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61. Induced pluripotent stem-cell-derived corneal epithelium for transplant surgery: a single-arm, open-label, first-in-human interventional study in Japan.
作者: Takeshi Soma.;Yoshinori Oie.;Hiroshi Takayanagi.;Shoko Matsubara.;Tomomi Yamada.;Masaki Nomura.;Yu Yoshinaga.;Kazuichi Maruyama.;Atsushi Watanabe.;Kayo Takashima.;Zaixing Mao.;Andrew J Quantock.;Ryuhei Hayashi.;Kohji Nishida.
来源: Lancet. 2024年404卷10466期1929-1939页
The loss of corneal epithelial stem cells from the limbus at the edge of the cornea has severe consequences for vision, with the pathological manifestations of a limbal stem-cell deficiency (LSCD) difficult to treat. Here, to the best of our knowledge, we report the world's first use of corneal epithelial cell sheets derived from human induced pluripotent stem cells (iPSCs) to treat LSCD.
62. Effectiveness, cost-effectiveness, and positive externalities of integrated chronic care for adults with major depressive disorder in Malawi (IC3D): a stepped-wedge, cluster-randomised, controlled trial.
作者: Ryan K McBain.;Owen Mwale.;Kondwani Mpinga.;Myrrah Kamwiyo.;Waste Kayira.;Todd Ruderman.;Emilia Connolly.;Samuel I Watson.;Emily B Wroe.;Fabien Munyaneza.;Luckson Dullie.;Giuseppe Raviola.;Stephanie L Smith.;Kazione Kulisewa.;Michael Udedi.;Vikram Patel.;Glenn J Wagner.
来源: Lancet. 2024年404卷10465期1823-1834页
In low-income and middle-income countries, individuals with major depressive disorder often do not receive screening and treatment. We assessed effectiveness and cost-effectiveness of an integrated care model for treating major depressive disorder in Malawi, accounting for two sets of positive externalities: household benefits and improvements in comorbidities.
63. Quantitative flow ratio versus fractional flow reserve for coronary revascularisation guidance (FAVOR III Europe): a multicentre, randomised, non-inferiority trial.
作者: Birgitte Krogsgaard Andersen.;Martin Sejr-Hansen.;Luc Maillard.;Gianluca Campo.;Truls Råmunddal.;Barbara E Stähli.;Vincenzo Guiducci.;Luigi Di Serafino.;Javier Escaned.;Ignacio Amat Santos.;Ramón López-Palop.;Ulf Landmesser.;Ruthe Storgaard Dieu.;Hernán Mejía-Rentería.;Lukasz Koltowski.;Greta Žiubrytė.;Laura Cetran.;Julien Adjedj.;Youssef S Abdelwahed.;Tommy Liu.;Lone Juul Hune Mogensen.;Ashkan Eftekhari.;Jelmer Westra.;Karsten Lenk.;Gianni Casella.;Eric Van Belle.;Simone Biscaglia.;Niels Thue Olsen.;Paul Knaapen.;Janusz Kochman.;Ramón Calviño Santos.;Roberto Scarsini.;Evald Høj Christiansen.;Niels Ramsing Holm.
来源: Lancet. 2024年404卷10465期1835-1846页
Fractional flow reserve (FFR) or non-hyperaemic pressure ratios are recommended to assess functional relevance of intermediate coronary stenosis. Both diagnostic methods require the placement of a pressure wire in the coronary artery during invasive coronary angiography. Quantitative flow ratio (QFR) is an angiography-based computational method for the estimation of FFR that does not require the use of pressure wires. We aimed to investigate whether a QFR-based diagnostic strategy yields a non-inferior 12-month clinical outcome compared with an FFR-based strategy.
64. Bioadaptor implant versus contemporary drug-eluting stent in percutaneous coronary interventions in Sweden (INFINITY-SWEDEHEART): a single-blind, non-inferiority, registry-based, randomised controlled trial.
