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1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. 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.
14. Safety and immunogenicity of a pentavalent meningococcal conjugate vaccine targeting serogroups A, C, W, Y, and X when co-administered with routine childhood vaccines at ages 9 months and 15 months in Mali: a single-centre, double-blind, randomised, controlled, phase 3, non-inferiority trial.
作者: Fatoumata Diallo.;Fadima C Haidara.;Milagritos D Tapia.;Clara P Dominguez Islas.;Mark R Alderson.;William P Hausdorff.;Lionel Martellet.;Nancy Hosken.;Dhananjay Kapse.;Prasad S Kulkarni.;Kelly Townsend-Payne.;Francesca Vanni.;Christine M Posavad.;Samba O Sow.;Karen L Kotloff.;Wilbur H Chen.; .
来源: Lancet. 2025年405卷10484期1069-1080页
Invasive meningococcal disease is a devastating public health problem for the African meningitis belt. We assessed the safety and immunogenicity of a pentavalent meningococcal conjugate vaccine targeting serogroups A, C, Y, W, and X (NmCV-5) relative to a licensed, quadrivalent meningococcal conjugate vaccine (MenACWY-TT) when co-administered with routine childhood vaccines at ages 9 months and 15 months.
15. Pharmacokinetics and safety of once-yearly lenacapavir: a phase 1, open-label study.
作者: Vamshi Jogiraju.;Pallavi Pawar.;Jenna Yager.;John Ling.;Gong Shen.;Anna Chiu.;Emma Hughes.;Ramesh Palaparthy.;Christoph Carter.;Renu Singh.
来源: Lancet. 2025年405卷10485期1147-1154页
Long-acting antiretrovirals can address barriers to HIV pre-exposure prophylaxis (PrEP), such as stigma and adherence. In two phase 3 trials, twice-yearly subcutaneous lenacapavir was safe and highly efficacious for PrEP in diverse populations. Furthering long-acting PrEP efforts, this study assessed the pharmacokinetics and safety of two once-yearly intramuscular lenacapavir formulations.
16. Effect of digital adherence technologies on treatment outcomes in people with drug-susceptible tuberculosis: four pragmatic, cluster-randomised trials.
作者: Degu Jerene.;Kristian van Kalmthout.;Jens Levy.;Jason Alacapa.;Natasha Deyanova.;Tanyaradzwa Dube.;Andrew Mganga.;Bianca Tasca.;Alexsey Bogdanov.;Egwuma Efo.;Katya Gamazina.;Anna Marie Celina Garfin.;Volodymyr Kochanov.;Adrian Leung.;Norma Madden.;Noriah Maraba.;Christopher Finn McQuaid.;Liberate Mleoh.;Baraka Onjare.;Rachel Powers.;Yana Terleiva.;Job van Rest.;Agnes Gebhard.;Katherine Fielding.;Salome Charalambous.
来源: Lancet. 2025年405卷10485期1155-1166页
The impact of digital adherence technologies on tuberculosis treatment outcomes remains poorly understood. We investigated whether smart pillboxes and medication labels can reduce poor treatment outcomes in patients with tuberculosis.
17. Ivonescimab versus pembrolizumab for PD-L1-positive non-small cell lung cancer (HARMONi-2): a randomised, double-blind, phase 3 study in China.
作者: Anwen Xiong.;Lei Wang.;Jianhua Chen.;Lin Wu.;Baogang Liu.;Jun Yao.;Hua Zhong.;Jie Li.;Ying Cheng.;Yulan Sun.;Hui Ge.;Jifang Yao.;Qin Shi.;Ming Zhou.;Bolin Chen.;Zhengxiang Han.;Jinliang Wang.;Qing Bu.;Yanqiu Zhao.;Junqiang Chen.;Ligong Nie.;Gaofeng Li.;Xingya Li.;Xinmin Yu.;Yinghua Ji.;Daqiang Sun.;Xiaohong Ai.;Qian Chu.;Yu Lin.;Jiqing Hao.;Dingzhi Huang.;Chengzhi Zhou.;Jinlu Shan.;Hongzhong Yang.;Xuewen Liu.;Jing Wang.;Yanhong Shang.;Xiaodong Mei.;Jie Yang.;Dongmei Lu.;Mingxiu Hu.;Zhongmin Maxwell Wang.;Baiyong Li.;Michelle Xia.;Caicun Zhou.
