4983. Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico.
作者: Lisa M Dunkle.;Karen L Kotloff.;Cynthia L Gay.;Germán Áñez.;Jeffrey M Adelglass.;Alejandro Q Barrat Hernández.;Wayne L Harper.;Daniel M Duncanson.;Monica A McArthur.;Diana F Florescu.;R Scott McClelland.;Veronica Garcia-Fragoso.;Robert A Riesenberg.;David B Musante.;David L Fried.;Beth E Safirstein.;Mark McKenzie.;Robert J Jeanfreau.;Jeffrey K Kingsley.;Jeffrey A Henderson.;Dakotah C Lane.;Guillermo M Ruíz-Palacios.;Lawrence Corey.;Kathleen M Neuzil.;Robert W Coombs.;Alex L Greninger.;Julia Hutter.;Julie A Ake.;Katherine Smith.;Wayne Woo.;Iksung Cho.;Gregory M Glenn.;Filip Dubovsky.; .
来源: N Engl J Med. 2022年386卷6期531-543页
NVX-CoV2373 is an adjuvanted, recombinant spike protein nanoparticle vaccine that was shown to have clinical efficacy for the prevention of coronavirus disease 2019 (Covid-19) in phase 2b-3 trials in the United Kingdom and South Africa, but its efficacy had not yet been tested in North America.
4984. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma.
作者: Hervé Tilly.;Franck Morschhauser.;Laurie H Sehn.;Jonathan W Friedberg.;Marek Trněný.;Jeff P Sharman.;Charles Herbaux.;John M Burke.;Matthew Matasar.;Shinya Rai.;Koji Izutsu.;Neha Mehta-Shah.;Lucie Oberic.;Adrien Chauchet.;Wojciech Jurczak.;Yuqin Song.;Richard Greil.;Larysa Mykhalska.;Juan M Bergua-Burgués.;Matthew C Cheung.;Antonio Pinto.;Ho-Jin Shin.;Greg Hapgood.;Eduardo Munhoz.;Pau Abrisqueta.;Jyh-Pyng Gau.;Jamie Hirata.;Yanwen Jiang.;Mark Yan.;Calvin Lee.;Christopher R Flowers.;Gilles Salles.
来源: N Engl J Med. 2022年386卷4期351-363页
Diffuse large B-cell lymphoma (DLBCL) is typically treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). However, only 60% of patients are cured with R-CHOP. Polatuzumab vedotin is an antibody-drug conjugate targeting CD79b, which is ubiquitously expressed on the surface of malignant B cells.
4985. Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma.
作者: Michael R Bishop.;Michael Dickinson.;Duncan Purtill.;Pere Barba.;Armando Santoro.;Nada Hamad.;Koji Kato.;Anna Sureda.;Richard Greil.;Catherine Thieblemont.;Franck Morschhauser.;Martin Janz.;Ian Flinn.;Werner Rabitsch.;Yok-Lam Kwong.;Marie J Kersten.;Monique C Minnema.;Harald Holte.;Esther H L Chan.;Joaquin Martinez-Lopez.;Antonia M S Müller.;Richard T Maziarz.;Joseph P McGuirk.;Emmanuel Bachy.;Steven Le Gouill.;Martin Dreyling.;Hideo Harigae.;David Bond.;Charalambos Andreadis.;Peter McSweeney.;Mohamed Kharfan-Dabaja.;Simon Newsome.;Evgeny Degtyarev.;Rakesh Awasthi.;Christopher Del Corral.;Giovanna Andreola.;Aisha Masood.;Stephen J Schuster.;Ulrich Jäger.;Peter Borchmann.;Jason R Westin.
来源: N Engl J Med. 2022年386卷7期629-639页
Patient outcomes are poor for aggressive B-cell non-Hodgkin's lymphomas not responding to or progressing within 12 months after first-line therapy. Tisagenlecleucel is an anti-CD19 chimeric antigen receptor T-cell therapy approved for diffuse large B-cell lymphoma after at least two treatment lines.
4987. Acute Myeloid Leukemia Case after Gene Therapy for Sickle Cell Disease.
作者: Sunita Goyal.;John Tisdale.;Manfred Schmidt.;Julie Kanter.;Jennifer Jaroscak.;Dustin Whitney.;Hans Bitter.;Philip D Gregory.;Geoffrey Parsons.;Marianna Foos.;Ashish Yeri.;Maple Gioia.;Sarah B Voytek.;Alex Miller.;Jessie Lynch.;Richard A Colvin.;Melissa Bonner.