作者: David Erlinge.;Jonas Andersson.;Ole Fröbert.;Mattias Törnerud.;Mehmet Hamid.;Thomas Kellerth.;Per Grimfjärd.;Oscar Winnberg.;Juliane Jurga.;Henrik Wagner.;Sammy Zwackman.;Martin Adielsson.;Patrik Alström.;Elli Masoe.;Anders Ulvenstam.;Jonas Millgård.;Felix Böhm.;Claes Held.;Henrik Renlund.;Jonas Oldgren.;Pieter C Smits.;Candace Elek.;Andrea Abizaid.;Stefan James.
来源: Lancet. 2024年404卷10464期1750-1759页
Persistent non-plateauing adverse event rates in patients who underwent percutaneous coronary intervention (PCI) remain a challenge. A bioadaptor is a novel implant that addresses this issue by restoring the haemodynamic modulation of the artery, allowing cyclic pulsatility, vasomotion, and adaptative remodelling, by unlocking and providing dynamic support to the artery. We aimed to assess outcomes with the device versus a contemporary drug-eluting stent (DES) in a representative PCI population.
65. The effect of tranexamic acid on postpartum bleeding in women with moderate and severe anaemia (WOMAN-2): an international, randomised, double-blind, placebo-controlled trial.
Tranexamic acid, given within 3 h of birth, reduces bleeding deaths in women with postpartum haemorrhage. We examined whether giving tranexamic acid shortly after birth can prevent postpartum haemorrhage in women with moderate or severe anaemia.
66. Efficacy and safety of a novel low-dose triple single-pill combination of telmisartan, amlodipine and indapamide, compared with dual combinations for treatment of hypertension: a randomised, double-blind, active-controlled, international clinical trial.
作者: Anthony Rodgers.;Abdul Salam.;Aletta E Schutte.;William C Cushman.;H Asita de Silva.;Gian Luca Di Tanna.;Diederick E Grobbee.;Krzysztof Narkiewicz.;Dike B Ojji.;Neil R Poulter.;Markus P Schlaich.;Suzanne Oparil.;Wilko Spiering.;Bryan Williams.;Jackson T Wright.;P Lakshman.;W Uluwattage.;P Hay.;T Pereira.;N Amarasena.;G Ranasinghe.;Chris Gianacas.;Mathangi Shanthakumar.;Xiaoqiu Liu.;Nelson Wang.;Sonali R Gnanenthiran.;Paul K Whelton.; .
来源: Lancet. 2024年404卷10462期1536-1546页
Single-pill combinations (SPCs) of three low-dose antihypertensive drugs can improve hypertension control but are not widely available. A key issue for any combination product is the contribution of each component to efficacy and tolerability. This trial compared a new triple SPC called GMRx2, containing telmisartan, amlodipine, and indapamide, with dual combinations of components for efficacy and safety.
67. Cadonilimab plus platinum-based chemotherapy with or without bevacizumab as first-line treatment for persistent, recurrent, or metastatic cervical cancer (COMPASSION-16): a randomised, double-blind, placebo-controlled phase 3 trial in China.
作者: Xiaohua Wu.;Yang Sun.;Hongying Yang.;Jing Wang.;Hanmei Lou.;Dan Li.;Ke Wang.;Hui Zhang.;Tao Wu.;Yuzhi Li.;Chunyan Wang.;Guiling Li.;Yifeng Wang.;Dapeng Li.;Ying Tang.;Mei Pan.;Hongyi Cai.;Weihu Wang.;Bing Yang.;Hua Qian.;Qiuhong Tian.;Desheng Yao.;Ying Cheng.;Bing Wei.;Xiumin Li.;Tao Wang.;Min Hao.;Xiaohong Wang.;Tiejun Wang.;Juntao Ran.;Hong Zhu.;Lijing Zhu.;Xianling Liu.;Yunxia Li.;Lihong Chen.;Qingshan Li.;Xiaojian Yan.;Fei Wang.;Hongbing Cai.;Yunyan Zhang.;Zhiqing Liang.;Funan Liu.;Yi Huang.;Bairong Xia.;Pengpeng Qu.;Genhai Zhu.;Youguo Chen.;Kun Song.;Meili Sun.;Zhengzheng Chen.;Qiang Zhou.;Lina Hu.;Guzhalinuer Abulizi.;Hongyan Guo.;Sihai Liao.;Yijing Ye.;Ping Yan.;Qiu Tang.;Guoping Sun.;Ting Liu.;Dongmei Lu.;Mingxiu Hu.;Zhongmin M Wang.;Baiyong Li.;Michelle Xia.
