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381. 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.
382. 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.
383. 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.
384. Comparison of two chemotherapy regimens in patients with newly diagnosed Ewing sarcoma (EE2012): an open-label, randomised, phase 3 trial.
作者: Bernadette Brennan.;Laura Kirton.;Perrine Marec-Bérard.;Nathalie Gaspar.;Valerie Laurence.;Javier Martín-Broto.;Ana Sastre.;Hans Gelderblom.;Cormac Owens.;Nicola Fenwick.;Sandra Strauss.;Veronica Moroz.;Jeremy Whelan.;Keith Wheatley.
来源: Lancet. 2022年400卷10362期1513-1521页
Internationally, a single standard chemotherapy treatment for Ewing sarcoma is not defined. Because different chemotherapy regimens were standard in Europe and the USA for newly diagnosed Ewing sarcoma, and in the absence of novel agents to investigate, we aimed to compare these two strategies.
385. An anti-OX40 antibody to treat moderate-to-severe atopic dermatitis: a multicentre, double-blind, placebo-controlled phase 2b study.
作者: Emma Guttman-Yassky.;Eric L Simpson.;Kristian Reich.;Kenji Kabashima.;Ken Igawa.;Tetsuya Suzuki.;Hirotaka Mano.;Takeshi Matsui.;Ehsanollah Esfandiari.;Masutaka Furue.
来源: Lancet. 2023年401卷10372期204-214页
OX40 is crucial for T-cell differentiation and memory induction. The anti-OX40 antibody, rocatinlimab inhibits the OX40 pathway. We evaluated the efficacy and safety of rocatinlimab in adults with moderate-to-severe atopic dermatitis.
386. Evaluation of the safety, immunogenicity, and faecal shedding of novel oral polio vaccine type 2 in healthy newborn infants in Bangladesh: a randomised, controlled, phase 2 clinical trial.
作者: Khaelqu Zaman.;Ananda S Bandyopadhyay.;Masuma Hoque.;Christopher Gast.;Mohammad Yunus.;Khondoker M Jamil.;Bernardo A Mainou.;Jennifer L Konopka-Anstadt.;William S Hendley.;Annelet Vincent.;Ralf Clemens.;Sue Ann Costa Clemens.;Allen G Ross.;John D Clemens.;Erman Tritama.
来源: Lancet. 2023年401卷10371期131-139页
Type 2 circulating vaccine-derived polioviruses (cVDPV2) from Sabin oral poliovirus vaccines (OPVs) are the leading cause of poliomyelitis. A novel type 2 OPV (nOPV2) has been developed to be more genetically stable with similar tolerability and immunogenicity to that of Sabin type 2 vaccines to mitigate the risk of cVDPV2. We aimed to assess these aspects of nOPV2 in poliovirus vaccine-naive newborn infants.
387. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE).
作者: Joseph F Merola.;Robert Landewé.;Iain B McInnes.;Philip J Mease.;Christopher T Ritchlin.;Yoshiya Tanaka.;Akihiko Asahina.;Frank Behrens.;Dafna D Gladman.;Laure Gossec.;Alice B Gottlieb.;Diamant Thaçi.;Richard B Warren.;Barbara Ink.;Deepak Assudani.;Rajan Bajracharya.;Vishvesh Shende.;Jason Coarse.;Laura C Coates.
来源: Lancet. 2023年401卷10370期38-48页
Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F and IL-17A. This study compared the efficacy and safety of bimekizumab with placebo over 16 weeks in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α (TNFα) inhibitors.
388. Trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer: updated results from DESTINY-Breast03, a randomised, open-label, phase 3 trial.
作者: Sara A Hurvitz.;Roberto Hegg.;Wei-Pang Chung.;Seock-Ah Im.;William Jacot.;Vinod Ganju.;Joanne Wing Yan Chiu.;Binghe Xu.;Erika Hamilton.;Srinivasan Madhusudan.;Hiroji Iwata.;Sevilay Altintas.;Jan-Willem Henning.;Giuseppe Curigliano.;José Manuel Perez-Garcia.;Sung-Bae Kim.;Vanessa Petry.;Chiun-Sheng Huang.;Wei Li.;Jean-Sebastien Frenel.;Silvia Antolin.;Winnie Yeo.;Giampaolo Bianchini.;Sherene Loi.;Junji Tsurutani.;Anton Egorov.;Yali Liu.;Jillian Cathcart.;Shahid Ashfaque.;Javier Cortés.
