund Povlsen.;Steen Hvitfeldt Poulsen.;Lars Pedersen.;Jakob Hjort.;Julia Ellert.;Evald Høj Christiansen.;Henrik Toft Sørensen.;Henrik Nissen.
来源: Lancet. 2025年405卷10487期1362-1372页
Transcatheter aortic valve implantation (TAVI) is a guideline-directed treatment for severe aortic stenosis and degenerated aortic bioprostheses. When new transcatheter heart valve (THV) platforms for TAVI are launched, they should be compared with best-in-practice contemporary THVs for their short-term and long-term performance. The COMPARE-TAVI 1 trial was designed to provide a head-to-head comparison of the SAPIEN 3 or SAPIEN 3 Ultra THVs and the Myval or Myval Octacor THVs.
110. Durability and efficacy of solbinsiran, a GalNAc-conjugated siRNA targeting ANGPTL3, in adults with mixed dyslipidaemia (PROLONG-ANG3): a double-blind, randomised, placebo-controlled, phase 2 trial.
作者: Kausik K Ray.;Ena Oru.;Robert S Rosenson.;Jeremiah Jones.;Xiaosu Ma.;Jennie Walgren.;Axel Haupt.;Subodh Verma.;Daniel Gaudet.;Stephen J Nicholls.;Giacomo Ruotolo.
来源: Lancet. 2025年405卷10489期1594-1607页
Mixed dyslipidaemia, characterised by elevated concentrations of circulating triglycerides and LDL cholesterol (LDL-C), is associated with an increased risk of atherosclerotic cardiovascular disease. Solbinsiran, a GalNAc-conjugated small interfering RNA targeting hepatic angiopoietin-like protein 3 (ANGPTL3), reduced triglycerides and LDL-C concentrations in a phase 1 study. This study aimed to assess the durability and efficacy of solbinsiran in reducing concentrations of atherogenic lipoproteins in adults with mixed dyslipidaemia.
111. Efficacy and safety of clopidogrel versus aspirin monotherapy in patients at high risk of subsequent cardiovascular event after percutaneous coronary intervention (SMART-CHOICE 3): a randomised, open-label, multicentre trial.
作者: Ki Hong Choi.;Yong Hwan Park.;Jong-Young Lee.;Jin-Ok Jeong.;Chan Joon Kim.;Kyeong Ho Yun.;Han Cheol Lee.;Kiyuk Chang.;Mahn-Won Park.;Jang-Whan Bae.;Joon-Hyung Doh.;Byung Ryul Cho.;Hee-Yeol Kim.;Weon Kim.;Ung Kim.;Seung-Woon Rha.;Young Joon Hong.;Hyun-Jong Lee.;Sung Gyun Ahn.;Doo-Il Kim.;Jang Hyun Cho.;Sung Ho Her.;Doo Soo Jeon.;Seung Hwan Han.;Jin-Bae Lee.;Cheol Whan Lee.;Danbee Kang.;Joo Myung Lee.;Taek Kyu Park.;Jeong Hoon Yang.;Soo-Youn Lee.;Seung-Hyuk Choi.;Hyeon-Cheol Gwon.;Young Bin Song.;Joo-Yong Hahn.; .
来源: Lancet. 2025年405卷10486期1252-1263页
The optimal strategy for long-term antiplatelet maintenance for patients who underwent percutaneous coronary intervention (PCI) remains uncertain. This study aimed to compare the efficacy and safety of clopidogrel versus aspirin monotherapy in patients who completed a standard duration of dual antiplatelet therapy (DAPT) following PCI with drug-eluting stents.
112. Outcomes after fractional flow reserve-guided percutaneous coronary intervention versus coronary artery bypass grafting (FAME 3): 5-year follow-up of a multicentre, open-label, randomised trial.
作者: William F Fearon.;Frederik M Zimmermann.;Victoria Y Ding.;Kuniaki Takahashi.;Zsolt Piroth.;Albert H M van Straten.;Laszlo Szekely.;Giedrius Davidavičius.;Gintaras Kalinauskas.;Samer Mansour.;Rajesh Kharbanda.;Nikolaos Östlund-Papadogeorgos.;Adel Aminian.;Keith G Oldroyd.;Nawwar Al-Attar.;Nikola Jagic.;Jan-Henk E Dambrink.;Petr Kala.;Oskar Angerås.;Philip MacCarthy.;Olaf Wendler.;Filip Casselman.;Nils Witt.;Kreton Mavromatis.;Steven E S Miner.;Jaydeep Sarma.;Thomas Engstrøm.;Evald H Christiansen.;Pim A L Tonino.;Michael J Reardon.;Hisao Otsuki.;Yuhei Kobayashi.;Mark A Hlatky.;Kenneth W Mahaffey.;Manisha Desai.;Y Joseph Woo.;Alan C Yeung.;Nico H J Pijls.;Bernard De Bruyne.