来源: Lancet. 2024年404卷10463期1668-1676页
Cadonilimab is a bispecific antibody targeting PD-1 and CTLA-4, which has shown substantial clinical benefits in advanced cervical cancer. In the COMPASSION-16 trial, we aimed to evaluate the addition of cadonilimab to first-line standard chemotherapy in persistent, recurrent, or metastatic cervical cancer.
68. Induction chemotherapy followed by standard chemoradiotherapy versus standard chemoradiotherapy alone in patients with locally advanced cervical cancer (GCIG INTERLACE): an international, multicentre, randomised phase 3 trial.
作者: Mary McCormack.;Gemma Eminowicz.;Dolores Gallardo.;Patricia Diez.;Laura Farrelly.;Christopher Kent.;Emma Hudson.;Miguel Panades.;Tony Mathew.;Anjana Anand.;Mojca Persic.;Jennifer Forrest.;Rajanee Bhana.;Nicholas Reed.;Anne Drake.;Madhavi Adusumalli.;Asima Mukhopadhyay.;Margaret King.;Karen Whitmarsh.;John McGrane.;Nicoletta Colombo.;Choi Mak.;Ranajit Mandal.;Rahul Roy Chowdhury.;Gabriela Alamilla-Garcia.;Adriana Chávez-Blanco.;Hilary Stobart.;Amanda Feeney.;Simran Vaja.;Anne-Marie Hacker.;Allan Hackshaw.;Jonathan Andrew Ledermann.; .
来源: Lancet. 2024年404卷10462期1525-1535页
Locally advanced cervical cancer is treated with chemoradiotherapy (standard of care), but many patients still relapse and die from metastatic disease. We investigated chemoradiotherapy with or without induction chemotherapy to determine whether induction chemotherapy improves both progression-free survival and overall survival.
69. Efficacy of a culturally adapted, cognitive behavioural therapy-based intervention for postnatal depression in British south Asian women (ROSHNI-2): a multicentre, randomised controlled trial.
作者: Nusrat Husain.;Farah Lunat.;Karina Lovell.;Jahanara Miah.;Carolyn A Chew-Graham.;Penny Bee.;Ahmed Waqas.;Matthias Pierce.;Deepali Sharma.;Najia Atif.;Saadia Aseem.;Kamaldeep Bhui.;Peter Bower.;Traolach Brugha.;Nasim Chaudhry.;Akbar Ullah.;Linda Davies.;Nadeem Gire.;Joe Kai.;Jillian Morrison.;Naeem Mohmed.;Shanaya Rathod.;Najma Siddiqi.;Siham Sikander.;Waquas Waheed.;Ilyas Mirza.;Christopher Williams.;Nosheen Zaidi.;Richard Emsley.;Atif Rahman.;Richard Morriss.
来源: Lancet. 2024年404卷10461期1430-1443页
Postnatal depression necessitates timely and effective interventions to mitigate adverse maternal and child outcomes in the short term and over the life course. British south Asian women with depression are often underserved and undertreated due to stigma, language barriers, and cultural barriers. This trial aimed to test the clinical efficacy of a culturally adapted, group cognitive behavioural therapy (CBT)-based intervention, the Positive Health Programme (PHP), delivered by non-specialist health workers for postnatal depression in British south Asian women.
70. 5-year vaccine protection following a single dose of Vi-tetanus toxoid conjugate vaccine in Bangladeshi children (TyVOID): a cluster randomised trial.
作者: Firdausi Qadri.;Farhana Khanam.;Yiyuan Zhang.;Prasanta Kumar Biswas.;Merryn Voysey.;Yama F Mujadidi.;Sarah Kelly.;Amirul Islam Bhuiyan.;Nazmul Hasan Rajib.;Ismail Hossen.;Nazia Rahman.;Sadia Islam.;Virginia E Pitzer.;Young Chan Kim.;John D Clemens.;Andrew J Pollard.;Xinxue Liu.
