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141. Long-term efficacy of a recombinant hepatitis E vaccine in adults: 10-year results from a randomised, double-blind, placebo-controlled, phase 3 trial.
作者: Shoujie Huang.;Xuefeng Zhang.;Yingying Su.;Chunlan Zhuang.;Zimin Tang.;Xingcheng Huang.;Qi Chen.;Kongxin Zhu.;Xiaowen Hu.;Dong Ying.;Xiaohui Liu.;Hanmin Jiang.;Xia Zang.;Zhongze Wang.;Changlin Yang.;Donglin Liu.;Yijun Wang.;Quan Tang.;Wentong Shen.;Huanhuan Cao.;Huirong Pan.;Shengxiang Ge.;Yue Huang.;Ting Wu.;Zizheng Zheng.;Fengcai Zhu.;Jun Zhang.;Ningshao Xia.
来源: Lancet. 2024年403卷10429期813-823页
Hepatitis E virus (HEV) is a frequently overlooked causative agent of acute hepatitis. Evaluating the long-term durability of hepatitis E vaccine efficacy holds crucial importance.
142. Targeted prophylactic anticoagulation based on the TRiP(cast) score in patients with lower limb immobilisation: a multicentre, stepped wedge, randomised implementation trial.
作者: Delphine Douillet.;Andrea Penaloza.;Damien Viglino.;Jean-Jacques Banihachemi.;Anmar Abboodi.;Mathilde Helderlé.;Emmanuel Montassier.;Fréderic Balen.;Christian Brice.;Saïd Laribi.;Thibault Duchenoy.;Philippe Vives.;Louis Soulat.;Nicolas Marjanovic.;Thomas Moumneh.;Dominique Savary.;Jérémie Riou.;Pierre-Marie Roy.
来源: Lancet. 2024年403卷10431期1051-1060页
Prophylactic anticoagulation in emergency department patients with lower limb trauma requiring immobilisation is controversial. The Thrombosis Risk Prediction for Patients with Cast Immobilisation-TRiP(cast)-score could identify a large subgroup of patients at low risk of venous thromboembolism for whom prophylactic anticoagulation can be safely withheld. We aimed to prospectively assess the safety of withholding anticoagulation for patients with lower limb trauma at low risk of venous thromboembolism, defined by a TRiP(cast) score of less than 7.
143. Solar-powered O2 delivery for the treatment of children with hypoxaemia in Uganda: a stepped-wedge, cluster randomised controlled trial.
作者: Nicholas Conradi.;Robert O Opoka.;Qaasim Mian.;Andrea L Conroy.;Laura L Hermann.;Olaro Charles.;Jackson Amone.;Juliet Nabwire.;Bonita E Lee.;Abdullah Saleh.;Piush Mandhane.;Sophie Namasopo.;Michael T Hawkes.
来源: Lancet. 2024年403卷10428期756-765页
Supplemental O2 is not always available at health facilities in low-income and middle-income countries (LMICs). Solar-powered O2 delivery can overcome gaps in O2 access, generating O2 independent of grid electricity. We hypothesized that installation of solar-powered O2 systems on the paediatrics ward of rural Ugandan hospitals would lead to a reduction in mortality among hypoxaemic children.
144. Abatacept inhibits inflammation and onset of rheumatoid arthritis in individuals at high risk (ARIAA): a randomised, international, multicentre, double-blind, placebo-controlled trial.
作者: Juergen Rech.;Koray Tascilar.;Melanie Hagen.;Arnd Kleyer.;Bernhard Manger.;Verena Schoenau.;Axel J Hueber.;Stefan Kleinert.;Xenofon Baraliakos.;Jürgen Braun.;Uta Kiltz.;Martin Fleck.;Andrea Rubbert-Roth.;David M Kofler.;Frank Behrens.;Martin Feuchtenberger.;Michael Zaenker.;Reinhard Voll.;Nils Venhoff.;Jens Thiel.;Cornelia Glaser.;Eugen Feist.;Gerd R Burmester.;Kirsten Karberg.;Johannes Strunk.;Juan D Cañete.;Ladislav Senolt.;Maria Filkova.;Esperanza Naredo.;Raquel Largo.;Gerhard Krönke.;Maria-Antonietta D'Agostino.;Mikkel Østergaard.;Georg Schett.
