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441. Factor XIa inhibition with asundexian after acute non-cardioembolic ischaemic stroke (PACIFIC-Stroke): an international, randomised, double-blind, placebo-controlled, phase 2b trial.
作者: Ashkan Shoamanesh.;Hardi Mundl.;Eric E Smith.;Jaime Masjuan.;Ivan Milanov.;Teruyuki Hirano.;Alina Agafina.;Bruce Campbell.;Valeria Caso.;Jean-Louis Mas.;Qiang Dong.;Peter Turcani.;Hanne Christensen.;Jose M Ferro.;Roland Veltkamp.;Robert Mikulik.;Gian Marco De Marchis.;Thompson Robinson.;Robin Lemmens.;Adam Stepien.;Stefan Greisenegger.;Risto Roine.;Laszlo Csiba.;Pooja Khatri.;Jonathan Coutinho.;Arne G Lindgren.;Andrew M Demchuk.;Pablo Colorado.;Bodo Kirsch.;Christoph Neumann.;Laura Heenan.;Lizhen Xu.;Stuart J Connolly.;Robert G Hart.; .
来源: Lancet. 2022年400卷10357期997-1007页
Asundexian (Bayer AG, Leverkusen, Germany), an oral small molecule factor XIa (FXIa) inhibitor, might prevent thrombosis without increasing bleeding. Asundexian's effect for secondary prevention of recurrent stroke is unknown.
442. A telemedicine model for abortion in South Africa: a randomised, controlled, non-inferiority trial.
作者: Margit Endler.;Gregory Petro.;Kristina Gemzell Danielsson.;Dan Grossman.;Rebecca Gomperts.;Maja Weinryb.;Deborah Constant.
来源: Lancet. 2022年400卷10353期670-679页
Telemedicine for medical abortion increases access to safe abortion but its use has not been described in a controlled trial. We aimed to investigate the effectiveness, adherence, safety, and acceptability of a modified telemedicine protocol for abortion compared with standard care in a low-resource setting.
443. Comparison of amitriptyline supplemented with pregabalin, pregabalin supplemented with amitriptyline, and duloxetine supplemented with pregabalin for the treatment of diabetic peripheral neuropathic pain (OPTION-DM): a multicentre, double-blind, randomised crossover trial.
作者: Solomon Tesfaye.;Gordon Sloan.;Jennifer Petrie.;David White.;Mike Bradburn.;Stephen Julious.;Satyan Rajbhandari.;Sanjeev Sharma.;Gerry Rayman.;Ravikanth Gouni.;Uazman Alam.;Cindy Cooper.;Amanda Loban.;Katie Sutherland.;Rachel Glover.;Simon Waterhouse.;Emily Turton.;Michelle Horspool.;Rajiv Gandhi.;Deirdre Maguire.;Edward B Jude.;Syed H Ahmed.;Prashanth Vas.;Christian Hariman.;Claire McDougall.;Marion Devers.;Vasileios Tsatlidis.;Martin Johnson.;Andrew S C Rice.;Didier Bouhassira.;David L Bennett.;Dinesh Selvarajah.; .
来源: Lancet. 2022年400卷10353期680-690页
Diabetic peripheral neuropathic pain (DPNP) is common and often distressing. Most guidelines recommend amitriptyline, duloxetine, pregabalin, or gabapentin as initial analgesic treatment for DPNP, but there is little comparative evidence on which one is best or whether they should be combined. We aimed to assess the efficacy and tolerability of different combinations of first-line drugs for treatment of DPNP.
444. Rehabilitation versus surgical reconstruction for non-acute anterior cruciate ligament injury (ACL SNNAP): a pragmatic randomised controlled trial.
作者: David J Beard.;Loretta Davies.;Jonathan A Cook.;Jamie Stokes.;Jose Leal.;Heidi Fletcher.;Simon Abram.;Katie Chegwin.;Akiko Greshon.;William Jackson.;Nicholas Bottomley.;Matt Dodd.;Henry Bourke.;Beverly A Shirkey.;Arsenio Paez.;Sarah E Lamb.;Karen Barker.;Michael Phillips.;Mark Brown.;Vanessa Lythe.;Burhan Mirza.;Andrew Carr.;Paul Monk.;Carlos Morgado Areia.;Sean O'Leary.;Fares Haddad.;Chris Wilson.;Andrew Price.; .
