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481. Effectiveness and cost-effectiveness against malaria of three types of dual-active-ingredient long-lasting insecticidal nets (LLINs) compared with pyrethroid-only LLINs in Tanzania: a four-arm, cluster-randomised trial.
作者: Jacklin F Mosha.;Manisha A Kulkarni.;Eliud Lukole.;Nancy S Matowo.;Catherine Pitt.;Louisa A Messenger.;Elizabeth Mallya.;Mohamed Jumanne.;Tatu Aziz.;Robert Kaaya.;Boniface A Shirima.;Gladness Isaya.;Monica Taljaard.;Jacklin Martin.;Ramadhan Hashim.;Charles Thickstun.;Alphaxard Manjurano.;Immo Kleinschmidt.;Franklin W Mosha.;Mark Rowland.;Natacha Protopopoff.
来源: Lancet. 2022年399卷10331期1227-1241页
Long-lasting insecticidal nets (LLINs) have successfully reduced malaria in sub-Saharan Africa, but their effectiveness is now partly compromised by widespread resistance to insecticides among vectors. We evaluated new classes of LLINs with two active ingredients with differing modes of action against resistant malaria vectors.
482. The effect of two midwives during the second stage of labour to reduce severe perineal trauma (Oneplus): a multicentre, randomised controlled trial in Sweden.
作者: Malin Edqvist.;Hannah G Dahlen.;Cecilia Häggsgård.;Helena Tern.;Karin Ängeby.;Pia Teleman.;Gunilla Ajne.;Christine Rubertsson.
来源: Lancet. 2022年399卷10331期1242-1253页
Severe perineal trauma (SPT) affecting the anal sphincter muscle complex is a serious complication following childbirth, associated with short-term and long-term maternal morbidity. Effective preventive strategies are still scarce. The aim of the Oneplus trial was to test the hypothesis that the presence of a second midwife during the second stage of labour, with the purpose of preventing SPT, would result in fewer injuries affecting the anal sphincter than if attended by one midwife.
483. Repeated intravenous cardiosphere-derived cell therapy in late-stage Duchenne muscular dystrophy (HOPE-2): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.
作者: Craig M McDonald.;Eduardo Marbán.;Suzanne Hendrix.;Nathaniel Hogan.;Rachel Ruckdeschel Smith.;Michelle Eagle.;Richard S Finkel.;Cuixia Tian.;Joanne Janas.;Matthew M Harmelink.;Arun S Varadhachary.;Michael D Taylor.;Kan N Hor.;Oscar H Mayer.;Erik K Henricson.;Pat Furlong.;Deborah D Ascheim.;Siegfried Rogy.;Paula Williams.;Linda Marbán.; .
来源: Lancet. 2022年399卷10329期1049-1058页
Cardiosphere-derived cells (CDCs) ameliorate skeletal and cardiac muscle deterioration in experimental models of Duchenne muscular dystrophy. The HOPE-2 trial examined the safety and efficacy of sequential intravenous infusions of human allogeneic CDCs in late-stage Duchenne muscular dystrophy.
484. Efficacy and safety of gefapixant, a P2X3 receptor antagonist, in refractory chronic cough and unexplained chronic cough (COUGH-1 and COUGH-2): results from two double-blind, randomised, parallel-group, placebo-controlled, phase 3 trials.
作者: Lorcan P McGarvey.;Surinder S Birring.;Alyn H Morice.;Peter V Dicpinigaitis.;Ian D Pavord.;Jonathan Schelfhout.;Allison Martin Nguyen.;Qing Li.;Anjela Tzontcheva.;Beata Iskold.;Stuart A Green.;Carmen La Rosa.;David R Muccino.;Jaclyn A Smith.; .
来源: Lancet. 2022年399卷10328期909-923页
Gefapixant is an oral P2X3 receptor antagonist that has previously shown efficacy and safety in refractory chronic cough and unexplained chronic cough. We therefore aim to confirm the efficacy and safety of gefapixant in participants with refractory chronic cough and unexplained chronic cough.
