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181. Pembrolizumab plus chemotherapy versus chemotherapy in untreated advanced pleural mesothelioma in Canada, Italy, and France: a phase 3, open-label, randomised controlled trial.
作者: Quincy Chu.;Francesco Perrone.;Laurent Greillier.;Wei Tu.;Maria Carmela Piccirillo.;Federica Grosso.;Giuseppe Lo Russo.;Marie Florescu.;Manlio Mencoboni.;Alessandro Morabito.;Fabiana Letizia Cecere.;Giovanni Luca Ceresoli.;David E Dawe.;Paolo Andrea Zucali.;Maria Pagano.;John R Goffin.;Myriam Locatelli Sanchez.;Cesare Gridelli.;Gerard Zalcman.;Xavier Quantin.;Virginie Westeel.;Piera Gargiulo.;Sara Delfanti.;Dongsheng Tu.;Christopher W Lee.;Natasha Leighl.;Joana Sederias.;Pamela Brown-Walker.;Yiwen Luo.;Sylvie Lantuejoul.;Ming-Sound Tsao.;Arnaud Scherpereel.;Penelope Bradbury.;Scott A Laurie.;Lesley Seymour.
来源: Lancet. 2023年402卷10419期2295-2306页
Pleural mesothelioma usually presents at an advanced, incurable stage. Chemotherapy with platinum-pemetrexed is a standard treatment. We hypothesised that the addition of pembrolizumab to platinum-pemetrexed would improve overall survival in patients with pleural mesothelioma.
182. Zibotentan in combination with dapagliflozin compared with dapagliflozin in patients with chronic kidney disease (ZENITH-CKD): a multicentre, randomised, active-controlled, phase 2b, clinical trial.
作者: Hiddo J L Heerspink.;Arihiro Kiyosue.;David C Wheeler.;Min Lin.;Emma Wijkmark.;Glenn Carlson.;Anne-Kristina Mercier.;Magnus Åstrand.;Sebastian Ueckert.;Peter J Greasley.;Phil Ambery.
来源: Lancet. 2023年402卷10416期2004-2017页
In patients with chronic kidney disease, SGLT2 inhibitors and endothelin A receptor antagonists (ERAs) can reduce albuminuria and glomerular filtration rate (GFR) decline. We assessed the albuminuria-lowering efficacy and safety of the ERA zibotentan combined with the SGLT2 inhibitor dapagliflozin.
183. Long-term outcomes with biodegradable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents in ST-segment elevation myocardial infarction: 5-year follow-up of the BIOSTEMI randomised superiority trial.
作者: Juan F Iglesias.;Marco Roffi.;Sylvain Losdat.;Olivier Muller.;Sophie Degrauwe.;David J Kurz.;Laurent Haegeli.;Daniel Weilenmann.;Christoph Kaiser.;Maxime Tapponnier.;Stéphane Cook.;Florim Cuculi.;Dik Heg.;Stephan Windecker.;Thomas Pilgrim.
来源: Lancet. 2023年402卷10416期1979-1990页
Biodegradable polymer sirolimus-eluting stents improve early stent-related clinical outcomes compared to durable polymer everolimus-eluting stents in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention. The long-term advantages of biodegradable polymer sirolimus-eluting stents after complete degradation of its polymer coating in patients with STEMI remains however uncertain.
184. Atezolizumab plus bevacizumab versus active surveillance in patients with resected or ablated high-risk hepatocellular carcinoma (IMbrave050): a randomised, open-label, multicentre, phase 3 trial.
作者: Shukui Qin.;Minshan Chen.;Ann-Lii Cheng.;Ahmed O Kaseb.;Masatoshi Kudo.;Han Chu Lee.;Adam C Yopp.;Jian Zhou.;Lu Wang.;Xiaoyu Wen.;Jeong Heo.;Won Young Tak.;Shinichiro Nakamura.;Kazushi Numata.;Thomas Uguen.;David Hsiehchen.;Edward Cha.;Stephen P Hack.;Qinshu Lian.;Ning Ma.;Jessica H Spahn.;Yulei Wang.;Chun Wu.;Pierce K H Chow.; .
来源: Lancet. 2023年402卷10415期1835-1847页
No adjuvant treatment has been established for patients who remain at high risk for hepatocellular carcinoma recurrence after curative-intent resection or ablation. We aimed to assess the efficacy of adjuvant atezolizumab plus bevacizumab versus active surveillance in patients with high-risk hepatocellular carcinoma.
