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461. Ustekinumab versus adalimumab for induction and maintenance therapy in biologic-naive patients with moderately to severely active Crohn's disease: a multicentre, randomised, double-blind, parallel-group, phase 3b trial.
作者: Bruce E Sands.;Peter M Irving.;Timothy Hoops.;James L Izanec.;Long-Long Gao.;Christopher Gasink.;Andrew Greenspan.;Matthieu Allez.;Silvio Danese.;Stephen B Hanauer.;Vipul Jairath.;Tanja Kuehbacher.;James D Lewis.;Edward V Loftus.;Emese Mihaly.;Remo Panaccione.;Ellen Scherl.;Oksana B Shchukina.;William J Sandborn.; .
来源: Lancet. 2022年399卷10342期2200-2211页
Active-comparator trials are important to inform patient and physician choice. We aimed to evaluate the efficacy and safety of monotherapy with either ustekinumab or adalimumab in biologic-naive patients with moderately to severely active Crohn's disease.
462. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials.
作者: Silvio Danese.;Séverine Vermeire.;Wen Zhou.;Aileen L Pangan.;Jesse Siffledeen.;Susan Greenbloom.;Xavier Hébuterne.;Geert D'Haens.;Hiroshi Nakase.;Julian Panés.;Peter D R Higgins.;Pascal Juillerat.;James O Lindsay.;Edward V Loftus.;William J Sandborn.;Walter Reinisch.;Min-Hu Chen.;Yuri Sanchez Gonzalez.;Bidan Huang.;Wangang Xie.;John Liu.;Michael A Weinreich.;Remo Panaccione.
来源: Lancet. 2022年399卷10341期2113-2128页
There is a great unmet need for advanced therapies that provide rapid, robust, and sustained disease control for patients with ulcerative colitis. We assessed the efficacy and safety of upadacitinib, an oral selective Janus kinase 1 inhibitor, as induction and maintenance therapy in patients with moderately to severely active ulcerative colitis.
463. Risankizumab as maintenance therapy for moderately to severely active Crohn's disease: results from the multicentre, randomised, double-blind, placebo-controlled, withdrawal phase 3 FORTIFY maintenance trial.
作者: Marc Ferrante.;Remo Panaccione.;Filip Baert.;Peter Bossuyt.;Jean-Frederic Colombel.;Silvio Danese.;Marla Dubinsky.;Brian G Feagan.;Tadakazu Hisamatsu.;Allen Lim.;James O Lindsay.;Edward V Loftus.;Julián Panés.;Laurent Peyrin-Biroulet.;Zhihua Ran.;David T Rubin.;William J Sandborn.;Stefan Schreiber.;Ezequiel Neimark.;Alexandra Song.;Kristina Kligys.;Yinuo Pang.;Valerie Pivorunas.;Sofie Berg.;W Rachel Duan.;Bidan Huang.;Jasmina Kalabic.;Xiaomei Liao.;Anne Robinson.;Kori Wallace.;Geert D'Haens.
来源: Lancet. 2022年399卷10340期2031-2046页
There is a great unmet need for new therapeutics with novel mechanisms of action for patients with Crohn's disease. The ADVANCE and MOTIVATE studies showed that intravenous risankizumab, a selective p19 anti-interleukin (IL)-23 antibody, was efficacious and well tolerated as induction therapy. Here, we report the efficacy and safety of subcutaneous risankizumab as maintenance therapy.
464. Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials.
作者: Geert D'Haens.;Remo Panaccione.;Filip Baert.;Peter Bossuyt.;Jean-Frederic Colombel.;Silvio Danese.;Marla Dubinsky.;Brian G Feagan.;Tadakazu Hisamatsu.;Allen Lim.;James O Lindsay.;Edward V Loftus.;Julian Panés.;Laurent Peyrin-Biroulet.;Zhihua Ran.;David T Rubin.;William J Sandborn.;Stefan Schreiber.;Ezequiel Neimark.;Alexandra Song.;Kristina Kligys.;Yinuo Pang.;Valerie Pivorunas.;Sofie Berg.;W Rachel Duan.;Bidan Huang.;Jasmina Kalabic.;Xiaomei Liao.;Anne Robinson.;Kori Wallace.;Marc Ferrante.
来源: Lancet. 2022年399卷10340期2015-2030页
Risankizumab, an interleukin (IL)-23 p19 inhibitor, was evaluated for safety and efficacy as induction therapy in patients with moderately to severely active Crohn's disease.