485. Safety and efficacy of aspirin, unfractionated heparin, both, or neither during endovascular stroke treatment (MR CLEAN-MED): an open-label, multicentre, randomised controlled trial.
作者: Wouter van der Steen.;Rob A van de Graaf.;Vicky Chalos.;Hester F Lingsma.;Pieter Jan van Doormaal.;Jonathan M Coutinho.;Bart J Emmer.;Inger de Ridder.;Wim van Zwam.;H Bart van der Worp.;Irene van der Schaaf.;Rob A R Gons.;Lonneke S F Yo.;Jelis Boiten.;Ido van den Wijngaard.;Jeannette Hofmeijer.;Jasper Martens.;Wouter Schonewille.;Jan Albert Vos.;Anil Man Tuladhar.;Karlijn F de Laat.;Boudewijn van Hasselt.;Michel Remmers.;Douwe Vos.;Anouk Rozeman.;Otto Elgersma.;Maarten Uyttenboogaart.;Reinoud P H Bokkers.;Julia van Tuijl.;Issam Boukrab.;René van den Berg.;Ludo F M Beenen.;Stefan D Roosendaal.;Alida Annechien Postma.;Menno Krietemeijer.;Geert Lycklama.;Frederick J A Meijer.;Sebastiaan Hammer.;Anouk van der Hoorn.;Albert J Yoo.;Dick Gerrits.;Martine T B Truijman.;Sanne Zinkstok.;Peter J Koudstaal.;Sanne Manschot.;Henk Kerkhoff.;Daan Nieboer.;Olvert Berkhemer.;Lennard Wolff.;P Matthijs van der Sluijs.;Henk van Voorst.;Manon Tolhuisen.;Yvo B W E M Roos.;Charles B L M Majoie.;Julie Staals.;Robert J van Oostenbrugge.;Sjoerd F M Jenniskens.;Lukas C van Dijk.;Heleen M den Hertog.;Adriaan C G M van Es.;Aad van der Lugt.;Diederik W J Dippel.;Bob Roozenbeek.; .
来源: Lancet. 2022年399卷10329期1059-1069页
Aspirin and unfractionated heparin are often used during endovascular stroke treatment to improve reperfusion and outcomes. However, the effects and risks of anti-thrombotics for this indication are unknown. We therefore aimed to assess the safety and efficacy of intravenous aspirin, unfractionated heparin, both, or neither started during endovascular treatment in patients with ischaemic stroke.
486. Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.
Casirivimab and imdevimab are non-competing monoclonal antibodies that bind to two different sites on the receptor binding domain of the SARS-CoV-2 spike glycoprotein, blocking viral entry into host cells. We aimed to evaluate the efficacy and safety of casirivimab and imdevimab administered in combination in patients admitted to hospital with COVID-19.
487. Trametinib versus standard of care in patients with recurrent low-grade serous ovarian cancer (GOG 281/LOGS): an international, randomised, open-label, multicentre, phase 2/3 trial.
作者: David M Gershenson.;Austin Miller.;William E Brady.;James Paul.;Karen Carty.;William Rodgers.;David Millan.;Robert L Coleman.;Kathleen N Moore.;Susana Banerjee.;Kate Connolly.;Angeles Alvarez Secord.;David M O'Malley.;Oliver Dorigo.;Stephanie Gaillard.;Hani Gabra.;Brian Slomovitz.;Parviz Hanjani.;John Farley.;Michael Churchman.;Ailith Ewing.;Robert L Hollis.;C Simon Herrington.;Helen Q Huang.;Lari Wenzel.;Charlie Gourley.
来源: Lancet. 2022年399卷10324期541-553页
Low-grade serous carcinoma of the ovary or peritoneum is characterised by MAPK pathway aberrations and its reduced sensitivity to chemotherapy relative to high-grade serous carcinoma. We compared the MEK inhibitor trametinib to physician's choice standard of care in patients with recurrent low-grade serous carcinoma.
488. Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial.
