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341. Efficacy and safety of garadacimab, a factor XIIa inhibitor for hereditary angioedema prevention (VANGUARD): a global, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.
作者: Timothy J Craig.;Avner Reshef.;H Henry Li.;Joshua S Jacobs.;Jonathan A Bernstein.;Henriette Farkas.;William H Yang.;Erik S G Stroes.;Isao Ohsawa.;Raffi Tachdjian.;Michael E Manning.;William R Lumry.;Inmaculada Martinez Saguer.;Emel Aygören-Pürsün.;Bruce Ritchie.;Gordon L Sussman.;John Anderson.;Kimito Kawahata.;Yusuke Suzuki.;Petra Staubach.;Regina Treudler.;Henrike Feuersenger.;Fiona Glassman.;Iris Jacobs.;Markus Magerl.
来源: Lancet. 2023年401卷10382期1079-1090页
Hereditary angioedema is a rare and potentially life-threatening genetic disease that is associated with kallikrein-kinin system dysregulation. Garadacimab (CSL312), a novel, fully-human monoclonal antibody that inhibits activated factor XII (FXIIa), is being studied for the prevention of hereditary angioedema attacks. The aim of this study was to evaluate the efficacy and safety of once-monthly subcutaneous administrations of garadacimab as prophylaxis for hereditary angioedema.
342. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-II).
作者: Michelle Petri.;Ian N Bruce.;Thomas Dörner.;Yoshiya Tanaka.;Eric F Morand.;Kenneth C Kalunian.;Mario H Cardiel.;Maria E Silk.;Christina L Dickson.;Gabriella Meszaros.;Lu Zhang.;Bochao Jia.;Youna Zhao.;Conor J McVeigh.;Marta Mosca.
来源: Lancet. 2023年401卷10381期1011-1019页
Baricitinib is an oral selective inhibitor of Janus kinase 1 and 2 approved for the treatment of rheumatoid arthritis, atopic dermatitis, and alopecia areata. In a 24-week phase 2 study in patients with systemic lupus erythematosus (SLE), baricitinib 4 mg significantly improved SLE disease activity compared with placebo. In this Article, we report the evaluation of efficacy and safety of baricitinib in patients with SLE in a 52-week phase 3 study.
343. Baricitinib for systemic lupus erythematosus: a double-blind, randomised, placebo-controlled, phase 3 trial (SLE-BRAVE-I).
作者: Eric F Morand.;Edward M Vital.;Michelle Petri.;Ronald van Vollenhoven.;Daniel J Wallace.;Marta Mosca.;Richard A Furie.;Maria E Silk.;Christina L Dickson.;Gabriella Meszaros.;Bochao Jia.;Brenda Crowe.;Inmaculada de la Torre.;Thomas Dörner.
来源: Lancet. 2023年401卷10381期1001-1010页
Baricitinib is an oral selective inhibitor of Janus kinase 1 and 2 approved for the treatment of rheumatoid arthritis, atopic dermatitis, and alopecia areata. In a 24-week phase 2 study in patients with systemic lupus erythematosus (SLE), baricitinib 4 mg significantly improved SLE disease activity compared with placebo. The objective of this trial was to evaluate the efficacy and safety of baricitinib in patients with active SLE in a 52-week phase 3 study.
344. Hyperfractionation compared with standard fractionation in intensity-modulated radiotherapy for patients with locally advanced recurrent nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial.
作者: Rui You.;You-Ping Liu.;Yu-Long Xie.;Chao Lin.;Chong-Yang Duan.;Dong-Ping Chen.;Yi Pan.;Bin Qi.;Xiong Zou.;Ling Guo.;Jing-Yu Cao.;Yi-Nuan Zhang.;Zhi-Qiang Wang.;Yong-Long Liu.;Yan-Feng Ouyang.;Kai Wen.;Qi Yang.;Ruo-Qi Xie.;Hui-Feng Li.;Xiao-Tong Duan.;Xi Ding.;Lan Peng.;Si-Yuan Chen.;Jiong-Lin Liang.;Zheng-Kai Feng.;Tian-Liang Xia.;Rui-Ling Xie.;Rou Jiang.;Chen-Mei Gu.;Rong-Zeng Liu.;Rui Sun.;Xin Yang.;Li-Zhi Liu.;Li Ling.;Qing Liu.;Wai Tong Ng.;Yi-Jun Hua.;Pei-Yu Huang.;Ming-Yuan Chen.