465. The addition of androgen deprivation therapy and pelvic lymph node treatment to prostate bed salvage radiotherapy (NRG Oncology/RTOG 0534 SPPORT): an international, multicentre, randomised phase 3 trial.
作者: Alan Pollack.;Theodore G Karrison.;Alexander G Balogh.;Leonard G Gomella.;Daniel A Low.;Deborah W Bruner.;Jeffrey S Wefel.;Andre-Guy Martin.;Jeff M Michalski.;Steve J Angyalfi.;Himanshu Lukka.;Sergio L Faria.;George B Rodrigues.;Marie-Claude Beauchemin.;R Jeffrey Lee.;Samantha A Seaward.;Aaron M Allen.;Drew C Monitto.;Wendy Seiferheld.;Oliver Sartor.;Felix Feng.;Howard M Sandler.
来源: Lancet. 2022年399卷10338期1886-1901页
In men with a detectable prostate-specific antigen (PSA) level after prostatectomy for prostate cancer, salvage prostate bed radiotherapy (PBRT) results in about 70% of patients being free of progression at 5 years. A three-group randomised trial was designed to determine whether incremental gains in patient outcomes can be achieved by adding either 4-6 months of short-term androgen deprivation therapy (ADT) to PBRT, or both short-term ADT and pelvic lymph node radiotherapy (PLNRT) to PBRT.
466. Long-term secondary prevention of cardiovascular disease with a Mediterranean diet and a low-fat diet (CORDIOPREV): a randomised controlled trial.
作者: Javier Delgado-Lista.;Juan F Alcala-Diaz.;Jose D Torres-Peña.;Gracia M Quintana-Navarro.;Francisco Fuentes.;Antonio Garcia-Rios.;Ana M Ortiz-Morales.;Ana I Gonzalez-Requero.;Ana I Perez-Caballero.;Elena M Yubero-Serrano.;Oriol A Rangel-Zuñiga.;Antonio Camargo.;Fernando Rodriguez-Cantalejo.;Fernando Lopez-Segura.;Lina Badimon.;Jose M Ordovas.;Francisco Perez-Jimenez.;Pablo Perez-Martinez.;Jose Lopez-Miranda.; .
来源: Lancet. 2022年399卷10338期1876-1885页
Mediterranean and low-fat diets are effective in the primary prevention of cardiovascular disease. We did a long-term randomised trial to compare the effects of these two diets in secondary prevention of cardiovascular disease.
467. A village doctor-led multifaceted intervention for blood pressure control in rural China: an open, cluster randomised trial.
作者: Yingxian Sun.;Jianjun Mu.;Dao Wen Wang.;Nanxiang Ouyang.;Liying Xing.;Xiaofan Guo.;Chunxia Zhao.;Guocheng Ren.;Ning Ye.;Ying Zhou.;Jun Wang.;Zhao Li.;Guozhe Sun.;Ruihai Yang.;Chung-Shiuan Chen.;Jiang He.; .
来源: Lancet. 2022年399卷10339期1964-1975页
The prevalence of uncontrolled hypertension is high and increasing in low-income and middle-income countries. We tested the effectiveness of a multifaceted intervention for blood pressure control in rural China led by village doctors (community health workers on the front line of primary health care).
468. Algorithm-based care versus usual care for the early recognition and management of complications after pancreatic resection in the Netherlands: an open-label, nationwide, stepped-wedge cluster-randomised trial.
作者: F Jasmijn Smits.;Anne Claire Henry.;Marc G Besselink.;Olivier R Busch.;Casper H van Eijck.;Mark Arntz.;Thomas L Bollen.;Otto M van Delden.;Daniel van den Heuvel.;Christiaan van der Leij.;Krijn P van Lienden.;Adriaan Moelker.;Bert A Bonsing.;Inne H Borel Rinkes.;Koop Bosscha.;Ronald M van Dam.;Wouter J M Derksen.;Marcel den Dulk.;Sebastiaan Festen.;Bas Groot Koerkamp.;Robbert J de Haas.;Jeroen Hagendoorn.;Erwin van der Harst.;Ignace H de Hingh.;Geert Kazemier.;Marion van der Kolk.;Mike Liem.;Daan J Lips.;Misha D Luyer.;Vincent E de Meijer.;J Sven Mieog.;Vincent B Nieuwenhuijs.;Gijs A Patijn.;Wouter W Te Riele.;Daphne Roos.;Jennifer M Schreinemakers.;Martijn W J Stommel.;Fennie Wit.;Babs A Zonderhuis.;Lois A Daamen.;C Henri van Werkhoven.;I Quintus Molenaar.;Hjalmar C van Santvoort.; .