来源: Lancet. 2022年400卷10352期605-615页
Anterior cruciate ligament (ACL) rupture is a common debilitating injury that can cause instability of the knee. We aimed to investigate the best management strategy between reconstructive surgery and non-surgical treatment for patients with a non-acute ACL injury and persistent symptoms of instability.
445. Neonatal outcomes for women at risk of preterm delivery given half dose versus full dose of antenatal betamethasone: a randomised, multicentre, double-blind, placebo-controlled, non-inferiority trial.
作者: Thomas Schmitz.;Muriel Doret-Dion.;Loic Sentilhes.;Olivier Parant.;Olivier Claris.;Laurent Renesme.;Julie Abbal.;Aude Girault.;Héloïse Torchin.;Marie Houllier.;Nolwenn Le Saché.;Alexandre J Vivanti.;Daniele De Luca.;Norbert Winer.;Cyril Flamant.;Claire Thuillier.;Pascal Boileau.;Julie Blanc.;Véronique Brevaut.;Pierre-Emmanuel Bouet.;Géraldine Gascoin.;Gaël Beucher.;Valérie Datin-Dorriere.;Stéphane Bounan.;Pascal Bolot.;Christophe Poncelet.;Corinne Alberti.;Moreno Ursino.;Camille Aupiais.;Olivier Baud.; .; .
来源: Lancet. 2022年400卷10352期592-604页
Antenatal betamethasone is recommended before preterm delivery to accelerate fetal lung maturation. However, reports of growth and neurodevelopmental dose-related side-effects suggest that the current dose (12 mg plus 12 mg, 24 h apart) might be too high. We therefore investigated whether a half dose would be non-inferior to the current full dose for preventing respiratory distress syndrome.
446. Mepolizumab for urban children with exacerbation-prone eosinophilic asthma in the USA (MUPPITS-2): a randomised, double-blind, placebo-controlled, parallel-group trial.
作者: Daniel J Jackson.;Leonard B Bacharier.;Peter J Gergen.;Lisa Gagalis.;Agustin Calatroni.;Stephanie Wellford.;Michelle A Gill.;Jeffrey Stokes.;Andrew H Liu.;Rebecca S Gruchalla.;Robyn T Cohen.;Melanie Makhija.;Gurjit K Khurana Hershey.;George T O'Connor.;Jacqueline A Pongracic.;Michael G Sherenian.;Katherine Rivera-Spoljaric.;Edward M Zoratti.;Stephen J Teach.;Meyer Kattan.;Cullen M Dutmer.;Haejin Kim.;Carin Lamm.;William J Sheehan.;R Max Segnitz.;Kimberly A Dill-McFarland.;Cynthia M Visness.;Patrice M Becker.;James E Gern.;Christine A Sorkness.;William W Busse.;Matthew C Altman.; .
来源: Lancet. 2022年400卷10351期502-511页
Black and Hispanic children living in urban environments in the USA have an excess burden of morbidity and mortality from asthma. Therapies directed at the eosinophilic phenotype reduce asthma exacerbations in adults, but few data are available in children and diverse populations. Furthermore, the molecular mechanisms that underlie exacerbations either being prevented by, or persisting despite, immune-based therapies are not well understood. We aimed to determine whether mepolizumab, added to guidelines-based care, reduced the number of asthma exacerbations during a 52-week period compared with guidelines-based care alone.
447. Radiation doses and fractionation schedules in non-low-risk ductal carcinoma in situ in the breast (BIG 3-07/TROG 07.01): a randomised, factorial, multicentre, open-label, phase 3 study.