来源: Lancet. 2023年401卷10380期917-927页
Reirradiation in standard fractionation for locally advanced recurrent nasopharyngeal carcinoma after a previous course of high-dose radiotherapy is often associated with substantial late toxicity, negating its overall benefit. We therefore aimed to investigate the efficacy and safety of hyperfractionation compared with standard fractionation in intensity-modulated radiotherapy.
345. Tenecteplase versus alteplase in acute ischaemic cerebrovascular events (TRACE-2): a phase 3, multicentre, open-label, randomised controlled, non-inferiority trial.
作者: Yongjun Wang.;Shuya Li.;Yuesong Pan.;Hao Li.;Mark W Parsons.;Bruce C V Campbell.;Lee H Schwamm.;Marc Fisher.;Fengyuan Che.;Hongguo Dai.;Deyang Li.;Runhui Li.;Junhai Wang.;Yilong Wang.;Xingquan Zhao.;Zixiao Li.;Huaguang Zheng.;Yunyun Xiong.;Xia Meng.; .
来源: Lancet. 2023年401卷10377期645-654页
There is increasing interest in replacing alteplase with tenecteplase as the preferred thrombolytic treatment for patients with acute ischaemic stroke. We aimed to establish the non-inferiority of tenecteplase to alteplase for these patients.
346. Adjuvant nivolumab plus ipilimumab versus placebo for localised renal cell carcinoma after nephrectomy (CheckMate 914): a double-blind, randomised, phase 3 trial.
作者: Robert J Motzer.;Paul Russo.;Viktor Grünwald.;Yoshihiko Tomita.;Bogdan Zurawski.;Omi Parikh.;Sebastiano Buti.;Philippe Barthélémy.;Jeffrey C Goh.;Dingwei Ye.;Alejo Lingua.;Jean-Baptiste Lattouf.;Laurence Albigès.;Saby George.;Brian Shuch.;Jeffrey Sosman.;Michael Staehler.;Sergio Vázquez Estévez.;Burcin Simsek.;Julia Spiridigliozzi.;Aleksander Chudnovsky.;Axel Bex.
来源: Lancet. 2023年401卷10379期821-832页
Effective adjuvant therapy for patients with resected localised renal cell carcinoma represents an unmet need, with surveillance being the standard of care. We report results from part A of a phase 3, randomised trial that aimed to assess the efficacy and safety of adjuvant nivolumab plus ipilimumab versus placebo.
347. An investigational oral plasma kallikrein inhibitor for on-demand treatment of hereditary angioedema: a two-part, randomised, double-blind, placebo-controlled, crossover phase 2 trial.
作者: Emel Aygören-Pürsün.;Andrea Zanichelli.;Danny M Cohn.;Mauro Cancian.;Roman Hakl.;Tamar Kinaciyan.;Markus Magerl.;Inmaculada Martinez-Saguer.;Marcin Stobiecki.;Henriette Farkas.;Sorena Kiani-Alikhan.;Vesna Grivcheva-Panovska.;Jonathan A Bernstein.;H Henry Li.;Hilary J Longhurst.;Paul K Audhya.;Michael D Smith.;Christopher M Yea.;Andreas Maetzel.;Daniel K Lee.;Edward P Feener.;Richard Gower.;William R Lumry.;Aleena Banerji.;Marc A Riedl.;Marcus Maurer.
来源: Lancet. 2023年401卷10375期458-469页
Guidelines recommend effective on-demand therapy for all individuals with hereditary angioedema. We aimed to assess the novel oral plasma kallikrein inhibitor, sebetralstat, which is in development, for on-demand treatment of hereditary angioedema attacks.