来源: Lancet. 2022年399卷10338期1867-1875页
Early recognition and management of postoperative complications, before they become clinically relevant, can improve postoperative outcomes for patients, especially for high-risk procedures such as pancreatic resection.
469. Topical imiquimod versus surgery for vulvar intraepithelial neoplasia: a multicentre, randomised, phase 3, non-inferiority trial.
作者: Gerda Trutnovsky.;Olaf Reich.;Elmar A Joura.;Magdalena Holter.;Alexandra Ciresa-König.;Andreas Widschwendter.;Christian Schauer.;Gerhard Bogner.;Ziga Jan.;Angelika Boandl.;Martin S Kalteis.;Sigrid Regauer.;Karl Tamussino.
来源: Lancet. 2022年399卷10337期1790-1798页
The optimal management of vulvar high-grade squamous intraepithelial lesions (vHSILs) is challenging. Surgery is the standard treatment, but recurrences are observed in half of patients. Medical treatment with imiquimod is an effective alternative, but the two modalities have not been compared in a randomised trial. The aim of this study was to compare the clinical effectiveness, histological response, human papillomavirus (HPV) clearance, acceptance, and psychosexual morbidity of primary imiquimod treatment versus surgical treatment in women with vHSIL.
470. Subacromial balloon spacer for irreparable rotator cuff tears of the shoulder (START:REACTS): a group-sequential, double-blind, multicentre randomised controlled trial.
作者: Andrew Metcalfe.;Helen Parsons.;Nicholas Parsons.;Jaclyn Brown.;Josephine Fox.;Elke Gemperlé Mannion.;Aminul Haque.;Charles Hutchinson.;Rebecca Kearney.;Iftekhar Khan.;Tom Lawrence.;James Mason.;Nigel Stallard.;Martin Underwood.;Stephen Drew.; .
来源: Lancet. 2022年399卷10339期1954-1963页
New surgical procedures can expose patients to harm and should be carefully evaluated before widespread use. The InSpace balloon (Stryker, USA) is an innovative surgical device used to treat people with rotator cuff tears that cannot be repaired. We aimed to determine the effectiveness of the InSpace balloon for people with irreparable rotator cuff tears.
471. Segmentectomy versus lobectomy in small-sized peripheral non-small-cell lung cancer (JCOG0802/WJOG4607L): a multicentre, open-label, phase 3, randomised, controlled, non-inferiority trial.
作者: Hisashi Saji.;Morihito Okada.;Masahiro Tsuboi.;Ryu Nakajima.;Kenji Suzuki.;Keiju Aokage.;Tadashi Aoki.;Jiro Okami.;Ichiro Yoshino.;Hiroyuki Ito.;Norihito Okumura.;Masafumi Yamaguchi.;Norihiko Ikeda.;Masashi Wakabayashi.;Kenichi Nakamura.;Haruhiko Fukuda.;Shinichiro Nakamura.;Tetsuya Mitsudomi.;Shun-Ichi Watanabe.;Hisao Asamura.; .
来源: Lancet. 2022年399卷10335期1607-1617页
Lobectomy is the standard of care for early-stage non-small-cell lung cancer (NSCLC). The survival and clinical benefits of segmentectomy have not been investigated in a randomised trial setting. We aimed to investigate if segmentectomy was non-inferior to lobectomy in patients with small-sized peripheral NSCLC.
472. Efficacy, safety, and immunogenicity of an inactivated, adjuvanted enterovirus 71 vaccine in infants and children: a multiregion, double-blind, randomised, placebo-controlled, phase 3 trial.
作者: Trong Toan Nguyen.;Cheng-Hsun Chiu.;Chien-Yu Lin.;Nan-Chang Chiu.;Po-Yen Chen.;Thi Tuong Vy Le.;Dang Ngan Le.;An Han Duong.;Van Luan Nguyen.;Thi Nguyet Huynh.;Huu Khanh Truong.;Trong Lan Phan.;Thi Thanh Thao Nguyen.;Shin-Ru Shih.;Chung-Guei Huang.;Yi-Jen Weng.;Erh-Fang Hsieh.;Stanley Chang.;Charles Chen.;I-Chen Tai.;Li-Min Huang.
来源: Lancet. 2022年399卷10336期1708-1717页
Children are susceptible to severe or fatal enterovirus 71 (EV71) infections. We aimed to evaluate the efficacy, safety, and immunogenicity of EV71vac, an aluminium phosphate-adjuvanted inactivated EV71 vaccine in children aged 2-71 months.
473. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2 × 2 factorial design.
作者: Karim Fizazi.;Stéphanie Foulon.;Joan Carles.;Guilhem Roubaud.;Ray McDermott.;Aude Fléchon.;Bertrand Tombal.;Stéphane Supiot.;Dominik Berthold.;Philippe Ronchin.;Gabriel Kacso.;Gwenaëlle Gravis.;Fabio Calabro.;Jean-François Berdah.;Ali Hasbini.;Marlon Silva.;Antoine Thiery-Vuillemin.;Igor Latorzeff.;Loïc Mourey.;Brigitte Laguerre.;Sophie Abadie-Lacourtoisie.;Etienne Martin.;Claude El Kouri.;Anne Escande.;Alvar Rosello.;Nicolas Magne.;Friederike Schlurmann.;Frank Priou.;Marie-Eve Chand-Fouche.;Salvador Villà Freixa.;Muhammad Jamaluddin.;Isabelle Rieger.;Alberto Bossi.; .
来源: Lancet. 2022年399卷10336期1695-1707页
Current standard of care for metastatic castration-sensitive prostate cancer supplements androgen deprivation therapy with either docetaxel, second-generation hormonal therapy, or radiotherapy. We aimed to evaluate the efficacy and safety of abiraterone plus prednisone, with or without radiotherapy, in addition to standard of care.
474. Aggressive intraoperative warming versus routine thermal management during non-cardiac surgery (PROTECT): a multicentre, parallel group, superiority trial.
作者: Daniel I Sessler.;Lijian Pei.;Kai Li.;Shusen Cui.;Matthew T V Chan.;Yuguang Huang.;Jingxiang Wu.;Xuemei He.;Gausan R Bajracharya.;Eva Rivas.;Carmen K M Lam.; .
来源: Lancet. 2022年399卷10337期1799-1808页
Moderate intraoperative hypothermia promotes myocardial injury, surgical site infections, and blood loss. Whether aggressive warming to a truly normothermic temperature near 37°C improves outcomes remains unknown. We aimed to test the hypothesis that aggressive intraoperative warming reduces major perioperative complications.
475. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial.
作者: Felix Mahfoud.;David E Kandzari.;Kazuomi Kario.;Raymond R Townsend.;Michael A Weber.;Roland E Schmieder.;Konstantinos Tsioufis.;Stuart Pocock.;Kyriakos Dimitriadis.;James W Choi.;Cara East.;Richard D'Souza.;Andrew S P Sharp.;Sebastian Ewen.;Antony Walton.;Ingrid Hopper.;Sandeep Brar.;Pamela McKenna.;Martin Fahy.;Michael Böhm.
来源: Lancet. 2022年399卷10333期1401-1410页
Renal denervation has been shown to lower blood pressure in the presence of antihypertensive medications; however, long-term safety and efficacy data from randomised trials of renal denervation are lacking. In this pre-specified analysis of the SPYRAL HTN-ON MED study, we compared changes in blood pressure, antihypertensive drug use, and safety up to 36 months in renal denervation versus a sham control group.
476. Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study.
作者: Jonathan P Piccini.;Valeria Caso.;Stuart J Connolly.;Keith A A Fox.;Jonas Oldgren.;W Schuyler Jones.;Diana A Gorog.;Václav Durdil.;Thomas Viethen.;Christoph Neumann.;Hardi Mundl.;Manesh R Patel.; .
来源: Lancet. 2022年399卷10333期1383-1390页
Direct-acting oral anticoagulant use for stroke prevention in atrial fibrillation is limited by bleeding concerns. Asundexian, a novel, oral small molecule activated coagulation factor XIa (FXIa) inhibitor, might reduce thrombosis with minimal effect on haemostasis. We aimed to determine the optimal dose of asundexian and to compare the incidence of bleeding with that of apixaban in patients with atrial fibrillation.
477. Reduction of dietary sodium to less than 100 mmol in heart failure (SODIUM-HF): an international, open-label, randomised, controlled trial.
作者: Justin A Ezekowitz.;Eloisa Colin-Ramirez.;Heather Ross.;Jorge Escobedo.;Peter Macdonald.;Richard Troughton.;Clara Saldarriaga.;Wendimagegn Alemayehu.;Finlay A McAlister.;JoAnne Arcand.;John Atherton.;Robert Doughty.;Milan Gupta.;Jonathan Howlett.;Shahin Jaffer.;Andrea Lavoie.;Mayanna Lund.;Thomas Marwick.;Robert McKelvie.;Gordon Moe.;A Shekhar Pandey.;Liane Porepa.;Miroslaw Rajda.;Haunnah Rheault.;Jitendra Singh.;Mustafa Toma.;Sean Virani.;Shelley Zieroth.; .
