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161. Efficacy and safety of ligelizumab in adults and adolescents with chronic spontaneous urticaria: results of two phase 3 randomised controlled trials.
作者: Marcus Maurer.;Luis Felipe Ensina.;Ana Maria Gimenez-Arnau.;Gordon Sussman.;Michihiro Hide.;Sarbjit Saini.;Clive Grattan.;Daria Fomina.;Dimitrios Rigopoulos.;Frederic Berard.;Giorgio Walter Canonica.;Heike Rockmann.;Carla Irani.;Jacek C Szepietowski.;Jeffrey Leflein.;Jonathan A Bernstein.;Jonny G Peter.;Kanokvalai Kulthanan.;Kiran Godse.;Ledit Ardusso.;Olga Ukhanova.;Petra Staubach.;Rodney Sinclair.;Shaila Gogate.;Simon Francis Thomsen.;Tonny Tanus.;Young Min Ye.;Alis Burciu.;Avantika Barve.;Darshna Modi.;Emil Scosyrev.;Eva Hua.;Kerstin Letzelter.;Vineeth Varanasi.;Manmath Patekar.;Thomas Severin.; .
来源: Lancet. 2024年403卷10422期147-159页
Many patients with chronic spontaneous urticaria (CSU) do not achieve complete control of their symptoms with current available treatments. In a dose-finding phase 2b study, ligelizumab improved urticaria symptoms in patients with H1-antihistamine (H1-AH) refractory CSU. Here, we report the efficacy and safety outcomes from two ligelizumab phase 3 studies.
162. Type of goals set and progress towards these goals, as part of a behaviour change intervention, in people with mild cognitive impairment: a secondary analysis.
作者: Tasmin Rookes.;Rachael Frost.;Yolanda Barrado-Martin.;Louise Marston.;Claudia Cooper.;Benjamin Gardner.;Megan Armstrong.;Kate Walters.
来源: Lancet. 2023年402 Suppl 1卷S80页
Mild cognitive impairment (MCI) affects 5-20% of older people in the UK, but often goes undiagnosed and is associated with increased risk of dementia. Targeting risk factors such as physical inactivity and social isolation through behaviour-change interventions could reduce this risk. However, it is unclear how MCI impacts engagement with these interventions. We aimed to explore how MCI affects goal-setting priorities and progress towards these goals in a behaviour-change intervention (HomeHealth).
163. A peer-led walking intervention for adolescent girls (the WISH study): a cluster-randomised controlled trial.
作者: Marie H Murphy.;S Maria O'Kane.;Angela Carlin.;Ian M Lahart.;Leanne C Doherty.;Russell Jago.;Gary McDermott.;Maria Faulkner.;Alison M Gallagher.
来源: Lancet. 2023年402 Suppl 1卷S72页
Adolescent girls in the UK and Ireland fail to meet physical activity (PA) guidelines. PA behaviours track from childhood into adulthood. The effects of walking interventions on adult health are known; however, the potential of walking to promote PA in adolescents is less known. This study evaluated the effectiveness of a novel, school-based walking intervention aimed at increasing PA levels of adolescent girls.
164. Enabling health and maintaining independence for older people at home (HomeHealth trial): a multicentre randomised controlled trial.
作者: Rachael Frost.;Christina Avgerinou.;Sarah Kalwarowsky.;Farah Mahmood.;Claire Goodman.;Andrew Clegg.;Jane Hopkins.;Rebecca Gould.;Benjamin Gardner.;Louise Marston.;Rachael Hunter.;Kalpa Kharicha.;Claudia Cooper.;Dawn A Skelton.;Vari Drennan.;Pip Logan.;Kate Walters.