来源: Lancet. 2025年405卷10488期1481-1490页
Long-term outcomes following percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) might be changing because of improved techniques and better medical therapy. This final prespecified analysis of the Fractional Flow Reserve (FFR) versus Angiography for Multivessel Evaluation (FAME) 3 trial aimed to reassess their comparative effectiveness at 5 years.
113. Angiography-derived fractional flow reserve versus intravascular ultrasound to guide percutaneous coronary intervention in patients with coronary artery disease (FLAVOUR II): a multicentre, randomised, non-inferiority trial.
作者: Xinyang Hu.;Jinlong Zhang.;Seokhun Yang.;Jun Jiang.;Xiaoping Peng.;Dongsheng Lu.;Yibin Pan.;Lijun Guo.;Jilin Li.;Wenming He.;Hao Zhou.;Jun Pu.;Jinyu Huang.;Fan Jiang.;Qiang Liu.;Daqing Song.;Liang Lu.;Zhenfeng Cheng.;Bin Yang.;Jianliang Ma.;Peng Chen.;Shiqiang Li.;Zhaohui Meng.;Lijiang Tang.;Yongzhen Fan.;Eun-Seok Shin.;Shengxian Tu.;Chang-Wook Nam.;William F Fearon.;Bon-Kwon Koo.;Jian'an Wang.; .
来源: Lancet. 2025年405卷10488期1491-1504页
Revascularisation decisions based on angiography-derived fractional flow reserve (FFR) or optimisation of stent implantation with intravascular ultrasound yield superior clinical outcomes compared with percutaneous coronary intervention (PCI) guided by angiography alone. However, the differences in outcomes when a single approach is used for both purposes remain unclear. We aimed to assess the non-inferiority of angiography-derived FFR versus intravascular ultrasound guidance in terms of clinical outcomes at 12 months in patients with angiographically significant stenosis.
114. Orbital atherectomy versus balloon angioplasty before drug-eluting stent implantation in severely calcified lesions eligible for both treatment strategies (ECLIPSE): a multicentre, open-label, randomised trial.
作者: Ajay J Kirtane.;Philippe Généreux.;Bruce Lewis.;Richard A Shlofmitz.;Suhail Dohad.;Jithendra Choudary.;Thom Dahle.;Andres M Pineda.;Kendrick Shunk.;Akiko Maehara.;Alexandra Popma.;Bjorn Redfors.;Ziad A Ali.;Mitchell Krucoff.;Ehrin Armstrong.;David E Kandzari.;William O'Neill.;Carlye Kraemer.;Krista M Stiefel.;Denise E Jones.;Jeff Chambers.;Gregg W Stone.; .
来源: Lancet. 2025年405卷10486期1240-1251页
Coronary artery calcification is common among patients undergoing percutaneous coronary intervention (PCI), and severe coronary artery lesion calcification is associated with increased procedural complexity, stent under-expansion, and high rates of intraprocedural complications and out-of-hospital adverse events. Whether calcium ablation before stent implantation can mitigate these adverse events is not currently established. We aimed to prospectively compare orbital atherectomy with a balloon angioplasty-based strategy before stent implantation for the treatment of severely calcified coronary lesions.
115. Semaglutide and walking capacity in people with symptomatic peripheral artery disease and type 2 diabetes (STRIDE): a phase 3b, double-blind, randomised, placebo-controlled trial.
作者: Marc P Bonaca.;Andrei-Mircea Catarig.;Kim Houlind.;Bernhard Ludvik.;Joakim Nordanstig.;Chethana Kalmady Ramesh.;Neda Rasouli.;Harald Sourij.;Alex Videmark.;Subodh Verma.; .
来源: Lancet. 2025年405卷10489期1580-1593页
Peripheral artery disease is a highly morbid type of atherosclerotic vascular disease involving the legs and is estimated to affect over 230 million individuals globally. Few therapies improve functional capacity and health-related quality of life in people with lower limb peripheral artery disease. We aimed to evaluate whether semaglutide improves function as measured by walking ability as well as symptoms, quality of life, and outcomes in people with peripheral artery disease and type 2 diabetes.
116. Chikungunya virus virus-like particle vaccine safety and immunogenicity in adolescents and adults in the USA: a phase 3, randomised, double-blind, placebo-controlled trial.