来源: Lancet. 2024年403卷10429期850-859页
Individuals with anti-citrullinated protein antibodies (ACPAs) and subclinical inflammatory changes in joints are at high risk of developing rheumatoid arthritis. Treatment strategies to intercept this pre-stage clinical disease remain to be developed. We aimed to assess whether 6-month treatment with abatacept improves inflammation in preclinical rheumatoid arthritis.
145. Abatacept in individuals at high risk of rheumatoid arthritis (APIPPRA): a randomised, double-blind, multicentre, parallel, placebo-controlled, phase 2b clinical trial.
作者: Andrew P Cope.;Marianna Jasenecova.;Joana C Vasconcelos.;Andrew Filer.;Karim Raza.;Sumera Qureshi.;Maria Antonietta D'Agostino.;Iain B McInnes.;John D Isaacs.;Arthur G Pratt.;Benjamin A Fisher.;Christopher D Buckley.;Paul Emery.;Pauline Ho.;Maya H Buch.;Coziana Ciurtin.;Dirkjan van Schaardenburg.;Thomas Huizinga.;René Toes.;Evangelos Georgiou.;Joanna Kelly.;Caroline Murphy.;A Toby Prevost.; .
来源: Lancet. 2024年403卷10429期838-849页
Individuals with serum antibodies to citrullinated protein antigens (ACPA), rheumatoid factor, and symptoms, such as inflammatory joint pain, are at high risk of developing rheumatoid arthritis. In the arthritis prevention in the pre-clinical phase of rheumatoid arthritis with abatacept (APIPPRA) trial, we aimed to evaluate the feasibility, efficacy, and acceptability of treating high risk individuals with the T-cell co-stimulation modulator abatacept.
146. Endovascular thrombectomy plus medical care versus medical care alone for large ischaemic stroke: 1-year outcomes of the SELECT2 trial.
作者: Amrou Sarraj.;Michael G Abraham.;Ameer E Hassan.;Spiros Blackburn.;Scott E Kasner.;Santiago Ortega-Gutierrez.;Muhammad Shazam Hussain.;Michael Chen.;Hannah Johns.;Leonid Churilov.;Deep K Pujara.;Faris Shaker.;Laith Maali.;Pere Cardona Portela.;Nabeel A Herial.;Daniel Gibson.;Osman Kozak.;Juan F Arenillas.;Bernard Yan.;Natalia Pérez de la Ossa.;Sophia Sundararajan.;Yin C Hu.;Dennis J Cordato.;Nathan W Manning.;Ricardo A Hanel.;Amin N Aghaebrahim.;Ronald F Budzik.;William J Hicks.;Jordi Blasco.;Teddy Y Wu.;Jenny P Tsai.;Joanna D Schaafsma.;Chirag D Gandhi.;Fawaz Al-Mufti.;Navdeep Sangha.;Steven Warach.;Timothy J Kleinig.;Vignan Yogendrakumar.;Felix Ng.;Edgar A Samaniego.;Mohammad A Abdulrazzak.;Mark W Parsons.;Mohammad H Rahbar.;Thanh N Nguyen.;Johanna T Fifi.;Vitor Mendes Pereira.;Maarten G Lansberg.;Greg W Albers.;Anthony J Furlan.;Pascal Jabbour.;Clark W Sitton.;Cathy Sila.;Nicholas Bambakidis.;Stephen M Davis.;Lawrence Wechsler.;Michael D Hill.;James C Grotta.;Marc Ribo.;Bruce C V Campbell.; .
来源: Lancet. 2024年403卷10428期731-740页
Multiple randomised trials have shown efficacy and safety of endovascular thrombectomy in patients with large ischaemic stroke. The aim of this study was to evaluate long-term (ie, at 1 year) evidence of benefit of thrombectomy for these patients.