作者: Boon H Chua.;Emma K Link.;Ian H Kunkler.;Timothy J Whelan.;A Helen Westenberg.;Guenther Gruber.;Guy Bryant.;Verity Ahern.;Kash Purohit.;Peter H Graham.;Mohamed Akra.;Orla McArdle.;Peter O'Brien.;Jennifer A Harvey.;Carine Kirkove.;John H Maduro.;Ian D Campbell.;Geoff P Delaney.;Joseph D Martin.;T Trinh T Vu.;Thierry M Muanza.;Anthony Neal.;Ivo A Olivotto.; .
来源: Lancet. 2022年400卷10350期431-440页
Whole breast irradiation (WBI) after conservative surgery for ductal carcinoma in situ (DCIS) reduces local recurrence. We investigated whether a tumour bed boost after WBI improved outcomes, and examined radiation dose fractionation sensitivity for non-low-risk DCIS.
448. Upadacitinib for the treatment of active non-radiographic axial spondyloarthritis (SELECT-AXIS 2): a randomised, double-blind, placebo-controlled, phase 3 trial.
作者: Atul Deodhar.;Filip Van den Bosch.;Denis Poddubnyy.;Walter P Maksymowych.;Désirée van der Heijde.;Tae-Hwan Kim.;Mitsumasa Kishimoto.;Ricardo Blanco.;Yuanyuan Duan.;Yihan Li.;Aileen L Pangan.;Peter Wung.;In-Ho Song.
来源: Lancet. 2022年400卷10349期369-379页
Upadacitinib, a Janus kinase inhibitor, has been shown to be effective in patients with ankylosing spondylitis. We aimed to assess the efficacy and safety of upadacitinib in non-radiographic axial spondyloarthritis.
449. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial.
作者: Barham K Abu Dayyeh.;Fateh Bazerbachi.;Eric J Vargas.;Reem Z Sharaiha.;Christopher C Thompson.;Bradley C Thaemert.;Andre F Teixeira.;Christopher G Chapman.;Vivek Kumbhari.;Michael B Ujiki.;Jeanette Ahrens.;Courtney Day.; .;Manoel Galvao Neto.;Natan Zundel.;Erik B Wilson.
来源: Lancet. 2022年400卷10350期441-451页
Endoscopic sleeve gastroplasty (ESG) is an endolumenal, organ-sparing therapy for obesity, with wide global adoption. We aimed to explore the efficacy and safety of ESG with lifestyle modifications compared with lifestyle modifications alone.
450. Intervention with methotrexate in patients with arthralgia at risk of rheumatoid arthritis to reduce the development of persistent arthritis and its disease burden (TREAT EARLIER): a randomised, double-blind, placebo-controlled, proof-of-concept trial.
作者: Doortje I Krijbolder.;Marloes Verstappen.;Bastiaan T van Dijk.;Yousra J Dakkak.;Leonie E Burgers.;Aleid C Boer.;Yune Jung Park.;Marianne E de Witt-Luth.;Karen Visser.;Marc R Kok.;Esmeralda T H Molenaar.;Pascal H P de Jong.;Stefan Böhringer.;Tom W J Huizinga.;Cornelia F Allaart.;Ellis Niemantsverdriet.;Annette H M van der Helm-van Mil.
来源: Lancet. 2022年400卷10348期283-294页
Rheumatoid arthritis is the most common autoimmune disease worldwide and requires long-term treatment to suppress inflammation. Currently, treatment is started when arthritis is clinically apparent. We aimed to evaluate whether earlier intervention, in the preceding phase of arthralgia and subclinical joint inflammation, could prevent the development of clinical arthritis or reduce the disease burden.
451. Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: a randomised, double-blind, multicentre phase 3 trial.
作者: Kristian Reich.;Jacob P Thyssen.;Andrew Blauvelt.;Kilian Eyerich.;Weily Soong.;Zakiya P Rice.;H Chih-Ho Hong.;Norito Katoh.;Fernando Valenzuela.;Marco DiBonaventura.;Tamara A Bratt.;Fan Zhang.;Claire Clibborn.;Ricardo Rojo.;Hernan Valdez.;Urs Kerkmann.
来源: Lancet. 2022年400卷10348期273-282页
Phase 3 trials have assessed efficacy of abrocitinib versus placebo in moderate-to-severe atopic dermatitis, a common immunoinflammatory skin disease. This study assessed the efficacy and safety of abrocitinib versus dupilumab.