来源: Lancet. 2025年405卷10481期839-849页
Ivonescimab is a bispecific antibody against programmed cell death protein 1 and vascular endothelial growth factor, yielding promising clinical outcomes for patients with advanced non-small cell lung cancer in early-phase studies. We compared the efficacy and safety of ivonescimab with pembrolizumab in patients with programmed cell death ligand-1 (PD-L1)-positive advanced non-small cell lung cancer.
18. Atosiban versus placebo for threatened preterm birth (APOSTEL 8): a multicentre, randomised controlled trial.
作者: Larissa I van der Windt.;Job Klumper.;Ruben G Duijnhoven.;Marjolein Kok.;Carrie Ris-Stalpers.;Marjon A de Boer.;Anton H van Kaam.;Eva Pajkrt.;Ben W Mol.;Kate F Walker.;Fionnuala M McAuliffe.;Joris A van der Post.;Carolien Roos.;Martijn A Oudijk.; .
来源: Lancet. 2025年405卷10483期1004-1013页
Tocolytics are recommended in international guidelines as treatment for threatened preterm birth. Atosiban, an oxytocin receptor antagonist, is a registered tocolytic drug specifically indicated for the treatment of threatened preterm birth. Although tocolytics have been shown to delay birth, benefits on neonatal outcomes have not been demonstrated. In the APOSTEL 8 trial we aimed to assess superiority of tocolysis with atosiban compared with placebo in threatened preterm birth from 30 weeks and 0 days (30+0 weeks) to 33+6 weeks of gestation in improving neonatal morbidity and mortality.
19. Efficacy and safety of twice per year depemokimab in chronic rhinosinusitis with nasal polyps (ANCHOR-1 and ANCHOR-2): phase 3, randomised, double-blind, parallel trials.
作者: Philippe Gevaert.;Martin Desrosiers.;Marjolein Cornet.;Joaquim Mullol.;Eugenio De Corso.;Nesil Keles Turel.;Jorge Maspero.;Shigeharu Fujieda.;Luo Zhang.;Ana R Sousa.;Samantha J Woods.;Angela M Davis.;Stein Schalkwijk.;Dawn Edwards.;Prerna Ranganathan.;Richard Follows.;Carolynne Marshall.;Joseph K Han.; .
来源: Lancet. 2025年405卷10482期911-926页
Chronic rhinosinusitis with nasal polyps (CRSwNP) symptoms are frequently driven by type 2 inflammation. Depemokimab is the first ultra-long-acting biological drug engineered with enhanced interleukin-5 binding affinity, high potency, and an extended half-life, enabling twice per year dosing and sustained type 2 inflammation inhibition. The ANCHOR-1 and ANCHOR-2 trials investigated the efficacy and safety of depemokimab in people with CRSwNP.
20. Extended treatment of venous thromboembolism with reduced-dose versus full-dose direct oral anticoagulants in patients at high risk of recurrence: a non-inferiority, multicentre, randomised, open-label, blinded endpoint trial.
作者: Francis Couturaud.;Jeannot Schmidt.;Olivier Sanchez.;Alice Ballerie.;Marie-Antoinette Sevestre.;Nicolas Meneveau.;Laurent Bertoletti.;Jérôme Connault.;Ygal Benhamou.;Joël Constans.;Thomas Quemeneur.;François-Xavier Lapébie.;Gilles Pernod.;Gaël Picart.;Antoine Elias.;Caroline Doutrelon.;Claire Neveux.;Lina Khider.;Pierre-Marie Roy.;Stéphane Zuily.;Nicolas Falvo.;Philippe Lacroix.;Joseph Emmerich.;Isabelle Mahé.;Julien Boileau.;Azzedine Yaici.;Sylvain Le Jeune.;Dominique Stéphan.;Pierre Plissonneau-Duquene.;Valérie Ray.;Marc Danguy des Déserts.;Rafik Belhadj-Chaidi.;Bouchra Lamia.;Yves Gruel.;Emilie Presles.;Philippe Girard.;Cécile Tromeur.;Farès Moustafa.;Vincent Rothstein.;Karine Lacut.;Solen Melac.;Sophie Barillot.;Patrick Mismetti.;Silvy Laporte.;Dominique Mottier.;Guy Meyer.;Christophe Leroyer.; .
来源: Lancet. 2025年405卷10480期725-735页
In patients with venous thromboembolism at high risk of recurrence for whom extended treatment with direct oral anticoagulants has been indicated, the optimal dose is unknown. We aimed to assess efficacy and safety of reduced-dose versus full-dose direct oral anticoagulants in patients in whom extended anticoagulation has been indicated.
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