348. Sotorasib versus docetaxel for previously treated non-small-cell lung cancer with KRASG12C mutation: a randomised, open-label, phase 3 trial.
作者: Adrianus Johannes de Langen.;Melissa L Johnson.;Julien Mazieres.;Anne-Marie C Dingemans.;Giannis Mountzios.;Miklos Pless.;Jürgen Wolf.;Martin Schuler.;Hervé Lena.;Ferdinandos Skoulidis.;Yasuto Yoneshima.;Sang-We Kim.;Helena Linardou.;Silvia Novello.;Anthonie J van der Wekken.;Yuanbin Chen.;Solange Peters.;Enriqueta Felip.;Benjamin J Solomon.;Suresh S Ramalingam.;Christophe Dooms.;Colin R Lindsay.;Carlos Gil Ferreira.;Normand Blais.;Cynthia C Obiozor.;Yang Wang.;Bhakti Mehta.;Tracy Varrieur.;Gataree Ngarmchamnanrith.;Björn Stollenwerk.;David Waterhouse.;Luis Paz-Ares.; .
来源: Lancet. 2023年401卷10378期733-746页
Sotorasib is a specific, irreversible inhibitor of the GTPase protein, KRASG12C. We compared the efficacy and safety of sotorasib with a standard-of-care treatment in patients with non-small-cell lung cancer (NSCLC) with the KRASG12C mutation who had been previously treated with other anticancer drugs.
349. Secukinumab in moderate-to-severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo-controlled, double-blind phase 3 trials.
作者: Alexa B Kimball.;Gregor B E Jemec.;Afsaneh Alavi.;Ziad Reguiai.;Alice B Gottlieb.;Falk G Bechara.;Carle Paul.;Evangelos J Giamarellos Bourboulis.;Axel P Villani.;Andreas Schwinn.;Franziska Ruëff.;Larisha Pillay Ramaya.;Adam Reich.;Ines Lobo.;Rodney Sinclair.;Thierry Passeron.;Antonio Martorell.;Pedro Mendes-Bastos.;Georgios Kokolakis.;Pierre-Andre Becherel.;Magdalena B Wozniak.;Angela Llobet Martinez.;Xiaoling Wei.;Lorenz Uhlmann.;Anna Passera.;Deborah Keefe.;Ruvie Martin.;Clarice Field.;Li Chen.;Marc Vandemeulebroecke.;Shoba Ravichandran.;Elisa Muscianisi.
来源: Lancet. 2023年401卷10378期747-761页
Few therapeutic options are available for patients with moderate-to-severe hidradenitis suppurativa. We aimed to assess the efficacy of secukinumab in patients with moderate-to-severe hidradenitis suppurativa in two randomised trials.
350. A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster-randomised crossover implementation study.
作者: Jesse J Swen.;Cathelijne H van der Wouden.;Lisanne En Manson.;Heshu Abdullah-Koolmees.;Kathrin Blagec.;Tanja Blagus.;Stefan Böhringer.;Anne Cambon-Thomsen.;Erika Cecchin.;Ka-Chun Cheung.;Vera Hm Deneer.;Mathilde Dupui.;Magnus Ingelman-Sundberg.;Siv Jonsson.;Candace Joefield-Roka.;Katja S Just.;Mats O Karlsson.;Lidija Konta.;Rudolf Koopmann.;Marjolein Kriek.;Thorsten Lehr.;Christina Mitropoulou.;Emmanuelle Rial-Sebbag.;Victoria Rollinson.;Rossana Roncato.;Matthias Samwald.;Elke Schaeffeler.;Maria Skokou.;Matthias Schwab.;Daniela Steinberger.;Julia C Stingl.;Roman Tremmel.;Richard M Turner.;Mandy H van Rhenen.;Cristina L Dávila Fajardo.;Vita Dolžan.;George P Patrinos.;Munir Pirmohamed.;Gere Sunder-Plassmann.;Giuseppe Toffoli.;Henk-Jan Guchelaar.; .