来源: Lancet. 2023年401卷10371期105-117页
An improvement in progression-free survival was shown with trastuzumab deruxtecan versus trastuzumab emtansine in patients with HER2-positive metastatic breast cancer in the progression-free survival interim analysis of the DESTINY-Breast03 trial. The aim of DESTINY-Breast03 was to compare the efficacy and safety of trastuzumab deruxtecan versus trastuzumab emtansine.
389. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL).
作者: Iain B McInnes.;Akihiko Asahina.;Laura C Coates.;Robert Landewé.;Joseph F Merola.;Christopher T Ritchlin.;Yoshiya Tanaka.;Laure Gossec.;Alice B Gottlieb.;Richard B Warren.;Barbara Ink.;Deepak Assudani.;Rajan Bajracharya.;Vishvesh Shende.;Jason Coarse.;Philip J Mease.
来源: Lancet. 2023年401卷10370期25-37页
Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17A and IL-17F. We assessed the efficacy and safety of bimekizumab in patients with active psoriatic arthritis who were naive to biologic disease-modifying antirheumatic drugs (DMARDs).
390. Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial.
作者: George R Thompson.;Alex Soriano.;Oliver A Cornely.;Bart Jan Kullberg.;Marin Kollef.;Jose Vazquez.;Patrick M Honore.;Matteo Bassetti.;John Pullman.;Methee Chayakulkeeree.;Ivan Poromanski.;Cecilia Dignani.;Anita F Das.;Taylor Sandison.;Peter G Pappas.; .
来源: Lancet. 2023年401卷10370期49-59页
Rezafungin is a next-generation, once-a-week echinocandin in development for the treatment of candidaemia and invasive candidiasis and for the prevention of invasive fungal disease caused by Candida, Aspergillus, and Pneumocystis spp after blood and marrow transplantation. We aimed to compare the efficacy and safety of intravenous rezafungin versus intravenous caspofungin in patients with candidaemia and invasive candidiasis.
391. Evaluation of two short standardised regimens for the treatment of rifampicin-resistant tuberculosis (STREAM stage 2): an open-label, multicentre, randomised, non-inferiority trial.
作者: Ruth L Goodall.;Sarah K Meredith.;Andrew J Nunn.;Adamu Bayissa.;Anuj K Bhatnagar.;Gay Bronson.;Chen-Yuan Chiang.;Francesca Conradie.;Meera Gurumurthy.;Bruce Kirenga.;Nana Kiria.;Daniel Meressa.;Ronelle Moodliar.;Gopalan Narendran.;Nosipho Ngubane.;Mohammed Rassool.;Karen Sanders.;Rajesh Solanki.;S Bertel Squire.;Gabriela Torrea.;Bazarragchaa Tsogt.;Elena Tudor.;Armand Van Deun.;I D Rusen.; .
来源: Lancet. 2022年400卷10366期1858-1868页
The STREAM stage 1 trial showed that a 9-month regimen for the treatment of rifampicin-resistant tuberculosis was non-inferior to the 20-month 2011 WHO-recommended regimen. In STREAM stage 2, we aimed to compare two bedaquiline-containing regimens with the 9-month STREAM stage 1 regimen.
392. Q-122 as a novel, non-hormonal, oral treatment for vasomotor symptoms in women taking tamoxifen or an aromatase inhibitor after breast cancer: a phase 2, randomised, double-blind, placebo-controlled trial.
作者: Amanda Vrselja.;Ardian Latifi.;Rodney J Baber.;Bronwyn G A Stuckey.;Michael G Walker.;Vered Stearns.;Martha Hickey.;Susan R Davis.
来源: Lancet. 2022年400卷10364期1704-1711页
Vasomotor symptoms (hot flushes and night sweats) are experienced by more than two-thirds of women with breast cancer taking oral adjuvant endocrine therapy. Safe and effective treatments are lacking. Q-122 is a novel, non-hormonal compound that has shown promise for reducing vasomotor symptoms by modulation of oestrogen-responsive neurons in the hypothalamus. We aimed to assess the efficacy and safety of Q-122 in women with breast cancer taking oral adjuvant endocrine therapy and experiencing vasomotor symptoms.