作者: Jason S Richardson.;Deborah M Anderson.;Jason Mendy.;Lauren C Tindale.;Sufia Muhammad.;Tobi Loreth.;Sarah Royalty Tredo.;Kelly L Warfield.;Roshan Ramanathan.;Jorge T Caso.;Victoria A Jenkins.;Patrick Ajiboye.;Lisa Bedell.; .
来源: Lancet. 2025年405卷10487期1343-1352页
Chikungunya disease is a growing global public health concern. Vimkunya (previously chikungunya virus virus-like particle vaccine, previously PXVX0317) is a single-dose, pre-filled syringe for intramuscular injection. Here, we report safety, tolerability, and immunogenicity data for Vimkunya versus placebo in healthy adolescents and adults aged 12-64 years, and evaluate lot-to-lot consistency.
117. Effect of invitation to colonoscopy versus faecal immunochemical test screening on colorectal cancer mortality (COLONPREV): a pragmatic, randomised, controlled, non-inferiority trial.
作者: Antoni Castells.;Enrique Quintero.;Luis Bujanda.;Susana Castán-Cameo.;Joaquín Cubiella.;José Díaz-Tasende.;Ángel Lanas.;Akiko Ono.;Miquel Serra-Burriel.;Eladio Frías-Arrocha.;Cristina Hernández.;Rodrigo Jover.;Montserrat Andreu.;Fernando Carballo.;Juan Diego Morillas.;Dolores Salas.;Raquel Almazán.;Inmaculada Alonso-Abreu.;Jesús M Banales.;Vicent Hernández.;Isabel Portillo.;Mercedes Vanaclocha-Espí.;Mariola de la Vega.; .
来源: Lancet. 2025年405卷10486期1231-1239页
Colonoscopy and the faecal immunochemical test are accepted strategies for colorectal cancer screening in the average-risk population (ie, people aged ≥50 years without personal or family history of colorectal cancer). In this trial, we aimed to compare whether invitation to screening with faecal immunochemical test was non-inferior to colonoscopy in a screening programme.
118. Chikungunya virus virus-like particle vaccine safety and immunogenicity in adults older than 65 years: a phase 3, randomised, double-blind, placebo-controlled trial.
作者: Lauren C Tindale.;Jason S Richardson.;Deborah M Anderson.;Jason Mendy.;Sufia Muhammad.;Tobi Loreth.;Sarah Royalty Tredo.;Roshan Ramanathan.;Victoria A Jenkins.;Lisa Bedell.;Patrick Ajiboye.; .
来源: Lancet. 2025年405卷10487期1353-1361页
Adults older than 65 years are at increased risk for atypical presentations of chikungunya disease, as well as for severe outcomes including death.
119. Invasive urodynamic investigations in the management of women with refractory overactive bladder symptoms (FUTURE) in the UK: a multicentre, superiority, parallel, open-label, randomised controlled trial.
作者: Mohamed Abdel-Fattah.;Christopher Chapple.;David Cooper.;Suzanne Breeman.;Helen Bell-Gorrod.;Preksha Kuppanda.;Karen Guerrero.;Simon Dixon.;Nikki Cotterill.;Karen Ward.;Hashim Hashim.;Ash Monga.;Karen Brown.;Marcus Drake.;Andrew Gammie.;Alyaa Mostafa.;Rebecca Bruce.;Victoria Bell.;Christine Kennedy.;Suzanne Evans.;Graeme MacLennan.;John Norrie.; .
来源: Lancet. 2025年405卷10484期1057-1068页
Overactive bladder is a common problem affecting women worldwide, with a negative effect on their social and professional lives. Before considering invasive treatments, guidelines recommend urodynamics to identify detrusor overactivity. However, the clinical-effectiveness and cost-effectiveness of urodynamics has never been robustly assessed in this cohort of women. We aimed to compare the clinical-effectiveness and cost-effectiveness of urodynamics plus comprehensive clinical assessment (CCA) versus CCA only in the management of women with refractory overactive bladder symptoms.
120. Behavioural interventions to increase uptake of FIT colorectal screening in Scotland (TEMPO): a nationwide, eight-arm, factorial, randomised controlled trial.
作者: Kathryn A Robb.;Ben Young.;Marie K Murphy.;Patrycja Duklas.;Alex McConnachie.;Gareth J Hollands.;Colin McCowan.;Sara Macdonald.;Ronan E O'Carroll.;Rory C O'Connor.;Robert J C Steele.
来源: Lancet. 2025年405卷10484期1081-1092页
Uptake of colorectal cancer screening is suboptimal. The TEMPO trial evaluated the impact of two evidence-based, theory-informed, and co-designed behavioural interventions on uptake of faecal immunochemical test (FIT) colorectal screening.
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