来源: Lancet. 2024年404卷10461期1419-1429页
WHO currently recommends a single dose of typhoid conjugate vaccine (TCV) in high-burden countries based on 2-year vaccine efficacy data from large randomised controlled trials. Given the decay of immunogenicity, the protection beyond 2 years is unknown. We therefore extended the follow-up of the TyVAC trial in Bangladesh to assess waning of vaccine protection to 5 years after vaccination.
71. Effects of oral sepiapterin on blood Phe concentration in a broad range of patients with phenylketonuria (APHENITY): results of an international, phase 3, randomised, double-blind, placebo-controlled trial.
作者: Ania C Muntau.;Nicola Longo.;Fatih Ezgu.;Ida Vanessa D Schwartz.;Melissa Lah.;Drago Bratkovic.;Lali Margvelashvili.;Ertugrul Kiykim.;Roberto Zori.;Jaume Campistol Plana.;Amaya Bélanger-Quintana.;Allan Lund.;Laura Guilder.;Anupam Chakrapani.;Halise Neslihan Mungan.;Arlindo Guimas.;Ixiu Del Carmen Cabrales Guerra.;Anita MacDonald.;Kimberly Ingalls.;Neil Smith.; .
来源: Lancet. 2024年404卷10460期1333-1345页
Phenylketonuria is an inherited condition characterised by neurotoxic accumulation of phenylalanine (Phe). APHENITY assessed the efficacy and safety of orally administered synthetic sepiapterin in children and adults with phenylketonuria.
72. Liver transplantation plus chemotherapy versus chemotherapy alone in patients with permanently unresectable colorectal liver metastases (TransMet): results from a multicentre, open-label, prospective, randomised controlled trial.
作者: René Adam.;Céline Piedvache.;Laurence Chiche.;Jean Philippe Adam.;Ephrem Salamé.;Petru Bucur.;Daniel Cherqui.;Olivier Scatton.;Victoire Granger.;Michel Ducreux.;Umberto Cillo.;François Cauchy.;Jean-Yves Mabrut.;Chris Verslype.;Laurent Coubeau.;Jean Hardwigsen.;Emmanuel Boleslawski.;Fabrice Muscari.;Heithem Jeddou.;Denis Pezet.;Bruno Heyd.;Valerio Lucidi.;Karen Geboes.;Jan Lerut.;Pietro Majno.;Lamiae Grimaldi.;Francis Levi.;Maïté Lewin.;Maximiliano Gelli.; .
来源: Lancet. 2024年404卷10458期1107-1118页
Despite the increasing efficacy of chemotherapy, permanently unresectable colorectal liver metastases are associated with poor long-term survival. We aimed to assess whether liver transplantation plus chemotherapy could improve overall survival.
73. 177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial.
作者: Michael J Morris.;Daniel Castellano.;Ken Herrmann.;Johann S de Bono.;Neal D Shore.;Kim N Chi.;Michael Crosby.;Josep M Piulats.;Aude Fléchon.;Xiao X Wei.;Hakim Mahammedi.;Guilhem Roubaud.;Hana Študentová.;James Nagarajah.;Begoña Mellado.;Álvaro Montesa-Pino.;Euloge Kpamegan.;Samson Ghebremariam.;Teri N Kreisl.;Celine Wilke.;Katja Lehnhoff.;Oliver Sartor.;Karim Fizazi.; .
来源: Lancet. 2024年404卷10459期1227-1239页
[177Lu]Lu-PSMA-617 (177Lu-PSMA-617) prolongs radiographic progression-free survival and overall survival in patients with metastatic castration-resistant prostate cancer previously treated with androgen receptor pathway inhibitor (ARPI) and taxane therapy. We aimed to investigate the efficacy of 177Lu-PSMA-617 in patients with taxane-naive metastatic castration-resistant prostate cancer.
74. Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab compared with neoadjuvant chemotherapy alone in patients with early-stage non-small-cell lung cancer (KEYNOTE-671): a randomised, double-blind, placebo-controlled, phase 3 trial.