147. Repeat placental growth factor-based testing in women with suspected preterm pre-eclampsia (PARROT-2): a multicentre, parallel-group, superiority, randomised controlled trial.
作者: Alice Hurrell.;Louise Webster.;Jenie Sparkes.;Cheryl Battersby.;Anna Brockbank.;Katherine Clark.;Kate E Duhig.;Carolyn Gill.;Marcus Green.;Rachael M Hunter.;Paul T Seed.;Zoe Vowles.;Jenny Myers.;Andrew H Shennan.;Lucy C Chappell.; .
来源: Lancet. 2024年403卷10427期619-631页
Placental growth factor (PlGF)-based testing has high diagnostic accuracy for predicting pre-eclampsia needing delivery, significantly reducing time to diagnosis and severe maternal adverse outcomes. The clinical benefit of repeat PlGF-based testing is unclear. We aimed to determine whether repeat PlGF-based testing (using a clinical management algorithm and nationally recommended thresholds) reduces adverse perinatal outcomes in pregnant individuals with suspected preterm pre-eclampsia.
148. Oral gepotidacin versus nitrofurantoin in patients with uncomplicated urinary tract infection (EAGLE-2 and EAGLE-3): two randomised, controlled, double-blind, double-dummy, phase 3, non-inferiority trials.
作者: Florian Wagenlehner.;Caroline R Perry.;Thomas M Hooton.;Nicole E Scangarella-Oman.;Helen Millns.;Marcy Powell.;Emily Jarvis.;Jeremy Dennison.;Amanda Sheets.;Deborah Butler.;John Breton.;Salim Janmohamed.
来源: Lancet. 2024年403卷10428期741-755页
Gepotidacin is a novel, bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a distinct mechanism of action and a unique binding site, providing well balanced inhibition of two type II topoisomerase enzymes. Oral gepotidacin is under investigation to treat uncomplicated urinary tract infections. We aimed to compare the efficacy and safety of oral gepotidacin with that of nitrofurantoin in adolescent and adult female individuals with uncomplicated urinary tract infections.
149. Intracytoplasmic sperm injection versus conventional in-vitro fertilisation for couples with infertility with non-severe male factor: a multicentre, open-label, randomised controlled trial.
作者: Yuanyuan Wang.;Rong Li.;Rui Yang.;Danni Zheng.;Lin Zeng.;Ying Lian.;Yimin Zhu.;Junli Zhao.;Xiaoyan Liang.;Wen Li.;Jianqiao Liu.;Li Tang.;Yunxia Cao.;Guimin Hao.;Huichun Wang.;Hua Zhang.;Rui Wang.;Ben W Mol.;Hefeng Huang.;Jie Qiao.
来源: Lancet. 2024年403卷10430期924-934页
Introduced in 1992, intracytoplasmic sperm injection (ICSI) was initially indicated for severe male infertility; however, its use has since been expanded to non-severe male infertility. We aimed to compare the efficacy and safety of ICSI versus conventional in-vitro fertilisation (IVF) in couples with infertility with non-severe male factor.
150. Safety and efficacy of malaria vaccine candidate R21/Matrix-M in African children: a multicentre, double-blind, randomised, phase 3 trial.
作者: Mehreen S Datoo.;Alassane Dicko.;Halidou Tinto.;Jean-Bosco Ouédraogo.;Mainga Hamaluba.;Ally Olotu.;Emma Beaumont.;Fernando Ramos Lopez.;Hamtandi Magloire Natama.;Sophie Weston.;Mwajuma Chemba.;Yves Daniel Compaore.;Djibrilla Issiaka.;Diallo Salou.;Athanase M Some.;Sharon Omenda.;Alison Lawrie.;Philip Bejon.;Harish Rao.;Daniel Chandramohan.;Rachel Roberts.;Sandesh Bharati.;Lisa Stockdale.;Sunil Gairola.;Brian M Greenwood.;Katie J Ewer.;John Bradley.;Prasad S Kulkarni.;Umesh Shaligram.;Adrian V S Hill.; .