来源: Lancet. 2023年401卷10374期347-356页
The benefit of pharmacogenetic testing before starting drug therapy has been well documented for several single gene-drug combinations. However, the clinical utility of a pre-emptive genotyping strategy using a pharmacogenetic panel has not been rigorously assessed.
351. Combination of gefitinib and methotrexate to treat tubal ectopic pregnancy (GEM3): a multicentre, randomised, double-blind, placebo-controlled trial.
作者: Andrew W Horne.;Stephen Tong.;Catherine A Moakes.;Lee J Middleton.;W Colin Duncan.;Ben W Mol.;Lucy H R Whitaker.;Davor Jurkovic.;Arri Coomarasamy.;Natalie Nunes.;Tom Holland.;Fiona Clarke.;Ann M Doust.;Jane P Daniels.; .
来源: Lancet. 2023年401卷10377期655-663页
Tubal ectopic pregnancies can cause substantial morbidity or even death. Current treatment is with methotrexate or surgery. Methotrexate treatment fails in approximately 30% of women who subsequently require rescue surgery. Gefitinib, an epidermal growth factor receptor inhibitor, might improve the effects of methotrexate. We assessed the efficacy of oral gefitinib with methotrexate, versus methotrexate alone, to treat tubal ectopic pregnancy.
352. Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis (MOMENTUM): results from an international, double-blind, randomised, controlled, phase 3 study.
作者: Srdan Verstovsek.;Aaron T Gerds.;Alessandro M Vannucchi.;Haifa Kathrin Al-Ali.;David Lavie.;Andrew T Kuykendall.;Sebastian Grosicki.;Alessandra Iurlo.;Yeow Tee Goh.;Mihaela C Lazaroiu.;Miklos Egyed.;Maria Laura Fox.;Donal McLornan.;Andrew Perkins.;Sung-Soo Yoon.;Vikas Gupta.;Jean-Jacques Kiladjian.;Nikki Granacher.;Sung-Eun Lee.;Luminita Ocroteala.;Francesco Passamonti.;Claire N Harrison.;Barbara J Klencke.;Sunhee Ro.;Rafe Donahue.;Jun Kawashima.;Ruben Mesa.; .
来源: Lancet. 2023年401卷10373期269-280页
Janus kinase (JAK) inhibitors approved for myelofibrosis provide spleen and symptom improvements but do not meaningfully improve anaemia. Momelotinib, a first-in-class inhibitor of activin A receptor type 1 as well as JAK1 and JAK2, has shown symptom, spleen, and anaemia benefits in myelofibrosis. We aimed to confirm the differentiated clinical benefits of momelotinib versus the active comparator danazol in JAK-inhibitor-exposed, symptomatic patients with anaemia and intermediate-risk or high-risk myelofibrosis.
353. Sodium bicarbonate for kidney transplant recipients with metabolic acidosis in Switzerland: a multicentre, randomised, single-blind, placebo-controlled, phase 3 trial.
作者: Nilufar Mohebbi.;Alexander Ritter.;Anna Wiegand.;Nicole Graf.;Suzan Dahdal.;Daniel Sidler.;Spyridon Arampatzis.;Karine Hadaya.;Thomas F Mueller.;Carsten A Wagner.;Rudolf P Wüthrich.
来源: Lancet. 2023年401卷10376期557-567页
Metabolic acidosis is common in kidney transplant recipients and is associated with declining graft function. Sodium bicarbonate treatment effectively corrects metabolic acidosis, but no prospective studies have examined its effect on graft function. Therefore, we aimed to test whether sodium bicarbonate treatment would preserve graft function and slow the progression of estimated glomerular filtration rate (GFR) decline in kidney transplant recipients.
354. The effect of higher protein dosing in critically ill patients with high nutritional risk (EFFORT Protein): an international, multicentre, pragmatic, registry-based randomised trial.
作者: Daren K Heyland.;Jayshil Patel.;Charlene Compher.;Todd W Rice.;Danielle E Bear.;Zheng-Yii Lee.;Victoria C González.;Kevin O'Reilly.;Racquel Regala.;Courtney Wedemire.;Miguel Ibarra-Estrada.;Christian Stoppe.;Luis Ortiz-Reyes.;Xuran Jiang.;Andrew G Day.; .