Passive immunotherapy using hyperimmune intravenous immunoglobulin (hIVIG) to SARS-CoV-2, derived from recovered donors, is a potential rapidly available, specific therapy for an outbreak infection such as SARS-CoV-2. Findings from randomised clinical trials of hIVIG for the treatment of COVID-19 are limited.
489. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials.
作者: Charles C Wykoff.;Francis Abreu.;Anthony P Adamis.;Karen Basu.;David A Eichenbaum.;Zdenka Haskova.;Hugh Lin.;Anat Loewenstein.;Shaun Mohan.;Ian A Pearce.;Taiji Sakamoto.;Patricio G Schlottmann.;David Silverman.;Jennifer K Sun.;John A Wells.;Jeffrey R Willis.;Ramin Tadayoni.; .
来源: Lancet. 2022年399卷10326期741-755页
To reduce treatment burden and optimise patient outcomes in diabetic macular oedema, we present 1-year results from two phase 3 trials of faricimab, a novel angiopoietin-2 and vascular endothelial growth factor-A bispecific antibody.
490. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials.
作者: Jeffrey S Heier.;Arshad M Khanani.;Carlos Quezada Ruiz.;Karen Basu.;Philip J Ferrone.;Christopher Brittain.;Marta S Figueroa.;Hugh Lin.;Frank G Holz.;Vaibhavi Patel.;Timothy Y Y Lai.;David Silverman.;Carl Regillo.;Balakumar Swaminathan.;Francesco Viola.;Chui Ming Gemmy Cheung.;Tien Y Wong.; .
来源: Lancet. 2022年399卷10326期729-740页
Faricimab is a bispecific antibody that acts through dual inhibition of both angiopoietin-2 and vascular endothelial growth factor A. We report primary results of two phase 3 trials evaluating intravitreal faricimab with extension up to every 16 weeks for neovascular age-related macular degeneration (nAMD).
491. Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study.
作者: Sue Ann Costa Clemens.;Lily Weckx.;Ralf Clemens.;Ana Verena Almeida Mendes.;Alessandra Ramos Souza.;Mariana B V Silveira.;Suzete Nascimento Farias da Guarda.;Maristela Miyamoto de Nobrega.;Maria Isabel de Moraes Pinto.;Isabela G S Gonzalez.;Natalia Salvador.;Marilia Miranda Franco.;Renata Navis de Avila Mendonça.;Isabelle Silva Queiroz Oliveira.;Bruno Solano de Freitas Souza.;Mayara Fraga.;Parvinder Aley.;Sagida Bibi.;Liberty Cantrell.;Wanwisa Dejnirattisai.;Xinxue Liu.;Juthathip Mongkolsapaya.;Piyada Supasa.;Gavin R Screaton.;Teresa Lambe.;Merryn Voysey.;Andrew J Pollard.; .
来源: Lancet. 2022年399卷10324期521-529页
The inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac, Sinovac) has been widely used in a two-dose schedule. We assessed whether a third dose of the homologous or a different vaccine could boost immune responses.
492. An educational programme in neonatal intensive care units (SEPREVEN): a stepped-wedge, cluster-randomised controlled trial.
作者: Laurence Caeymaex.;Dominique Astruc.;Valérie Biran.;Leila Marcus.;Florence Flamein.;Stephane Le Bouedec.;Bernard Guillois.;Radia Remichi.;Faiza Harbi.;Xavier Durrmeyer.;Florence Casagrande.;Nolwenn Le Saché.;Darina Todorova.;Ali Bilal.;Damien Olivier.;Audrey Reynaud.;Cécile Jacquin.;Jean-Christophe Rozé.;Richard Layese.;Claude Danan.;Camille Jung.;Fabrice Decobert.;Etienne Audureau.
来源: Lancet. 2022年399卷10322期384-392页
Patients in neonatal intensive care units (NICUs) are at high risk of adverse events. The effects of medical and paramedical education programmes to reduce these have not yet been assessed.
493. Efficacy and safety of oral immunotherapy in children aged 1-3 years with peanut allergy (the Immune Tolerance Network IMPACT trial): a randomised placebo-controlled study.