来源: Lancet. 2024年403卷10426期533-544页
Recently, we found that a new malaria vaccine, R21/Matrix-M, had over 75% efficacy against clinical malaria with seasonal administration in a phase 2b trial in Burkina Faso. Here, we report on safety and efficacy of the vaccine in a phase 3 trial enrolling over 4800 children across four countries followed for up to 18 months at seasonal sites and 12 months at standard sites.
151. Effectiveness of a comprehensive package based on electronic medication monitors at improving treatment outcomes among tuberculosis patients in Tibet: a multicentre randomised controlled trial.
作者: Xiaolin Wei.;Joseph Paul Hicks.;Zhitong Zhang.;Victoria Haldane.;Pande Pasang.;Linhua Li.;Tingting Yin.;Bei Zhang.;Yinlong Li.;Qiuyu Pan.;Xiaoqiu Liu.;John Walley.;Jun Hu.
来源: Lancet. 2024年403卷10430期913-923页
WHO recommends that electronic medication monitors, a form of digital adherence technology, be used as a complement to directly observed treatment (DOT) for tuberculosis, as DOT is inconvenient and costly. However, existing evidence about the effectiveness of these monitors is inconclusive. Therefore, we evaluated the effectiveness of a comprehensive package based on electronic medication monitors among patients with tuberculosis in Tibet Autonomous Region (hereafter Tibet), China.
152. Efficacy of typhoid conjugate vaccine: final analysis of a 4-year, phase 3, randomised controlled trial in Malawian children.
作者: Priyanka D Patel.;Yuanyuan Liang.;James E Meiring.;Nedson Chasweka.;Pratiksha Patel.;Theresa Misiri.;Felistas Mwakiseghile.;Richard Wachepa.;Happy C Banda.;Florence Shumba.;Gift Kawalazira.;Queen Dube.;Nginache Nampota-Nkomba.;Osward M Nyirenda.;Tsion Girmay.;Shrimati Datta.;Leslie P Jamka.;J Kathleen Tracy.;Matthew B Laurens.;Robert S Heyderman.;Kathleen M Neuzil.;Melita A Gordon.; .
来源: Lancet. 2024年403卷10425期459-468页
Randomised controlled trials of typhoid conjugate vaccines among children in Africa and Asia have shown high short-term efficacy. Data on the durability of protection beyond 2 years are sparse. We present the final analysis of a randomised controlled trial in Malawi, encompassing more than 4 years of follow-up, with the aim of investigating vaccine efficacy over time and by age group.
153. AAV1-hOTOF gene therapy for autosomal recessive deafness 9: a single-arm trial.
作者: Jun Lv.;Hui Wang.;Xiaoting Cheng.;Yuxin Chen.;Daqi Wang.;Longlong Zhang.;Qi Cao.;Honghai Tang.;Shaowei Hu.;Kaiyu Gao.;Mengzhao Xun.;Jinghan Wang.;Zijing Wang.;Biyun Zhu.;Chong Cui.;Ziwen Gao.;Luo Guo.;Sha Yu.;Luoying Jiang.;Yanbo Yin.;Jiajia Zhang.;Bing Chen.;Wuqing Wang.;Renjie Chai.;Zheng-Yi Chen.;Huawei Li.;Yilai Shu.
来源: Lancet. 2024年403卷10441期2317-2325页
Autosomal recessive deafness 9, caused by mutations of the OTOF gene, is characterised by congenital or prelingual, severe-to-complete, bilateral hearing loss. However, no pharmacological treatment is currently available for congenital deafness. In this Article, we report the safety and efficacy of gene therapy with an adeno-associated virus (AAV) serotype 1 carrying a human OTOF transgene (AAV1-hOTOF) as a treatment for children with autosomal recessive deafness 9.
154. Evaluating the efficacy and safety of pozelimab in patients with CD55 deficiency with hyperactivation of complement, angiopathic thrombosis, and protein-losing enteropathy disease: an open-label phase 2 and 3 study.