452. Long-term efficacy and safety of moderate-intensity statin with ezetimibe combination therapy versus high-intensity statin monotherapy in patients with atherosclerotic cardiovascular disease (RACING): a randomised, open-label, non-inferiority trial.
作者: Byeong-Keuk Kim.;Sung-Jin Hong.;Yong-Joon Lee.;Soon Jun Hong.;Kyeong Ho Yun.;Bum-Kee Hong.;Jung Ho Heo.;Seung-Woon Rha.;Yun-Hyeong Cho.;Seung-Jun Lee.;Chul-Min Ahn.;Jung-Sun Kim.;Young-Guk Ko.;Donghoon Choi.;Yangsoo Jang.;Myeong-Ki Hong.; .
来源: Lancet. 2022年400卷10349期380-390页
Drug combinations rather than increasing doses of one drug can achieve greater efficacy and lower risks. Thus, as an alternative to high-intensity statin monotherapy, moderate-intensity statin with ezetimibe combination therapy can lower LDL cholesterol concentrations effectively while reducing adverse effects. However, evidence from randomised trials to compare long-term clinical outcomes is needed.
453. Endovascular thrombectomy versus standard bridging thrombolytic with endovascular thrombectomy within 4·5 h of stroke onset: an open-label, blinded-endpoint, randomised non-inferiority trial.
作者: Peter J Mitchell.;Bernard Yan.;Leonid Churilov.;Richard J Dowling.;Steven J Bush.;Andrew Bivard.;Xiao Chuan Huo.;Guoqing Wang.;Shi Yong Zhang.;Mai Duy Ton.;Dennis J Cordato.;Timothy J Kleinig.;Henry Ma.;Ronil V Chandra.;Helen Brown.;Bruce C V Campbell.;Andrew K Cheung.;Brendan Steinfort.;Rebecca Scroop.;Kendal Redmond.;Ferdinand Miteff.;Yan Liu.;Dang Phuc Duc.;Hal Rice.;Mark W Parsons.;Teddy Y Wu.;Huy-Thang Nguyen.;Geoffrey A Donnan.;Zhong Rong Miao.;Stephen M Davis.; .
来源: Lancet. 2022年400卷10346期116-125页
The benefit of combined treatment with intravenous thrombolysis before endovascular thrombectomy in patients with acute ischaemic stroke caused by large vessel occlusion remains unclear. We hypothesised that the clinical outcomes of patients with stroke with large vessel occlusion treated with direct endovascular thrombectomy within 4·5 h would be non-inferior compared with the outcomes of those treated with standard bridging therapy (intravenous thrombolysis before endovascular thrombectomy).
454. Thrombectomy alone versus intravenous alteplase plus thrombectomy in patients with stroke: an open-label, blinded-outcome, randomised non-inferiority trial.
作者: Urs Fischer.;Johannes Kaesmacher.;Daniel Strbian.;Omer Eker.;Christoph Cognard.;Patricia S Plattner.;Lukas Bütikofer.;Pasquale Mordasini.;Sandro Deppeler.;Vitor M Pereira.;Jean François Albucher.;Jean Darcourt.;Romain Bourcier.;Guillon Benoit.;Chrysanthi Papagiannaki.;Ozlem Ozkul-Wermester.;Gerli Sibolt.;Marjaana Tiainen.;Benjamin Gory.;Sébastien Richard.;Jan Liman.;Marielle Sophie Ernst.;Marion Boulanger.;Charlotte Barbier.;Laura Mechtouff.;Liqun Zhang.;Gaultier Marnat.;Igor Sibon.;Omid Nikoubashman.;Arno Reich.;Arturo Consoli.;Bertrand Lapergue.;Marc Ribo.;Alejandro Tomasello.;Suzana Saleme.;Francisco Macian.;Solène Moulin.;Paolo Pagano.;Guillaume Saliou.;Emmanuel Carrera.;Kevin Janot.;María Hernández-Pérez.;Raoul Pop.;Lucie Della Schiava.;Andreas R Luft.;Michel Piotin.;Jean Christophe Gentric.;Aleksandra Pikula.;Waltraud Pfeilschifter.;Marcel Arnold.;Adnan H Siddiqui.;Michael T Froehler.;Anthony J Furlan.;René Chapot.;Martin Wiesmann.;Paolo Machi.;Hans-Christoph Diener.;Zsolt Kulcsar.;Leo H Bonati.;Claudio L Bassetti.;Mikael Mazighi.;David S Liebeskind.;Jeffrey L Saver.;Jan Gralla.; .