作者: Stacie M Jones.;Edwin H Kim.;Kari C Nadeau.;Anna Nowak-Wegrzyn.;Robert A Wood.;Hugh A Sampson.;Amy M Scurlock.;Sharon Chinthrajah.;Julie Wang.;Robert D Pesek.;Sayantani B Sindher.;Mike Kulis.;Jacqueline Johnson.;Katharine Spain.;Denise C Babineau.;Hyunsook Chin.;Joy Laurienzo-Panza.;Rachel Yan.;David Larson.;Tielin Qin.;Don Whitehouse.;Michelle L Sever.;Srinath Sanda.;Marshall Plaut.;Lisa M Wheatley.;A Wesley Burks.; .
来源: Lancet. 2022年399卷10322期359-371页
For young children with peanut allergy, dietary avoidance is the current standard of care. We aimed to assess whether peanut oral immunotherapy can induce desensitisation (an increased allergic reaction threshold while on therapy) or remission (a state of non-responsiveness after discontinuation of immunotherapy) in this population.
494. Efficacy of the adjuvanted subunit protein COVID-19 vaccine, SCB-2019: a phase 2 and 3 multicentre, double-blind, randomised, placebo-controlled trial.
作者: Lulu Bravo.;Igor Smolenov.;Htay Htay Han.;Ping Li.;Romana Hosain.;Frank Rockhold.;Sue Ann Costa Clemens.;Camilo Roa.;Charissa Borja-Tabora.;Antoinette Quinsaat.;Pio Lopez.;Eduardo López-Medina.;Leonardo Brochado.;Eder A Hernández.;Humberto Reynales.;Tatiana Medina.;Hector Velasquez.;Leonardo Bautista Toloza.;Edith Johana Rodriguez.;Dora Ines Molina de Salazar.;Camilo A Rodríguez.;Eduardo Sprinz.;José Cerbino-Neto.;Kleber Giovanni Luz.;Alexandre Vargas Schwarzbold.;Maria Sanali Paiva.;Josefina Carlos.;May Emmeline B Montellano.;Mari Rose A de Los Reyes.;Charles Y Yu.;Edison R Alberto.;Mario M Panaligan.;Milagros Salvani-Bautista.;Erik Buntinx.;Maya Hites.;Jean-Benoit Martinot.;Qasim E Bhorat.;Aysha Badat.;Carmen Baccarini.;Branda Hu.;Jaco Jurgens.;Jan Engelbrecht.;Donna Ambrosino.;Peter Richmond.;George Siber.;Joshua Liang.;Ralf Clemens.
来源: Lancet. 2022年399卷10323期461-472页
A range of safe and effective vaccines against SARS CoV 2 are needed to address the COVID 19 pandemic. We aimed to assess the safety and efficacy of the COVID-19 vaccine SCB-2019.
495. A three-step support strategy for relatives of patients dying in the intensive care unit: a cluster randomised trial.
作者: Nancy Kentish-Barnes.;Sylvie Chevret.;Sandrine Valade.;Samir Jaber.;Lionel Kerhuel.;Olivier Guisset.;Maëlle Martin.;Amélie Mazaud.;Laurent Papazian.;Laurent Argaud.;Alexandre Demoule.;David Schnell.;Eddy Lebas.;Frédéric Ethuin.;Emmanuelle Hammad.;Sybille Merceron.;Juliette Audibert.;Clarisse Blayau.;Pierre-Yves Delannoy.;Alexandre Lautrette.;Olivier Lesieur.;Anne Renault.;Danielle Reuter.;Nicolas Terzi.;Bénédicte Philippon-Jouve.;Maud Fiancette.;Michel Ramakers.;Jean-Philippe Rigaud.;Virginie Souppart.;Karim Asehnoune.;Benoît Champigneulle.;Dany Goldgran-Toledano.;Jean-Louis Dubost.;Pierre-Edouard Bollaert.;Renaud Chouquer.;Frédéric Pochard.;Alain Cariou.;Elie Azoulay.