作者: Ahmet Ozen.;Voranush Chongsrisawat.;Asena Pinar Sefer.;Burcu Kolukisa.;Jessica J Jalbert.;Karoline A Meagher.;Taylor Brackin.;Hagit Baris Feldman.;Safa Baris.;Elif Karakoc-Aydiner.;Rabia Ergelen.;Ivan J Fuss.;Heather Moorman.;Narissara Suratannon.;Kanya Suphapeetiporn.;Lorah Perlee.;Olivier A Harari.;George D Yancopoulos.;Michael J Lenardo.; .
来源: Lancet. 2024年403卷10427期645-656页
CD55 deficiency with hyperactivation of complement, angiopathic thrombosis, and protein-losing enteropathy (CHAPLE) is an ultra-rare genetic disorder characterised by intestinal lymphatic damage, lymphangiectasia, and protein-losing enteropathy caused by overactivation of the complement system. We assessed the efficacy and safety of pozelimab, an antibody blocking complement component 5.
155. The effect of computerised decision support alerts tailored to intensive care on the administration of high-risk drug combinations, and their monitoring: a cluster randomised stepped-wedge trial.
作者: Tinka Bakker.;Joanna E Klopotowska.;Dave A Dongelmans.;Saeid Eslami.;Wytze J Vermeijden.;Stefaan Hendriks.;Julia Ten Cate.;Attila Karakus.;Ilse M Purmer.;Sjoerd H W van Bree.;Peter E Spronk.;Martijn Hoeksema.;Evert de Jonge.;Nicolette F de Keizer.;Ameen Abu-Hanna.; .
来源: Lancet. 2024年403卷10425期439-449页
Drug-drug interactions (DDIs) can harm patients admitted to the intensive care unit (ICU). Yet, clinical decision support systems (CDSSs) aimed at helping physicians prevent DDIs are plagued by low-yield alerts, causing alert fatigue and compromising patient safety. The aim of this multicentre study was to evaluate the effect of tailoring potential DDI alerts to the ICU setting on the frequency of administered high-risk drug combinations.
156. Individualised neoantigen therapy mRNA-4157 (V940) plus pembrolizumab versus pembrolizumab monotherapy in resected melanoma (KEYNOTE-942): a randomised, phase 2b study.
作者: Jeffrey S Weber.;Matteo S Carlino.;Adnan Khattak.;Tarek Meniawy.;George Ansstas.;Matthew H Taylor.;Kevin B Kim.;Meredith McKean.;Georgina V Long.;Ryan J Sullivan.;Mark Faries.;Thuy T Tran.;C Lance Cowey.;Andrew Pecora.;Montaser Shaheen.;Jennifer Segar.;Theresa Medina.;Victoria Atkinson.;Geoffrey T Gibney.;Jason J Luke.;Sajeve Thomas.;Elizabeth I Buchbinder.;Jane A Healy.;Mo Huang.;Manju Morrissey.;Igor Feldman.;Vasudha Sehgal.;Celine Robert-Tissot.;Peijie Hou.;Lili Zhu.;Michelle Brown.;Praveen Aanur.;Robert S Meehan.;Tal Zaks.
来源: Lancet. 2024年403卷10427期632-644页
Checkpoint inhibitors are standard adjuvant treatment for stage IIB-IV resected melanoma, but many patients recur. Our study aimed to evaluate whether mRNA-4157 (V940), a novel mRNA-based individualised neoantigen therapy, combined with pembrolizumab, improved recurrence-free survival and distant metastasis-free survival versus pembrolizumab monotherapy in resected high-risk melanoma.
157. Chemoprevention for malaria with monthly intermittent preventive treatment with dihydroartemisinin-piperaquine in pregnant women living with HIV on daily co-trimoxazole in Kenya and Malawi: a randomised, double-blind, placebo-controlled trial.
作者: Hellen C Barsosio.;Mwayiwawo Madanitsa.;Everlyne D Ondieki.;James Dodd.;Eric D Onyango.;Kephas Otieno.;Duolao Wang.;Jenny Hill.;Victor Mwapasa.;Kamija S Phiri.;Kenneth Maleta.;Miriam Taegtmeyer.;Simon Kariuki.;Christentze Schmiegelow.;Julie R Gutman.;Feiko O Ter Kuile.