185. Pembrolizumab plus trastuzumab and chemotherapy for HER2-positive gastric or gastro-oesophageal junction adenocarcinoma: interim analyses from the phase 3 KEYNOTE-811 randomised placebo-controlled trial.
作者: Yelena Y Janjigian.;Akihito Kawazoe.;Yuxian Bai.;Jianming Xu.;Sara Lonardi.;Jean Phillipe Metges.;Patricio Yanez.;Lucjan S Wyrwicz.;Lin Shen.;Yuriy Ostapenko.;Mehmet Bilici.;Hyun Cheol Chung.;Kohei Shitara.;Shu-Kui Qin.;Eric Van Cutsem.;Josep Tabernero.;Kan Li.;Chie-Schin Shih.;Pooja Bhagia.;Sun Young Rha.; .
来源: Lancet. 2023年402卷10418期2197-2208页
Evidence for the efficacy of combined PD-1 and HER2 blockade with chemotherapy on progression-free and overall survival in HER2-positive gastro-oesophageal cancer is scarce. The first interim analysis of the randomised, phase 3 KEYNOTE-811 study showed a superior objective response with pembrolizumab compared with placebo when added to trastuzumab plus fluoropyrimidine and platinum-based chemotherapy. Here, we report results from protocol-specified subsequent interim analyses of KEYNOTE-811.
186. Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials.
作者: Jeffrey S Heier.;Eleonora M Lad.;Frank G Holz.;Philip J Rosenfeld.;Robyn H Guymer.;David Boyer.;Federico Grossi.;Caroline R Baumal.;Jean-Francois Korobelnik.;Jason S Slakter.;Nadia K Waheed.;Ravi Metlapally.;Ian Pearce.;Nathan Steinle.;Anibal A Francone.;Allen Hu.;David R Lally.;Pascal Deschatelets.;Cedric Francois.;Caleb Bliss.;Giovanni Staurenghi.;Jordi Monés.;Rishi P Singh.;Ramiro Ribeiro.;Charles C Wykoff.; .
来源: Lancet. 2023年402卷10411期1434-1448页
Geographic atrophy is a leading cause of progressive, irreversible vision loss. The objectives of OAKS and DERBY were to assess the efficacy and safety of pegcetacoplan compared with sham treatment in patients with geographic atrophy.
187. Once-weekly insulin icodec versus once-daily insulin degludec as part of a basal-bolus regimen in individuals with type 1 diabetes (ONWARDS 6): a phase 3a, randomised, open-label, treat-to-target trial.
作者: David Russell-Jones.;Tetsuya Babazono.;Roman Cailleteau.;Susanne Engberg.;Concetta Irace.;Maiken Ina Siegismund Kjaersgaard.;Chantal Mathieu.;Julio Rosenstock.;Vincent Woo.;David C Klonoff.
来源: Lancet. 2023年402卷10413期1636-1647页
ONWARDS 6 compared the efficacy and safety of once-weekly subcutaneous insulin icodec (icodec) and once-daily insulin degludec (degludec) in adults with type 1 diabetes.
188. Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment in primary care (ATLANTIS): a randomised, double-blind, placebo-controlled, phase 3 trial.
作者: Alexander C Ford.;Alexandra Wright-Hughes.;Sarah L Alderson.;Pei-Loo Ow.;Matthew J Ridd.;Robbie Foy.;Gina Bianco.;Felicity L Bishop.;Matthew Chaddock.;Heather Cook.;Deborah Cooper.;Catherine Fernandez.;Elspeth A Guthrie.;Suzanne Hartley.;Amy Herbert.;Daniel Howdon.;Delia P Muir.;Taposhi Nath.;Sonia Newman.;Thomas Smith.;Christopher A Taylor.;Emma J Teasdale.;Ruth Thornton.;Amanda J Farrin.;Hazel A Everitt.; .
来源: Lancet. 2023年402卷10414期1773-1785页
Most patients with irritable bowel syndrome (IBS) are managed in primary care. When first-line therapies for IBS are ineffective, the UK National Institute for Health and Care Excellence guideline suggests considering low- dose tricyclic antidepressants as second-line treatment, but their effectiveness in primary care is unknown, and they are infrequently prescribed in this setting.
189. Methotrexate to treat hand osteoarthritis with synovitis (METHODS): an Australian, multisite, parallel-group, double-blind, randomised, placebo-controlled trial.