作者: Jonathan D Spicer.;Marina C Garassino.;Heather Wakelee.;Moishe Liberman.;Terufumi Kato.;Masahiro Tsuboi.;Se-Hoon Lee.;Ke-Neng Chen.;Christophe Dooms.;Margarita Majem.;Ekkehard Eigendorff.;Gastón L Martinengo.;Olivier Bylicki.;Delvys Rodríguez-Abreu.;Jamie E Chaft.;Silvia Novello.;Jing Yang.;Ashwini Arunachalam.;Steven M Keller.;Ayman Samkari.;Shugeng Gao.; .
来源: Lancet. 2024年404卷10459期1240-1252页
At the first interim analysis of the KEYNOTE-671 trial, adding perioperative pembrolizumab to neoadjuvant chemotherapy significantly improved event-free survival in participants with early-stage non-small-cell lung cancer (NSCLC). We report overall survival and health-related quality of life outcomes from the second interim analysis.
75. Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 trial.
作者: Domenica Lorusso.;Yang Xiang.;Kosei Hasegawa.;Giovanni Scambia.;Manuel Leiva.;Pier Ramos-Elias.;Alejandro Acevedo.;Jakub Cvek.;Leslie Randall.;Andrea Juliana Pereira de Santana Gomes.;Fernando Contreras Mejía.;Limor Helpman.;Hüseyin Akıllı.;Jung-Yun Lee.;Valeriya Saevets.;Flora Zagouri.;Lucy Gilbert.;Jalid Sehouli.;Ekkasit Tharavichitkul.;Kristina Lindemann.;Nicoletta Colombo.;Chih-Long Chang.;Marketa Bednarikova.;Hong Zhu.;Ana Oaknin.;Melissa Christiaens.;Edgar Petru.;Tomoka Usami.;Peng Liu.;Karin Yamada.;Sarper Toker.;Stephen M Keefe.;Sandro Pignata.;Linda R Duska.; .
来源: Lancet. 2024年404卷10460期1321-1332页
At the first interim analysis of the phase 3 ENGOT-cx11/GOG-3047/KEYNOTE-A18 study, the addition of pembrolizumab to chemoradiotherapy provided a statistically significant and clinically meaningful improvement in progression-free survival in patients with locally advanced cervical cancer. We report the overall survival results from the second interim analysis of this study.
76. Tivozanib plus nivolumab versus tivozanib monotherapy in patients with renal cell carcinoma following an immune checkpoint inhibitor: results of the phase 3 TiNivo-2 Study.
作者: Toni K Choueiri.;Laurence Albiges.;Philippe Barthélémy.;Roberto Iacovelli.;Sheik Emambux.;Javier Molina-Cerrillo.;Benjamin Garmezy.;Pedro Barata.;Arnab Basu.;Maria T Bourlon.;Helen Moon.;Raffaele Ratta.;Rana R McKay.;Alexander Chehrazi-Raffle.;Hans Hammers.;Daniel Y C Heng.;Edgar Braendle.;Kathryn E Beckermann.;Bradley A McGregor.;Robert J Motzer.
来源: Lancet. 2024年404卷10460期1309-1320页
Immune checkpoint inhibitors (ICIs) and vascular endothelial growth factor receptor tyrosine kinase inhibitors are cornerstones of first-line treatment for advanced renal cell carcinoma; however, optimal treatment sequencing after progression is unknown. This study aimed to assess clinical outcomes of tivozanib-nivolumab versus tivozanib monotherapy in patients with metastatic renal cell carcinoma who have progressed following one or two lines of therapy in the post-ICI setting.
77. Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 1 diabetes (QWINT-5): a phase 3 randomised non-inferiority trial.
作者: Richard M Bergenstal.;Ruth S Weinstock.;Chantal Mathieu.;Yukiko Onishi.;Vishali Vijayanagaram.;Michelle L Katz.;Molly C Carr.;Annette M Chang.
来源: Lancet. 2024年404卷10458期1132-1142页
Insulin efsitora alfa (efsitora) is a once-weekly basal insulin. This phase 3 study aimed to assess the efficacy and safety of efsitora compared with insulin degludec (degludec) in adults with type 1 diabetes.