来源: Lancet. 2022年399卷10333期1391-1400页
Dietary restriction of sodium has been suggested to prevent fluid overload and adverse outcomes for patients with heart failure. We designed the Study of Dietary Intervention under 100 mmol in Heart Failure (SODIUM-HF) to test whether or not a reduction in dietary sodium reduces the incidence of future clinical events.
478. Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial.
作者: Sinead Delany-Moretlwe.;James P Hughes.;Peter Bock.;Samuel Gurrion Ouma.;Portia Hunidzarira.;Dishiki Kalonji.;Noel Kayange.;Joseph Makhema.;Patricia Mandima.;Carrie Mathew.;Elizabeth Spooner.;Juliet Mpendo.;Pamela Mukwekwerere.;Nyaradzo Mgodi.;Patricia Nahirya Ntege.;Gonasagrie Nair.;Clemensia Nakabiito.;Harriet Nuwagaba-Biribonwoha.;Ravindre Panchia.;Nishanta Singh.;Bekezela Siziba.;Jennifer Farrior.;Scott Rose.;Peter L Anderson.;Susan H Eshleman.;Mark A Marzinke.;Craig W Hendrix.;Stephanie Beigel-Orme.;Sybil Hosek.;Elizabeth Tolley.;Nirupama Sista.;Adeola Adeyeye.;James F Rooney.;Alex Rinehart.;William R Spreen.;Kimberly Smith.;Brett Hanscom.;Myron S Cohen.;Mina C Hosseinipour.; .
来源: Lancet. 2022年399卷10337期1779-1789页
Oral pre-exposure prophylaxis has been introduced in more than 70 countries, including many in sub-Saharan Africa, but women experience considerable barriers to daily pill-taking, such as stigma, judgement, and the fear of violence. Safe and effective long-acting agents for HIV prevention are needed for women. We aimed to evaluate the safety and efficacy of injectable cabotegravir compared with daily oral tenofovir diphosphate plus emtricitabine (TDF-FTC) for HIV prevention in HIV-uninfected women.
479. Pembrolizumab versus placebo as adjuvant therapy in completely resected stage IIB or IIC melanoma (KEYNOTE-716): a randomised, double-blind, phase 3 trial.
作者: Jason J Luke.;Piotr Rutkowski.;Paola Queirolo.;Michele Del Vecchio.;Jacek Mackiewicz.;Vanna Chiarion-Sileni.;Luis de la Cruz Merino.;Muhammad A Khattak.;Dirk Schadendorf.;Georgina V Long.;Paolo A Ascierto.;Mario Mandala.;Federica De Galitiis.;Andrew Haydon.;Reinhard Dummer.;Jean-Jacques Grob.;Caroline Robert.;Matteo S Carlino.;Peter Mohr.;Andrew Poklepovic.;Vernon K Sondak.;Richard A Scolyer.;John M Kirkwood.;Ke Chen.;Scott J Diede.;Sama Ahsan.;Nageatte Ibrahim.;Alexander M M Eggermont.; .
来源: Lancet. 2022年399卷10336期1718-1729页
Pembrolizumab prolongs progression-free and overall survival among patients with advanced melanoma and recurrence-free survival in resected stage III disease. KEYNOTE-716 assessed pembrolizumab as adjuvant therapy in patients with completely resected, high-risk, stage II melanoma. We report results from the planned first and second interim analyses for recurrence-free survival.
480. Efficacy, safety, and immunogenicity of the DNA SARS-CoV-2 vaccine (ZyCoV-D): the interim efficacy results of a phase 3, randomised, double-blind, placebo-controlled study in India.
作者: Akash Khobragade.;Suresh Bhate.;Vijendra Ramaiah.;Shrikant Deshpande.;Krishna Giri.;Himanshu Phophle.;Pravin Supe.;Inderjeet Godara.;Ramesh Revanna.;Rajnish Nagarkar.;Jayesh Sanmukhani.;Ayan Dey.;T M Chozhavel Rajanathan.;Kevinkumar Kansagra.;Parshottam Koradia.; .
来源: Lancet. 2022年399卷10332期1313-1321页
ZyCoV-D, a DNA-based vaccine, showed promising safety and immunogenicity in a phase 1/2 trial. We now report the interim efficacy results of phase 3 clinical trial with ZyCoV-D vaccine in India.
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