来源: Lancet. 2024年403卷10424期365-378页
The efficacy of daily co-trimoxazole, an antifolate used for malaria chemoprevention in pregnant women living with HIV, is threatened by cross-resistance of Plasmodium falciparum to the antifolate sulfadoxine-pyrimethamine. We assessed whether addition of monthly dihydroartemisinin-piperaquine to daily co-trimoxazole is more effective at preventing malaria infection than monthly placebo plus daily co-trimoxazole in pregnant women living with HIV.
158. Term planned delivery based on fetal growth assessment with or without the cerebroplacental ratio in low-risk pregnancies (RATIO37): an international, multicentre, open-label, randomised controlled trial.
作者: Marta Rial-Crestelo.;Marek Lubusky.;Mauro Parra-Cordero.;Ladislav Krofta.;Anna Kajdy.;Eyal Zohav.;Elena Ferriols-Perez.;Rogelio Cruz-Martinez.;Marian Kacerovsky.;Elena Scazzocchio.;Lucie Roubalova.;Pamela Socias.;Lubomir Hašlík.;Jan Modzelewski.;Eran Ashwal.;Julia Castellá-Cesari.;Monica Cruz-Lemini.;Eduard Gratacos.;Francesc Figueras.; .
来源: Lancet. 2024年403卷10426期545-553页
The cerebroplacental ratio is associated with perinatal mortality and morbidity, but it is unknown whether routine measurement improves pregnancy outcomes. We aimed to evaluate whether the addition of cerebroplacental ratio measurement to the standard ultrasound growth assessment near term reduces perinatal mortality and severe neonatal morbidity, compared with growth assessment alone.
159. Indomethacin with or without prophylactic pancreatic stent placement to prevent pancreatitis after ERCP: a randomised non-inferiority trial.
作者: B Joseph Elmunzer.;Lydia D Foster.;Jose Serrano.;Gregory A Coté.;Steven A Edmundowicz.;Sachin Wani.;Raj Shah.;Ji Young Bang.;Shyam Varadarajulu.;Vikesh K Singh.;Mouen Khashab.;Richard S Kwon.;James M Scheiman.;Field F Willingham.;Steven A Keilin.;Georgios I Papachristou.;Amitabh Chak.;Adam Slivka.;Daniel Mullady.;Vladimir Kushnir.;James Buxbaum.;Rajesh Keswani.;Timothy B Gardner.;Nauzer Forbes.;Amit Rastogi.;Andrew Ross.;Joanna Law.;Patrick Yachimski.;Yen-I Chen.;Alan Barkun.;Zachary L Smith.;Bret Petersen.;Andrew Y Wang.;John R Saltzman.;Rebecca L Spitzer.;Collins Ordiah.;Cathie Spino.;Valerie Durkalski-Mauldin.; .
来源: Lancet. 2024年403卷10425期450-458页
The combination of rectally administered indomethacin and placement of a prophylactic pancreatic stent is recommended to prevent pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients. Preliminary evidence suggests that the use of indomethacin might eliminate or substantially reduce the need for stent placement, a technically complex, costly, and potentially harmful intervention.
160. Efficacy and safety of aldosterone synthase inhibition with and without empagliflozin for chronic kidney disease: a randomised, controlled, phase 2 trial.
作者: Katherine R Tuttle.;Sibylle J Hauske.;Maria Eugenia Canziani.;Maria Luiza Caramori.;David Cherney.;Lisa Cronin.;Hiddo J L Heerspink.;Christian Hugo.;Masaomi Nangaku.;Ricardo Correa Rotter.;Arnold Silva.;Shimoli V Shah.;Zhichao Sun.;Dorothea Urbach.;Dick de Zeeuw.;Peter Rossing.; .
来源: Lancet. 2024年403卷10424期379-390页
Excess aldosterone accelerates chronic kidney disease progression. This phase 2 clinical trial assessed BI 690517, an aldosterone synthase inhibitor, for efficacy, safety, and dose selection.
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