来源: N Engl J Med. 2022年386卷2期138-147页
Gene therapy with LentiGlobin for sickle cell disease (bb1111, lovotibeglogene autotemcel) consists of autologous transplantation of a patient's hematopoietic stem cells transduced with the BB305 lentiviral vector that encodes the βA-T87Q-globin gene. Acute myeloid leukemia developed in a woman approximately 5.5 years after she had received LentiGlobin for sickle cell disease as part of the initial cohort (Group A) of the HGB-206 study. An analysis of peripheral-blood samples revealed that blast cells contained a BB305 lentiviral vector insertion site. The results of an investigation of causality indicated that the leukemia was unlikely to be related to vector insertion, given the location of the insertion site, the very low transgene expression in blast cells, and the lack of an effect on expression of surrounding genes. Several somatic mutations predisposing to acute myeloid leukemia were present after diagnosis, which suggests that patients with sickle cell disease are at increased risk for hematologic malignant conditions after transplantation, most likely because of a combination of risks associated with underlying sickle cell disease, transplantation procedure, and inadequate disease control after treatment. (Funded by Bluebird Bio.).
4988. Biologic and Clinical Efficacy of LentiGlobin for Sickle Cell Disease.
作者: Julie Kanter.;Mark C Walters.;Lakshmanan Krishnamurti.;Markus Y Mapara.;Janet L Kwiatkowski.;Stacey Rifkin-Zenenberg.;Banu Aygun.;Kimberly A Kasow.;Francis J Pierciey.;Melissa Bonner.;Alex Miller.;Xinyan Zhang.;Jessie Lynch.;Dennis Kim.;Jean-Antoine Ribeil.;Mohammed Asmal.;Sunita Goyal.;Alexis A Thompson.;John F Tisdale.
来源: N Engl J Med. 2022年386卷7期617-628页
Sickle cell disease is characterized by the painful recurrence of vaso-occlusive events. Gene therapy with the use of LentiGlobin for sickle cell disease (bb1111; lovotibeglogene autotemcel) consists of autologous transplantation of hematopoietic stem and progenitor cells transduced with the BB305 lentiviral vector encoding a modified β-globin gene, which produces an antisickling hemoglobin, HbAT87Q.
4989. Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma.
作者: Frederick L Locke.;David B Miklos.;Caron A Jacobson.;Miguel-Angel Perales.;Marie-José Kersten.;Olalekan O Oluwole.;Armin Ghobadi.;Aaron P Rapoport.;Joseph McGuirk.;John M Pagel.;Javier Muñoz.;Umar Farooq.;Tom van Meerten.;Patrick M Reagan.;Anna Sureda.;Ian W Flinn.;Peter Vandenberghe.;Kevin W Song.;Michael Dickinson.;Monique C Minnema.;Peter A Riedell.;Lori A Leslie.;Sridhar Chaganti.;Yin Yang.;Simone Filosto.;Jina Shah.;Marco Schupp.;Christina To.;Paul Cheng.;Leo I Gordon.;Jason R Westin.; .
来源: N Engl J Med. 2022年386卷7期640-654页
The prognosis of patients with early relapsed or refractory large B-cell lymphoma after the receipt of first-line chemoimmunotherapy is poor.
4990. Betibeglogene Autotemcel Gene Therapy for Non-β0/β0 Genotype β-Thalassemia.
作者: Franco Locatelli.;Alexis A Thompson.;Janet L Kwiatkowski.;John B Porter.;Adrian J Thrasher.;Suradej Hongeng.;Martin G Sauer.;Isabelle Thuret.;Ashutosh Lal.;Mattia Algeri.;Jennifer Schneiderman.;Timothy S Olson.;Ben Carpenter.;Persis J Amrolia.;Usanarat Anurathapan.;Axel Schambach.;Christian Chabannon.;Manfred Schmidt.;Ivan Labik.;Heidi Elliot.;Ruiting Guo.;Mohammed Asmal.;Richard A Colvin.;Mark C Walters.
来源: N Engl J Med. 2022年386卷5期415-427页
Betibeglogene autotemcel (beti-cel) gene therapy for transfusion-dependent β-thalassemia contains autologous CD34+ hematopoietic stem cells and progenitor cells transduced with the BB305 lentiviral vector encoding the β-globin (βA-T87Q) gene.
4991. Abortion Safety and Use with Normally Prescribed Mifepristone in Canada.
作者: Laura Schummers.;Elizabeth K Darling.;Sheila Dunn.;Kimberlyn McGrail.;Anastasia Gayowsky.;Michael R Law.;Tracey-Lea Laba.;Janusz Kaczorowski.;Wendy V Norman.
来源: N Engl J Med. 2022年386卷1期57-67页
In the United States, mifepristone is available for medical abortion (for use with misoprostol) only with Risk Evaluation and Mitigation Strategy (REMS) restrictions, despite an absence of evidence to support such restrictions. Mifepristone has been available in Canada with a normal prescription since November 2017.
4996. 24-Hour Urinary Sodium and Potassium Excretion and Cardiovascular Risk.