作者: Yuanyuan Wang.;Graeme Jones.;Helen I Keen.;Catherine L Hill.;Anita E Wluka.;Jessica Kasza.;Andrew J Teichtahl.;Benny Antony.;Richard O'Sullivan.;Flavia M Cicuttini.
来源: Lancet. 2023年402卷10414期1764-1772页
Hand osteoarthritis is a disabling condition with few effective therapies. Hand osteoarthritis with synovitis is a common inflammatory phenotype associated with pain. We aimed to examine the efficacy and safety of methotrexate at 6 months in participants with hand osteoarthritis and synovitis.
190. Endovascular thrombectomy for acute ischaemic stroke with established large infarct: multicentre, open-label, randomised trial.
作者: Martin Bendszus.;Jens Fiehler.;Fabien Subtil.;Susanne Bonekamp.;Anne Hege Aamodt.;Blanca Fuentes.;Elke R Gizewski.;Michael D Hill.;Antonin Krajina.;Laurent Pierot.;Claus Z Simonsen.;Kamil Zeleňák.;Rolf A Blauenfeldt.;Bastian Cheng.;Angélique Denis.;Hannes Deutschmann.;Franziska Dorn.;Fabian Flottmann.;Susanne Gellißen.;Johannes C Gerber.;Mayank Goyal.;Jozef Haring.;Christian Herweh.;Silke Hopf-Jensen.;Vi Tuan Hua.;Märit Jensen.;Andreas Kastrup.;Christiane Fee Keil.;Andrej Klepanec.;Egon Kurča.;Ronni Mikkelsen.;Markus Möhlenbruch.;Stefan Müller-Hülsbeck.;Nico Münnich.;Paolo Pagano.;Panagiotis Papanagiotou.;Gabor C Petzold.;Mirko Pham.;Volker Puetz.;Jan Raupach.;Gernot Reimann.;Peter Arthur Ringleb.;Maximilian Schell.;Eckhard Schlemm.;Silvia Schönenberger.;Bjørn Tennøe.;Christian Ulfert.;Kateřina Vališ.;Eva Vítková.;Dominik F Vollherbst.;Wolfgang Wick.;Götz Thomalla.; .
来源: Lancet. 2023年402卷10414期1753-1763页
Recent evidence suggests a beneficial effect of endovascular thrombectomy in acute ischaemic stroke with large infarct; however, previous trials have relied on multimodal brain imaging, whereas non-contrast CT is mostly used in clinical practice.
191. Integrated management of HIV, diabetes, and hypertension in sub-Saharan Africa (INTE-AFRICA): a pragmatic cluster-randomised, controlled trial.
作者: Sokoine Kivuyo.;Josephine Birungi.;Joseph Okebe.;Duolao Wang.;Kaushik Ramaiya.;Samafilan Ainan.;Faith Tumuhairwe.;Simple Ouma.;Ivan Namakoola.;Anupam Garrib.;Erik van Widenfelt.;Gerald Mutungi.;Gerard Abou Jaoude.;Neha Batura.;Joshua Musinguzi.;Mina Nakawuka Ssali.;Bernard Michael Etukoit.;Kenneth Mugisha.;Meshack Shimwela.;Omary Said Ubuguyu.;Abel Makubi.;Caroline Jeffery.;Stephen Watiti.;Jolene Skordis.;Luis Cuevas.;Nelson K Sewankambo.;Geoff Gill.;Anne Katahoire.;Peter G Smith.;Max Bachmann.;Jeffrey V Lazarus.;Sayoki Mfinanga.;Moffat J Nyirenda.;Shabbar Jaffar.; .
来源: Lancet. 2023年402卷10409期1241-1250页
In sub-Saharan Africa, health-care provision for chronic conditions is fragmented. The aim of this study was to determine whether integrated management of HIV, diabetes, and hypertension led to improved rates of retention in care for people with diabetes or hypertension without adversely affecting rates of HIV viral suppression among people with HIV when compared to standard vertical care in medium and large health facilities in Uganda and Tanzania.
192. Efficacy and safety of the neonatal Fc receptor inhibitor efgartigimod in adults with primary immune thrombocytopenia (ADVANCE IV): a multicentre, randomised, placebo-controlled, phase 3 trial.
作者: Catherine M Broome.;Vickie McDonald.;Yoshitaka Miyakawa.;Monica Carpenedo.;David J Kuter.;Hanny Al-Samkari.;James B Bussel.;Marie Godar.;Jaume Ayguasanosa.;Kristof De Beuf.;Francesco Rodeghiero.;Marc Michel.;Adrian Newland.; .