来源: Lancet. 2022年400卷10346期104-115页
Whether thrombectomy alone is equally as effective as intravenous alteplase plus thrombectomy remains controversial. We aimed to determine whether thrombectomy alone would be non-inferior to intravenous alteplase plus thrombectomy in patients presenting with acute ischaemic stroke.
455. Immobilisation of torus fractures of the wrist in children (FORCE): a randomised controlled equivalence trial in the UK.
作者: Daniel C Perry.;Juul Achten.;Ruth Knight.;Duncan Appelbe.;Susan J Dutton.;Melina Dritsaki.;James M Mason.;Damian T Roland.;Shrouk Messahel.;James Widnall.;Matthew L Costa.; .
来源: Lancet. 2022年400卷10345期39-47页
The most common fractures in children are torus (buckle) fractures of the wrist. Controversy exists over treatment, which ranges from splint immobilisation and discharge to cast immobilisation, follow-up, and repeat imaging. This study compared pain and function in affected children offered a soft bandage and immediate discharge with those receiving rigid immobilisation and follow-up as per treating centre protocol.
456. Intravenous tenecteplase compared with alteplase for acute ischaemic stroke in Canada (AcT): a pragmatic, multicentre, open-label, registry-linked, randomised, controlled, non-inferiority trial.
作者: Bijoy K Menon.;Brian H Buck.;Nishita Singh.;Yan Deschaintre.;Mohammed A Almekhlafi.;Shelagh B Coutts.;Sibi Thirunavukkarasu.;Houman Khosravani.;Ramana Appireddy.;Francois Moreau.;Gord Gubitz.;Aleksander Tkach.;Luciana Catanese.;Dar Dowlatshahi.;George Medvedev.;Jennifer Mandzia.;Aleksandra Pikula.;Jai Shankar.;Heather Williams.;Thalia S Field.;Alejandro Manosalva.;Muzaffar Siddiqui.;Atif Zafar.;Oje Imoukhuede.;Gary Hunter.;Andrew M Demchuk.;Sachin Mishra.;Laura C Gioia.;Shirin Jalini.;Caroline Cayer.;Stephen Phillips.;Elsadig Elamin.;Ashkan Shoamanesh.;Suresh Subramaniam.;Mahesh Kate.;Gregory Jacquin.;Marie-Christine Camden.;Faysal Benali.;Ibrahim Alhabli.;Fouzi Bala.;MacKenzie Horn.;Grant Stotts.;Michael D Hill.;David J Gladstone.;Alexandre Poppe.;Arshia Sehgal.;Qiao Zhang.;Brendan Cord Lethebe.;Craig Doram.;Ayoola Ademola.;Michel Shamy.;Carol Kenney.;Tolulope T Sajobi.;Richard H Swartz.; .
来源: Lancet. 2022年400卷10347期161-169页
Intravenous thrombolysis with alteplase bolus followed by infusion is a global standard of care for patients with acute ischaemic stroke. We aimed to determine whether tenecteplase given as a single bolus might increase reperfusion compared with this standard of care.
457. Early food intervention and skin emollients to prevent food allergy in young children (PreventADALL): a factorial, multicentre, cluster-randomised trial.