393. Dual endothelin antagonist aprocitentan for resistant hypertension (PRECISION): a multicentre, blinded, randomised, parallel-group, phase 3 trial.
作者: Markus P Schlaich.;Marc Bellet.;Michael A Weber.;Parisa Danaietash.;George L Bakris.;John M Flack.;Roland F Dreier.;Mouna Sassi-Sayadi.;Lloyd P Haskell.;Krzysztof Narkiewicz.;Ji-Guang Wang.; .
来源: Lancet. 2022年400卷10367期1927-1937页
Resistant hypertension is associated with increased cardiovascular risk. The endothelin pathway has been implicated in the pathogenesis of hypertension, but it is currently not targeted therapeutically, thereby leaving this relevant pathophysiological pathway unopposed with currently available drugs. The aim of the study was to assess the blood pressure lowering efficacy of the dual endothelin antagonist aprocitentan in patients with resistant hypertension.
394. Safety, tolerability and efficacy of up-titration of guideline-directed medical therapies for acute heart failure (STRONG-HF): a multinational, open-label, randomised, trial.
作者: Alexandre Mebazaa.;Beth Davison.;Ovidiu Chioncel.;Alain Cohen-Solal.;Rafael Diaz.;Gerasimos Filippatos.;Marco Metra.;Piotr Ponikowski.;Karen Sliwa.;Adriaan A Voors.;Christopher Edwards.;Maria Novosadova.;Koji Takagi.;Albertino Damasceno.;Hadiza Saidu.;Etienne Gayat.;Peter S Pang.;Jelena Celutkiene.;Gad Cotter.
来源: Lancet. 2022年400卷10367期1938-1952页
There is a paucity of evidence for dose and pace of up-titration of guideline-directed medical therapies after admission to hospital for acute heart failure.
395. LY3437943, a novel triple GIP, GLP-1, and glucagon receptor agonist in people with type 2 diabetes: a phase 1b, multicentre, double-blind, placebo-controlled, randomised, multiple-ascending dose trial.
作者: Shweta Urva.;Tamer Coskun.;Mei Teng Loh.;Yu Du.;Melissa K Thomas.;Sirel Gurbuz.;Axel Haupt.;Charles T Benson.;Martha Hernandez-Illas.;David A D'Alessio.;Zvonko Milicevic.
来源: Lancet. 2022年400卷10366期1869-1881页
Treating hyperglycaemia and obesity in individuals with type 2 diabetes using multi-receptor agonists can improve short-term and long-term outcomes. LY3437943 is a single peptide with agonist activity for glucagon, glucose-dependent insulinotropic polypeptide (GIP), and glucagon-like peptide 1 (GLP-1) receptors that is currently in development for the treatment of type 2 diabetes and for the treatment of obesity and associated comorbidities. We investigated the safety, pharmacokinetics, and pharmacodynamics of multiple weekly doses of LY3437943 in people with type 2 diabetes in a 12-week study.
396. Intermediate-dose versus low-dose low-molecular-weight heparin in pregnant and post-partum women with a history of venous thromboembolism (Highlow study): an open-label, multicentre, randomised, controlled trial.
作者: Ingrid M Bistervels.;Andrea Buchmüller.;Hanke M G Wiegers.;Fionnuala Ní Áinle.;Bernard Tardy.;Jennifer Donnelly.;Peter Verhamme.;Anne F Jacobsen.;Anette T Hansen.;Marc A Rodger.;Maria T DeSancho.;Roman G Shmakov.;Nick van Es.;Martin H Prins.;Céline Chauleur.;Saskia Middeldorp.; .; .
来源: Lancet. 2022年400卷10365期1777-1787页
Pregnancy-related venous thromboembolism is a leading cause of maternal morbidity and mortality, and thromboprophylaxis is indicated in pregnant and post-partum women with a history of venous thromboembolism. The optimal dose of low-molecular-weight heparin to prevent recurrent venous thromboembolism in pregnancy and the post-partum period is uncertain.
397. Bivalirudin plus a high-dose infusion versus heparin monotherapy in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: a randomised trial.
作者: Yi Li.;Zhenyang Liang.;Lei Qin.;Mian Wang.;Xianzhao Wang.;Huanyi Zhang.;Yin Liu.;Yan Li.;Zhisheng Jia.;Limin Liu.;Hongyan Zhang.;Jun Luo.;Songwu Dong.;Jincheng Guo.;Hengqing Zhu.;Shengli Li.;Haijun Zheng.;Lijun Liu.;Yanqing Wu.;Yiming Zhong.;Miaohan Qiu.;Yaling Han.;Gregg W Stone.