来源: Lancet. 2023年402卷10413期1648-1659页
Primary immune thrombocytopenia is an autoimmune disorder mediated partly by platelet autoantibodies, resulting in thrombocytopenia, bleeding, and constitutional symptoms. Efgartigimod, a first-in-class novel human IgG1 Fc fragment, binds the neonatal Fc receptor with high affinity and thus reduces serum IgG concentrations, including autoantibodies. The objective of this study was to evaluate the efficacy and safety of efgartigimod in adults with persistent and chronic primary immune thrombocytopenia.
193. Efficacy and safety of subcutaneous spesolimab for the prevention of generalised pustular psoriasis flares (Effisayil 2): an international, multicentre, randomised, placebo-controlled trial.
作者: Akimichi Morita.;Bruce Strober.;A David Burden.;Siew Eng Choon.;Milan J Anadkat.;Slaheddine Marrakchi.;Tsen-Fang Tsai.;Kenneth B Gordon.;Diamant Thaçi.;Min Zheng.;Na Hu.;Thomas Haeufel.;Christian Thoma.;Mark G Lebwohl.
来源: Lancet. 2023年402卷10412期1541-1551页
Spesolimab is an anti-interleukin-36 receptor monoclonal antibody approved to treat generalised pustular psoriasis (GPP) flares. We aimed to assess the efficacy and safety of spesolimab for GPP flare prevention.
194. Role of preoperative in-hospital delay on appendiceal perforation while awaiting appendicectomy (PERFECT): a Nordic, pragmatic, open-label, multicentre, non-inferiority, randomised controlled trial.
作者: Karoliina Jalava.;Ville Sallinen.;Hanna Lampela.;Hanna Malmi.;Ingeborg Steinholt.;Knut Magne Augestad.;Ari Leppäniemi.;Panu Mentula.
来源: Lancet. 2023年402卷10412期1552-1561页
Appendicectomy remains the standard treatment for appendicitis. No international consensus exists on the surgical urgency for acute uncomplicated appendicitis, and recommendations vary from surgery without delay to surgery within 24 h. Longer in-hospital delay has been thought to increase the risk of perforation and further morbidity. Therefore, we aimed to compare the rate of appendiceal perforation in patients undergoing appendicectomy scheduled to two different urgencies (<8 h vs <24 h).
195. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial.
作者: Zev A Wainberg.;Davide Melisi.;Teresa Macarulla.;Roberto Pazo Cid.;Sreenivasa R Chandana.;Christelle De La Fouchardière.;Andrew Dean.;Igor Kiss.;Woo Jin Lee.;Thorsten O Goetze.;Eric Van Cutsem.;A Scott Paulson.;Tanios Bekaii-Saab.;Shubham Pant.;Richard A Hubner.;Zhimin Xiao.;Huanyu Chen.;Fawzi Benzaghou.;Eileen M O'Reilly.
来源: Lancet. 2023年402卷10409期1272-1281页
Pancreatic ductal adenocarcinoma remains one of the most lethal malignancies, with few treatment options. NAPOLI 3 aimed to compare the efficacy and safety of NALIRIFOX versus nab-paclitaxel and gemcitabine as first-line therapy for metastatic pancreatic ductal adenocarcinoma (mPDAC).
196. Expedited transfer to a cardiac arrest centre for non-ST-elevation out-of-hospital cardiac arrest (ARREST): a UK prospective, multicentre, parallel, randomised clinical trial.
作者: Tiffany Patterson.;Gavin D Perkins.;Alexander Perkins.;Tim Clayton.;Richard Evans.;Matthew Dodd.;Steven Robertson.;Karen Wilson.;Adam Mellett-Smith.;Rachael T Fothergill.;Paul McCrone.;Miles Dalby.;Philip MacCarthy.;Sam Firoozi.;Iqbal Malik.;Roby Rakhit.;Ajay Jain.;Jerry P Nolan.;Simon R Redwood.; .
来源: Lancet. 2023年402卷10410期1329-1337页
The International Liaison Committee on Resuscitation has called for a randomised trial of delivery to a cardiac arrest centre. We aimed to assess whether expedited delivery to a cardiac arrest centre compared with current standard of care following resuscitated cardiac arrest reduces deaths.
197. Effect of colchicine on perioperative atrial fibrillation and myocardial injury after non-cardiac surgery in patients undergoing major thoracic surgery (COP-AF): an international randomised trial.