作者: Håvard Ove Skjerven.;Anine Lie.;Riyas Vettukattil.;Eva Maria Rehbinder.;Marissa LeBlanc.;Anna Asarnoj.;Kai-Håkon Carlsen.;Åshild Wik Despriee.;Martin Färdig.;Sabina Wärnberg Gerdin.;Berit Granum.;Hrefna Katrín Gudmundsdóttir.;Guttorm Haugen.;Gunilla Hedlin.;Geir Håland.;Christine Monceyron Jonassen.;Linn Landrø.;Caroline-Aleksi Olsson Mägi.;Inge Christoffer Olsen.;Knut Rudi.;Carina Madelen Saunders.;Marius Kurås Skram.;Anne Cathrine Staff.;Cilla Söderhäll.;Sandra G Tedner.;Sigve Aadalen.;Hilde Aaneland.;Björn Nordlund.;Karin C Lødrup Carlsen.
来源: Lancet. 2022年399卷10344期2398-2411页
Primary prevention of food allergy by early introduction of allergenic foods seems promising. We aimed to determine whether early food introduction or the application of regular skin emollients in infants from a general population reduced the risk of food allergy.
458. Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, randomised, phase 3 trial.
作者: Manali Kamdar.;Scott R Solomon.;Jon Arnason.;Patrick B Johnston.;Bertram Glass.;Veronika Bachanova.;Sami Ibrahimi.;Stephan Mielke.;Pim Mutsaers.;Francisco Hernandez-Ilizaliturri.;Koji Izutsu.;Franck Morschhauser.;Matthew Lunning.;David G Maloney.;Alessandro Crotta.;Sandrine Montheard.;Alessandro Previtali.;Lara Stepan.;Ken Ogasawara.;Timothy Mack.;Jeremy S Abramson.; .
来源: Lancet. 2022年399卷10343期2294-2308页
Patients with large B-cell lymphoma (LBCL) primary refractory to or relapsed within 12 months of first-line therapy are at high risk for poor outcomes with current standard of care, platinum-based salvage immunochemotherapy and autologous haematopoietic stem cell transplantation (HSCT). Lisocabtagene maraleucel (liso-cel), an autologous, CD19-directed chimeric antigen receptor (CAR) T-cell therapy, has previously demonstrated efficacy and manageable safety in third-line or later LBCL. In this Article, we report a prespecified interim analysis of liso-cel versus standard of care as second-line treatment for primary refractory or early relapsed (within 12 months after response to initial therapy) LBCL.
459. Once daily oral relugolix combination therapy versus placebo in patients with endometriosis-associated pain: two replicate phase 3, randomised, double-blind, studies (SPIRIT 1 and 2).
作者: Linda C Giudice.;Sawsan As-Sanie.;Juan C Arjona Ferreira.;Christian M Becker.;Mauricio S Abrao.;Bruce A Lessey.;Eric Brown.;Krzysztof Dynowski.;Krzysztof Wilk.;Yulan Li.;Vandana Mathur.;Qurratul Ann Warsi.;Rachel B Wagman.;Neil P Johnson.
来源: Lancet. 2022年399卷10343期2267-2279页
Endometriosis is a common cause of pelvic pain in women, for which current treatment options are suboptimal. Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, combined with estradiol and a progestin, was evaluated for treatment of endometriosis-associated pain.
460. Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in children aged 6-17 years: a preliminary report of COV006, a phase 2 single-blind, randomised, controlled trial.
作者: Grace Li.;Federica Cappuccini.;Natalie G Marchevsky.;Parvinder K Aley.;Robert Aley.;Rachel Anslow.;Sagida Bibi.;Katrina Cathie.;Elizabeth Clutterbuck.;Saul N Faust.;Shuo Feng.;Paul T Heath.;Simon Kerridge.;Alice Lelliott.;Yama Mujadidi.;Khuen Foong Ng.;Sarah Rhead.;Hannah Roberts.;Hannah Robinson.;Marion R Roderick.;Nisha Singh.;David Smith.;Matthew D Snape.;Rinn Song.;Karly Tang.;Andy Yao.;Xinxue Liu.;Teresa Lambe.;Andrew J Pollard.; .
来源: Lancet. 2022年399卷10342期2212-2225页
Vaccination of children and young people against SARS-CoV-2 is recommended in some countries. Scarce data have been published on immune responses induced by COVID-19 vaccines in people younger than 18 years compared with the same data that are available in adults.
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