来源: Lancet. 2022年399卷10325期656-664页
In relatives of patients dying in intensive care units (ICUs), inadequate team support can increase the prevalence of prolonged grief and other psychological harm. We aimed to evaluate whether a proactive communication and support intervention would improve relatives' outcomes.
496. Final efficacy analysis, interim safety analysis, and immunogenicity of a single dose of recombinant novel coronavirus vaccine (adenovirus type 5 vector) in adults 18 years and older: an international, multicentre, randomised, double-blinded, placebo-controlled phase 3 trial.
作者: Scott A Halperin.;Lingyun Ye.;Donna MacKinnon-Cameron.;Bruce Smith.;Pedro E Cahn.;Guillermo M Ruiz-Palacios.;Aamer Ikram.;Fernando Lanas.;M Lourdes Guerrero.;Sergio Raúl Muñoz Navarro.;Omar Sued.;Dmitry A Lioznov.;Vitalina Dzutseva.;Ghazala Parveen.;Fengcai Zhu.;Laura Leppan.;Joanne M Langley.;Luis Barreto.;Jinbo Gou.;Tao Zhu.; .
来源: Lancet. 2022年399卷10321期237-248页
The Ad5-nCoV vaccine is a single-dose adenovirus type 5 (Ad5) vectored vaccine expressing the SARS-CoV-2 spike protein that was well-tolerated and immunogenic in phase 1 and 2 studies. In this study, we report results on the final efficacy and interim safety analyses of the phase 3 trial.
497. Rivaroxaban versus no anticoagulation for post-discharge thromboprophylaxis after hospitalisation for COVID-19 (MICHELLE): an open-label, multicentre, randomised, controlled trial.
作者: Eduardo Ramacciotti.;Leandro Barile Agati.;Daniela Calderaro.;Valéria Cristina Resende Aguiar.;Alex C Spyropoulos.;Caroline Candida Carvalho de Oliveira.;Jessica Lins Dos Santos.;Giuliano Giova Volpiani.;Marcone Lima Sobreira.;Edwaldo Edner Joviliano.;Milton Sérgio Bohatch Júnior.;Benedito Antônio Lopes da Fonseca.;Maurício Serra Ribeiro.;Cesar Dusilek.;Kengi Itinose.;Suzanna Maria Viana Sanches.;Karine de Almeida Araujo Ramos.;Nara Franzin de Moraes.;Paulo Fernando Guimarães Morando Marzocchi Tierno.;André Luiz Malavasi Longo de Oliveira.;Adriano Tachibana.;Rodrigo Caruso Chate.;Marcus Vinícius Barbosa Santos.;Bruno Bezerra de Menezes Cavalcante.;Ricardo Cesar Rocha Moreira.;Chiann Chang.;Alfonso Tafur.;Jawed Fareed.;Renato D Lopes.; .
来源: Lancet. 2022年399卷10319期50-59页
Patients hospitalised with COVID-19 are at risk for thrombotic events after discharge; the role of extended thromboprophylaxis in this population is unknown.
498. Immunogenicity, safety, and reactogenicity of heterologous COVID-19 primary vaccination incorporating mRNA, viral-vector, and protein-adjuvant vaccines in the UK (Com-COV2): a single-blind, randomised, phase 2, non-inferiority trial.
作者: Arabella S V Stuart.;Robert H Shaw.;Xinxue Liu.;Melanie Greenland.;Parvinder K Aley.;Nick J Andrews.;J C Cameron.;Sue Charlton.;Elizabeth A Clutterbuck.;Andrea M Collins.;Tom Darton.;Tanya Dinesh.;Christopher J A Duncan.;Anna England.;Saul N Faust.;Daniela M Ferreira.;Adam Finn.;Anna L Goodman.;Christopher A Green.;Bassam Hallis.;Paul T Heath.;Helen Hill.;Bryn M Horsington.;Teresa Lambe.;Rajeka Lazarus.;Vincenzo Libri.;Patrick J Lillie.;Yama F Mujadidi.;Ruth Payne.;Emma L Plested.;Samuel Provstgaard-Morys.;Maheshi N Ramasamy.;Mary Ramsay.;Robert C Read.;Hannah Robinson.;Gavin R Screaton.;Nisha Singh.;David P J Turner.;Paul J Turner.;Iason Vichos.;Rachel White.;Jonathan S Nguyen-Van-Tam.;Matthew D Snape.; .