作者: David Conen.;Michael Ke Wang.;Ekaterine Popova.;Matthew T V Chan.;Giovanni Landoni.;Juan P Cata.;Cara Reimer.;Sean R McLean.;Sadeesh K Srinathan.;Juan Carlos Trujillo Reyes.;Ascension Martín Grande.;Anna Gonzalez Tallada.;Daniel I Sessler.;Edith Fleischmann.;Barbara Kabon.;Luca Voltolini.;Patrícia Cruz.;Donna E Maziak.;Laura Gutiérrez-Soriano.;William F McIntyre.;Vikas Tandon.;Elisabeth Martínez-Téllez.;Juan Jose Guerra-Londono.;Deborah DuMerton.;Randolph H L Wong.;Anna L McGuire.;Biniam Kidane.;Diego Parise Roux.;Yaron Shargall.;Jennifer R Wells.;Sandra N Ofori.;Jessica Vincent.;Lizhen Xu.;Zhuoru Li.;John W Eikelboom.;Sanjit S Jolly.;Jeff S Healey.;P J Devereaux.; .
来源: Lancet. 2023年402卷10413期1627-1635页
Higher levels of inflammatory biomarkers are associated with an increased risk of perioperative atrial fibrillation and myocardial injury after non-cardiac surgery (MINS). Colchicine is an anti-inflammatory drug that might reduce the incidence of these complications.
198. Adaptive versus conventional cardiac resynchronisation therapy in patients with heart failure (AdaptResponse): a global, prospective, randomised controlled trial.
作者: Bruce L Wilkoff.;Gerasimos Filippatos.;Christophe Leclercq.;Michael R Gold.;Ahmad S Hersi.;Kengo Kusano.;Wilfried Mullens.;G Michael Felker.;Charan Kantipudi.;Mikhael F El-Chami.;Vidal Essebag.;Bertrand Pierre.;Francois Philippon.;Francisco Perez-Gil.;Eugene S Chung.;Juan Sotomonte.;Stanley Tung.;Balbir Singh.;Babak Bozorgnia.;Satish Goel.;Hans Holger Ebert.;Niraj Varma.;Kara J Quan.;Fiorella Salerno.;Bart Gerritse.;Janelle van Wel.;Daniel E Schaber.;Dedra H Fagan.;David Birnie.; .
来源: Lancet. 2023年402卷10408期1147-1157页
Continuous automatic optimisation of cardiac resynchronisation therapy (CRT), stimulating only the left ventricle to fuse with intrinsic right bundle conduction (synchronised left ventricular stimulation), might offer better outcomes than conventional CRT in patients with heart failure, left bundle branch block, and normal atrioventricular conduction. This study aimed to compare clinical outcomes of adaptive CRT versus conventional CRT in patients with heart failure with intact atrioventricular conduction and left bundle branch block.
199. Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial.
作者: Hope S Rugo.;Aditya Bardia.;Frederik Marmé.;Javier Cortés.;Peter Schmid.;Delphine Loirat.;Olivier Trédan.;Eva Ciruelos.;Florence Dalenc.;Patricia Gómez Pardo.;Komal L Jhaveri.;Rosemary Delaney.;Theresa Valdez.;Hao Wang.;Monica Motwani.;Oh Kyu Yoon.;Wendy Verret.;Sara M Tolaney.
来源: Lancet. 2023年402卷10411期1423-1433页
Sacituzumab govitecan demonstrated significant progression-free survival benefit over chemotherapy in the phase 3 TROPiCS-02 trial in patients with pretreated, endocrine-resistant hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+ and HER2-) metastatic breast cancer with limited treatment options. Here, we report the protocol-specified final analysis of overall survival and endpoints by trophoblast cell-surface antigen 2 (Trop-2) expression and other variables.
200. Oral emergency contraception with levonorgestrel plus piroxicam: a randomised double-blind placebo-controlled trial.
作者: Raymond Hang Wun Li.;Sue Seen Tsing Lo.;Kristina Gemzell-Danielsson.;Carol Ho Yi Fong.;Pak Chung Ho.;Ernest Hung Yu Ng.
来源: Lancet. 2023年402卷10405期851-858页
Levonorgestrel, a standard drug for emergency contraception (EC), is not effective if administered post-ovulation. A cyclo-oxygenase inhibitor could contribute synergistic effects. We investigated whether a single 40 mg oral dose of piroxicam as co-treatment with levonorgestrel improved emergency contraceptive efficacy.
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