来源: Lancet. 2023年402 Suppl 1卷S42页
NHS frailty services commonly target more severely frail older people, despite evidence suggesting frailty can be prevented or reversed when addressed at an earlier stage. HomeHealth is a new home-based, manualised voluntary sector service supporting older people with mild frailty to maintain their independence through behaviour change. Over six appointments, a trained HomeHealth worker discusses what matters to the older person and supports them to set and achieve goals around mobility, nutrition, socialising and/or psychological wellbeing. The service showed promising effects in a feasibility trial. We aimed to test the clinical and cost-effectiveness of HomeHealth for maintaining independence in older people with mild frailty compared with treatment as usual.
165. Lessons from the Gateway programme, aimed at improving health and life chances for young people committing low-level offences: a qualitative evaluation.
Young people who commit criminal offences are often affected by mental health issues, including drug and alcohol misuse, with many leading chaotic lifestyles. Gateway was a pioneering court-diversion programme aimed to reduce reoffending and improve the health and wellbeing of people aged 18-24 years who had been questioned for a low-level offence. The Gateway Study consisted of a pragmatic, parallel-group, superiority randomised controlled trial (RCT) of the programme's effectiveness, and its qualitative evaluation. We aimed to determine barriers and enablers for implementation of Gateway and recruitment into the RCT.
166. Evaluation of the impact of letters to GP practices to promote asthma prescription uptake in school-age children during summer (TRAINS study): a pragmatic cluster-randomised controlled trial.
作者: Rami A Alyami.;Rebecca Simpson.;Phillip Oliver.;Steven A Julious.
来源: Lancet. 2023年402 Suppl 1卷S22页
Asthma exacerbations peak in school-aged children after the return to school in September. Previous studies have shown a decline in collections of asthma prescriptions during August. The PLEASANT trial demonstrated that sending a reminder letter to parents increased prescription uptake; reduced unscheduled care, and was cost saving to the health service. We aimed to assess whether informing general practitioner (GP) practices about the PLEASANT trial and its results could lead to its implementation in routine practice.
167. An SMS and animated video intervention to increase uptake of breast cancer screening: a randomised controlled trial.
Breast cancer screening attendance in the UK has fallen, and London has the lowest uptake nationally. This study tested the impact of a behavioural science-informed reminder SMS, and animated video intervention on screening uptake.
168. Goal setting as part of a holistic intervention to promote independence in older people with mild frailty: a process evaluation alongside a randomised controlled trial.
作者: Yolanda Barrado-Martín.;Rachael Frost.;Jessica Catchpole.;Tasmin Rookes.;Sarah Gibson.;Christina Avgerinou.;Benjamin Gardner.;Rebecca Gould.;Paul Chadwick.;Claire Jowett.;Jane Hopkins.;Rashmi Kumar.;Rekha Elaswarapu.;Louise Marston.;Kalpa Kharicha.;Vari M Drennan.;Kate Walters.
来源: Lancet. 2023年402 Suppl 1卷S1页
Frailty is a condition resulting from a decline in physiological reserves caused by an accumulation of several deficits, which progressively impairs the ability to recover from health adverse events. Following a promising feasibility study, the HomeHealth trial assessed a holistic tailored intervention for older adults with mild frailty to promote independence in their own homes, compared with usual care. We aimed to understand how goal setting worked among older people with mild frailty.
169. Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA.
作者: David W Dodick.;Peter J Goadsby.;Todd J Schwedt.;Richard B Lipton.;Chengcheng Liu.;Kaifeng Lu.;Sung Yun Yu.;Lawrence Severt.;Michelle Finnegan.;Joel M Trugman.
来源: Lancet. 2023年402卷10419期2307-2316页
Ubrogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist that is approved for acute treatment of migraine. The prodrome is the earliest phase of a migraine attack and is characterised by non-aura symptoms that precede headache onset. The aim of this trial was to evaluate the efficacy, safety, and tolerability of ubrogepant 100 mg compared with placebo for the acute treatment of migraine when administered during the prodrome.