78. Safety and efficacy of ATSN-101 in patients with Leber congenital amaurosis caused by biallelic mutations in GUCY2D: a phase 1/2, multicentre, open-label, unilateral dose escalation study.
作者: Paul Yang.;Laura P Pardon.;Allen C Ho.;Andreas K Lauer.;Dan Yoon.;Shannon E Boye.;Sanford L Boye.;Alejandro J Roman.;Vivian Wu.;Alexandra V Garafalo.;Alexander Sumaroka.;Malgorzata Swider.;Iryna Viarbitskaya.;Tomas S Aleman.;Mark E Pennesi.;Christine N Kay.;Kenji P Fujita.;Artur V Cideciyan.
来源: Lancet. 2024年404卷10456期962-970页
Leber congenital amaurosis 1 (LCA1), caused by mutations in GUCY2D, is a rare inherited retinal disease that typically causes blindness in early childhood. The aim of this study was to evaluate the safety and preliminary efficacy of ascending doses of ATSN-101, a subretinal AAV5 gene therapy for LCA1.
79. Optical coherence tomography-guided versus angiography-guided percutaneous coronary intervention for patients with complex lesions (OCCUPI): an investigator-initiated, multicentre, randomised, open-label, superiority trial in South Korea.
作者: Sung-Jin Hong.;Seung-Jun Lee.;Sang-Hyup Lee.;Jong-Young Lee.;Deok-Kyu Cho.;Jin Won Kim.;Sang Min Kim.;Seung-Ho Hur.;Jung Ho Heo.;Ji-Yong Jang.;Jin Sin Koh.;Hoyoun Won.;Jun-Won Lee.;Soon Jun Hong.;Dong-Kie Kim.;Jeong Cheon Choe.;Jin Bae Lee.;Soo-Joong Kim.;Tae-Hyun Yang.;Jung-Hee Lee.;Young Joon Hong.;Jong-Hwa Ahn.;Yong-Joon Lee.;Chul-Min Ahn.;Jung-Sun Kim.;Young-Guk Ko.;Donghoon Choi.;Myeong-Ki Hong.;Yangsoo Jang.;Byeong-Keuk Kim.; .
来源: Lancet. 2024年404卷10457期1029-1039页
Despite the detailed imaging information provided by optical coherence tomography (OCT) during percutaneous coronary intervention (PCI), clinical benefits of this imaging technique in this setting remain uncertain. The aim of the OCCUPI trial was to compare the clinical benefits of OCT-guided versus angiography-guided PCI for complex lesions, assessed as the rate of major adverse cardiac events at 1 year.
80. Drug-coated balloon angioplasty with rescue stenting versus intended stenting for the treatment of patients with de novo coronary artery lesions (REC-CAGEFREE I): an open-label, randomised, non-inferiority trial.
作者: Chao Gao.;Xingqiang He.;Fan Ouyang.;Zhihui Zhang.;Guidong Shen.;Mingxing Wu.;Ping Yang.;Likun Ma.;Feng Yang.;Zheng Ji.;Hua Wang.;Yanqing Wu.;Zhenfei Fang.;Hong Jiang.;Shangyu Wen.;Yi Liu.;Fei Li.;Jingyu Zhou.;Bin Zhu.;Yunpeng Liu.;Ruining Zhang.;Tingting Zhang.;Ping Wang.;Jianzheng Liu.;Zhiwei Jiang.;Jielai Xia.;Robert-Jan van Geuns.;Davide Capodanno.;Scot Garg.;Yoshinobu Onuma.;Duolao Wang.;Patrick W Serruys.;Ling Tao.; .
来源: Lancet. 2024年404卷10457期1040-1050页
The long-term impact of drug-coated balloon (DCB) angioplasty for the treatment of patients with de novo coronary artery lesions remains uncertain. We aimed to assess the non-inferiority of DCB angioplasty with rescue stenting to intended drug-eluting stent (DES) deployment for patients with de novo, non-complex coronary artery lesions.
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