来源: Lancet. 2023年401卷10376期568-576页
On the basis of low-quality evidence, international critical care nutrition guidelines recommend a wide range of protein doses. The effect of delivering high-dose protein during critical illness is unknown. We aimed to test the hypothesis that a higher dose of protein provided to critically ill patients would improve their clinical outcomes.
355. Efficacy of pyriproxyfen-pyrethroid long-lasting insecticidal nets (LLINs) and chlorfenapyr-pyrethroid LLINs compared with pyrethroid-only LLINs for malaria control in Benin: a cluster-randomised, superiority trial.
作者: Manfred Accrombessi.;Jackie Cook.;Edouard Dangbenon.;Boulais Yovogan.;Hilaire Akpovi.;Arthur Sovi.;Constantin Adoha.;Landry Assongba.;Aboubacar Sidick.;Bruno Akinro.;Razaki Ossè.;Filémon Tokponnon.;Rock Aïkpon.;Aurore Ogouyemi-Hounto.;Germain Gil Padonou.;Immo Kleinschmidt.;Louisa A Messenger.;Mark Rowland.;Corine Ngufor.;Natacha Protopopoff.;Martin C Akogbeto.
来源: Lancet. 2023年401卷10375期435-446页
New classes of long-lasting insecticidal nets (LLINs) combining mixtures of insecticides with different modes of action could put malaria control back on track after rebounds in transmission across sub-Saharan Africa. We evaluated the relative efficacy of pyriproxyfen-pyrethroid LLINs and chlorfenapyr-pyrethroid LLINs compared with standard LLINs against malaria transmission in an area of high pyrethroid resistance in Benin.
356. Adjuvant S-1 compared with observation in resected biliary tract cancer (JCOG1202, ASCOT): a multicentre, open-label, randomised, controlled, phase 3 trial.
作者: Kohei Nakachi.;Masafumi Ikeda.;Masaru Konishi.;Shogo Nomura.;Hiroshi Katayama.;Tomoko Kataoka.;Akiko Todaka.;Hiroaki Yanagimoto.;Soichiro Morinaga.;Shogo Kobayashi.;Kazuaki Shimada.;Yu Takahashi.;Toshio Nakagohri.;Kunihito Gotoh.;Ken Kamata.;Yasuhiro Shimizu.;Makoto Ueno.;Hiroshi Ishii.;Takuji Okusaka.;Junji Furuse.; .
来源: Lancet. 2023年401卷10372期195-203页
S-1 has shown promising efficacy with a mild toxicity profile in patients with advanced biliary tract cancer. The aim of this study was to evaluate whether adjuvant S-1 improved overall survival compared with observation for resected biliary tract cancer.
357. 2 days versus 5 days of postoperative antibiotics for complex appendicitis: a pragmatic, open-label, multicentre, non-inferiority randomised trial.
作者: Elisabeth M L de Wijkerslooth.;Evert-Jan G Boerma.;Charles C van Rossem.;Joost van Rosmalen.;Coen I M Baeten.;Frédérique H Beverdam.;Johanna W A M Bosmans.;Esther C J Consten.;Jan Willem T Dekker.;Marloes Emous.;Anna A W van Geloven.;Anton F Gijsen.;Luc A Heijnen.;An P Jairam.;Damian C Melles.;Augustinus P T van der Ploeg.;Pascal Steenvoorde.;Boudewijn R Toorenvliet.;Maarten Vermaas.;Bas Wiering.;Bas P L Wijnhoven.;Anne Loes van den Boom.; .
来源: Lancet. 2023年401卷10374期366-376页
The appropriate duration of postoperative antibiotics for complex appendicitis is unclear. The increasing global threat of antimicrobial resistance warrants restrictive antibiotic use, which could also reduce side-effects, length of hospital stay, and costs.
358. Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform-adaptive randomised controlled trial.