170. Primaquine radical cure in patients with Plasmodium falciparum malaria in areas co-endemic for P falciparum and Plasmodium vivax (PRIMA): a multicentre, open-label, superiority randomised controlled trial.
作者: Kamala Thriemer.;Tamiru Shibiru Degaga.;Michael Christian.;Mohammad Shafiul Alam.;Megha Rajasekhar.;Benedikt Ley.;Mohammad Sharif Hossain.;Mohammad Golam Kibria.;Tedla Teferi Tego.;Dagamawie Tadesse Abate.;Sophie Weston.;Hellen Mnjala.;Angela Rumaseb.;Ari Winasti Satyagraha.;Arkasha Sadhewa.;Lydia Vista Panggalo.;Lenny L Ekawati.;Grant Lee.;Rodas Temesgen Anose.;Fitsum Getahun Kiros.;Julie A Simpson.;Amalia Karahalios.;Adugna Woyessa.;J Kevin Baird.;Inge Sutanto.;Asrat Hailu.;Ric N Price.
来源: Lancet. 2023年402卷10417期2101-2110页
In areas co-endemic for Plasmodium vivax and Plasmodium falciparum there is an increased risk of P vivax parasitaemia following P falciparum malaria. Radical cure is currently only recommended for patients presenting with P vivax malaria. Expanding the indication for radical cure to patients presenting with P falciparum malaria could reduce their risk of subsequent P vivax parasitaemia.
171. Impact of discontinuing oxytocin in active labour on neonatal morbidity: an open-label, multicentre, randomised trial.
作者: Aude Girault.;Loïc Sentilhes.;Raoul Desbrière.;Paul Berveiller.;Diane Korb.;Charline Bertholdt.;Julie Carrara.;Norbert Winer.;Eric Verspyck.;Eric Boudier.;Tiphaine Barjat.;Gilles Levy.;Georges Emmanuel Roth.;Gilles Kayem.;Mona Massoud.;Caroline Bohec.;Paul Guerby.;Elie Azria.;Julie Blanc.;Hélène Heckenroth.;Jessica Rousseau.;Charles Garabedian.;Camille Le Ray.; .
来源: Lancet. 2023年402卷10417期2091-2100页
Oxytocin is effective in reducing labour duration but can be associated with fetal and maternal complications that could potentially be reduced by discontinuing the treatment during labour. We aimed to assess the impact of discontinuing oxytocin during active labour on neonatal morbidity.
172. Efficacy and safety of sparsentan versus irbesartan in patients with IgA nephropathy (PROTECT): 2-year results from a randomised, active-controlled, phase 3 trial.
作者: Brad H Rovin.;Jonathan Barratt.;Hiddo J L Heerspink.;Charles E Alpers.;Stewart Bieler.;Dong-Wan Chae.;Ulysses A Diva.;Jürgen Floege.;Loreto Gesualdo.;Jula K Inrig.;Donald E Kohan.;Radko Komers.;Laura Ann Kooienga.;Richard Lafayette.;Bart Maes.;Robert Małecki.;Alex Mercer.;Irene L Noronha.;Se Won Oh.;Chen Au Peh.;Manuel Praga.;Priscila Preciado.;Jai Radhakrishnan.;Michelle N Rheault.;William E Rote.;Sydney C W Tang.;Vladimir Tesar.;Howard Trachtman.;Hernán Trimarchi.;James A Tumlin.;Muh Geot Wong.;Vlado Perkovic.; .
来源: Lancet. 2023年402卷10417期2077-2090页
Sparsentan, a novel, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist, significantly reduced proteinuria versus irbesartan, an angiotensin II receptor blocker, at 36 weeks (primary endpoint) in patients with immunoglobulin A nephropathy in the phase 3 PROTECT trial's previously reported interim analysis. Here, we report kidney function and outcomes over 110 weeks from the double-blind final analysis.
173. 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.
174. 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.
175. 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.
176. 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.
177. 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.
178. 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.
179. 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.
180. 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.
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