来源: Lancet. 2022年399卷10319期36-49页
Given the importance of flexible use of different COVID-19 vaccines within the same schedule to facilitate rapid deployment, we studied mixed priming schedules incorporating an adenoviral-vectored vaccine (ChAdOx1 nCoV-19 [ChAd], AstraZeneca), two mRNA vaccines (BNT162b2 [BNT], Pfizer-BioNTech, and mRNA-1273 [m1273], Moderna) and a nanoparticle vaccine containing SARS-CoV-2 spike glycoprotein and Matrix-M adjuvant (NVX-CoV2373 [NVX], Novavax).
499. Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial.
作者: Alasdair P S Munro.;Leila Janani.;Victoria Cornelius.;Parvinder K Aley.;Gavin Babbage.;David Baxter.;Marcin Bula.;Katrina Cathie.;Krishna Chatterjee.;Kate Dodd.;Yvanne Enever.;Karishma Gokani.;Anna L Goodman.;Christopher A Green.;Linda Harndahl.;John Haughney.;Alexander Hicks.;Agatha A van der Klaauw.;Jonathan Kwok.;Teresa Lambe.;Vincenzo Libri.;Martin J Llewelyn.;Alastair C McGregor.;Angela M Minassian.;Patrick Moore.;Mehmood Mughal.;Yama F Mujadidi.;Jennifer Murira.;Orod Osanlou.;Rostam Osanlou.;Daniel R Owens.;Mihaela Pacurar.;Adrian Palfreeman.;Daniel Pan.;Tommy Rampling.;Karen Regan.;Stephen Saich.;Jo Salkeld.;Dinesh Saralaya.;Sunil Sharma.;Ray Sheridan.;Ann Sturdy.;Emma C Thomson.;Shirley Todd.;Chris Twelves.;Robert C Read.;Sue Charlton.;Bassam Hallis.;Mary Ramsay.;Nick Andrews.;Jonathan S Nguyen-Van-Tam.;Matthew D Snape.;Xinxue Liu.;Saul N Faust.; .
来源: Lancet. 2021年398卷10318期2258-2276页
Few data exist on the comparative safety and immunogenicity of different COVID-19 vaccines given as a third (booster) dose. To generate data to optimise selection of booster vaccines, we investigated the reactogenicity and immunogenicity of seven different COVID-19 vaccines as a third dose after two doses of ChAdOx1 nCov-19 (Oxford-AstraZeneca; hereafter referred to as ChAd) or BNT162b2 (Pfizer-BioNtech, hearafter referred to as BNT).
500. Safety and efficacy of subcutaneous ianalumab (VAY736) in patients with primary Sjögren's syndrome: a randomised, double-blind, placebo-controlled, phase 2b dose-finding trial.
作者: Simon J Bowman.;Robert Fox.;Thomas Dörner.;Xavier Mariette.;Athena Papas.;Thomas Grader-Beck.;Benjamin A Fisher.;Filipe Barcelos.;Salvatore De Vita.;Hendrik Schulze-Koops.;Robert J Moots.;Guido Junge.;Janice N Woznicki.;Monika A Sopala.;Wen-Lin Luo.;Wolfgang Hueber.
来源: Lancet. 2022年399卷10320期161-171页
Sjögren's syndrome is an autoimmune disease characterised by dry eyes and mouth, systemic features, and reduced quality of life. There are no disease-modifying treatments. A new biologic, ianalumab (VAY736), with two modes of suppressing B cells, has previously shown preliminary efficacy. This dose-finding trial aimed to assess the safety and efficacy of different subcutaneous doses of ianalumab in patients with moderate to severe primary Sjögren's syndrome.
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