作者: Christopher C Butler.;F D Richard Hobbs.;Oghenekome A Gbinigie.;Najib M Rahman.;Gail Hayward.;Duncan B Richards.;Jienchi Dorward.;David M Lowe.;Joseph F Standing.;Judith Breuer.;Saye Khoo.;Stavros Petrou.;Kerenza Hood.;Jonathan S Nguyen-Van-Tam.;Mahendra G Patel.;Benjamin R Saville.;Joe Marion.;Emma Ogburn.;Julie Allen.;Heather Rutter.;Nick Francis.;Nicholas P B Thomas.;Philip Evans.;Melissa Dobson.;Tracie-Ann Madden.;Jane Holmes.;Victoria Harris.;May Ee Png.;Mark Lown.;Oliver van Hecke.;Michelle A Detry.;Christina T Saunders.;Mark Fitzgerald.;Nicholas S Berry.;Lazaro Mwandigha.;Ushma Galal.;Sam Mort.;Bhautesh D Jani.;Nigel D Hart.;Haroon Ahmed.;Daniel Butler.;Micheal McKenna.;Jem Chalk.;Layla Lavallee.;Elizabeth Hadley.;Lucy Cureton.;Magdalena Benysek.;Monique Andersson.;Maria Coates.;Sarah Barrett.;Clare Bateman.;Jennifer C Davies.;Ivy Raymundo-Wood.;Andrew Ustianowski.;Andrew Carson-Stevens.;Ly-Mee Yu.;Paul Little.; .
来源: Lancet. 2023年401卷10373期281-293页
The safety, effectiveness, and cost-effectiveness of molnupiravir, an oral antiviral medication for SARS-CoV-2, has not been established in vaccinated patients in the community at increased risk of morbidity and mortality from COVID-19. We aimed to establish whether the addition of molnupiravir to usual care reduced hospital admissions and deaths associated with COVID-19 in this population.
359. Emraclidine, a novel positive allosteric modulator of cholinergic M4 receptors, for the treatment of schizophrenia: a two-part, randomised, double-blind, placebo-controlled, phase 1b trial.
作者: John H Krystal.;John M Kane.;Christoph U Correll.;David P Walling.;Matthew Leoni.;Sridhar Duvvuri.;Shrinal Patel.;Ih Chang.;Philip Iredale.;Lillian Frohlich.;Stacey Versavel.;Pamela Perry.;Raymond Sanchez.;John Renger.
来源: Lancet. 2022年400卷10369期2210-2220页
Emraclidine is a novel, brain-penetrant, highly selective M4 receptor positive allosteric modulator in development for the treatment of schizophrenia. We aimed to evaluate the safety and tolerability of multiple ascending doses of emraclidine in patients with schizophrenia.
360. 9 months of delamanid, linezolid, levofloxacin, and pyrazinamide versus conventional therapy for treatment of fluoroquinolone-sensitive multidrug-resistant tuberculosis (MDR-END): a multicentre, randomised, open-label phase 2/3 non-inferiority trial in South Korea.
作者: Jeongha Mok.;Myungsun Lee.;Deog Kyeom Kim.;Ju Sang Kim.;Byung Woo Jhun.;Kyung-Wook Jo.;Doosoo Jeon.;Taehoon Lee.;Ji Yeon Lee.;Jae Seuk Park.;Seung Heon Lee.;Young Ae Kang.;Jung-Kyu Lee.;Nakwon Kwak.;Joong Hyun Ahn.;Tae Sun Shim.;Song Yee Kim.;Seungmo Kim.;Kyungjong Kim.;Kwang-Hyuk Seok.;Soyeong Yoon.;Young Ran Kim.;Jisu Kim.;Dahae Yim.;Seokyung Hahn.;Sang Nae Cho.;Jae-Joon Yim.; .
来源: Lancet. 2022年400卷10362期1522-1530页
With the introduction of new anti-tuberculosis drugs, all-oral regimens with shorter treatment durations for multidrug-resistant tuberculosis have been anticipated. We aimed to investigate whether a new all-oral regimen was non-inferior to the conventional regimen including second-line anti-tuberculosis drugs for 20-24 months in the treatment of fluoroquinolone-sensitive multidrug-resistant tuberculosis.
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