来源: Lancet. 2022年400卷10366期1847-1857页
Previous randomised trials of bivalirudin versus heparin in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) have reported conflicting results, in part because of treatment with different pharmacological regimens. We designed a large-scale trial examining bivalirudin with a post-PCI high-dose infusion compared with heparin alone, the regimens that previous studies have shown to have the best balance of safety and efficacy.
398. Intravenous ferric derisomaltose in patients with heart failure and iron deficiency in the UK (IRONMAN): an investigator-initiated, prospective, randomised, open-label, blinded-endpoint trial.
作者: Paul R Kalra.;John G F Cleland.;Mark C Petrie.;Elizabeth A Thomson.;Philip A Kalra.;Iain B Squire.;Fozia Z Ahmed.;Abdallah Al-Mohammad.;Peter J Cowburn.;Paul W X Foley.;Fraser J Graham.;Alan G Japp.;Rebecca E Lane.;Ninian N Lang.;Andrew J Ludman.;Iain C Macdougall.;Pierpaolo Pellicori.;Robin Ray.;Michele Robertson.;Alison Seed.;Ian Ford.; .
来源: Lancet. 2022年400卷10369期2199-2209页
For patients with heart failure, reduced left ventricular ejection fraction and iron deficiency, intravenous ferric carboxymaltose administration improves quality of life and exercise capacity in the short-term and reduces hospital admissions for heart failure up to 1 year. We aimed to evaluate the longer-term effects of intravenous ferric derisomaltose on cardiovascular events in patients with heart failure.
399. Personalised cooler dialysate for patients receiving maintenance haemodialysis (MyTEMP): a pragmatic, cluster-randomised trial.
Haemodialysis centres have conventionally provided maintenance haemodialysis using a standard dialysate temperature (eg, 36·5°C) for all patients. Many centres now use cooler dialysate (eg, 36·0°C or lower) for potential cardiovascular benefits. We aimed to assess whether personalised cooler dialysate, implemented as centre-wide policy, reduced the risk of cardiovascular-related death or hospital admission compared with standard temperature dialysate.
400. Intensive blood pressure control after endovascular thrombectomy for acute ischaemic stroke (ENCHANTED2/MT): a multicentre, open-label, blinded-endpoint, randomised controlled trial.
作者: Pengfei Yang.;Lili Song.;Yongwei Zhang.;Xiaoxi Zhang.;Xiaoying Chen.;Yunke Li.;Lingli Sun.;Yingfeng Wan.;Laurent Billot.;Qiang Li.;Xinwen Ren.;Hongjian Shen.;Lei Zhang.;Zifu Li.;Pengfei Xing.;Yongxin Zhang.;Ping Zhang.;Weilong Hua.;Fang Shen.;Yihan Zhou.;Bing Tian.;Wenhuo Chen.;Hongxing Han.;Liyong Zhang.;Chenghua Xu.;Tong Li.;Ya Peng.;Xincan Yue.;Shengli Chen.;Changming Wen.;Shu Wan.;Congguo Yin.;Ming Wei.;Hansheng Shu.;Guangxian Nan.;Sheng Liu.;Wenhua Liu.;Yiling Cai.;Yi Sui.;Maohua Chen.;Yu Zhou.;Qiao Zuo.;Dongwei Dai.;Rui Zhao.;Qiang Li.;Qinghai Huang.;Yi Xu.;Benqiang Deng.;Tao Wu.;Jianping Lu.;Xia Wang.;Mark W Parsons.;Ken Butcher.;Bruce Campbell.;Thompson G Robinson.;Mayank Goyal.;Diederik Dippel.;Yvo Roos.;Charles Majoie.;Longde Wang.;Yongjun Wang.;Jianmin Liu.;Craig S Anderson.; .
来源: Lancet. 2022年400卷10363期1585-1596页
The optimum systolic blood pressure after endovascular thrombectomy for acute ischaemic stroke is uncertain. We aimed to compare the safety and efficacy of blood pressure lowering treatment according to more intensive versus less intensive treatment targets in patients with elevated blood pressure after reperfusion with endovascular treatment.
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