作者: Yuan Ma.;Feng J He.;Qi Sun.;Changzheng Yuan.;Lyanne M Kieneker.;Gary C Curhan.;Graham A MacGregor.;Stephan J L Bakker.;Norm R C Campbell.;Molin Wang.;Eric B Rimm.;JoAnn E Manson.;Walter C Willett.;Albert Hofman.;Ron T Gansevoort.;Nancy R Cook.;Frank B Hu.
来源: N Engl J Med. 2022年386卷3期252-263页
The relation between sodium intake and cardiovascular disease remains controversial, owing in part to inaccurate assessment of sodium intake. Assessing 24-hour urinary excretion over a period of multiple days is considered to be an accurate method.
4997. Concomitant Tricuspid Repair in Patients with Degenerative Mitral Regurgitation.
作者: James S Gammie.;Michael W A Chu.;Volkmar Falk.;Jessica R Overbey.;Alan J Moskowitz.;Marc Gillinov.;Michael J Mack.;Pierre Voisine.;Markus Krane.;Babatunde Yerokun.;Michael E Bowdish.;Lenard Conradi.;Steven F Bolling.;Marissa A Miller.;Wendy C Taddei-Peters.;Neal O Jeffries.;Michael K Parides.;Richard Weisel.;Mariell Jessup.;Eric A Rose.;John C Mullen.;Samantha Raymond.;Ellen G Moquete.;Karen O'Sullivan.;Mary E Marks.;Alexander Iribarne.;Friedhelm Beyersdorf.;Michael A Borger.;Arnar Geirsson.;Emilia Bagiella.;Judy Hung.;Annetine C Gelijns.;Patrick T O'Gara.;Gorav Ailawadi.; .
来源: N Engl J Med. 2022年386卷4期327-339页
Tricuspid regurgitation is common in patients with severe degenerative mitral regurgitation. However, the evidence base is insufficient to inform a decision about whether to perform tricuspid-valve repair during mitral-valve surgery in patients who have moderate tricuspid regurgitation or less-than-moderate regurgitation with annular dilatation.
4998. Secondary Antibiotic Prophylaxis for Latent Rheumatic Heart Disease.
作者: Andrea Beaton.;Emmy Okello.;Joselyn Rwebembera.;Anneke Grobler.;Daniel Engelman.;Juliet Alepere.;Lesley Canales.;Jonathan Carapetis.;Alyssa DeWyer.;Peter Lwabi.;Mariana Mirabel.;Ana O Mocumbi.;Meghna Murali.;Miriam Nakitto.;Emma Ndagire.;Maria C P Nunes.;Isaac O Omara.;Rachel Sarnacki.;Amy Scheel.;Nigel Wilson.;Meghan Zimmerman.;Liesl Zühlke.;Ganesan Karthikeyan.;Craig A Sable.;Andrew C Steer.
来源: N Engl J Med. 2022年386卷3期230-240页
Rheumatic heart disease affects more than 40.5 million people worldwide and results in 306,000 deaths annually. Echocardiographic screening detects rheumatic heart disease at an early, latent stage. Whether secondary antibiotic prophylaxis is effective in preventing progression of latent rheumatic heart disease is unknown.
4999. Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age.
作者: Emmanuel B Walter.;Kawsar R Talaat.;Charu Sabharwal.;Alejandra Gurtman.;Stephen Lockhart.;Grant C Paulsen.;Elizabeth D Barnett.;Flor M Muñoz.;Yvonne Maldonado.;Barbara A Pahud.;Joseph B Domachowske.;Eric A F Simões.;Uzma N Sarwar.;Nicholas Kitchin.;Luke Cunliffe.;Pablo Rojo.;Ernest Kuchar.;Mika Rämet.;Iona Munjal.;John L Perez.;Robert W Frenck.;Eleni Lagkadinou.;Kena A Swanson.;Hua Ma.;Xia Xu.;Kenneth Koury.;Susan Mather.;Todd J Belanger.;David Cooper.;Özlem Türeci.;Philip R Dormitzer.;Uğur Şahin.;Kathrin U Jansen.;William C Gruber.; .
来源: N Engl J Med. 2022年386卷1期35-46页
Safe, effective vaccines against coronavirus disease 2019 (Covid-19) are urgently needed in children younger than 12 years of age.
5000. Fractional Flow Reserve-Guided PCI as Compared with Coronary Bypass Surgery.
作者: William F Fearon.;Frederik M Zimmermann.;Bernard De Bruyne.;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.;Di Lu.;Victoria Y Ding.;Yuhei Kobayashi.;Mark A Hlatky.;Kenneth W Mahaffey.;Manisha Desai.;Y Joseph Woo.;Alan C Yeung.;Nico H J Pijls.; .
来源: N Engl J Med. 2022年386卷2期128-137页
Patients with three-vessel coronary artery disease have been found to have better outcomes with coronary-artery bypass grafting (CABG) than with percutaneous coronary intervention (PCI), but studies in which PCI is guided by measurement of fractional flow reserve (FFR) have been lacking.
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